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extacy
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.
Response to “The Other Pandemic: Addiction”
To the Editor: Normally I would skip the editorial; however, the title “The Other Pandemic: Addiction” caught my eye (Fed Pract. 2020;37[10]:440-441). This will, of course, require me going in for eye care in the next couple of days, but my concerns are low. After all, the hook you used wasn’t that big.
Bravo! Your choice to focus on the effects of isolation was a masterful touch. I started skimming with the assumption that you would say something along the lines of ‘COVID bad, everybody depressed, blah, blah.’ But you cut into the abscess of the issue cleanly, exposing the core—isolation “amplifies negative thoughts, dysphoria, and fearful emotions.” A deadly combination for our patients and ourselves.
I have been a physician assistant in the US Army, and as a civilian at Brooke Army Medical Center and US Department of Veterans Affairs (VA) Puget Sound Health Care System. One thing I have seen throughout that time was the effects of isolation on the active duty enlisted young, and even more so on retired older warriors. Throughout the time of our military service, we transfer to many places and make a lot of friends, but more so, we lose track of them over time.
I have cared for many older warriors who cannot get something as simple as a colonoscopy because they do not have someone to drive them home after they have been sedated. Family and friends were scattered over the country, or the world. At the VA, many older warriors come not just for an appointment, but also as a time to socialize and ‘BS’ with those who understand them.
One goal I set for myself many years ago was to have the warrior laughing before they left my office. If I did that, I knew I had made a difference. Thank you for your editorial.
Anthony J Passaniti, PA, USA (ret) [email protected]
To the Editor: Normally I would skip the editorial; however, the title “The Other Pandemic: Addiction” caught my eye (Fed Pract. 2020;37[10]:440-441). This will, of course, require me going in for eye care in the next couple of days, but my concerns are low. After all, the hook you used wasn’t that big.
Bravo! Your choice to focus on the effects of isolation was a masterful touch. I started skimming with the assumption that you would say something along the lines of ‘COVID bad, everybody depressed, blah, blah.’ But you cut into the abscess of the issue cleanly, exposing the core—isolation “amplifies negative thoughts, dysphoria, and fearful emotions.” A deadly combination for our patients and ourselves.
I have been a physician assistant in the US Army, and as a civilian at Brooke Army Medical Center and US Department of Veterans Affairs (VA) Puget Sound Health Care System. One thing I have seen throughout that time was the effects of isolation on the active duty enlisted young, and even more so on retired older warriors. Throughout the time of our military service, we transfer to many places and make a lot of friends, but more so, we lose track of them over time.
I have cared for many older warriors who cannot get something as simple as a colonoscopy because they do not have someone to drive them home after they have been sedated. Family and friends were scattered over the country, or the world. At the VA, many older warriors come not just for an appointment, but also as a time to socialize and ‘BS’ with those who understand them.
One goal I set for myself many years ago was to have the warrior laughing before they left my office. If I did that, I knew I had made a difference. Thank you for your editorial.
Anthony J Passaniti, PA, USA (ret) [email protected]
To the Editor: Normally I would skip the editorial; however, the title “The Other Pandemic: Addiction” caught my eye (Fed Pract. 2020;37[10]:440-441). This will, of course, require me going in for eye care in the next couple of days, but my concerns are low. After all, the hook you used wasn’t that big.
Bravo! Your choice to focus on the effects of isolation was a masterful touch. I started skimming with the assumption that you would say something along the lines of ‘COVID bad, everybody depressed, blah, blah.’ But you cut into the abscess of the issue cleanly, exposing the core—isolation “amplifies negative thoughts, dysphoria, and fearful emotions.” A deadly combination for our patients and ourselves.
I have been a physician assistant in the US Army, and as a civilian at Brooke Army Medical Center and US Department of Veterans Affairs (VA) Puget Sound Health Care System. One thing I have seen throughout that time was the effects of isolation on the active duty enlisted young, and even more so on retired older warriors. Throughout the time of our military service, we transfer to many places and make a lot of friends, but more so, we lose track of them over time.
I have cared for many older warriors who cannot get something as simple as a colonoscopy because they do not have someone to drive them home after they have been sedated. Family and friends were scattered over the country, or the world. At the VA, many older warriors come not just for an appointment, but also as a time to socialize and ‘BS’ with those who understand them.
One goal I set for myself many years ago was to have the warrior laughing before they left my office. If I did that, I knew I had made a difference. Thank you for your editorial.
Anthony J Passaniti, PA, USA (ret) [email protected]
A Veteran Presenting With Chronic Progressive Dyspnea on Exertion
Case Presentation: A 45-year-old US Coast Guard veteran with a medical history of asthma and chronic back pain was referred to the VA Boston Healthcare System (VABHS) for evaluation of progressive, unexplained dyspnea. Two years prior to presentation, the patient was an avid outdoorsman and highly active. At the time of his initial primary care physician (PCP) evaluation he reported dyspnea on exertion, and symptoms consistent with an upper respiratory tract infection (URTI) and a recent tick bite with an associated rash. He was treated with intranasal fluticasone and a course of antibiotics. His URTI symptoms and rash improved; however the dyspnea persisted and progressed over the ensuing winter and he was referred for pulmonary function testing. Additional history included a 20 pack-year history of smoking (resolved 10 years prior to the first VABHS clinical encounter) and a family history of premature coronary artery disease (CAD) in his father and 2 paternal uncles. He lived in northern New England where he previously worked as a cemetery groundskeeper.
►Kristopher Clark, MD, Chief Medical Resident, VABHS and Boston University/Boston Medical Center: Dr. Goldstein, how do you approach a patient who presents with progressive dyspnea?
►Ronald Goldstein, MD, Chief of Pulmonary and Critical Care VABHS: The evaluation of dyspnea is a common problem for pulmonary physicians. The sensation of dyspnea may originate from a wide variety of etiologies that involve pulmonary and cardiovascular disorders, neuromuscular impairment, deconditioning, or psychological issues. It is important to characterize the temporal pattern, severity, progression, relation to exertion or other triggers, the smoking history, environmental and occupational exposures to pulmonary toxins, associated symptoms, and the history of pulmonary problems.1
The physical examination may help to identify an airway or parenchymal disorder. Wheezing on chest examination would point to an obstructive defect and crackles to a possible restrictive problem, including pulmonary fibrosis. A cardiac examination should be performed to assess for evidence of heart failure, valvular heart disease, or the presence of loud P2 suggestive of pulmonary hypertension (PH). Laboratory studies, including complete blood counts are indicated.
A more complete pulmonary evaluation usually involves pulmonary function tests (PFTs), oximetry with exertion, and chest imaging. Additional cardiac testing might include electrocardiogram (ECG) and cardiac echocardiogram, followed by an exercise study, if needed. A B-natriuretic peptide determination could be considered if there is concern for congestive heart failure.2
►Dr. Clark: The initial physical examination was normal and laboratory tests were unrevealing. Given his history of asthma, he underwent spirometry testing (Table 1).
Dr. Goldstein, aside from unexplained dyspnea, what are other indications for spirometry and when should we consider ordering a full PFT, including lung volumes and diffusion capacity? Can you interpret this patient’s spirometry results?
►Dr. Goldstein: Spirometry is indicated to evaluate for a suspected obstructive defect. The test is usually performed with and without a bronchodilator to assess airway reactivity. A change in > 12% and > 200 mL suggests acute bronchodilator responsiveness. Periodic spirometry determinations are useful to assess the effect of medications or progression of disease. A reduction in forced vital capacity (FVC) may suggest a restrictive component. This possibility requires measure of lung volumes.
A full set of PFTs (ie, spirometry plus assessment of lung volumes and diffusion capacity) is required to evaluate the abnormalities associated with chronic obstructive pulmonary disease (COPD), interstitial diseases, vascular abnormalities (particularly PH), as well as for certain preoperative assessments. The single breath diffusing capacity for carbon monoxide is a measure of the overall capillary alveolar surface area of the lung. It is decreased in emphysema and interstitial disease as well as pulmonary vascular disorders. It would be particularly useful in this case as the spirometry studies were normal.
In this case, the normal FVC renders a significant restrictive disorder unlikely and his normal forced expiratory volume (FEV1) and FEV1/FVC make a significant obstructive disorder unlikely. He did not show any bronchodilator response; however, this finding does not exclude the presence of underlying asthma or reactive airway disease as patients often will not show a bronchodilator response at time of testing if they are not experiencing active bronchospasm or constriction. Further provocative testing with a methacholine challenge could be used to assess for reactive airway disease.
►Dr. Clark: The patient continued to have dyspnea when he returned to his PCP. Given his family history of premature CAD, an ECG was obtained that showed normal sinus rhythm at a rate of 70 beats per minute. A cardiology consult was placed, and he was referred for cardiac stress testing.
Dr. Maron, there are many forms of cardiac stress tests. In this case, the patient is referred for a stress test due his dyspnea. Does that symptom help you decide which test to order? How often does dyspnea present as an anginal equivalent in the absence of other cardiovascular symptoms or known cardiovascular disease?
►Bradley Maron, MD, Codirector, Pulmonary Vascular Disease Center, VABHS: In this case, stress testing should include a functional (ie, exercise) assessment if possible. Exercise capacity is a critical determinant of prognosis across the spectrum of cardiovascular disease and in a young person can be particularly informative on global health status. Furthermore, the chief complaint from this patient is dyspnea on exertion, and therefore, exercise testing is likely to be needed to reproduce or provoke the main symptom in this case. Estimates for dyspnea as a presenting symptom for ischemic heart disease vary but may be as high as 25%.3 It should be noted that cardiopulmonary exercise testing is useful for evaluating patients with unexplained dyspnea, as exercise hypoxemia, blunted decrease in VD/VT (ventilatory dead space/tidal volume), and evidence of a pulmonary mechanical limit to physical activity can inform the differential diagnosis.
►Dr. Clark: The patient underwent exercise treadmill testing and was able reach the target heart rate (> 85% age-predicted maximal heart rate) and achieve 11 metabolic equivalents. He had no chest pain or diagnostic ECG changes. The report made no mention of whether he experienced dyspnea during the test and was read as negative for exercise-induced ischemia.
He was seen by a cardiologist who noted an increased intensity S2 heart sound on examination without any other cardiopulmonary findings. It was noted that his symptoms occurred when tamping the ground or starting to walk up a hill but resolved with rest. It was also noted that his symptoms did not occur with gradual increased activity such as that performed during an exercise tolerance test. A 2-view chest X-ray was obtained and read as normal. Given the data from this evaluation thus far, the patient was told that his symptoms were most likely a result of his asthma exacerbated by dirt and dust exposure. Continued use of albuterol inhaler therapy was recommended, and no further diagnostic assessment was pursued.
Approximately 11 months later, the patient presented again to his PCP and reported progressive dyspnea. He had delayed seeking further care as he started to “feel like my symptoms were possibly in my head” given his prior negative workup. His symptoms had escalated drastically to the point where he felt short of breath with minimal exertion in addition to feeling sweaty, dizzy, fatigued, and having near-syncope when standing.
He was referred for a transthoracic echocardiogram (TTE) that revealed a left ventricular ejection fraction (LVEF) of 55 to 60% with diastolic relaxation abnormality and a normal-sized left atrium. The TTE also showed (qualitatively) a moderately dilated right ventricle with reduced systolic function, moderately severe tricuspid regurgitation, and severe elevation (> 60 mm Hg) in estimated right ventricular systolic pressure.
Dr. Maron, can you comment on how these findings may explain the patient’s symptoms? What differential diagnoses would you now consider?
►Dr. Maron: These echocardiography results exclude left ventricular systolic dysfunction or primary left-sided valvular disease at rest as a cause of the patient’s symptoms. In light of the patient’s prior normal stress test, high grade coronary disease in the absence of LV systolic dysfunction on echocardiography also seems unlikely. Estimated pulmonary artery systolic pressure > 60 mm Hg by echocardiography is highly suggestive of PH, but in and of itself does not diagnose PH nor inform pulmonary artery wedge pressure or pulmonary vascular resistance. Along with a direct measurement of pulmonary artery (PA) pressure, these data are needed to establish, classify, and prognosticate PH clinically.
►Dr. Clark: The patient was referred to a pulmonologist. His examination included bibasilar crackles and an enhanced P2 heart sound. A comprehensive pulmonary history was obtained, which noted his smoking history, possible asbestos exposure while serving in the Coast Guard, nighttime snoring without witnessed apnea events, and no personal or family history of thromboembolism or connective tissue disease.
Dr. Goldstein, is there anything in this patient’s history that could explain his symptoms and echocardiograph findings? Which tests would you order next?
►Dr. Goldstein: PH may be secondary to a wide variety of disorders including left heart disease (Group 2), advanced COPD, interstitial fibrosis, obstructive sleep apnea (OSA), or other lung diseases (Group 3), thromboembolic disorders (Group 4), and other systemic diseases such as sarcoidosis (Group 5). Group 1 is pulmonary arterial hypertension. (Table 2).
A right heart catheterization should be done to confirm the PA pressures estimated by echocardiogram. As to a cause, clinically he does not have heart failure. The limited smoking history and spirometry data do not support advanced COPD. He was noted to have crackles on physical examination suggesting an interstitial disorder. To assess the extent of interstitial disease, we would obtain a noncontrast computed tomography (CT) of the chest. The history of snoring suggesting the possibility of OSA indicating the need for overnight oximetry as significant nocturnal hypoxemia is a possible contributing cause to PH. A polysomnogram would be required to fully evaluate a sleep disturbance. The possible asbestos exposure is not likely a contributing factor as asbestosis requires significant exposure. We would obtain a ventilation/perfusion (V/Q) scan to rule out chronic thromboembolic disease. Targeted tests for causes of Group 5 disease should also be done.
►Dr. Clark: The impression from his pulmonologist was that the patient has severe PH, though the specific etiology was not yet known. Dr. Maron, can you review for us the pathophysiology behind PH and describe how the disease is classified?
►Dr. Maron: Elevated mean pulmonary artery pressure (> 20 mm Hg) diagnosed by supine right heart catheterization is the sine qua non of PH.4 However, this alone does not inform pathophysiology. As Dr. Goldstein noted, elevated PA pressure may be due to left heart disease, primary parenchymal lung disease/sleep-disordered breathing, in situ thrombotic remodeling of pulmonary arterioles following prior luminal pulmonary embolism, or in the setting of various specific predisposing conditions, such as sickle cell disease and sarcoidosis among others.5
Alternatively, pulmonary arterial hypertension (PAH) is suspected in patients with no identifiable cause of PH, pulmonary artery wedge pressure 15 mm Hg and pulmonary vascular resistance of 3.0 Wood units.6 Importantly, PAH is not synonymous with PH but is a circumspect PH disease subgroup. In turn, PAH may be idiopathic, hereditary, or associated with other select, predisposing disorders, namely systemic sclerosis. In PAH, the interplay between genetic and molecular factors results in effacement of distal pulmonary arterioles due to plexigenic, fibrotic, and/or concentric hypertrophic remodeling. Increased vascular resistance promotes early right ventricular dilation and impaired systolic function. As a result, patients with PAH are at particularly elevated risk for cor pulmonale.
►Dr. Clark: Overnight oximetry revealed baseline oxygen saturation of 94%, an oxygen nadir of 84% with a total of 7 minutes with oxygen < 90%. On a 6-minute walk test, the patient had a max heart rate of 116 and oxygen nadir of 93%. Chest CT with and without contrast showed no evidence of pulmonary emboli but noted mild emphysematous changes. A V/Q revealed no evidence of acute or chronic pulmonary thromboembolic disease. Coronary catheterization showed normal coronary anatomy without significant CAD. A right heart catheterization showed findings consistent with severe PH with normal left-sided filling pressures (Table 3).
The patient returned a normal antinuclear antibody, C-reactive protein, HIV, and liver function panel. Based on these findings, a presumptive diagnosis of group 1 PH (idiopathic PAH) was made. Given the severity of his right heart dysfunction, he was transferred to the cardiac care unit and initiated on epoprostenol.
Dr. Maron, can you review the different treatment options for idiopathic PAH and explain why epoprostenol was chosen for this patient?
►Dr. Maron: There are 14 US Food and Drug Administration-approved drug therapies for patients with PAH, which all target either nitric oxide signaling, endothelin receptors, or the prostacyclin pathway. In the current era, treatment-naïve patients with PAH are generally initiated on calcium channel antagonist therapy if there is evidence of vasoreactivity during right heart catheterization (following nitric oxide administration), dual therapy most often with an endothelin receptor antagonist and phosphodiesterase inhibitor, or parenteral prostacyclin therapy. Since < 5% of patients will demonstrate vasoreactivity, the decision at point of care in incident patients with PAH often focuses on dual oral therapy or initiation of parenteral prostacyclin therapy. In this case, the patient reported presyncope with minimal physical activity (eg, bending over or walking up stairs) and severely decreased functional status (ie, New York Heart Association Functional [NYHA] Class III – IV), and he had a cardiac index within the range of cardiogenic shock (< 2.0 L/min/m2). Collectively, this clinical profile is considered particularly high risk, therefore, a recommendation for parenteral continuous prostacyclin therapy was made.
► Dr. Clark: The patient tolerated epoprostenol and reported improvement in his symptoms. He had a tunneled line catheter placed for continuous epoprostenol infusion. He was discharged home and scheduled for outpatient follow-up in a PH clinic. At 4 months following discharge, he was reporting steady clinical and functional improvement as well as improvement in his dyspnea. A second therapy (oral phosphodiesterase type-V inhibitor) was initiated and tolerated well. Overall, he reported resolution of presyncope, NYHA Functional Class II symptoms, and the absence of important drug effects.
1.. Manning HL, Schwartzstein RM. Pathophysiology of dyspnea. N Engl J Med. 1995;333(23):1547-1553. doi:10.1056/NEJM199512073332307
2. Parshall MB, Schwartzstein RM, Adams L, et al. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012;185(4):435-452. doi:10.1164/rccm.201111-2042ST
3. Phibbs B, Holmes RW, Lowe CR. Transient myocardial ischemia: the significance of dyspnea. Am J Med Sci. 1968;256(4):210-221. doi:10.1097/00000441-196810000-00002
4. Maron BA, Hess E, Maddox TM, et al. Association of borderline pulmonary hypertension with mortality and hospitalization in a large patient cohort: insights from the veterans affairs clinical assessment, reporting, and tracking program. Circulation. 2016;133(13):1240-1248. doi:10.1161/CIRCULATIONAHA.115.020207
5. Simonneau G, Montani D, Celermajer DS, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019;53(1):1801913. Published 2019 Jan 24. doi:10.1183/13993003.01913-2018
6. Maron BA, Galiè N. Diagnosis, Treatment, and Clinical Management of Pulmonary Arterial Hypertension in the Contemporary Era: A Review. JAMA Cardiol. 2016;1(9):1056-1065. doi:10.1001/jamacardio.2016.4471
Case Presentation: A 45-year-old US Coast Guard veteran with a medical history of asthma and chronic back pain was referred to the VA Boston Healthcare System (VABHS) for evaluation of progressive, unexplained dyspnea. Two years prior to presentation, the patient was an avid outdoorsman and highly active. At the time of his initial primary care physician (PCP) evaluation he reported dyspnea on exertion, and symptoms consistent with an upper respiratory tract infection (URTI) and a recent tick bite with an associated rash. He was treated with intranasal fluticasone and a course of antibiotics. His URTI symptoms and rash improved; however the dyspnea persisted and progressed over the ensuing winter and he was referred for pulmonary function testing. Additional history included a 20 pack-year history of smoking (resolved 10 years prior to the first VABHS clinical encounter) and a family history of premature coronary artery disease (CAD) in his father and 2 paternal uncles. He lived in northern New England where he previously worked as a cemetery groundskeeper.
►Kristopher Clark, MD, Chief Medical Resident, VABHS and Boston University/Boston Medical Center: Dr. Goldstein, how do you approach a patient who presents with progressive dyspnea?
►Ronald Goldstein, MD, Chief of Pulmonary and Critical Care VABHS: The evaluation of dyspnea is a common problem for pulmonary physicians. The sensation of dyspnea may originate from a wide variety of etiologies that involve pulmonary and cardiovascular disorders, neuromuscular impairment, deconditioning, or psychological issues. It is important to characterize the temporal pattern, severity, progression, relation to exertion or other triggers, the smoking history, environmental and occupational exposures to pulmonary toxins, associated symptoms, and the history of pulmonary problems.1
The physical examination may help to identify an airway or parenchymal disorder. Wheezing on chest examination would point to an obstructive defect and crackles to a possible restrictive problem, including pulmonary fibrosis. A cardiac examination should be performed to assess for evidence of heart failure, valvular heart disease, or the presence of loud P2 suggestive of pulmonary hypertension (PH). Laboratory studies, including complete blood counts are indicated.
A more complete pulmonary evaluation usually involves pulmonary function tests (PFTs), oximetry with exertion, and chest imaging. Additional cardiac testing might include electrocardiogram (ECG) and cardiac echocardiogram, followed by an exercise study, if needed. A B-natriuretic peptide determination could be considered if there is concern for congestive heart failure.2
►Dr. Clark: The initial physical examination was normal and laboratory tests were unrevealing. Given his history of asthma, he underwent spirometry testing (Table 1).
Dr. Goldstein, aside from unexplained dyspnea, what are other indications for spirometry and when should we consider ordering a full PFT, including lung volumes and diffusion capacity? Can you interpret this patient’s spirometry results?
►Dr. Goldstein: Spirometry is indicated to evaluate for a suspected obstructive defect. The test is usually performed with and without a bronchodilator to assess airway reactivity. A change in > 12% and > 200 mL suggests acute bronchodilator responsiveness. Periodic spirometry determinations are useful to assess the effect of medications or progression of disease. A reduction in forced vital capacity (FVC) may suggest a restrictive component. This possibility requires measure of lung volumes.
A full set of PFTs (ie, spirometry plus assessment of lung volumes and diffusion capacity) is required to evaluate the abnormalities associated with chronic obstructive pulmonary disease (COPD), interstitial diseases, vascular abnormalities (particularly PH), as well as for certain preoperative assessments. The single breath diffusing capacity for carbon monoxide is a measure of the overall capillary alveolar surface area of the lung. It is decreased in emphysema and interstitial disease as well as pulmonary vascular disorders. It would be particularly useful in this case as the spirometry studies were normal.
In this case, the normal FVC renders a significant restrictive disorder unlikely and his normal forced expiratory volume (FEV1) and FEV1/FVC make a significant obstructive disorder unlikely. He did not show any bronchodilator response; however, this finding does not exclude the presence of underlying asthma or reactive airway disease as patients often will not show a bronchodilator response at time of testing if they are not experiencing active bronchospasm or constriction. Further provocative testing with a methacholine challenge could be used to assess for reactive airway disease.
►Dr. Clark: The patient continued to have dyspnea when he returned to his PCP. Given his family history of premature CAD, an ECG was obtained that showed normal sinus rhythm at a rate of 70 beats per minute. A cardiology consult was placed, and he was referred for cardiac stress testing.
Dr. Maron, there are many forms of cardiac stress tests. In this case, the patient is referred for a stress test due his dyspnea. Does that symptom help you decide which test to order? How often does dyspnea present as an anginal equivalent in the absence of other cardiovascular symptoms or known cardiovascular disease?
►Bradley Maron, MD, Codirector, Pulmonary Vascular Disease Center, VABHS: In this case, stress testing should include a functional (ie, exercise) assessment if possible. Exercise capacity is a critical determinant of prognosis across the spectrum of cardiovascular disease and in a young person can be particularly informative on global health status. Furthermore, the chief complaint from this patient is dyspnea on exertion, and therefore, exercise testing is likely to be needed to reproduce or provoke the main symptom in this case. Estimates for dyspnea as a presenting symptom for ischemic heart disease vary but may be as high as 25%.3 It should be noted that cardiopulmonary exercise testing is useful for evaluating patients with unexplained dyspnea, as exercise hypoxemia, blunted decrease in VD/VT (ventilatory dead space/tidal volume), and evidence of a pulmonary mechanical limit to physical activity can inform the differential diagnosis.
►Dr. Clark: The patient underwent exercise treadmill testing and was able reach the target heart rate (> 85% age-predicted maximal heart rate) and achieve 11 metabolic equivalents. He had no chest pain or diagnostic ECG changes. The report made no mention of whether he experienced dyspnea during the test and was read as negative for exercise-induced ischemia.
He was seen by a cardiologist who noted an increased intensity S2 heart sound on examination without any other cardiopulmonary findings. It was noted that his symptoms occurred when tamping the ground or starting to walk up a hill but resolved with rest. It was also noted that his symptoms did not occur with gradual increased activity such as that performed during an exercise tolerance test. A 2-view chest X-ray was obtained and read as normal. Given the data from this evaluation thus far, the patient was told that his symptoms were most likely a result of his asthma exacerbated by dirt and dust exposure. Continued use of albuterol inhaler therapy was recommended, and no further diagnostic assessment was pursued.
Approximately 11 months later, the patient presented again to his PCP and reported progressive dyspnea. He had delayed seeking further care as he started to “feel like my symptoms were possibly in my head” given his prior negative workup. His symptoms had escalated drastically to the point where he felt short of breath with minimal exertion in addition to feeling sweaty, dizzy, fatigued, and having near-syncope when standing.
He was referred for a transthoracic echocardiogram (TTE) that revealed a left ventricular ejection fraction (LVEF) of 55 to 60% with diastolic relaxation abnormality and a normal-sized left atrium. The TTE also showed (qualitatively) a moderately dilated right ventricle with reduced systolic function, moderately severe tricuspid regurgitation, and severe elevation (> 60 mm Hg) in estimated right ventricular systolic pressure.
Dr. Maron, can you comment on how these findings may explain the patient’s symptoms? What differential diagnoses would you now consider?
►Dr. Maron: These echocardiography results exclude left ventricular systolic dysfunction or primary left-sided valvular disease at rest as a cause of the patient’s symptoms. In light of the patient’s prior normal stress test, high grade coronary disease in the absence of LV systolic dysfunction on echocardiography also seems unlikely. Estimated pulmonary artery systolic pressure > 60 mm Hg by echocardiography is highly suggestive of PH, but in and of itself does not diagnose PH nor inform pulmonary artery wedge pressure or pulmonary vascular resistance. Along with a direct measurement of pulmonary artery (PA) pressure, these data are needed to establish, classify, and prognosticate PH clinically.
►Dr. Clark: The patient was referred to a pulmonologist. His examination included bibasilar crackles and an enhanced P2 heart sound. A comprehensive pulmonary history was obtained, which noted his smoking history, possible asbestos exposure while serving in the Coast Guard, nighttime snoring without witnessed apnea events, and no personal or family history of thromboembolism or connective tissue disease.
Dr. Goldstein, is there anything in this patient’s history that could explain his symptoms and echocardiograph findings? Which tests would you order next?
►Dr. Goldstein: PH may be secondary to a wide variety of disorders including left heart disease (Group 2), advanced COPD, interstitial fibrosis, obstructive sleep apnea (OSA), or other lung diseases (Group 3), thromboembolic disorders (Group 4), and other systemic diseases such as sarcoidosis (Group 5). Group 1 is pulmonary arterial hypertension. (Table 2).
A right heart catheterization should be done to confirm the PA pressures estimated by echocardiogram. As to a cause, clinically he does not have heart failure. The limited smoking history and spirometry data do not support advanced COPD. He was noted to have crackles on physical examination suggesting an interstitial disorder. To assess the extent of interstitial disease, we would obtain a noncontrast computed tomography (CT) of the chest. The history of snoring suggesting the possibility of OSA indicating the need for overnight oximetry as significant nocturnal hypoxemia is a possible contributing cause to PH. A polysomnogram would be required to fully evaluate a sleep disturbance. The possible asbestos exposure is not likely a contributing factor as asbestosis requires significant exposure. We would obtain a ventilation/perfusion (V/Q) scan to rule out chronic thromboembolic disease. Targeted tests for causes of Group 5 disease should also be done.
►Dr. Clark: The impression from his pulmonologist was that the patient has severe PH, though the specific etiology was not yet known. Dr. Maron, can you review for us the pathophysiology behind PH and describe how the disease is classified?
►Dr. Maron: Elevated mean pulmonary artery pressure (> 20 mm Hg) diagnosed by supine right heart catheterization is the sine qua non of PH.4 However, this alone does not inform pathophysiology. As Dr. Goldstein noted, elevated PA pressure may be due to left heart disease, primary parenchymal lung disease/sleep-disordered breathing, in situ thrombotic remodeling of pulmonary arterioles following prior luminal pulmonary embolism, or in the setting of various specific predisposing conditions, such as sickle cell disease and sarcoidosis among others.5
Alternatively, pulmonary arterial hypertension (PAH) is suspected in patients with no identifiable cause of PH, pulmonary artery wedge pressure 15 mm Hg and pulmonary vascular resistance of 3.0 Wood units.6 Importantly, PAH is not synonymous with PH but is a circumspect PH disease subgroup. In turn, PAH may be idiopathic, hereditary, or associated with other select, predisposing disorders, namely systemic sclerosis. In PAH, the interplay between genetic and molecular factors results in effacement of distal pulmonary arterioles due to plexigenic, fibrotic, and/or concentric hypertrophic remodeling. Increased vascular resistance promotes early right ventricular dilation and impaired systolic function. As a result, patients with PAH are at particularly elevated risk for cor pulmonale.
►Dr. Clark: Overnight oximetry revealed baseline oxygen saturation of 94%, an oxygen nadir of 84% with a total of 7 minutes with oxygen < 90%. On a 6-minute walk test, the patient had a max heart rate of 116 and oxygen nadir of 93%. Chest CT with and without contrast showed no evidence of pulmonary emboli but noted mild emphysematous changes. A V/Q revealed no evidence of acute or chronic pulmonary thromboembolic disease. Coronary catheterization showed normal coronary anatomy without significant CAD. A right heart catheterization showed findings consistent with severe PH with normal left-sided filling pressures (Table 3).
The patient returned a normal antinuclear antibody, C-reactive protein, HIV, and liver function panel. Based on these findings, a presumptive diagnosis of group 1 PH (idiopathic PAH) was made. Given the severity of his right heart dysfunction, he was transferred to the cardiac care unit and initiated on epoprostenol.
Dr. Maron, can you review the different treatment options for idiopathic PAH and explain why epoprostenol was chosen for this patient?
►Dr. Maron: There are 14 US Food and Drug Administration-approved drug therapies for patients with PAH, which all target either nitric oxide signaling, endothelin receptors, or the prostacyclin pathway. In the current era, treatment-naïve patients with PAH are generally initiated on calcium channel antagonist therapy if there is evidence of vasoreactivity during right heart catheterization (following nitric oxide administration), dual therapy most often with an endothelin receptor antagonist and phosphodiesterase inhibitor, or parenteral prostacyclin therapy. Since < 5% of patients will demonstrate vasoreactivity, the decision at point of care in incident patients with PAH often focuses on dual oral therapy or initiation of parenteral prostacyclin therapy. In this case, the patient reported presyncope with minimal physical activity (eg, bending over or walking up stairs) and severely decreased functional status (ie, New York Heart Association Functional [NYHA] Class III – IV), and he had a cardiac index within the range of cardiogenic shock (< 2.0 L/min/m2). Collectively, this clinical profile is considered particularly high risk, therefore, a recommendation for parenteral continuous prostacyclin therapy was made.
► Dr. Clark: The patient tolerated epoprostenol and reported improvement in his symptoms. He had a tunneled line catheter placed for continuous epoprostenol infusion. He was discharged home and scheduled for outpatient follow-up in a PH clinic. At 4 months following discharge, he was reporting steady clinical and functional improvement as well as improvement in his dyspnea. A second therapy (oral phosphodiesterase type-V inhibitor) was initiated and tolerated well. Overall, he reported resolution of presyncope, NYHA Functional Class II symptoms, and the absence of important drug effects.
Case Presentation: A 45-year-old US Coast Guard veteran with a medical history of asthma and chronic back pain was referred to the VA Boston Healthcare System (VABHS) for evaluation of progressive, unexplained dyspnea. Two years prior to presentation, the patient was an avid outdoorsman and highly active. At the time of his initial primary care physician (PCP) evaluation he reported dyspnea on exertion, and symptoms consistent with an upper respiratory tract infection (URTI) and a recent tick bite with an associated rash. He was treated with intranasal fluticasone and a course of antibiotics. His URTI symptoms and rash improved; however the dyspnea persisted and progressed over the ensuing winter and he was referred for pulmonary function testing. Additional history included a 20 pack-year history of smoking (resolved 10 years prior to the first VABHS clinical encounter) and a family history of premature coronary artery disease (CAD) in his father and 2 paternal uncles. He lived in northern New England where he previously worked as a cemetery groundskeeper.
►Kristopher Clark, MD, Chief Medical Resident, VABHS and Boston University/Boston Medical Center: Dr. Goldstein, how do you approach a patient who presents with progressive dyspnea?
►Ronald Goldstein, MD, Chief of Pulmonary and Critical Care VABHS: The evaluation of dyspnea is a common problem for pulmonary physicians. The sensation of dyspnea may originate from a wide variety of etiologies that involve pulmonary and cardiovascular disorders, neuromuscular impairment, deconditioning, or psychological issues. It is important to characterize the temporal pattern, severity, progression, relation to exertion or other triggers, the smoking history, environmental and occupational exposures to pulmonary toxins, associated symptoms, and the history of pulmonary problems.1
The physical examination may help to identify an airway or parenchymal disorder. Wheezing on chest examination would point to an obstructive defect and crackles to a possible restrictive problem, including pulmonary fibrosis. A cardiac examination should be performed to assess for evidence of heart failure, valvular heart disease, or the presence of loud P2 suggestive of pulmonary hypertension (PH). Laboratory studies, including complete blood counts are indicated.
A more complete pulmonary evaluation usually involves pulmonary function tests (PFTs), oximetry with exertion, and chest imaging. Additional cardiac testing might include electrocardiogram (ECG) and cardiac echocardiogram, followed by an exercise study, if needed. A B-natriuretic peptide determination could be considered if there is concern for congestive heart failure.2
►Dr. Clark: The initial physical examination was normal and laboratory tests were unrevealing. Given his history of asthma, he underwent spirometry testing (Table 1).
Dr. Goldstein, aside from unexplained dyspnea, what are other indications for spirometry and when should we consider ordering a full PFT, including lung volumes and diffusion capacity? Can you interpret this patient’s spirometry results?
►Dr. Goldstein: Spirometry is indicated to evaluate for a suspected obstructive defect. The test is usually performed with and without a bronchodilator to assess airway reactivity. A change in > 12% and > 200 mL suggests acute bronchodilator responsiveness. Periodic spirometry determinations are useful to assess the effect of medications or progression of disease. A reduction in forced vital capacity (FVC) may suggest a restrictive component. This possibility requires measure of lung volumes.
A full set of PFTs (ie, spirometry plus assessment of lung volumes and diffusion capacity) is required to evaluate the abnormalities associated with chronic obstructive pulmonary disease (COPD), interstitial diseases, vascular abnormalities (particularly PH), as well as for certain preoperative assessments. The single breath diffusing capacity for carbon monoxide is a measure of the overall capillary alveolar surface area of the lung. It is decreased in emphysema and interstitial disease as well as pulmonary vascular disorders. It would be particularly useful in this case as the spirometry studies were normal.
In this case, the normal FVC renders a significant restrictive disorder unlikely and his normal forced expiratory volume (FEV1) and FEV1/FVC make a significant obstructive disorder unlikely. He did not show any bronchodilator response; however, this finding does not exclude the presence of underlying asthma or reactive airway disease as patients often will not show a bronchodilator response at time of testing if they are not experiencing active bronchospasm or constriction. Further provocative testing with a methacholine challenge could be used to assess for reactive airway disease.
►Dr. Clark: The patient continued to have dyspnea when he returned to his PCP. Given his family history of premature CAD, an ECG was obtained that showed normal sinus rhythm at a rate of 70 beats per minute. A cardiology consult was placed, and he was referred for cardiac stress testing.
Dr. Maron, there are many forms of cardiac stress tests. In this case, the patient is referred for a stress test due his dyspnea. Does that symptom help you decide which test to order? How often does dyspnea present as an anginal equivalent in the absence of other cardiovascular symptoms or known cardiovascular disease?
►Bradley Maron, MD, Codirector, Pulmonary Vascular Disease Center, VABHS: In this case, stress testing should include a functional (ie, exercise) assessment if possible. Exercise capacity is a critical determinant of prognosis across the spectrum of cardiovascular disease and in a young person can be particularly informative on global health status. Furthermore, the chief complaint from this patient is dyspnea on exertion, and therefore, exercise testing is likely to be needed to reproduce or provoke the main symptom in this case. Estimates for dyspnea as a presenting symptom for ischemic heart disease vary but may be as high as 25%.3 It should be noted that cardiopulmonary exercise testing is useful for evaluating patients with unexplained dyspnea, as exercise hypoxemia, blunted decrease in VD/VT (ventilatory dead space/tidal volume), and evidence of a pulmonary mechanical limit to physical activity can inform the differential diagnosis.
►Dr. Clark: The patient underwent exercise treadmill testing and was able reach the target heart rate (> 85% age-predicted maximal heart rate) and achieve 11 metabolic equivalents. He had no chest pain or diagnostic ECG changes. The report made no mention of whether he experienced dyspnea during the test and was read as negative for exercise-induced ischemia.
He was seen by a cardiologist who noted an increased intensity S2 heart sound on examination without any other cardiopulmonary findings. It was noted that his symptoms occurred when tamping the ground or starting to walk up a hill but resolved with rest. It was also noted that his symptoms did not occur with gradual increased activity such as that performed during an exercise tolerance test. A 2-view chest X-ray was obtained and read as normal. Given the data from this evaluation thus far, the patient was told that his symptoms were most likely a result of his asthma exacerbated by dirt and dust exposure. Continued use of albuterol inhaler therapy was recommended, and no further diagnostic assessment was pursued.
Approximately 11 months later, the patient presented again to his PCP and reported progressive dyspnea. He had delayed seeking further care as he started to “feel like my symptoms were possibly in my head” given his prior negative workup. His symptoms had escalated drastically to the point where he felt short of breath with minimal exertion in addition to feeling sweaty, dizzy, fatigued, and having near-syncope when standing.
He was referred for a transthoracic echocardiogram (TTE) that revealed a left ventricular ejection fraction (LVEF) of 55 to 60% with diastolic relaxation abnormality and a normal-sized left atrium. The TTE also showed (qualitatively) a moderately dilated right ventricle with reduced systolic function, moderately severe tricuspid regurgitation, and severe elevation (> 60 mm Hg) in estimated right ventricular systolic pressure.
Dr. Maron, can you comment on how these findings may explain the patient’s symptoms? What differential diagnoses would you now consider?
►Dr. Maron: These echocardiography results exclude left ventricular systolic dysfunction or primary left-sided valvular disease at rest as a cause of the patient’s symptoms. In light of the patient’s prior normal stress test, high grade coronary disease in the absence of LV systolic dysfunction on echocardiography also seems unlikely. Estimated pulmonary artery systolic pressure > 60 mm Hg by echocardiography is highly suggestive of PH, but in and of itself does not diagnose PH nor inform pulmonary artery wedge pressure or pulmonary vascular resistance. Along with a direct measurement of pulmonary artery (PA) pressure, these data are needed to establish, classify, and prognosticate PH clinically.
►Dr. Clark: The patient was referred to a pulmonologist. His examination included bibasilar crackles and an enhanced P2 heart sound. A comprehensive pulmonary history was obtained, which noted his smoking history, possible asbestos exposure while serving in the Coast Guard, nighttime snoring without witnessed apnea events, and no personal or family history of thromboembolism or connective tissue disease.
Dr. Goldstein, is there anything in this patient’s history that could explain his symptoms and echocardiograph findings? Which tests would you order next?
►Dr. Goldstein: PH may be secondary to a wide variety of disorders including left heart disease (Group 2), advanced COPD, interstitial fibrosis, obstructive sleep apnea (OSA), or other lung diseases (Group 3), thromboembolic disorders (Group 4), and other systemic diseases such as sarcoidosis (Group 5). Group 1 is pulmonary arterial hypertension. (Table 2).
A right heart catheterization should be done to confirm the PA pressures estimated by echocardiogram. As to a cause, clinically he does not have heart failure. The limited smoking history and spirometry data do not support advanced COPD. He was noted to have crackles on physical examination suggesting an interstitial disorder. To assess the extent of interstitial disease, we would obtain a noncontrast computed tomography (CT) of the chest. The history of snoring suggesting the possibility of OSA indicating the need for overnight oximetry as significant nocturnal hypoxemia is a possible contributing cause to PH. A polysomnogram would be required to fully evaluate a sleep disturbance. The possible asbestos exposure is not likely a contributing factor as asbestosis requires significant exposure. We would obtain a ventilation/perfusion (V/Q) scan to rule out chronic thromboembolic disease. Targeted tests for causes of Group 5 disease should also be done.
►Dr. Clark: The impression from his pulmonologist was that the patient has severe PH, though the specific etiology was not yet known. Dr. Maron, can you review for us the pathophysiology behind PH and describe how the disease is classified?
►Dr. Maron: Elevated mean pulmonary artery pressure (> 20 mm Hg) diagnosed by supine right heart catheterization is the sine qua non of PH.4 However, this alone does not inform pathophysiology. As Dr. Goldstein noted, elevated PA pressure may be due to left heart disease, primary parenchymal lung disease/sleep-disordered breathing, in situ thrombotic remodeling of pulmonary arterioles following prior luminal pulmonary embolism, or in the setting of various specific predisposing conditions, such as sickle cell disease and sarcoidosis among others.5
Alternatively, pulmonary arterial hypertension (PAH) is suspected in patients with no identifiable cause of PH, pulmonary artery wedge pressure 15 mm Hg and pulmonary vascular resistance of 3.0 Wood units.6 Importantly, PAH is not synonymous with PH but is a circumspect PH disease subgroup. In turn, PAH may be idiopathic, hereditary, or associated with other select, predisposing disorders, namely systemic sclerosis. In PAH, the interplay between genetic and molecular factors results in effacement of distal pulmonary arterioles due to plexigenic, fibrotic, and/or concentric hypertrophic remodeling. Increased vascular resistance promotes early right ventricular dilation and impaired systolic function. As a result, patients with PAH are at particularly elevated risk for cor pulmonale.
►Dr. Clark: Overnight oximetry revealed baseline oxygen saturation of 94%, an oxygen nadir of 84% with a total of 7 minutes with oxygen < 90%. On a 6-minute walk test, the patient had a max heart rate of 116 and oxygen nadir of 93%. Chest CT with and without contrast showed no evidence of pulmonary emboli but noted mild emphysematous changes. A V/Q revealed no evidence of acute or chronic pulmonary thromboembolic disease. Coronary catheterization showed normal coronary anatomy without significant CAD. A right heart catheterization showed findings consistent with severe PH with normal left-sided filling pressures (Table 3).
The patient returned a normal antinuclear antibody, C-reactive protein, HIV, and liver function panel. Based on these findings, a presumptive diagnosis of group 1 PH (idiopathic PAH) was made. Given the severity of his right heart dysfunction, he was transferred to the cardiac care unit and initiated on epoprostenol.
Dr. Maron, can you review the different treatment options for idiopathic PAH and explain why epoprostenol was chosen for this patient?
►Dr. Maron: There are 14 US Food and Drug Administration-approved drug therapies for patients with PAH, which all target either nitric oxide signaling, endothelin receptors, or the prostacyclin pathway. In the current era, treatment-naïve patients with PAH are generally initiated on calcium channel antagonist therapy if there is evidence of vasoreactivity during right heart catheterization (following nitric oxide administration), dual therapy most often with an endothelin receptor antagonist and phosphodiesterase inhibitor, or parenteral prostacyclin therapy. Since < 5% of patients will demonstrate vasoreactivity, the decision at point of care in incident patients with PAH often focuses on dual oral therapy or initiation of parenteral prostacyclin therapy. In this case, the patient reported presyncope with minimal physical activity (eg, bending over or walking up stairs) and severely decreased functional status (ie, New York Heart Association Functional [NYHA] Class III – IV), and he had a cardiac index within the range of cardiogenic shock (< 2.0 L/min/m2). Collectively, this clinical profile is considered particularly high risk, therefore, a recommendation for parenteral continuous prostacyclin therapy was made.
► Dr. Clark: The patient tolerated epoprostenol and reported improvement in his symptoms. He had a tunneled line catheter placed for continuous epoprostenol infusion. He was discharged home and scheduled for outpatient follow-up in a PH clinic. At 4 months following discharge, he was reporting steady clinical and functional improvement as well as improvement in his dyspnea. A second therapy (oral phosphodiesterase type-V inhibitor) was initiated and tolerated well. Overall, he reported resolution of presyncope, NYHA Functional Class II symptoms, and the absence of important drug effects.
1.. Manning HL, Schwartzstein RM. Pathophysiology of dyspnea. N Engl J Med. 1995;333(23):1547-1553. doi:10.1056/NEJM199512073332307
2. Parshall MB, Schwartzstein RM, Adams L, et al. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012;185(4):435-452. doi:10.1164/rccm.201111-2042ST
3. Phibbs B, Holmes RW, Lowe CR. Transient myocardial ischemia: the significance of dyspnea. Am J Med Sci. 1968;256(4):210-221. doi:10.1097/00000441-196810000-00002
4. Maron BA, Hess E, Maddox TM, et al. Association of borderline pulmonary hypertension with mortality and hospitalization in a large patient cohort: insights from the veterans affairs clinical assessment, reporting, and tracking program. Circulation. 2016;133(13):1240-1248. doi:10.1161/CIRCULATIONAHA.115.020207
5. Simonneau G, Montani D, Celermajer DS, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019;53(1):1801913. Published 2019 Jan 24. doi:10.1183/13993003.01913-2018
6. Maron BA, Galiè N. Diagnosis, Treatment, and Clinical Management of Pulmonary Arterial Hypertension in the Contemporary Era: A Review. JAMA Cardiol. 2016;1(9):1056-1065. doi:10.1001/jamacardio.2016.4471
1.. Manning HL, Schwartzstein RM. Pathophysiology of dyspnea. N Engl J Med. 1995;333(23):1547-1553. doi:10.1056/NEJM199512073332307
2. Parshall MB, Schwartzstein RM, Adams L, et al. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012;185(4):435-452. doi:10.1164/rccm.201111-2042ST
3. Phibbs B, Holmes RW, Lowe CR. Transient myocardial ischemia: the significance of dyspnea. Am J Med Sci. 1968;256(4):210-221. doi:10.1097/00000441-196810000-00002
4. Maron BA, Hess E, Maddox TM, et al. Association of borderline pulmonary hypertension with mortality and hospitalization in a large patient cohort: insights from the veterans affairs clinical assessment, reporting, and tracking program. Circulation. 2016;133(13):1240-1248. doi:10.1161/CIRCULATIONAHA.115.020207
5. Simonneau G, Montani D, Celermajer DS, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019;53(1):1801913. Published 2019 Jan 24. doi:10.1183/13993003.01913-2018
6. Maron BA, Galiè N. Diagnosis, Treatment, and Clinical Management of Pulmonary Arterial Hypertension in the Contemporary Era: A Review. JAMA Cardiol. 2016;1(9):1056-1065. doi:10.1001/jamacardio.2016.4471
COVID-19 and Venous Thromboembolism Pharmacologic Thromboprophylaxis
The novel coronavirus SARS-CoV-2 and resulting viral syndrome (COVID-19) was first reported in China during December 2019 and within weeks emerged in the US.1 Since it is a rapidly evolving situation, clinicians must remain current on best practices—a challenging institutional responsibility. According to LitCovid, a curated literature hub for tracking scientific information on COVID-19, there are > 54,000 articles on the subject in PubMed. Among these include venous thromboembolism (VTE) prophylaxis guidance from 4 respected thrombosis organizations/societies and the US National Institutes of Health.1-5
Observations
COVID-19 predisposes patients with and without a history of cardiovascular disease to thrombotic complications, occurring in either the venous or arterial circulation system.2,6 Early observational studies suggest that thrombotic rates may be in excess of 20 to 30%; however, the use of prophylactic anticoagulation was inconsistent among studies that were rushed to publication.6
Autopsy data have demonstrated the presence of fibrin thrombi within distended small vessels and capillaries and extensive extracellular fibrin deposition.6 Investigators compared the characteristics of acute pulmonary embolism in 23 cases with COVID-19 but with no clinical signs of deep vein thrombosis with 100 controls without COVID-19.7 They observed that thrombotic lesions had a greater distribution in peripheral lung segments (ie, peripheral arteries) and were less extensive for those with COVID-19 vs without COVID-19 infection. Thus, experts currently hypothesize that COVID-19 has a distinct “pathomechanism.” As a unique phenotype, thrombotic events represent a combination of thromboembolic disease influenced by components of the Virchow triad (eg, acute illness and immobility) and in situ immunothrombosis, a local inflammatory response.6,7
Well-established surgical and nonsurgical VTE thromboprophylaxis guidelines serve as the foundation for current COVID-19 thromboprophylaxis guidance.8,9 Condition specific guidance is extrapolated from small, retrospective observational studies or based on expert opinion, representing levels 2 and 3 evidence, respectively.1-5 Table 1 captures similarities and differences among COVID-19 VTE thromboprophylaxis recommendations which vary by time to publication and by society member expertise gained from practice in the field.
Three thrombosis societies recommend universal pharmacologic thromboprophylaxis for acutely ill COVID-19 patients who lack contraindications.3-5 Others recommend use of risk stratification scoring tools, such as the Padua risk assessment model (RAM) for medical patients or Caprini RAM for surgical patients, the disseminated intravascular coagulation (DIC) score, or the sepsis-induced coagulopathy score to determine therapeutic appropriateness (Tables 2 and 3).1,2 Since most patients hospitalized for COVID-19 will present with a pathognomonic pneumonia and an oxygen requirement, they will generally achieve a score of ≥ 4 when the Padua RAM is applied; thus, representing a clear indication for pharmacologic thromboprophylaxis.8,9 If the patient is pregnant, the Anticoagulation Forum recommends pharmacologic prophylaxis, consultation with an obstetrician, and use of obstetrical thromboprophylaxis guidelines.3,10,11
Most thrombosis experts prefer parenteral thromboprophylaxis, specifically low molecular-weight heparin (LMWH) or fondaparinux, for inpatients over use of direct oral anticoagulants (DOACs) in order to minimize the potential for drug interactions particularly when investigational antivirals are in use.4 Once-daily agents (eg, rivaroxaban, fondaparinux, and enoxaparin) are preferred over multiple daily doses to minimize staff contact with patients infected with COVID-19.4,5 Fondaparinux and DOACs should preferentially be used in patients with a recent history of heparin-induced thrombocytopenia with and without thrombosis (HIT/HITTS). Subcutaneous heparin is reserved for patients who are scheduled for invasive procedures or have reduced renal function (eg, creatinine clearance < 30 mL/min).1,3-5 In line with existing pharmacologic thromboprophylaxis guidance, standard prophylactic LMWH doses are recommended unless patients are obese (body mass index [BMI] > 30) or morbidly obese (BMI > 40) necessitating selection of intermediate doses.4
Since early non-US studies demonstrated high thrombotic risk without signaling a potential for harm from pharmacologic thromboprophylaxis, some organizations recommend empiric escalation of anticoagulation doses for critical illness.3,4,6 Thus, it may be reasonable to advance to either intermediate pharmacologic thromboprophylaxis dosing or therapeutic doses.3 However, observational studies question this aggressive practice unless a clear indication exists for intensification (ie, atrial fibrillation, known VTE).
A large multi-institutional registry study that included 400 subjects from 5 centers demonstrated a radiographically confirmed VTE rate of 4.8% and an arterial thrombosis rate of 2.8%.6 When limiting to the critically ill setting, VTE and arterial thrombosis occurred at slightly higher rates (7.6% and 5.6%, respectively). Patients also were at risk for nonvessel thrombotic complications (eg, CVVH circuit, central venous catheters, and arterial lines). Subsequently, the overall thrombotic complication rate was 9.5%. All thrombotic events except one arose in patients who were receiving standard doses of pharmacologic thromboprophylaxis. Unfortunately, D-dimer elevation at admission was not only predictive of thrombosis and death, but portended bleeding. The overall bleeding rate was 4.8%, with a major bleeding rate of 2.3%. In the context of observing thromboses at normally expected rates during critical illness in association with a significant bleeding risk, the authors recommended further investigation into the net clinical benefit.
Similarly, a National Institutes of Health funded, observational, single center US study evaluated 4,389 inpatients infected with COVID-19 and determined that therapeutic and prophylactic anticoagulation reduced inpatient mortality (adjusted hazard ratio [aHR], 0.53 and 0.50, respectively for the primary outcome) and intubation (aHR, 0.69 and 0.72, respectively) over no anticoagulation.12 Notably, use of inpatient therapeutic anticoagulation commonly represented a continuation of preadmission therapy or progressive COVID-19. A subanalysis demonstrated that timely use (eg, within 48 hours of admission) of prophylactic or therapeutic anticoagulation, resulted in no difference (P < .08) in the primary outcome. Bleeding rates were low overall: 3%, 1.7%, and 1.9% for therapeutic, prophylactic, and no anticoagulation groups, respectively. Furthermore, selection of DOACs seems to be associated with lower bleeding rates when compared with that of LMWH heparin (1.3% vs 2.6%, respectively). In those where site of bleeding could be ascertained, the most common sites were the gastrointestinal tract (50.7%) followed by mucocutaneous (19.4%), bronchopulmonary (14.9%), and intracranial (6%). In summary, prophylactic thromboprophylaxis doses seem to be associated with positive net clinical benefit.
As of October 30, 2020, the US Department of Veterans Affairs (VA) had reported 75,156 COVID-19 cases and 3,961 deaths.13 Since the VA Pharmacy Benefits Management (PBM) does not disseminate nationally prepared anticoagulation order sets to the field, facility anticoagulation leads should be encouraged to develop local guidance-based policies to help standardize care and minimize further variations in practice, which would likely lack evidential support. Per the VA Tennessee Valley Healthcare System (TVHS)- Nashville/Murfreesboro anticoagulation policy, we limit the ordering of parenteral anticoagulation to Computerized Patient Record System (CPRS) order sets in order to provide decision support (eFigure 1, available at doi:10.12788/fp.0063). Other facilities have shown that embedded clinical decision support tools increase adherence to guideline VTE prophylaxis recommendations within the VA.14
In April 2020, the TVHS anticoagulation clinical pharmacy leads developed a COVID-19 specific order set based on review of societal guidance and the evolving, supportive literature summarized in this review with consideration of provider familiarity (eFigure 2, available at doi:10.12788/fp.0063)). Between April and June 2020, the COVID-19 order set content consistently evolved with publication of each COVID-19 thromboprophylaxis guideline.1-5
Since TVHS is a high-complexity facility, we elected to use universal pharmacologic thromboprophylaxis for patients with COVID-19. This construct bypasses the use of scoring tools (eg, RAM), although we use Padua and Caprini RAMS for medical and surgical patients, respectively, who are not diagnosed with COVID-19. The order set displays all acceptable guideline recommended options, delineated by location of care (eg, medical ward vs intensive care unit), prior history of heparin-induced thrombocytopenia, and renal function. Subsequently, all potential agents, doses, and dosing interval options are offered so that the provider autonomously determines how to individualize the clinical care. Since TVHS has only diagnosed 932 ambulatory/inpatient COVID-19 cases combined, our plans are to complete a future observational analysis to determine the effectiveness of the inpatient COVID-19 thromboprophylaxis order set for our internal customers.
Conclusions
The COVID-19 pandemic has resulted in arguably the most challenging medical climate in the evidence-based medicine era. Until high-quality randomized controlled trials are published, the medical community is, in a sense, operating within a crucible of crisis having to navigate therapeutic policy with little certainty. This principle holds true for thromboprophylaxis in patients with COVID-19 despite the numerous advancements in this field over the past decade.
A review of societal guidance shows there is universal agreement with regards to supporting standard doses of pharmacologicalprophylaxis in acutely ill patients either when universally applied or guided by a RAM as well as the use of universal thromboprophylaxis in critically ill patients. All societies discourage the use of antiplatelet therapy for arterial thrombosis prevention and advocate for mechanical compression in patients with contraindications to pharmacologic anticoagulation. Beyond this, divergence between guidance statements begins to appear. For example, societies do not currently agree on the role and approach for extended pharmacologic prophylaxis postdischarge. The differences between societal guidance speaks to the degree of uncertainty among leading experts, which is considered to be the logical outworking of the current level of evidence. Regardless, these guidance documents should be considered the best resource currently available.
The medical community is fortunate to have robust societies that have published guidance on thromboprophylaxis in patients with COVID-19. The novelty of COVID-19 precludes these societal guidance publications from being based on high-quality evidence, but at the very least, they provide insight into how leading experts in the field of thrombosis and hemostasis are currently navigating the therapeutic landscape.
While this paper provides a summary of the current guidance, evidence is evolving at an unprecedented pace. Facilities and anticoagulation leads should be actively and frequently evaluating literature and guidance to ensure their practices and policies remain current.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville/Murfreesboro.
1. National Institutes of Health. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/whats-new/. Updated October 9, 2020. Accessed October 15, 2020.
2. Bikdeli B, Madhavan MV, Jimenez D, et al. COVID-19 and thrombotic or thromboembolic disease: implications for prevention, antithrombotic therapy, and follow-up: JACC state-of-the-art review. J Am Coll Cardiol. 2020;75(23):2950-2973. doi:10.1016/j.jacc.2020.04.031
3. Barnes GD, Burnett A, Allen A, et al. Thromboembolism and anticoagulant therapy during the COVID-19 pandemic: interim clinical guidance from the anticoagulation forum. J Thromb Thrombolysis. 2020;50(1):72-81. doi:10.1007/s11239-020-02138-z
4. Spyropoulos AC, Levy JH, Ageno W, et al. Scientific and Standardization Committee communication: Clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020;18(8):1859-1865. doi:10.1111/jth.14929
5. Moores LK, Tritschler T, Brosnahan S, et al. Prevention, Diagnosis, and Treatment of VTE in Patients With Coronavirus Disease 2019: CHEST Guideline and Expert Panel Report. Chest. 2020;158(3):1143-1163. doi:10.1016/j.chest.2020.05.559
6. Al-Samkari H, Karp Leaf RS, Dzik WH, et al. COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection. Blood. 2020;136(4):489-500. doi:10.1182/blood.2020006520.
7. van Dam LF, Kroft LJM, van der Wal LI, et al. Clinical and computed tomography characteristics of COVID-19 associated acute pulmonary embolism: a different phenotype of thrombotic disease?. Thromb Res. 2020;193:86-89. doi:10.1016/j.thromres.2020.06.010
8. Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(suppl 2):e195S-e226S. doi:10.1378/chest.11-2296
9. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines [published correction appears in Chest. 2012 May;141(5):1369]. Chest. 2012;141(suppl 2):e227S-e277S. doi:10.1378/chest.11-2297
10. ACOG Practice Bulletin No. 196 Summary: thromboembolism in pregnancy. Obstet Gynecol. 2018;132(1):243-248. doi:10.1097/AOG.0000000000002707
11. Royal College of Obstetricians and Gynaecologists. Reducing the risk of venous thromboembolism during pregnancy and the puerperium. Green-top Guideline. No. 37a. https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf. Published April 2015. Accessed October 15, 2020.
12. Nadkarni GN, Lala A, Bagiella E, et al. Anticoagulation, mortality, bleeding and pathology among patients hospitalized with COVID-19: a single health system study [published online ahead of print, 2020 Aug 24]. J Am Coll Cardiol. 2020;76(16):1815-1826. doi:10.1016/j.jacc.2020.08.041
13. US Department of Veterans Affairs. Department of Veterans Affairs COVID-19 national summary. https://www.accesstocare.va.gov/Healthcare/COVID19NationalSummary. Updated November 1, 2020. Accessed November 1, 2020.
14. George B, Gonzales S, Patel K, Petit S, Franck AJ, Bovio Franck J. Impact of a clinical decision-support tool on venous thromboembolism prophylaxis in acutely ill medical patients. J Pharm Technol. 2020;36(4):141-147. doi:10.1177/8755122520930288
The novel coronavirus SARS-CoV-2 and resulting viral syndrome (COVID-19) was first reported in China during December 2019 and within weeks emerged in the US.1 Since it is a rapidly evolving situation, clinicians must remain current on best practices—a challenging institutional responsibility. According to LitCovid, a curated literature hub for tracking scientific information on COVID-19, there are > 54,000 articles on the subject in PubMed. Among these include venous thromboembolism (VTE) prophylaxis guidance from 4 respected thrombosis organizations/societies and the US National Institutes of Health.1-5
Observations
COVID-19 predisposes patients with and without a history of cardiovascular disease to thrombotic complications, occurring in either the venous or arterial circulation system.2,6 Early observational studies suggest that thrombotic rates may be in excess of 20 to 30%; however, the use of prophylactic anticoagulation was inconsistent among studies that were rushed to publication.6
Autopsy data have demonstrated the presence of fibrin thrombi within distended small vessels and capillaries and extensive extracellular fibrin deposition.6 Investigators compared the characteristics of acute pulmonary embolism in 23 cases with COVID-19 but with no clinical signs of deep vein thrombosis with 100 controls without COVID-19.7 They observed that thrombotic lesions had a greater distribution in peripheral lung segments (ie, peripheral arteries) and were less extensive for those with COVID-19 vs without COVID-19 infection. Thus, experts currently hypothesize that COVID-19 has a distinct “pathomechanism.” As a unique phenotype, thrombotic events represent a combination of thromboembolic disease influenced by components of the Virchow triad (eg, acute illness and immobility) and in situ immunothrombosis, a local inflammatory response.6,7
Well-established surgical and nonsurgical VTE thromboprophylaxis guidelines serve as the foundation for current COVID-19 thromboprophylaxis guidance.8,9 Condition specific guidance is extrapolated from small, retrospective observational studies or based on expert opinion, representing levels 2 and 3 evidence, respectively.1-5 Table 1 captures similarities and differences among COVID-19 VTE thromboprophylaxis recommendations which vary by time to publication and by society member expertise gained from practice in the field.
Three thrombosis societies recommend universal pharmacologic thromboprophylaxis for acutely ill COVID-19 patients who lack contraindications.3-5 Others recommend use of risk stratification scoring tools, such as the Padua risk assessment model (RAM) for medical patients or Caprini RAM for surgical patients, the disseminated intravascular coagulation (DIC) score, or the sepsis-induced coagulopathy score to determine therapeutic appropriateness (Tables 2 and 3).1,2 Since most patients hospitalized for COVID-19 will present with a pathognomonic pneumonia and an oxygen requirement, they will generally achieve a score of ≥ 4 when the Padua RAM is applied; thus, representing a clear indication for pharmacologic thromboprophylaxis.8,9 If the patient is pregnant, the Anticoagulation Forum recommends pharmacologic prophylaxis, consultation with an obstetrician, and use of obstetrical thromboprophylaxis guidelines.3,10,11
Most thrombosis experts prefer parenteral thromboprophylaxis, specifically low molecular-weight heparin (LMWH) or fondaparinux, for inpatients over use of direct oral anticoagulants (DOACs) in order to minimize the potential for drug interactions particularly when investigational antivirals are in use.4 Once-daily agents (eg, rivaroxaban, fondaparinux, and enoxaparin) are preferred over multiple daily doses to minimize staff contact with patients infected with COVID-19.4,5 Fondaparinux and DOACs should preferentially be used in patients with a recent history of heparin-induced thrombocytopenia with and without thrombosis (HIT/HITTS). Subcutaneous heparin is reserved for patients who are scheduled for invasive procedures or have reduced renal function (eg, creatinine clearance < 30 mL/min).1,3-5 In line with existing pharmacologic thromboprophylaxis guidance, standard prophylactic LMWH doses are recommended unless patients are obese (body mass index [BMI] > 30) or morbidly obese (BMI > 40) necessitating selection of intermediate doses.4
Since early non-US studies demonstrated high thrombotic risk without signaling a potential for harm from pharmacologic thromboprophylaxis, some organizations recommend empiric escalation of anticoagulation doses for critical illness.3,4,6 Thus, it may be reasonable to advance to either intermediate pharmacologic thromboprophylaxis dosing or therapeutic doses.3 However, observational studies question this aggressive practice unless a clear indication exists for intensification (ie, atrial fibrillation, known VTE).
A large multi-institutional registry study that included 400 subjects from 5 centers demonstrated a radiographically confirmed VTE rate of 4.8% and an arterial thrombosis rate of 2.8%.6 When limiting to the critically ill setting, VTE and arterial thrombosis occurred at slightly higher rates (7.6% and 5.6%, respectively). Patients also were at risk for nonvessel thrombotic complications (eg, CVVH circuit, central venous catheters, and arterial lines). Subsequently, the overall thrombotic complication rate was 9.5%. All thrombotic events except one arose in patients who were receiving standard doses of pharmacologic thromboprophylaxis. Unfortunately, D-dimer elevation at admission was not only predictive of thrombosis and death, but portended bleeding. The overall bleeding rate was 4.8%, with a major bleeding rate of 2.3%. In the context of observing thromboses at normally expected rates during critical illness in association with a significant bleeding risk, the authors recommended further investigation into the net clinical benefit.
Similarly, a National Institutes of Health funded, observational, single center US study evaluated 4,389 inpatients infected with COVID-19 and determined that therapeutic and prophylactic anticoagulation reduced inpatient mortality (adjusted hazard ratio [aHR], 0.53 and 0.50, respectively for the primary outcome) and intubation (aHR, 0.69 and 0.72, respectively) over no anticoagulation.12 Notably, use of inpatient therapeutic anticoagulation commonly represented a continuation of preadmission therapy or progressive COVID-19. A subanalysis demonstrated that timely use (eg, within 48 hours of admission) of prophylactic or therapeutic anticoagulation, resulted in no difference (P < .08) in the primary outcome. Bleeding rates were low overall: 3%, 1.7%, and 1.9% for therapeutic, prophylactic, and no anticoagulation groups, respectively. Furthermore, selection of DOACs seems to be associated with lower bleeding rates when compared with that of LMWH heparin (1.3% vs 2.6%, respectively). In those where site of bleeding could be ascertained, the most common sites were the gastrointestinal tract (50.7%) followed by mucocutaneous (19.4%), bronchopulmonary (14.9%), and intracranial (6%). In summary, prophylactic thromboprophylaxis doses seem to be associated with positive net clinical benefit.
As of October 30, 2020, the US Department of Veterans Affairs (VA) had reported 75,156 COVID-19 cases and 3,961 deaths.13 Since the VA Pharmacy Benefits Management (PBM) does not disseminate nationally prepared anticoagulation order sets to the field, facility anticoagulation leads should be encouraged to develop local guidance-based policies to help standardize care and minimize further variations in practice, which would likely lack evidential support. Per the VA Tennessee Valley Healthcare System (TVHS)- Nashville/Murfreesboro anticoagulation policy, we limit the ordering of parenteral anticoagulation to Computerized Patient Record System (CPRS) order sets in order to provide decision support (eFigure 1, available at doi:10.12788/fp.0063). Other facilities have shown that embedded clinical decision support tools increase adherence to guideline VTE prophylaxis recommendations within the VA.14
In April 2020, the TVHS anticoagulation clinical pharmacy leads developed a COVID-19 specific order set based on review of societal guidance and the evolving, supportive literature summarized in this review with consideration of provider familiarity (eFigure 2, available at doi:10.12788/fp.0063)). Between April and June 2020, the COVID-19 order set content consistently evolved with publication of each COVID-19 thromboprophylaxis guideline.1-5
Since TVHS is a high-complexity facility, we elected to use universal pharmacologic thromboprophylaxis for patients with COVID-19. This construct bypasses the use of scoring tools (eg, RAM), although we use Padua and Caprini RAMS for medical and surgical patients, respectively, who are not diagnosed with COVID-19. The order set displays all acceptable guideline recommended options, delineated by location of care (eg, medical ward vs intensive care unit), prior history of heparin-induced thrombocytopenia, and renal function. Subsequently, all potential agents, doses, and dosing interval options are offered so that the provider autonomously determines how to individualize the clinical care. Since TVHS has only diagnosed 932 ambulatory/inpatient COVID-19 cases combined, our plans are to complete a future observational analysis to determine the effectiveness of the inpatient COVID-19 thromboprophylaxis order set for our internal customers.
Conclusions
The COVID-19 pandemic has resulted in arguably the most challenging medical climate in the evidence-based medicine era. Until high-quality randomized controlled trials are published, the medical community is, in a sense, operating within a crucible of crisis having to navigate therapeutic policy with little certainty. This principle holds true for thromboprophylaxis in patients with COVID-19 despite the numerous advancements in this field over the past decade.
A review of societal guidance shows there is universal agreement with regards to supporting standard doses of pharmacologicalprophylaxis in acutely ill patients either when universally applied or guided by a RAM as well as the use of universal thromboprophylaxis in critically ill patients. All societies discourage the use of antiplatelet therapy for arterial thrombosis prevention and advocate for mechanical compression in patients with contraindications to pharmacologic anticoagulation. Beyond this, divergence between guidance statements begins to appear. For example, societies do not currently agree on the role and approach for extended pharmacologic prophylaxis postdischarge. The differences between societal guidance speaks to the degree of uncertainty among leading experts, which is considered to be the logical outworking of the current level of evidence. Regardless, these guidance documents should be considered the best resource currently available.
The medical community is fortunate to have robust societies that have published guidance on thromboprophylaxis in patients with COVID-19. The novelty of COVID-19 precludes these societal guidance publications from being based on high-quality evidence, but at the very least, they provide insight into how leading experts in the field of thrombosis and hemostasis are currently navigating the therapeutic landscape.
While this paper provides a summary of the current guidance, evidence is evolving at an unprecedented pace. Facilities and anticoagulation leads should be actively and frequently evaluating literature and guidance to ensure their practices and policies remain current.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville/Murfreesboro.
The novel coronavirus SARS-CoV-2 and resulting viral syndrome (COVID-19) was first reported in China during December 2019 and within weeks emerged in the US.1 Since it is a rapidly evolving situation, clinicians must remain current on best practices—a challenging institutional responsibility. According to LitCovid, a curated literature hub for tracking scientific information on COVID-19, there are > 54,000 articles on the subject in PubMed. Among these include venous thromboembolism (VTE) prophylaxis guidance from 4 respected thrombosis organizations/societies and the US National Institutes of Health.1-5
Observations
COVID-19 predisposes patients with and without a history of cardiovascular disease to thrombotic complications, occurring in either the venous or arterial circulation system.2,6 Early observational studies suggest that thrombotic rates may be in excess of 20 to 30%; however, the use of prophylactic anticoagulation was inconsistent among studies that were rushed to publication.6
Autopsy data have demonstrated the presence of fibrin thrombi within distended small vessels and capillaries and extensive extracellular fibrin deposition.6 Investigators compared the characteristics of acute pulmonary embolism in 23 cases with COVID-19 but with no clinical signs of deep vein thrombosis with 100 controls without COVID-19.7 They observed that thrombotic lesions had a greater distribution in peripheral lung segments (ie, peripheral arteries) and were less extensive for those with COVID-19 vs without COVID-19 infection. Thus, experts currently hypothesize that COVID-19 has a distinct “pathomechanism.” As a unique phenotype, thrombotic events represent a combination of thromboembolic disease influenced by components of the Virchow triad (eg, acute illness and immobility) and in situ immunothrombosis, a local inflammatory response.6,7
Well-established surgical and nonsurgical VTE thromboprophylaxis guidelines serve as the foundation for current COVID-19 thromboprophylaxis guidance.8,9 Condition specific guidance is extrapolated from small, retrospective observational studies or based on expert opinion, representing levels 2 and 3 evidence, respectively.1-5 Table 1 captures similarities and differences among COVID-19 VTE thromboprophylaxis recommendations which vary by time to publication and by society member expertise gained from practice in the field.
Three thrombosis societies recommend universal pharmacologic thromboprophylaxis for acutely ill COVID-19 patients who lack contraindications.3-5 Others recommend use of risk stratification scoring tools, such as the Padua risk assessment model (RAM) for medical patients or Caprini RAM for surgical patients, the disseminated intravascular coagulation (DIC) score, or the sepsis-induced coagulopathy score to determine therapeutic appropriateness (Tables 2 and 3).1,2 Since most patients hospitalized for COVID-19 will present with a pathognomonic pneumonia and an oxygen requirement, they will generally achieve a score of ≥ 4 when the Padua RAM is applied; thus, representing a clear indication for pharmacologic thromboprophylaxis.8,9 If the patient is pregnant, the Anticoagulation Forum recommends pharmacologic prophylaxis, consultation with an obstetrician, and use of obstetrical thromboprophylaxis guidelines.3,10,11
Most thrombosis experts prefer parenteral thromboprophylaxis, specifically low molecular-weight heparin (LMWH) or fondaparinux, for inpatients over use of direct oral anticoagulants (DOACs) in order to minimize the potential for drug interactions particularly when investigational antivirals are in use.4 Once-daily agents (eg, rivaroxaban, fondaparinux, and enoxaparin) are preferred over multiple daily doses to minimize staff contact with patients infected with COVID-19.4,5 Fondaparinux and DOACs should preferentially be used in patients with a recent history of heparin-induced thrombocytopenia with and without thrombosis (HIT/HITTS). Subcutaneous heparin is reserved for patients who are scheduled for invasive procedures or have reduced renal function (eg, creatinine clearance < 30 mL/min).1,3-5 In line with existing pharmacologic thromboprophylaxis guidance, standard prophylactic LMWH doses are recommended unless patients are obese (body mass index [BMI] > 30) or morbidly obese (BMI > 40) necessitating selection of intermediate doses.4
Since early non-US studies demonstrated high thrombotic risk without signaling a potential for harm from pharmacologic thromboprophylaxis, some organizations recommend empiric escalation of anticoagulation doses for critical illness.3,4,6 Thus, it may be reasonable to advance to either intermediate pharmacologic thromboprophylaxis dosing or therapeutic doses.3 However, observational studies question this aggressive practice unless a clear indication exists for intensification (ie, atrial fibrillation, known VTE).
A large multi-institutional registry study that included 400 subjects from 5 centers demonstrated a radiographically confirmed VTE rate of 4.8% and an arterial thrombosis rate of 2.8%.6 When limiting to the critically ill setting, VTE and arterial thrombosis occurred at slightly higher rates (7.6% and 5.6%, respectively). Patients also were at risk for nonvessel thrombotic complications (eg, CVVH circuit, central venous catheters, and arterial lines). Subsequently, the overall thrombotic complication rate was 9.5%. All thrombotic events except one arose in patients who were receiving standard doses of pharmacologic thromboprophylaxis. Unfortunately, D-dimer elevation at admission was not only predictive of thrombosis and death, but portended bleeding. The overall bleeding rate was 4.8%, with a major bleeding rate of 2.3%. In the context of observing thromboses at normally expected rates during critical illness in association with a significant bleeding risk, the authors recommended further investigation into the net clinical benefit.
Similarly, a National Institutes of Health funded, observational, single center US study evaluated 4,389 inpatients infected with COVID-19 and determined that therapeutic and prophylactic anticoagulation reduced inpatient mortality (adjusted hazard ratio [aHR], 0.53 and 0.50, respectively for the primary outcome) and intubation (aHR, 0.69 and 0.72, respectively) over no anticoagulation.12 Notably, use of inpatient therapeutic anticoagulation commonly represented a continuation of preadmission therapy or progressive COVID-19. A subanalysis demonstrated that timely use (eg, within 48 hours of admission) of prophylactic or therapeutic anticoagulation, resulted in no difference (P < .08) in the primary outcome. Bleeding rates were low overall: 3%, 1.7%, and 1.9% for therapeutic, prophylactic, and no anticoagulation groups, respectively. Furthermore, selection of DOACs seems to be associated with lower bleeding rates when compared with that of LMWH heparin (1.3% vs 2.6%, respectively). In those where site of bleeding could be ascertained, the most common sites were the gastrointestinal tract (50.7%) followed by mucocutaneous (19.4%), bronchopulmonary (14.9%), and intracranial (6%). In summary, prophylactic thromboprophylaxis doses seem to be associated with positive net clinical benefit.
As of October 30, 2020, the US Department of Veterans Affairs (VA) had reported 75,156 COVID-19 cases and 3,961 deaths.13 Since the VA Pharmacy Benefits Management (PBM) does not disseminate nationally prepared anticoagulation order sets to the field, facility anticoagulation leads should be encouraged to develop local guidance-based policies to help standardize care and minimize further variations in practice, which would likely lack evidential support. Per the VA Tennessee Valley Healthcare System (TVHS)- Nashville/Murfreesboro anticoagulation policy, we limit the ordering of parenteral anticoagulation to Computerized Patient Record System (CPRS) order sets in order to provide decision support (eFigure 1, available at doi:10.12788/fp.0063). Other facilities have shown that embedded clinical decision support tools increase adherence to guideline VTE prophylaxis recommendations within the VA.14
In April 2020, the TVHS anticoagulation clinical pharmacy leads developed a COVID-19 specific order set based on review of societal guidance and the evolving, supportive literature summarized in this review with consideration of provider familiarity (eFigure 2, available at doi:10.12788/fp.0063)). Between April and June 2020, the COVID-19 order set content consistently evolved with publication of each COVID-19 thromboprophylaxis guideline.1-5
Since TVHS is a high-complexity facility, we elected to use universal pharmacologic thromboprophylaxis for patients with COVID-19. This construct bypasses the use of scoring tools (eg, RAM), although we use Padua and Caprini RAMS for medical and surgical patients, respectively, who are not diagnosed with COVID-19. The order set displays all acceptable guideline recommended options, delineated by location of care (eg, medical ward vs intensive care unit), prior history of heparin-induced thrombocytopenia, and renal function. Subsequently, all potential agents, doses, and dosing interval options are offered so that the provider autonomously determines how to individualize the clinical care. Since TVHS has only diagnosed 932 ambulatory/inpatient COVID-19 cases combined, our plans are to complete a future observational analysis to determine the effectiveness of the inpatient COVID-19 thromboprophylaxis order set for our internal customers.
Conclusions
The COVID-19 pandemic has resulted in arguably the most challenging medical climate in the evidence-based medicine era. Until high-quality randomized controlled trials are published, the medical community is, in a sense, operating within a crucible of crisis having to navigate therapeutic policy with little certainty. This principle holds true for thromboprophylaxis in patients with COVID-19 despite the numerous advancements in this field over the past decade.
A review of societal guidance shows there is universal agreement with regards to supporting standard doses of pharmacologicalprophylaxis in acutely ill patients either when universally applied or guided by a RAM as well as the use of universal thromboprophylaxis in critically ill patients. All societies discourage the use of antiplatelet therapy for arterial thrombosis prevention and advocate for mechanical compression in patients with contraindications to pharmacologic anticoagulation. Beyond this, divergence between guidance statements begins to appear. For example, societies do not currently agree on the role and approach for extended pharmacologic prophylaxis postdischarge. The differences between societal guidance speaks to the degree of uncertainty among leading experts, which is considered to be the logical outworking of the current level of evidence. Regardless, these guidance documents should be considered the best resource currently available.
The medical community is fortunate to have robust societies that have published guidance on thromboprophylaxis in patients with COVID-19. The novelty of COVID-19 precludes these societal guidance publications from being based on high-quality evidence, but at the very least, they provide insight into how leading experts in the field of thrombosis and hemostasis are currently navigating the therapeutic landscape.
While this paper provides a summary of the current guidance, evidence is evolving at an unprecedented pace. Facilities and anticoagulation leads should be actively and frequently evaluating literature and guidance to ensure their practices and policies remain current.
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville/Murfreesboro.
1. National Institutes of Health. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/whats-new/. Updated October 9, 2020. Accessed October 15, 2020.
2. Bikdeli B, Madhavan MV, Jimenez D, et al. COVID-19 and thrombotic or thromboembolic disease: implications for prevention, antithrombotic therapy, and follow-up: JACC state-of-the-art review. J Am Coll Cardiol. 2020;75(23):2950-2973. doi:10.1016/j.jacc.2020.04.031
3. Barnes GD, Burnett A, Allen A, et al. Thromboembolism and anticoagulant therapy during the COVID-19 pandemic: interim clinical guidance from the anticoagulation forum. J Thromb Thrombolysis. 2020;50(1):72-81. doi:10.1007/s11239-020-02138-z
4. Spyropoulos AC, Levy JH, Ageno W, et al. Scientific and Standardization Committee communication: Clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020;18(8):1859-1865. doi:10.1111/jth.14929
5. Moores LK, Tritschler T, Brosnahan S, et al. Prevention, Diagnosis, and Treatment of VTE in Patients With Coronavirus Disease 2019: CHEST Guideline and Expert Panel Report. Chest. 2020;158(3):1143-1163. doi:10.1016/j.chest.2020.05.559
6. Al-Samkari H, Karp Leaf RS, Dzik WH, et al. COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection. Blood. 2020;136(4):489-500. doi:10.1182/blood.2020006520.
7. van Dam LF, Kroft LJM, van der Wal LI, et al. Clinical and computed tomography characteristics of COVID-19 associated acute pulmonary embolism: a different phenotype of thrombotic disease?. Thromb Res. 2020;193:86-89. doi:10.1016/j.thromres.2020.06.010
8. Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(suppl 2):e195S-e226S. doi:10.1378/chest.11-2296
9. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines [published correction appears in Chest. 2012 May;141(5):1369]. Chest. 2012;141(suppl 2):e227S-e277S. doi:10.1378/chest.11-2297
10. ACOG Practice Bulletin No. 196 Summary: thromboembolism in pregnancy. Obstet Gynecol. 2018;132(1):243-248. doi:10.1097/AOG.0000000000002707
11. Royal College of Obstetricians and Gynaecologists. Reducing the risk of venous thromboembolism during pregnancy and the puerperium. Green-top Guideline. No. 37a. https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf. Published April 2015. Accessed October 15, 2020.
12. Nadkarni GN, Lala A, Bagiella E, et al. Anticoagulation, mortality, bleeding and pathology among patients hospitalized with COVID-19: a single health system study [published online ahead of print, 2020 Aug 24]. J Am Coll Cardiol. 2020;76(16):1815-1826. doi:10.1016/j.jacc.2020.08.041
13. US Department of Veterans Affairs. Department of Veterans Affairs COVID-19 national summary. https://www.accesstocare.va.gov/Healthcare/COVID19NationalSummary. Updated November 1, 2020. Accessed November 1, 2020.
14. George B, Gonzales S, Patel K, Petit S, Franck AJ, Bovio Franck J. Impact of a clinical decision-support tool on venous thromboembolism prophylaxis in acutely ill medical patients. J Pharm Technol. 2020;36(4):141-147. doi:10.1177/8755122520930288
1. National Institutes of Health. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/whats-new/. Updated October 9, 2020. Accessed October 15, 2020.
2. Bikdeli B, Madhavan MV, Jimenez D, et al. COVID-19 and thrombotic or thromboembolic disease: implications for prevention, antithrombotic therapy, and follow-up: JACC state-of-the-art review. J Am Coll Cardiol. 2020;75(23):2950-2973. doi:10.1016/j.jacc.2020.04.031
3. Barnes GD, Burnett A, Allen A, et al. Thromboembolism and anticoagulant therapy during the COVID-19 pandemic: interim clinical guidance from the anticoagulation forum. J Thromb Thrombolysis. 2020;50(1):72-81. doi:10.1007/s11239-020-02138-z
4. Spyropoulos AC, Levy JH, Ageno W, et al. Scientific and Standardization Committee communication: Clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020;18(8):1859-1865. doi:10.1111/jth.14929
5. Moores LK, Tritschler T, Brosnahan S, et al. Prevention, Diagnosis, and Treatment of VTE in Patients With Coronavirus Disease 2019: CHEST Guideline and Expert Panel Report. Chest. 2020;158(3):1143-1163. doi:10.1016/j.chest.2020.05.559
6. Al-Samkari H, Karp Leaf RS, Dzik WH, et al. COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection. Blood. 2020;136(4):489-500. doi:10.1182/blood.2020006520.
7. van Dam LF, Kroft LJM, van der Wal LI, et al. Clinical and computed tomography characteristics of COVID-19 associated acute pulmonary embolism: a different phenotype of thrombotic disease?. Thromb Res. 2020;193:86-89. doi:10.1016/j.thromres.2020.06.010
8. Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(suppl 2):e195S-e226S. doi:10.1378/chest.11-2296
9. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines [published correction appears in Chest. 2012 May;141(5):1369]. Chest. 2012;141(suppl 2):e227S-e277S. doi:10.1378/chest.11-2297
10. ACOG Practice Bulletin No. 196 Summary: thromboembolism in pregnancy. Obstet Gynecol. 2018;132(1):243-248. doi:10.1097/AOG.0000000000002707
11. Royal College of Obstetricians and Gynaecologists. Reducing the risk of venous thromboembolism during pregnancy and the puerperium. Green-top Guideline. No. 37a. https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf. Published April 2015. Accessed October 15, 2020.
12. Nadkarni GN, Lala A, Bagiella E, et al. Anticoagulation, mortality, bleeding and pathology among patients hospitalized with COVID-19: a single health system study [published online ahead of print, 2020 Aug 24]. J Am Coll Cardiol. 2020;76(16):1815-1826. doi:10.1016/j.jacc.2020.08.041
13. US Department of Veterans Affairs. Department of Veterans Affairs COVID-19 national summary. https://www.accesstocare.va.gov/Healthcare/COVID19NationalSummary. Updated November 1, 2020. Accessed November 1, 2020.
14. George B, Gonzales S, Patel K, Petit S, Franck AJ, Bovio Franck J. Impact of a clinical decision-support tool on venous thromboembolism prophylaxis in acutely ill medical patients. J Pharm Technol. 2020;36(4):141-147. doi:10.1177/8755122520930288
Why Accept a VA Detail or Short-Term Assignment? Benefits to Employees and the Service
In the Veterans Health Administration (VHA), there are frequent e-mails and requests for employees to accept a detail or short-term assignment across a wide range of positions from administrative to executive leadership. These opportunities afford an employee and the service line valuable benefits and growth opportunities; however, there are reasons why some may be reluctant to pursue these opportunities. In this article, we discuss the barriers to applying for and accepting detail positions and the benefits for the employee and the service lines during periods of standard operations as well as during emergencies requiring alternative staffing strategies.
Details are short-term assignments used to fill a vacant position while hiring for the permanent position or to fill a short-term need (eg, during a pandemic). Details usually last 30 to 120 days, though they may be extended, depending on the position, the number of people willing to serve in the detailed role, and the time to select a candidate for the permanent position. Details can be created for any skill level or type of position to meet an identified need, but they are most often needed for supervisory or leadership roles.
The COVID-19 pandemic has shed light on the importance of individuals’ flexibility and adaptability both within and between roles. Many US Department of Veterans Affairs (VA) facilities stood up Incident Command structures to support the changes required to adapt to the needs created by the pandemic. Establishing an Incident Command means that people within the organization must take on new responsibilities, and in many cases, they are detailed to new positions that were not needed or prioritized before the pandemic.
Barriers
An employee may be reluctant to apply for or accept a detail because he or she has little to no experience; feels uncomfortable stepping into an unfamiliar role; is concerned about making a leap from a clinical to administrative role; has uncertainty whether the job is a good professional fit; dislikes the lack of a pay increase during the detail period even if the new role has more responsibility; and has concern that serving in the detail may make them ineligible to apply for the permanent position due to a perception of being preselected. Additionally, the employee may recognize the added stress on colleagues because the same amount of work must be completed.
Benefits
Although leaving a position for a period of months can be stressful, serving in a detail position provides significant opportunities for professional growth. An employee can gain knowledge and experience in an unfamiliar role before applying for or committing to a permanent position. Those serving in temporary details are often given more support as colleagues and supervisors understand that the role was accepted on short notice with little time to prepare. Other benefits include expanding professional contacts, gaining perspective on a different part of the VHA, and working on skills, such as flexibility, time management, and perseverance. By succeeding in a detail, employees build professional acumen. After taking on additional challenges they become more competitive for future jobs. The VHA Executive Candidate Development Program requires a 120-day detail, serving as either assistant or associate director, chief of staff, or associate director for patient care services/nurse executive as part of the program.1
Temporarily leaving a service line to detail in a different service line has an impact on the home service because of the restrictions imposed. These restrictions guarantee that the employee can return to the original position at the end of a detail, thus providing a sense of job security; however, the home service line is down an employee.
Given these considerations, the following are key points to establish before undertaking the detail: (1) length of assignment; (2) once started, potential for the assignment to be extended; (3) will the employee be doing any of their prior job or just the new job or a blend of both; (4) possible changes in hours and site of work of the employee; (5) who will supervise the employee; (6) who will write the employee’s review; (7) training or skills needed prior to starting; (8) necessary paperwork; (9) how will the new assignment be communicated to others; (10) what happens if the detail ends sooner than planned; and (11) approval and support of all involved parties.
The employee’s home service may need a temporary plan to cover the employee’s workload, especially if the employee will be detailed to a different service line. The temporary plan may require creativity and flexibility and can be a way to trial the contingency plans for staffing the home service. One benefit to the home service is that the employee will have additional skills on returning that may benefit the home service, and the service will gain a potential leader.
When an employee goes to a different service, that service gains an employee who may bring a new perspective to help solve existing conflicts or problems. This can serve as a time to reset expectations or set new goals prior to the arrival of new leadership. If the detail is a good fit, then there is the chance that the employee may return in the future or refer others to it as a professional opportunity.
Conclusions
A detail can benefit the employee and the home and host services if planned in advance, and all parties support the process. A short-term leadership or administrative assignment can help an employee gain valuable experience for the future.
1. US Department of Veterans Affairs. Improve VA’s employee experience.obamaadministration.archives.performance.gov/node/65741.html. Published 2017. Accessed October 19, 2020.
In the Veterans Health Administration (VHA), there are frequent e-mails and requests for employees to accept a detail or short-term assignment across a wide range of positions from administrative to executive leadership. These opportunities afford an employee and the service line valuable benefits and growth opportunities; however, there are reasons why some may be reluctant to pursue these opportunities. In this article, we discuss the barriers to applying for and accepting detail positions and the benefits for the employee and the service lines during periods of standard operations as well as during emergencies requiring alternative staffing strategies.
Details are short-term assignments used to fill a vacant position while hiring for the permanent position or to fill a short-term need (eg, during a pandemic). Details usually last 30 to 120 days, though they may be extended, depending on the position, the number of people willing to serve in the detailed role, and the time to select a candidate for the permanent position. Details can be created for any skill level or type of position to meet an identified need, but they are most often needed for supervisory or leadership roles.
The COVID-19 pandemic has shed light on the importance of individuals’ flexibility and adaptability both within and between roles. Many US Department of Veterans Affairs (VA) facilities stood up Incident Command structures to support the changes required to adapt to the needs created by the pandemic. Establishing an Incident Command means that people within the organization must take on new responsibilities, and in many cases, they are detailed to new positions that were not needed or prioritized before the pandemic.
Barriers
An employee may be reluctant to apply for or accept a detail because he or she has little to no experience; feels uncomfortable stepping into an unfamiliar role; is concerned about making a leap from a clinical to administrative role; has uncertainty whether the job is a good professional fit; dislikes the lack of a pay increase during the detail period even if the new role has more responsibility; and has concern that serving in the detail may make them ineligible to apply for the permanent position due to a perception of being preselected. Additionally, the employee may recognize the added stress on colleagues because the same amount of work must be completed.
Benefits
Although leaving a position for a period of months can be stressful, serving in a detail position provides significant opportunities for professional growth. An employee can gain knowledge and experience in an unfamiliar role before applying for or committing to a permanent position. Those serving in temporary details are often given more support as colleagues and supervisors understand that the role was accepted on short notice with little time to prepare. Other benefits include expanding professional contacts, gaining perspective on a different part of the VHA, and working on skills, such as flexibility, time management, and perseverance. By succeeding in a detail, employees build professional acumen. After taking on additional challenges they become more competitive for future jobs. The VHA Executive Candidate Development Program requires a 120-day detail, serving as either assistant or associate director, chief of staff, or associate director for patient care services/nurse executive as part of the program.1
Temporarily leaving a service line to detail in a different service line has an impact on the home service because of the restrictions imposed. These restrictions guarantee that the employee can return to the original position at the end of a detail, thus providing a sense of job security; however, the home service line is down an employee.
Given these considerations, the following are key points to establish before undertaking the detail: (1) length of assignment; (2) once started, potential for the assignment to be extended; (3) will the employee be doing any of their prior job or just the new job or a blend of both; (4) possible changes in hours and site of work of the employee; (5) who will supervise the employee; (6) who will write the employee’s review; (7) training or skills needed prior to starting; (8) necessary paperwork; (9) how will the new assignment be communicated to others; (10) what happens if the detail ends sooner than planned; and (11) approval and support of all involved parties.
The employee’s home service may need a temporary plan to cover the employee’s workload, especially if the employee will be detailed to a different service line. The temporary plan may require creativity and flexibility and can be a way to trial the contingency plans for staffing the home service. One benefit to the home service is that the employee will have additional skills on returning that may benefit the home service, and the service will gain a potential leader.
When an employee goes to a different service, that service gains an employee who may bring a new perspective to help solve existing conflicts or problems. This can serve as a time to reset expectations or set new goals prior to the arrival of new leadership. If the detail is a good fit, then there is the chance that the employee may return in the future or refer others to it as a professional opportunity.
Conclusions
A detail can benefit the employee and the home and host services if planned in advance, and all parties support the process. A short-term leadership or administrative assignment can help an employee gain valuable experience for the future.
In the Veterans Health Administration (VHA), there are frequent e-mails and requests for employees to accept a detail or short-term assignment across a wide range of positions from administrative to executive leadership. These opportunities afford an employee and the service line valuable benefits and growth opportunities; however, there are reasons why some may be reluctant to pursue these opportunities. In this article, we discuss the barriers to applying for and accepting detail positions and the benefits for the employee and the service lines during periods of standard operations as well as during emergencies requiring alternative staffing strategies.
Details are short-term assignments used to fill a vacant position while hiring for the permanent position or to fill a short-term need (eg, during a pandemic). Details usually last 30 to 120 days, though they may be extended, depending on the position, the number of people willing to serve in the detailed role, and the time to select a candidate for the permanent position. Details can be created for any skill level or type of position to meet an identified need, but they are most often needed for supervisory or leadership roles.
The COVID-19 pandemic has shed light on the importance of individuals’ flexibility and adaptability both within and between roles. Many US Department of Veterans Affairs (VA) facilities stood up Incident Command structures to support the changes required to adapt to the needs created by the pandemic. Establishing an Incident Command means that people within the organization must take on new responsibilities, and in many cases, they are detailed to new positions that were not needed or prioritized before the pandemic.
Barriers
An employee may be reluctant to apply for or accept a detail because he or she has little to no experience; feels uncomfortable stepping into an unfamiliar role; is concerned about making a leap from a clinical to administrative role; has uncertainty whether the job is a good professional fit; dislikes the lack of a pay increase during the detail period even if the new role has more responsibility; and has concern that serving in the detail may make them ineligible to apply for the permanent position due to a perception of being preselected. Additionally, the employee may recognize the added stress on colleagues because the same amount of work must be completed.
Benefits
Although leaving a position for a period of months can be stressful, serving in a detail position provides significant opportunities for professional growth. An employee can gain knowledge and experience in an unfamiliar role before applying for or committing to a permanent position. Those serving in temporary details are often given more support as colleagues and supervisors understand that the role was accepted on short notice with little time to prepare. Other benefits include expanding professional contacts, gaining perspective on a different part of the VHA, and working on skills, such as flexibility, time management, and perseverance. By succeeding in a detail, employees build professional acumen. After taking on additional challenges they become more competitive for future jobs. The VHA Executive Candidate Development Program requires a 120-day detail, serving as either assistant or associate director, chief of staff, or associate director for patient care services/nurse executive as part of the program.1
Temporarily leaving a service line to detail in a different service line has an impact on the home service because of the restrictions imposed. These restrictions guarantee that the employee can return to the original position at the end of a detail, thus providing a sense of job security; however, the home service line is down an employee.
Given these considerations, the following are key points to establish before undertaking the detail: (1) length of assignment; (2) once started, potential for the assignment to be extended; (3) will the employee be doing any of their prior job or just the new job or a blend of both; (4) possible changes in hours and site of work of the employee; (5) who will supervise the employee; (6) who will write the employee’s review; (7) training or skills needed prior to starting; (8) necessary paperwork; (9) how will the new assignment be communicated to others; (10) what happens if the detail ends sooner than planned; and (11) approval and support of all involved parties.
The employee’s home service may need a temporary plan to cover the employee’s workload, especially if the employee will be detailed to a different service line. The temporary plan may require creativity and flexibility and can be a way to trial the contingency plans for staffing the home service. One benefit to the home service is that the employee will have additional skills on returning that may benefit the home service, and the service will gain a potential leader.
When an employee goes to a different service, that service gains an employee who may bring a new perspective to help solve existing conflicts or problems. This can serve as a time to reset expectations or set new goals prior to the arrival of new leadership. If the detail is a good fit, then there is the chance that the employee may return in the future or refer others to it as a professional opportunity.
Conclusions
A detail can benefit the employee and the home and host services if planned in advance, and all parties support the process. A short-term leadership or administrative assignment can help an employee gain valuable experience for the future.
1. US Department of Veterans Affairs. Improve VA’s employee experience.obamaadministration.archives.performance.gov/node/65741.html. Published 2017. Accessed October 19, 2020.
1. US Department of Veterans Affairs. Improve VA’s employee experience.obamaadministration.archives.performance.gov/node/65741.html. Published 2017. Accessed October 19, 2020.
The Veterans Affairs Patient Safety Center of Inquiry—Suicide Prevention Collaborative: Creating Novel Approaches to Suicide Prevention Among Veterans Receiving Community Services
Since 2008, suicide has ranked as the tenth leading cause of death for all ages in the US, with rates of suicide continuing to rise.1-3 Suicide is even more urgent to address in veteran populations. The age- and sex-adjusted suicide rate in 2017 was more than 1.5 times greater for veterans than it was for nonveteran adults.2 Of importance, rates of suicide are increasing at a faster rate in veterans who are not connected to Veterans Health Administration (VHA) care.4,5 These at-risk veterans include individuals who are eligible for VHA care yet have not had a VHA appointment within the year before death; veterans who may be ineligible to receive VHA care due to complex rules set by legislation; and veterans who are eligible but not enrolled in VHA care. Notably, between 2005 and 2016, the number of veterans not enrolled in VHA care rose more quickly than did the number of veterans enrolled in VHA care.5,6 Thus, to impact the high veteran suicide rates, an emergent challenge for VHA is to prevent suicide among unenrolled veterans and veterans receiving community care, while continuing to increase access to mental health services for veterans enrolled in VHA health care.
In response to the high rates of veteran suicide deaths, the US Department of Veterans Affairs (VA) has developed a broad, multicomponent suicide prevention program that is unparalleled in private US health care systems.4,7 Suicide prevention efforts are led and implemented by both the VHA National Center for Patient Safety and the VHA Office of Mental Health and Suicide Prevention. Program components are numerous and multifaceted, falling within the broad promotion and prevention strategies outlined by the National Academy of Medicine (NAM).1,8-11 The NAM continuum of prevention model encompassing multiple strategies is also referred to as the Universal, Selective, Indicated (USI) Model.7,8,10 The VHA suicide prevention program contains a wide spread of program components, making it both comprehensive and innovative (Table 1).
Although significant momentum and progress has been made within the VHA, policy set by legislation has historically limited access to VHA health care services to VHA-eligible veterans. This is particularly concerning given the rising suicide rates among veterans not engaged in VHA care.2 Adding to this complexity, recent legislation has increased veterans’ access to non-VHA health care, in addition to their existing access through Medicare, Medicaid, and other health care programs.12-14 Best practices for suicide prevention are not often implemented in the private sector; thus, these systems are ill prepared to adequately meet the suicide prevention care needs of veterans.4,15-18 Furthermore, VHA and non-VHA services generally are not well coordinated, and private sector health care providers (HCPs) are not required to complete a commensurate level of suicide prevention training as are VHA HCPs.16-18 Most non-VHA HCPs do not receive military cultural competence training.19 These issues create a significant gap in suicide prevention services and may contribute to the increases in suicide rates in veterans who do not receive VHA care. Thus, changes in policy to increase access through private sector care may have paradoxical effects on veteran suicide deaths. To impact the veteran suicide rate, VHA must develop and disseminate best practices for veterans who use non-VHA services.
A Roadmap to Suicide Prevention
There is significant momentum at the federal level regarding this issue. The President’s Roadmap to Empower Veterans and End the National Tragedy of Suicide (Executive Order 13,861) directs the VHA to work closely with community organizations to improve veteran suicide prevention.20 The VHA and partners, such as the Substance Abuse and Mental Health Services Administration (SAMHSA), are bridging this gap with collaborative efforts that increase suicide prevention resources for veterans living in the community through programs such as the Governor’s Challenges to Prevent Suicide Among Service Members, Veterans, and their Families. These programs intend to empower communities to develop statewide, strategic action plans to prevent veteran suicide.7,21-24
In addition to partnerships, VHA has built other aspects of outreach and intervention into its programming. A key VHA initiative is to “know all veterans” by committing to identifying and reaching out to all veterans who may be at risk for suicide.22 The VHA has committed to offering “emergency stabilization care for former service members who present at the facility with an emergent mental health need” regardless of eligibility.25 The intent is to provide temporary emergent mental health care to veterans who are otherwise ineligible for care, such as those who were discharged under other-than-honorable conditions while the VHA determines eligibility status.26 However, veterans must meet certain criteria, and there is a limit on services.
Although services are being expanded to reach veterans who do not access VHA health care, how to best implement these new directives with regard to suicide prevention is unclear. Strategic development and innovations to expand suicide prevention care to veterans outside the current reach of VHA are desperately needed.
Program Overview
VHA Patient Safety Center of Inquiry-Suicide Prevention Collaborative (PSCI-SPC), funded by the VHA National Center for Patient Safety, aims to help fill the gap in community-based suicide prevention for veterans. PSCI-SPC is located within the VHA Rocky Mountain Mental Illness Research, Education, and Clinical Center in Aurora, Colorado. The overarching mission of PSCI-SPC is to develop, implement, and evaluate practical solutions to reduce suicide among veterans not receiving VHA care. PSCI-SPC serves as a national clinical innovation and dissemination center for best practices in suicide prevention for organizations that serve veterans who receive care in the community. PSCI-SPC creates products to support dissemination of these practices to other VAMCs and works to ensure these programs are sustainable. PSCI-SPC focuses on 3 primary objectives. All PSCI-SPC projects are currently underway.
Objective 1: Growing a Community Learning Collaborative
Acknowledging that nearly two-thirds of veterans who die by suicide do not use VHA services, PSCI-SPC aims to reduce suicide among all veterans by expanding the reach of best practices for suicide prevention to veterans who receive myriad services in the community.27 Community organizations are defined here as organizations that may in some way serve, interact with, or work with veterans, and/or employ veterans. Examples include non-VHA health care systems, public services such as police and fire departments, nonprofit organizations, mental health clinics, and veterans’ courts. As veterans increasingly seek health care and other services within their communities, the success of suicide prevention will be influenced by the capability of non-VHA public and private organizations. Objective 1, therefore, seeks to develop a VHA-community collaborative that can be leveraged to improve systems of suicide prevention.
Current programs in the VHA have focused on implementation of suicide prevention awareness and prevention education campaigns instead of grassroots partnerships that are intended to be sustainable. Additionally, these programs typically lack the capacity and systems to sustain numerous meaningful community partnerships. Traditionally, community organizations have been hesitant to partner with government agencies, such as the VHA, due to histories of institutional mistrust and bureaucracy.28
The PSCI-SPC model for developing a VHA-community collaborative partnership draws from the tradition of community-based participatory research. The best community-based participatory research practices are to build on strengths and resources within the local community; develop collaborative, equitable partnerships that involve an empowering and power-sharing process; foster colearning, heuristics, and capacity building among partners; and focus on systems development using an iterative process. These practices also are consistent with the literature on learning collaboratives.29-31
The premise for a learning collaborative is to bridge the gap between knowledge and practice in health care.31 Figure 1 depicts how this collaborative was developed, and how it supports Objectives 2 and 3. To achieve Objective 1, we developed a VHA-learning collaborative of 13 influential community partners in the Denver and Colorado Springs region of Colorado. The VHA team consists of a learning collaborative leader, a program manager, and a program support assistant. The principal investigator attends and contributes to all meetings. Learning collaborative partners include a university psychology clinic that focuses on veterans’ care, 3 veterans service organizations, a mental health private practice, a university school of nursing, a community mental health center, veterans’ courts, and 5 city departments.
These partners participated in qualitative interviews to identify where gaps and breakdowns were occurring. With this information, the PSCI-SPC team and VHA-learning collaborative held a kickoff event. At this meeting the team discussed the qualitative findings, provided veteran suicide prevention information, and basic information regarding suicide prevention program building and implementation science.
Throughout quarterly learning collaborative meetings and monthly facilitation calls, we have worked to develop a blueprint and an action plan for each partner to develop best practices for dissemination to aid in providing consistency in the standard of care. A postimplementation event will be held to identify successes and challenges encountered while operationalizing project action plans.
Currently, activities of the learning collaborative are making a large impact on the community. Not all collaborative members track information regarding their populations served, nor specific metrics on veterans encountered. Even so, of those who do capture metrics, suicide prevention program components implemented by the collaborative will impact more than 21,000 individuals and at least 2,500 known veterans. In addition, 52 new connections have been made between community organizations or between community organizations and the VHA, and > 300 individuals have been trained.The learning collaborative support team has assisted in the dissemination of a large resource list for veterans. As the learning collaborative is ongoing and we are working with organizations to improve their data collection and analytics, we expect these numbers to increase. We anticipate that the learning collaborative will develop a stronger suicide prevention safety net within the community. In addition, we expect increased referrals of at-risk veterans to the VHA and enhance the long-term continuity of care between community and VHA services.
Objective 2: Implementation Toolkit
The second PSCI-SPC objective is to develop a toolkit for the implementation of best practices within a VHA-community suicide prevention learning collaborative. Lessons from the development of a successful suicide prevention learning collaborative will be shared through an online guide that other VHA facilities can use to support similar collaborative efforts within their communities. The toolkit will be disseminated across the VHA to assist suicide prevention coordinators and other staff in developing a suicide prevention learning collaborative at their facilities.
PSCI-SPC uses the Zero Suicide framework and the VA/US Department of Defense (DoD) Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide as models for preventing suicide in veterans not enrolled in VHA care.11,32 This implementation toolkit focuses on how to implement suicide prevention best practices into organizations that serve veterans. This toolkit differs from clinical practice guidelines in that it focuses on implementation strategies to promote success and effectively address challenges.
In order to provide a menu of available options for the learning collaborative and resulting toolkit, PSCI-SPC uses a logic model to compare the components of the VHA suicide prevention program, as well as other similar veteran and military suicide prevention programs.7,12,14,21,33,34 These programs are categorized into 2 types of prevention frameworks, the USI model as described above, and the SAMHSA Strategic Prevention Framework (Table 2).35 The SAMHSA framework was designed to promote mental health and prevent substance abuse, yet the derived classification is also applicable to suicide prevention programs.35 The results of the logic model comparison form the basis of the best practice interventions for the learning collaborative and initial toolkit. In addition to the best practice interventions, the toolkit consists of documents describing how to develop a veteran suicide prevention learning collaborative, as well as tools for learning collaborative members. Current tool development includes workbooks to guide collaborative members through the implementation process, guides for community organizations in implementing suicide prevention screening and risk assessment, a standard operating procedure for suicide prevention in a veterans court, and peer support training for veteran suicide prevention.
The methods to achieve Objective 2 include regular discussions with the VHA-learning collaborative on current best practices, identifying gaps and overlap of community programs. Successes and challenges of implementing suicide prevention best practices into learning collaborative organizations will be documented and incorporated into the toolkit. The learning collaborative will work iteratively as a team to improve the toolkit. Once complete, the toolkit will be disseminated to other VHA health care systems nationally, as well as to other state or regional partners that the learning collaborative identifies. A plan is under development for national suicide prevention entities to also disseminate the toolkit to lessen the burden of veteran suicide through their stakeholder base.
Objective 3: High-Risk Veterans Not Receiving VHA Care
Although veterans not receiving VHA care account for a number of veteran deaths by suicide, we are not aware of any current VHA programs that provide temporary psychotherapy and intensive case management to at-risk veterans ineligible for VHA care who are in need of immediate care while an appropriate permanent community placement is identified. In the current system, veterans in the community can present to VHA suicide prevention services through several different systems, including referrals to VHA and the Veterans Crisis Line (VCL). However, a portion of VCL calls are from veterans whose VHA eligibility is unknown or who are ineligible for services. If veterans are at imminent risk for suicide, emergency care is coordinated for them. However, if veterans are not at imminent suicide risk they are referred to the local suicide prevention coordinator and instructed to independently work toward determining their VHA eligibility.
It is currently unknown how many veterans follow through with these instructions. Nonetheless, if veterans are deemed eligible, they may present to VHA to obtain a same-day appointment. If not eligible, a suicide prevention coordinator may give them the phone number of a community referral. However, this practice is not standardized across VA medical centers, and the provided resources are up to the suicide prevention coordinator to research. Additionally, when a VHA suicide prevention coordinator leaves the position, knowledge of these community resources and rapport with community HCPs are often lost, leaving the next coordinator to develop these again, which reduces the efficiency and effectiveness of limited resources. It is also unknown how many veterans complete this contact and receive evidence-based treatment following referral. This is a complex system to navigate, particularly when at risk for suicide and in need of immediate but not emergency services.
Suicide prevention in such circumstances may be improved by adapting current suicide prevention practices, including evidence-based interventions, and the new VHA intensive case management program,11,36 within a Zero Suicide framework. PSCI-SPC has developed a brief intervention to transition ineligible veterans to permanent community treatment and provide them with additional resources to meet their varied needs. The brief 1 to 3 session intervention combines practices from brief cognitive behavioral therapy (BCBT) for suicide prevention, crisis response planning (CRP), and intensive case management within a Zero Suicide framework. Both the 2019 VA/DoD suicide prevention clinical practice guidelines and Zero Suicide recommend using cognitive behavioral therapy (CBT)-based interventions for suicide prevention.11,32 These interventions are packaged into a single intervention delivered by a PSCI-SPC therapist, typically a licensed clinical social worker, a licensed clinical psychologist, or an unlicensed psychologist under the supervision of a licensed clinical psychologist.
BCBT is one type of CBT that has shown initial efficacy in reducing suicide attempts.37 BCBT reduces the risk for suicide attempts both at the conclusion of treatment and at 24-month follow-up.37 BCBT is boiled down to its most essential components so it can be delivered in a distilled format. An essential element of BCBT that will remain is the CRP. A CRP11,37,38 entails collaboratively identifying effective, appropriate coping strategies and specific individuals to contact during a crisis. CRPs demonstrated efficacy as a stand-alone intervention to existing suicide prevention methods in a randomized clinical trial, such that individuals who received CRP had faster reductions in suicidal ideation and were 76% less likely to make a suicide attempt during the 6-month follow-up period.39 These results demonstrate that use of a CRP is connected to a decrease in suicidal behavior among suicidal patients.
The VHA has developed and is piloting a new initiative focused on restructuring its intensive case management services. RACETIME to Integrated Care (eg, Risk stratification, Assessment of complexity, Coordinator of lead assignment, Evaluate whole health needs, Trusting partnerships, Integrate care, Monitor progress, Experience of the veteran and employee) is a framework that assists VHA case managers in transitioning from a traditional case management mind-set to a more integrated and holistic method of care.36 RACETIME intensive case management practices will be incorporated into the intervention. However, RACETIME focuses on case management internally to the VHA. A modification for this treatment will be to focus on intensive case management from a mental health perspective and connecting to external community resources. Community referrals are mapped within a structured process and stored on a shared drive. This improves continuity between suicide prevention coordinators when they leave for a new position.
This intervention is conducted within a Zero Suicide framework. Pertinent to PSCI-SPC innovation to enhance care for non-VHA veterans is the care transitions element within the Zero Suicide framework, which has developed comprehensive suicide prevention guidance, including a pathway to care.32 This pathway refers a process to conduct follow-up supportive contacts that are tracked and recorded.
The PSCI-SPC pilot program incorporates the elements of CRP and brief CBT within a Zero Suicide framework. The PSCI-SPC team is developing and testing a protocol for providing brief treatment and community referrals to ineligible veterans that integrates these programming elements (Figure 2). A PSCI-SPC social worker will coordinate with the eligibility office to determine VHA eligibility. Ineligible veterans are referred to community partners and nonenrolled, eligible veterans are linked to VHA HCPs if they desire. These transitions will be coordinated, closely monitored, and verified.
Once the eligibility is determined, and the veteran’s preference is assessed, the team will perform a warm handoff to a VHA representative for enrollment into VHA care or to a community placement. We have sourced multiple community placements at varied payor levels. All veterans who are ineligible for care or who do not desire to be enrolled in VHA care will be provided the intervention package described above. After the veteran is placed in community care, PSCI-SPC team will follow up regularly with the veteran for 3 months to ensure continuity of care. If additional sessions are needed while the veteran needs a community placement, the PSCI team can accommodate this and will track the number of participants who needed additional sessions. If the veteran is deemed to be at imminent risk for suicide at any time during the pilot, he/she is transferred to emergency care. The veteran is allowed to participate once stabilized.
Findings from the pilot program will inform a manual intended for dissemination to patient safety and suicide prevention coordinators nationally across the VHA. The products from this objective will be integrated with the other objectives in training that will be provided on how to develop a local collaborative (Objective 1), disseminate the toolkit (Objective 2), and receive referrals into VHA or refer veterans to community clinical partners through the pilot program (Objective 3). Products developed and disseminated throughout PSCI-SPC aim to create momentum to reduce rates of suicide in veterans who are not connected to the VHA at the local community level.
Discussion
Improving suicide prevention for veterans who receive non-VHA health care is essential to significantly reduce veteran suicide rates. For the past decade, VHA suicide prevention initiatives have largely focused on veterans eligible for care, although the fastest increase in veteran suicide rates has occurred among veterans not connected to VHA services. Currently, if a veteran is deemed ineligible for care, it is up to the veteran to find other health care services in his or her community. There is not always a clear next step for the veteran to take, nor clear guidance provided to the VHA registration staff to assist with this care transition. This is particularly concerning for veterans at high risk for suicide as this could further thwart the veteran’s sense of belongingness and increase perceived burdensomeness, both suicide risk factors, and discourage them from attaining help.40 Overall, while the VHA has successfully implemented diverse suicide prevention initiatives and services, the need for continued system improvement focused on non-VHA veterans remains. PSCI-SPC was developed for this purpose.
By creating a collaborative that will connect VHA and community organizations, there will be better utilization of resources and more appropriate referrals throughout systems that interact with veterans. Sharing suicide prevention best practices between VHA and community partners is expected to increase access to mental health treatment to all veterans. Finally, by allowing best practices for suicide prevention in the VHA to serve as a guide in the development of best practices for suicide prevention between the VHA and the local health and behavioral health care community, PSCI-SPC will create a new suicide prevention intervention for veterans with mental health needs. Through these initiatives, PSCI-SPC will support providers’ and concerned citizens’ efforts to ensure that fewer veterans fall through the cracks of disjointed systems and will promote healthier communities where, regardless of VHA enrollment status, veterans receive suicide prevention care.
Conclusions
PSCI-SPC is a novel center for the innovation and dissemination of the nation’s best practices in suicide prevention for veterans who are ineligible for or otherwise not engaged in VHA services and who turn to their community for health care. PSCI-SPC not only seeks to create, develop, and measure various solutions to reduce suicide among veterans who receive non-VHA care, but also seeks to facilitate the overall quality of existing practices for suicide prevention and care coordination for enrolled veterans who use community resources. By bridging the gap between the VHA, civilian health care systems, and other community partners striving to prevent veteran suicides, we can create better access to care and a more seamless path of communication among these important entities that impact the lives of our veterans daily
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19. Tanielian T, Farris C, Epley C, et al. Ready to serve: community-based provider capacity to deliver culturally competent, quality mental health care to veterans and their families. https://www.rand.org/content/dam/rand/pubs/research_reports/RR800/RR806/RAND_RR806.pdf. Published 2014. Accessed October 15, 2020.
20. White House. Executive Order 13861: President’s roadmap to empower veterans and end the national tragedy of suicide (PREVENTS). https://www.va.gov/PREVENTS/docs/PRE-007-The-PREVENTS-Roadmap-1-2_508.pdf. Published June 17, 2020. Accessed October 15, 2020.
21. US Department of Veterans Affairs, Office of the Under Secretary for Health. Memorandum. VA continues community suicide prevention challenge at another mayor’s challenge policy academy. https://www.blogs.va.gov/VAntage/58468/va-continues-community-suicide-prevention-challenge-another-mayors-challenge-policy-academy. Published April 4, 2019. Accessed October 15, 2020.
22. US Department of Veterans Affairs, Veterans Health Administration (VHA) Veterans Health Administration (VHA) Fiscal Year (FY) 2018-2019 Operational Plan. www.navao.org/wp-content/uploads/2018/06/USH-Memo-10-2018-03-VHA_FY_2018-2019_Operational_Plan-4-19-18.pdf. Published April 19, 2018. Accessed October 15, 2020.
23. US Department of Veterans Affairs. VA, Health and Human Services announce governor’s challenge to prevent suicide. https://www.blogs.va.gov/VAntage/55707/va-health-human-services-announce-governors-challenge-prevent-suicide. Published January 17, 2019. Accessed October 15, 2020.
24. VA’s suicide prevention campaign “Be There’’ kicks off in Times Square. https://www.blogs.va.gov/VAntage/57272/vas-suicide-prevention-campaign-kicks-off-times-square. Published March 6, 2019. Accessed October 15, 2020.
25. US Department of Veterans Affairs, Office of Public Affairs Media Relations. Emergent mental health care for former service members. https://www.mentalhealth.va.gov/docs/Fact_Sheet-Emergent_Mental_Health_Care_Former_Service_Members.pdf. Published 2017. Accessed October 15, 2020.
26. US Department of Veterans Affairs. VA secretary formalizes expansion of emergency mental health care to former service members with other-than-honorable discharges. https://www.blogs.va.gov/VAntage/39092/va-secretary-formalizes-expansion-emergency-mental-health-care-former-service-members-honorable-discharges. Published June 27, 2017. Accessed October 15, 2020.
27. Shane L. New veteran suicide numbers raise concerns among experts hoping for positive news. Military Times. https://www.militarytimes.com/news/pentagon-congress/2019/10/09/new-veteran-suicide-numbers-raise-concerns-among-experts-hoping-for-positive-news. Published October 9, 2019. Accessed October 15, 2020.
28. US Department of Veterans Affairs. Department of Veterans Affairs FY 2018-2024 Strategic Plan. https://www.va.gov/oei/docs/VA2018-2024strategicPlan.pdf. Updated May 31, 2019. Accessed October 15, 2020.
29. Komaie G, Goodman M, McCall A, et al. Training community members in public health research: development and implementation of a community participatory research pilot project. Health Equity. 2018;2(1):282-287. doi:10.1089/heq.2018.0043
30. Wang KH, Ray NJ, Berg DN, et al. Using community-based participatory research and organizational diagnosis to characterize relationships between community leaders and academic researchers. Prev Med Reports. 2017;7:180-186. doi:10.1016/j.pmedr.2017.06.007
31. Institute for Healthcare Improvement. The breakthrough series: IHI’s collaborative model for achieving breakthrough improvement. http://www.ihi.org/resources/Pages/IHIWhitePapers/TheBreakthroughSeriesIHIsCollaborativeModelforAchievingBreakthroughImprovement.aspx. Published 2003. Accessed October 15, 2020.
32. Zero Suicide in Health and Behavioral Health Care Institute. Zero suicide toolkit. https://zerosuicide.sprc.org/toolkit. Accessed October 15, 2020.

33. Preventing suicide: a technical package of policy, programs, and practices. https://www.cdc.gov/violenceprevention/pdf/suicideTechnicalPackage.pdf. Published 2017. Accessed October 30, 2020.
34. US Department of Veterans Affairs. VA Office of Mental Health and Suicide Prevention guidebook. https://www.mentalhealth.va.gov/docs/VA-Office-of-Mental-Health-and-Suicide-Prevention-Guidebook-June-2018-FINAL-508.pdf. Published June 2018. Accessed October 15, 2020.
35. US Department of Health and Human Services, Substance Abuse and Mental Health Services, Administration Center for Substance Abuse Prevention. Focus on prevention: strategies and programs to prevent substance abuse. HHS Publication No. (SMA) 10-4120. https://helpandhopewv.org/docs/Focus%20on%20Prevention.pdf. Revised 2017. Accessed October 15, 2020.
36. Misiti R, Risinger A. RACETIME: an organizational care coordination approach to improving patient outcomes in a complex healthcare setting. Presentation at the Military Social Work & Behavioral Health Conference Austin, Texas. July 23, 2020. https://sites.utexas.edu/military-social-work-conference/misiti-risinger. Accessed October 23, 2020.
37. Rudd MD, Bryan CJ, Wertenberger EG, et al. Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up. Am J Psychiatry. 2015;172(5):441-449. doi:10.1176/appi.ajp.2014.14070843
38. Rudd MD, Mandrusiak M, Joiner TE Jr. The case against no-suicide contracts: The commitment to treatment statement as a practice alternative. Clin Psychol. 2006;62(2):243-251.
39. Bryan CJ, Mintz J, Clemans TA, et al. Effect of crisis response planning vs. contracts for safety on suicide risk in US Army soldiers: a randomized clinical trial. J Affect Disord. 2017;212:64-72. doi:10.1016/j.jad.2017.01.028
40. Joiner TE. Why People Die by Suicide. Cambridge, MA: First Harvard University Press; 2005:27.
41. Office of the Under Secretary of Defense for Personnel and Readiness. DoD Instruction 6490.16: Defense suicide prevention program. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/649016p.pdf?ver=2020-09-11-122632-850. Published November 6, 2017. Updated September 11, 2020. Accessed October 14, 2020.
42. Zero Suicide in Health and Behavioral Health Care Institute. Engage: engaging patients. http://zerosuicide.edc.org/toolkit/engage#quicktabs-engage=0. Accessed October 14, 2020.
43. Stone D, Holland K, Bartholow B, Crosby A, Davis S, Wilkins N. Preventing Suicide: A technical package of policy, programs, and practices. https://www.cdc.gov/violenceprevention/pdf/suicidetechnicalpackage.pdf. Published 2017. Accessed October 14, 2020.
44. Mills PD, Watts BV, Miller S, et al. A checklist to identify inpatient suicide hazards in veterans affairs hospitals. Jt Comm J Qual Patient Saf. 2010;36(2):87-93. doi:10.1016/s1553-7250(10)36015-6
45. US Department of Veterans Affairs, Office of Research and Development. Crisis prevention: study evaluates VA program that identifies vets at highest risk for suicide. https://www.research.va.gov/currents/0918-Study-evaluates-VA-program-that-identifies-Vets-at-highest-risk-for-suicide.cfm. Updated September, 20, 2018. Accessed October 14, 2020.
46. Zero Suicide in Health and Behavioral Health Care Institute. Engage: active engagement for safer suicide care--reducing access to lethal means. http://zerosuicide.edc.org/toolkit/engage#quicktabs-engage=1. Published 2017. Accessed October 14, 2020.
47. Zero Suicide in Health and Behavioral Health Care Institute. Train: training for all. http://zerosuicide.sprc.org/toolkit/train. Accessed October 14, 2020.
48. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention (OMHSP). Facts about veteran suicide. https://www.mentalhealth.va.gov/docs/FINAL_VA_OMHSP_Suicide_Prevention_Fact_Sheet_508.pdf. Published June 2018. Accessed October 14, 2020.
49. Zero Suicide in Health and Behavioral Health Care Institute. Treat: direct treatment. http://zerosuicide.edc.org/toolkit/treat. Accessed October 14, 2020.
50. Office of the Under Secretary of Defense for Personnel and Readiness. DoD Instruction 6490.04: Mental health evaluations of members of the military services. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/649004p.pdf. Published March 4, 2013. Updated April 22, 2020. Accessed October 14, 2020.
51. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention Frequently asked questions: VA National Suicide Data Report. https://www.mentalhealth.va.gov/docs/data-sheets/2015_Data_Release_FAQs_508.pdf. Published September 2018. Updated June 22, 2018. Accessed October 14, 2020.
52. Zero Suicide in Health and Behavioral Health Care Institute. ZERO Suicide engage: active engagement for safer suicide care safety planning. http://zerosuicide.edc.org/toolkit/engage#quicktabs-engage=1. Accessed October 14, 2020.
Since 2008, suicide has ranked as the tenth leading cause of death for all ages in the US, with rates of suicide continuing to rise.1-3 Suicide is even more urgent to address in veteran populations. The age- and sex-adjusted suicide rate in 2017 was more than 1.5 times greater for veterans than it was for nonveteran adults.2 Of importance, rates of suicide are increasing at a faster rate in veterans who are not connected to Veterans Health Administration (VHA) care.4,5 These at-risk veterans include individuals who are eligible for VHA care yet have not had a VHA appointment within the year before death; veterans who may be ineligible to receive VHA care due to complex rules set by legislation; and veterans who are eligible but not enrolled in VHA care. Notably, between 2005 and 2016, the number of veterans not enrolled in VHA care rose more quickly than did the number of veterans enrolled in VHA care.5,6 Thus, to impact the high veteran suicide rates, an emergent challenge for VHA is to prevent suicide among unenrolled veterans and veterans receiving community care, while continuing to increase access to mental health services for veterans enrolled in VHA health care.
In response to the high rates of veteran suicide deaths, the US Department of Veterans Affairs (VA) has developed a broad, multicomponent suicide prevention program that is unparalleled in private US health care systems.4,7 Suicide prevention efforts are led and implemented by both the VHA National Center for Patient Safety and the VHA Office of Mental Health and Suicide Prevention. Program components are numerous and multifaceted, falling within the broad promotion and prevention strategies outlined by the National Academy of Medicine (NAM).1,8-11 The NAM continuum of prevention model encompassing multiple strategies is also referred to as the Universal, Selective, Indicated (USI) Model.7,8,10 The VHA suicide prevention program contains a wide spread of program components, making it both comprehensive and innovative (Table 1).
Although significant momentum and progress has been made within the VHA, policy set by legislation has historically limited access to VHA health care services to VHA-eligible veterans. This is particularly concerning given the rising suicide rates among veterans not engaged in VHA care.2 Adding to this complexity, recent legislation has increased veterans’ access to non-VHA health care, in addition to their existing access through Medicare, Medicaid, and other health care programs.12-14 Best practices for suicide prevention are not often implemented in the private sector; thus, these systems are ill prepared to adequately meet the suicide prevention care needs of veterans.4,15-18 Furthermore, VHA and non-VHA services generally are not well coordinated, and private sector health care providers (HCPs) are not required to complete a commensurate level of suicide prevention training as are VHA HCPs.16-18 Most non-VHA HCPs do not receive military cultural competence training.19 These issues create a significant gap in suicide prevention services and may contribute to the increases in suicide rates in veterans who do not receive VHA care. Thus, changes in policy to increase access through private sector care may have paradoxical effects on veteran suicide deaths. To impact the veteran suicide rate, VHA must develop and disseminate best practices for veterans who use non-VHA services.
A Roadmap to Suicide Prevention
There is significant momentum at the federal level regarding this issue. The President’s Roadmap to Empower Veterans and End the National Tragedy of Suicide (Executive Order 13,861) directs the VHA to work closely with community organizations to improve veteran suicide prevention.20 The VHA and partners, such as the Substance Abuse and Mental Health Services Administration (SAMHSA), are bridging this gap with collaborative efforts that increase suicide prevention resources for veterans living in the community through programs such as the Governor’s Challenges to Prevent Suicide Among Service Members, Veterans, and their Families. These programs intend to empower communities to develop statewide, strategic action plans to prevent veteran suicide.7,21-24
In addition to partnerships, VHA has built other aspects of outreach and intervention into its programming. A key VHA initiative is to “know all veterans” by committing to identifying and reaching out to all veterans who may be at risk for suicide.22 The VHA has committed to offering “emergency stabilization care for former service members who present at the facility with an emergent mental health need” regardless of eligibility.25 The intent is to provide temporary emergent mental health care to veterans who are otherwise ineligible for care, such as those who were discharged under other-than-honorable conditions while the VHA determines eligibility status.26 However, veterans must meet certain criteria, and there is a limit on services.
Although services are being expanded to reach veterans who do not access VHA health care, how to best implement these new directives with regard to suicide prevention is unclear. Strategic development and innovations to expand suicide prevention care to veterans outside the current reach of VHA are desperately needed.
Program Overview
VHA Patient Safety Center of Inquiry-Suicide Prevention Collaborative (PSCI-SPC), funded by the VHA National Center for Patient Safety, aims to help fill the gap in community-based suicide prevention for veterans. PSCI-SPC is located within the VHA Rocky Mountain Mental Illness Research, Education, and Clinical Center in Aurora, Colorado. The overarching mission of PSCI-SPC is to develop, implement, and evaluate practical solutions to reduce suicide among veterans not receiving VHA care. PSCI-SPC serves as a national clinical innovation and dissemination center for best practices in suicide prevention for organizations that serve veterans who receive care in the community. PSCI-SPC creates products to support dissemination of these practices to other VAMCs and works to ensure these programs are sustainable. PSCI-SPC focuses on 3 primary objectives. All PSCI-SPC projects are currently underway.
Objective 1: Growing a Community Learning Collaborative
Acknowledging that nearly two-thirds of veterans who die by suicide do not use VHA services, PSCI-SPC aims to reduce suicide among all veterans by expanding the reach of best practices for suicide prevention to veterans who receive myriad services in the community.27 Community organizations are defined here as organizations that may in some way serve, interact with, or work with veterans, and/or employ veterans. Examples include non-VHA health care systems, public services such as police and fire departments, nonprofit organizations, mental health clinics, and veterans’ courts. As veterans increasingly seek health care and other services within their communities, the success of suicide prevention will be influenced by the capability of non-VHA public and private organizations. Objective 1, therefore, seeks to develop a VHA-community collaborative that can be leveraged to improve systems of suicide prevention.
Current programs in the VHA have focused on implementation of suicide prevention awareness and prevention education campaigns instead of grassroots partnerships that are intended to be sustainable. Additionally, these programs typically lack the capacity and systems to sustain numerous meaningful community partnerships. Traditionally, community organizations have been hesitant to partner with government agencies, such as the VHA, due to histories of institutional mistrust and bureaucracy.28
The PSCI-SPC model for developing a VHA-community collaborative partnership draws from the tradition of community-based participatory research. The best community-based participatory research practices are to build on strengths and resources within the local community; develop collaborative, equitable partnerships that involve an empowering and power-sharing process; foster colearning, heuristics, and capacity building among partners; and focus on systems development using an iterative process. These practices also are consistent with the literature on learning collaboratives.29-31
The premise for a learning collaborative is to bridge the gap between knowledge and practice in health care.31 Figure 1 depicts how this collaborative was developed, and how it supports Objectives 2 and 3. To achieve Objective 1, we developed a VHA-learning collaborative of 13 influential community partners in the Denver and Colorado Springs region of Colorado. The VHA team consists of a learning collaborative leader, a program manager, and a program support assistant. The principal investigator attends and contributes to all meetings. Learning collaborative partners include a university psychology clinic that focuses on veterans’ care, 3 veterans service organizations, a mental health private practice, a university school of nursing, a community mental health center, veterans’ courts, and 5 city departments.
These partners participated in qualitative interviews to identify where gaps and breakdowns were occurring. With this information, the PSCI-SPC team and VHA-learning collaborative held a kickoff event. At this meeting the team discussed the qualitative findings, provided veteran suicide prevention information, and basic information regarding suicide prevention program building and implementation science.
Throughout quarterly learning collaborative meetings and monthly facilitation calls, we have worked to develop a blueprint and an action plan for each partner to develop best practices for dissemination to aid in providing consistency in the standard of care. A postimplementation event will be held to identify successes and challenges encountered while operationalizing project action plans.
Currently, activities of the learning collaborative are making a large impact on the community. Not all collaborative members track information regarding their populations served, nor specific metrics on veterans encountered. Even so, of those who do capture metrics, suicide prevention program components implemented by the collaborative will impact more than 21,000 individuals and at least 2,500 known veterans. In addition, 52 new connections have been made between community organizations or between community organizations and the VHA, and > 300 individuals have been trained.The learning collaborative support team has assisted in the dissemination of a large resource list for veterans. As the learning collaborative is ongoing and we are working with organizations to improve their data collection and analytics, we expect these numbers to increase. We anticipate that the learning collaborative will develop a stronger suicide prevention safety net within the community. In addition, we expect increased referrals of at-risk veterans to the VHA and enhance the long-term continuity of care between community and VHA services.
Objective 2: Implementation Toolkit
The second PSCI-SPC objective is to develop a toolkit for the implementation of best practices within a VHA-community suicide prevention learning collaborative. Lessons from the development of a successful suicide prevention learning collaborative will be shared through an online guide that other VHA facilities can use to support similar collaborative efforts within their communities. The toolkit will be disseminated across the VHA to assist suicide prevention coordinators and other staff in developing a suicide prevention learning collaborative at their facilities.
PSCI-SPC uses the Zero Suicide framework and the VA/US Department of Defense (DoD) Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide as models for preventing suicide in veterans not enrolled in VHA care.11,32 This implementation toolkit focuses on how to implement suicide prevention best practices into organizations that serve veterans. This toolkit differs from clinical practice guidelines in that it focuses on implementation strategies to promote success and effectively address challenges.
In order to provide a menu of available options for the learning collaborative and resulting toolkit, PSCI-SPC uses a logic model to compare the components of the VHA suicide prevention program, as well as other similar veteran and military suicide prevention programs.7,12,14,21,33,34 These programs are categorized into 2 types of prevention frameworks, the USI model as described above, and the SAMHSA Strategic Prevention Framework (Table 2).35 The SAMHSA framework was designed to promote mental health and prevent substance abuse, yet the derived classification is also applicable to suicide prevention programs.35 The results of the logic model comparison form the basis of the best practice interventions for the learning collaborative and initial toolkit. In addition to the best practice interventions, the toolkit consists of documents describing how to develop a veteran suicide prevention learning collaborative, as well as tools for learning collaborative members. Current tool development includes workbooks to guide collaborative members through the implementation process, guides for community organizations in implementing suicide prevention screening and risk assessment, a standard operating procedure for suicide prevention in a veterans court, and peer support training for veteran suicide prevention.
The methods to achieve Objective 2 include regular discussions with the VHA-learning collaborative on current best practices, identifying gaps and overlap of community programs. Successes and challenges of implementing suicide prevention best practices into learning collaborative organizations will be documented and incorporated into the toolkit. The learning collaborative will work iteratively as a team to improve the toolkit. Once complete, the toolkit will be disseminated to other VHA health care systems nationally, as well as to other state or regional partners that the learning collaborative identifies. A plan is under development for national suicide prevention entities to also disseminate the toolkit to lessen the burden of veteran suicide through their stakeholder base.
Objective 3: High-Risk Veterans Not Receiving VHA Care
Although veterans not receiving VHA care account for a number of veteran deaths by suicide, we are not aware of any current VHA programs that provide temporary psychotherapy and intensive case management to at-risk veterans ineligible for VHA care who are in need of immediate care while an appropriate permanent community placement is identified. In the current system, veterans in the community can present to VHA suicide prevention services through several different systems, including referrals to VHA and the Veterans Crisis Line (VCL). However, a portion of VCL calls are from veterans whose VHA eligibility is unknown or who are ineligible for services. If veterans are at imminent risk for suicide, emergency care is coordinated for them. However, if veterans are not at imminent suicide risk they are referred to the local suicide prevention coordinator and instructed to independently work toward determining their VHA eligibility.
It is currently unknown how many veterans follow through with these instructions. Nonetheless, if veterans are deemed eligible, they may present to VHA to obtain a same-day appointment. If not eligible, a suicide prevention coordinator may give them the phone number of a community referral. However, this practice is not standardized across VA medical centers, and the provided resources are up to the suicide prevention coordinator to research. Additionally, when a VHA suicide prevention coordinator leaves the position, knowledge of these community resources and rapport with community HCPs are often lost, leaving the next coordinator to develop these again, which reduces the efficiency and effectiveness of limited resources. It is also unknown how many veterans complete this contact and receive evidence-based treatment following referral. This is a complex system to navigate, particularly when at risk for suicide and in need of immediate but not emergency services.
Suicide prevention in such circumstances may be improved by adapting current suicide prevention practices, including evidence-based interventions, and the new VHA intensive case management program,11,36 within a Zero Suicide framework. PSCI-SPC has developed a brief intervention to transition ineligible veterans to permanent community treatment and provide them with additional resources to meet their varied needs. The brief 1 to 3 session intervention combines practices from brief cognitive behavioral therapy (BCBT) for suicide prevention, crisis response planning (CRP), and intensive case management within a Zero Suicide framework. Both the 2019 VA/DoD suicide prevention clinical practice guidelines and Zero Suicide recommend using cognitive behavioral therapy (CBT)-based interventions for suicide prevention.11,32 These interventions are packaged into a single intervention delivered by a PSCI-SPC therapist, typically a licensed clinical social worker, a licensed clinical psychologist, or an unlicensed psychologist under the supervision of a licensed clinical psychologist.
BCBT is one type of CBT that has shown initial efficacy in reducing suicide attempts.37 BCBT reduces the risk for suicide attempts both at the conclusion of treatment and at 24-month follow-up.37 BCBT is boiled down to its most essential components so it can be delivered in a distilled format. An essential element of BCBT that will remain is the CRP. A CRP11,37,38 entails collaboratively identifying effective, appropriate coping strategies and specific individuals to contact during a crisis. CRPs demonstrated efficacy as a stand-alone intervention to existing suicide prevention methods in a randomized clinical trial, such that individuals who received CRP had faster reductions in suicidal ideation and were 76% less likely to make a suicide attempt during the 6-month follow-up period.39 These results demonstrate that use of a CRP is connected to a decrease in suicidal behavior among suicidal patients.
The VHA has developed and is piloting a new initiative focused on restructuring its intensive case management services. RACETIME to Integrated Care (eg, Risk stratification, Assessment of complexity, Coordinator of lead assignment, Evaluate whole health needs, Trusting partnerships, Integrate care, Monitor progress, Experience of the veteran and employee) is a framework that assists VHA case managers in transitioning from a traditional case management mind-set to a more integrated and holistic method of care.36 RACETIME intensive case management practices will be incorporated into the intervention. However, RACETIME focuses on case management internally to the VHA. A modification for this treatment will be to focus on intensive case management from a mental health perspective and connecting to external community resources. Community referrals are mapped within a structured process and stored on a shared drive. This improves continuity between suicide prevention coordinators when they leave for a new position.
This intervention is conducted within a Zero Suicide framework. Pertinent to PSCI-SPC innovation to enhance care for non-VHA veterans is the care transitions element within the Zero Suicide framework, which has developed comprehensive suicide prevention guidance, including a pathway to care.32 This pathway refers a process to conduct follow-up supportive contacts that are tracked and recorded.
The PSCI-SPC pilot program incorporates the elements of CRP and brief CBT within a Zero Suicide framework. The PSCI-SPC team is developing and testing a protocol for providing brief treatment and community referrals to ineligible veterans that integrates these programming elements (Figure 2). A PSCI-SPC social worker will coordinate with the eligibility office to determine VHA eligibility. Ineligible veterans are referred to community partners and nonenrolled, eligible veterans are linked to VHA HCPs if they desire. These transitions will be coordinated, closely monitored, and verified.
Once the eligibility is determined, and the veteran’s preference is assessed, the team will perform a warm handoff to a VHA representative for enrollment into VHA care or to a community placement. We have sourced multiple community placements at varied payor levels. All veterans who are ineligible for care or who do not desire to be enrolled in VHA care will be provided the intervention package described above. After the veteran is placed in community care, PSCI-SPC team will follow up regularly with the veteran for 3 months to ensure continuity of care. If additional sessions are needed while the veteran needs a community placement, the PSCI team can accommodate this and will track the number of participants who needed additional sessions. If the veteran is deemed to be at imminent risk for suicide at any time during the pilot, he/she is transferred to emergency care. The veteran is allowed to participate once stabilized.
Findings from the pilot program will inform a manual intended for dissemination to patient safety and suicide prevention coordinators nationally across the VHA. The products from this objective will be integrated with the other objectives in training that will be provided on how to develop a local collaborative (Objective 1), disseminate the toolkit (Objective 2), and receive referrals into VHA or refer veterans to community clinical partners through the pilot program (Objective 3). Products developed and disseminated throughout PSCI-SPC aim to create momentum to reduce rates of suicide in veterans who are not connected to the VHA at the local community level.
Discussion
Improving suicide prevention for veterans who receive non-VHA health care is essential to significantly reduce veteran suicide rates. For the past decade, VHA suicide prevention initiatives have largely focused on veterans eligible for care, although the fastest increase in veteran suicide rates has occurred among veterans not connected to VHA services. Currently, if a veteran is deemed ineligible for care, it is up to the veteran to find other health care services in his or her community. There is not always a clear next step for the veteran to take, nor clear guidance provided to the VHA registration staff to assist with this care transition. This is particularly concerning for veterans at high risk for suicide as this could further thwart the veteran’s sense of belongingness and increase perceived burdensomeness, both suicide risk factors, and discourage them from attaining help.40 Overall, while the VHA has successfully implemented diverse suicide prevention initiatives and services, the need for continued system improvement focused on non-VHA veterans remains. PSCI-SPC was developed for this purpose.
By creating a collaborative that will connect VHA and community organizations, there will be better utilization of resources and more appropriate referrals throughout systems that interact with veterans. Sharing suicide prevention best practices between VHA and community partners is expected to increase access to mental health treatment to all veterans. Finally, by allowing best practices for suicide prevention in the VHA to serve as a guide in the development of best practices for suicide prevention between the VHA and the local health and behavioral health care community, PSCI-SPC will create a new suicide prevention intervention for veterans with mental health needs. Through these initiatives, PSCI-SPC will support providers’ and concerned citizens’ efforts to ensure that fewer veterans fall through the cracks of disjointed systems and will promote healthier communities where, regardless of VHA enrollment status, veterans receive suicide prevention care.
Conclusions
PSCI-SPC is a novel center for the innovation and dissemination of the nation’s best practices in suicide prevention for veterans who are ineligible for or otherwise not engaged in VHA services and who turn to their community for health care. PSCI-SPC not only seeks to create, develop, and measure various solutions to reduce suicide among veterans who receive non-VHA care, but also seeks to facilitate the overall quality of existing practices for suicide prevention and care coordination for enrolled veterans who use community resources. By bridging the gap between the VHA, civilian health care systems, and other community partners striving to prevent veteran suicides, we can create better access to care and a more seamless path of communication among these important entities that impact the lives of our veterans daily
Since 2008, suicide has ranked as the tenth leading cause of death for all ages in the US, with rates of suicide continuing to rise.1-3 Suicide is even more urgent to address in veteran populations. The age- and sex-adjusted suicide rate in 2017 was more than 1.5 times greater for veterans than it was for nonveteran adults.2 Of importance, rates of suicide are increasing at a faster rate in veterans who are not connected to Veterans Health Administration (VHA) care.4,5 These at-risk veterans include individuals who are eligible for VHA care yet have not had a VHA appointment within the year before death; veterans who may be ineligible to receive VHA care due to complex rules set by legislation; and veterans who are eligible but not enrolled in VHA care. Notably, between 2005 and 2016, the number of veterans not enrolled in VHA care rose more quickly than did the number of veterans enrolled in VHA care.5,6 Thus, to impact the high veteran suicide rates, an emergent challenge for VHA is to prevent suicide among unenrolled veterans and veterans receiving community care, while continuing to increase access to mental health services for veterans enrolled in VHA health care.
In response to the high rates of veteran suicide deaths, the US Department of Veterans Affairs (VA) has developed a broad, multicomponent suicide prevention program that is unparalleled in private US health care systems.4,7 Suicide prevention efforts are led and implemented by both the VHA National Center for Patient Safety and the VHA Office of Mental Health and Suicide Prevention. Program components are numerous and multifaceted, falling within the broad promotion and prevention strategies outlined by the National Academy of Medicine (NAM).1,8-11 The NAM continuum of prevention model encompassing multiple strategies is also referred to as the Universal, Selective, Indicated (USI) Model.7,8,10 The VHA suicide prevention program contains a wide spread of program components, making it both comprehensive and innovative (Table 1).
Although significant momentum and progress has been made within the VHA, policy set by legislation has historically limited access to VHA health care services to VHA-eligible veterans. This is particularly concerning given the rising suicide rates among veterans not engaged in VHA care.2 Adding to this complexity, recent legislation has increased veterans’ access to non-VHA health care, in addition to their existing access through Medicare, Medicaid, and other health care programs.12-14 Best practices for suicide prevention are not often implemented in the private sector; thus, these systems are ill prepared to adequately meet the suicide prevention care needs of veterans.4,15-18 Furthermore, VHA and non-VHA services generally are not well coordinated, and private sector health care providers (HCPs) are not required to complete a commensurate level of suicide prevention training as are VHA HCPs.16-18 Most non-VHA HCPs do not receive military cultural competence training.19 These issues create a significant gap in suicide prevention services and may contribute to the increases in suicide rates in veterans who do not receive VHA care. Thus, changes in policy to increase access through private sector care may have paradoxical effects on veteran suicide deaths. To impact the veteran suicide rate, VHA must develop and disseminate best practices for veterans who use non-VHA services.
A Roadmap to Suicide Prevention
There is significant momentum at the federal level regarding this issue. The President’s Roadmap to Empower Veterans and End the National Tragedy of Suicide (Executive Order 13,861) directs the VHA to work closely with community organizations to improve veteran suicide prevention.20 The VHA and partners, such as the Substance Abuse and Mental Health Services Administration (SAMHSA), are bridging this gap with collaborative efforts that increase suicide prevention resources for veterans living in the community through programs such as the Governor’s Challenges to Prevent Suicide Among Service Members, Veterans, and their Families. These programs intend to empower communities to develop statewide, strategic action plans to prevent veteran suicide.7,21-24
In addition to partnerships, VHA has built other aspects of outreach and intervention into its programming. A key VHA initiative is to “know all veterans” by committing to identifying and reaching out to all veterans who may be at risk for suicide.22 The VHA has committed to offering “emergency stabilization care for former service members who present at the facility with an emergent mental health need” regardless of eligibility.25 The intent is to provide temporary emergent mental health care to veterans who are otherwise ineligible for care, such as those who were discharged under other-than-honorable conditions while the VHA determines eligibility status.26 However, veterans must meet certain criteria, and there is a limit on services.
Although services are being expanded to reach veterans who do not access VHA health care, how to best implement these new directives with regard to suicide prevention is unclear. Strategic development and innovations to expand suicide prevention care to veterans outside the current reach of VHA are desperately needed.
Program Overview
VHA Patient Safety Center of Inquiry-Suicide Prevention Collaborative (PSCI-SPC), funded by the VHA National Center for Patient Safety, aims to help fill the gap in community-based suicide prevention for veterans. PSCI-SPC is located within the VHA Rocky Mountain Mental Illness Research, Education, and Clinical Center in Aurora, Colorado. The overarching mission of PSCI-SPC is to develop, implement, and evaluate practical solutions to reduce suicide among veterans not receiving VHA care. PSCI-SPC serves as a national clinical innovation and dissemination center for best practices in suicide prevention for organizations that serve veterans who receive care in the community. PSCI-SPC creates products to support dissemination of these practices to other VAMCs and works to ensure these programs are sustainable. PSCI-SPC focuses on 3 primary objectives. All PSCI-SPC projects are currently underway.
Objective 1: Growing a Community Learning Collaborative
Acknowledging that nearly two-thirds of veterans who die by suicide do not use VHA services, PSCI-SPC aims to reduce suicide among all veterans by expanding the reach of best practices for suicide prevention to veterans who receive myriad services in the community.27 Community organizations are defined here as organizations that may in some way serve, interact with, or work with veterans, and/or employ veterans. Examples include non-VHA health care systems, public services such as police and fire departments, nonprofit organizations, mental health clinics, and veterans’ courts. As veterans increasingly seek health care and other services within their communities, the success of suicide prevention will be influenced by the capability of non-VHA public and private organizations. Objective 1, therefore, seeks to develop a VHA-community collaborative that can be leveraged to improve systems of suicide prevention.
Current programs in the VHA have focused on implementation of suicide prevention awareness and prevention education campaigns instead of grassroots partnerships that are intended to be sustainable. Additionally, these programs typically lack the capacity and systems to sustain numerous meaningful community partnerships. Traditionally, community organizations have been hesitant to partner with government agencies, such as the VHA, due to histories of institutional mistrust and bureaucracy.28
The PSCI-SPC model for developing a VHA-community collaborative partnership draws from the tradition of community-based participatory research. The best community-based participatory research practices are to build on strengths and resources within the local community; develop collaborative, equitable partnerships that involve an empowering and power-sharing process; foster colearning, heuristics, and capacity building among partners; and focus on systems development using an iterative process. These practices also are consistent with the literature on learning collaboratives.29-31
The premise for a learning collaborative is to bridge the gap between knowledge and practice in health care.31 Figure 1 depicts how this collaborative was developed, and how it supports Objectives 2 and 3. To achieve Objective 1, we developed a VHA-learning collaborative of 13 influential community partners in the Denver and Colorado Springs region of Colorado. The VHA team consists of a learning collaborative leader, a program manager, and a program support assistant. The principal investigator attends and contributes to all meetings. Learning collaborative partners include a university psychology clinic that focuses on veterans’ care, 3 veterans service organizations, a mental health private practice, a university school of nursing, a community mental health center, veterans’ courts, and 5 city departments.
These partners participated in qualitative interviews to identify where gaps and breakdowns were occurring. With this information, the PSCI-SPC team and VHA-learning collaborative held a kickoff event. At this meeting the team discussed the qualitative findings, provided veteran suicide prevention information, and basic information regarding suicide prevention program building and implementation science.
Throughout quarterly learning collaborative meetings and monthly facilitation calls, we have worked to develop a blueprint and an action plan for each partner to develop best practices for dissemination to aid in providing consistency in the standard of care. A postimplementation event will be held to identify successes and challenges encountered while operationalizing project action plans.
Currently, activities of the learning collaborative are making a large impact on the community. Not all collaborative members track information regarding their populations served, nor specific metrics on veterans encountered. Even so, of those who do capture metrics, suicide prevention program components implemented by the collaborative will impact more than 21,000 individuals and at least 2,500 known veterans. In addition, 52 new connections have been made between community organizations or between community organizations and the VHA, and > 300 individuals have been trained.The learning collaborative support team has assisted in the dissemination of a large resource list for veterans. As the learning collaborative is ongoing and we are working with organizations to improve their data collection and analytics, we expect these numbers to increase. We anticipate that the learning collaborative will develop a stronger suicide prevention safety net within the community. In addition, we expect increased referrals of at-risk veterans to the VHA and enhance the long-term continuity of care between community and VHA services.
Objective 2: Implementation Toolkit
The second PSCI-SPC objective is to develop a toolkit for the implementation of best practices within a VHA-community suicide prevention learning collaborative. Lessons from the development of a successful suicide prevention learning collaborative will be shared through an online guide that other VHA facilities can use to support similar collaborative efforts within their communities. The toolkit will be disseminated across the VHA to assist suicide prevention coordinators and other staff in developing a suicide prevention learning collaborative at their facilities.
PSCI-SPC uses the Zero Suicide framework and the VA/US Department of Defense (DoD) Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide as models for preventing suicide in veterans not enrolled in VHA care.11,32 This implementation toolkit focuses on how to implement suicide prevention best practices into organizations that serve veterans. This toolkit differs from clinical practice guidelines in that it focuses on implementation strategies to promote success and effectively address challenges.
In order to provide a menu of available options for the learning collaborative and resulting toolkit, PSCI-SPC uses a logic model to compare the components of the VHA suicide prevention program, as well as other similar veteran and military suicide prevention programs.7,12,14,21,33,34 These programs are categorized into 2 types of prevention frameworks, the USI model as described above, and the SAMHSA Strategic Prevention Framework (Table 2).35 The SAMHSA framework was designed to promote mental health and prevent substance abuse, yet the derived classification is also applicable to suicide prevention programs.35 The results of the logic model comparison form the basis of the best practice interventions for the learning collaborative and initial toolkit. In addition to the best practice interventions, the toolkit consists of documents describing how to develop a veteran suicide prevention learning collaborative, as well as tools for learning collaborative members. Current tool development includes workbooks to guide collaborative members through the implementation process, guides for community organizations in implementing suicide prevention screening and risk assessment, a standard operating procedure for suicide prevention in a veterans court, and peer support training for veteran suicide prevention.
The methods to achieve Objective 2 include regular discussions with the VHA-learning collaborative on current best practices, identifying gaps and overlap of community programs. Successes and challenges of implementing suicide prevention best practices into learning collaborative organizations will be documented and incorporated into the toolkit. The learning collaborative will work iteratively as a team to improve the toolkit. Once complete, the toolkit will be disseminated to other VHA health care systems nationally, as well as to other state or regional partners that the learning collaborative identifies. A plan is under development for national suicide prevention entities to also disseminate the toolkit to lessen the burden of veteran suicide through their stakeholder base.
Objective 3: High-Risk Veterans Not Receiving VHA Care
Although veterans not receiving VHA care account for a number of veteran deaths by suicide, we are not aware of any current VHA programs that provide temporary psychotherapy and intensive case management to at-risk veterans ineligible for VHA care who are in need of immediate care while an appropriate permanent community placement is identified. In the current system, veterans in the community can present to VHA suicide prevention services through several different systems, including referrals to VHA and the Veterans Crisis Line (VCL). However, a portion of VCL calls are from veterans whose VHA eligibility is unknown or who are ineligible for services. If veterans are at imminent risk for suicide, emergency care is coordinated for them. However, if veterans are not at imminent suicide risk they are referred to the local suicide prevention coordinator and instructed to independently work toward determining their VHA eligibility.
It is currently unknown how many veterans follow through with these instructions. Nonetheless, if veterans are deemed eligible, they may present to VHA to obtain a same-day appointment. If not eligible, a suicide prevention coordinator may give them the phone number of a community referral. However, this practice is not standardized across VA medical centers, and the provided resources are up to the suicide prevention coordinator to research. Additionally, when a VHA suicide prevention coordinator leaves the position, knowledge of these community resources and rapport with community HCPs are often lost, leaving the next coordinator to develop these again, which reduces the efficiency and effectiveness of limited resources. It is also unknown how many veterans complete this contact and receive evidence-based treatment following referral. This is a complex system to navigate, particularly when at risk for suicide and in need of immediate but not emergency services.
Suicide prevention in such circumstances may be improved by adapting current suicide prevention practices, including evidence-based interventions, and the new VHA intensive case management program,11,36 within a Zero Suicide framework. PSCI-SPC has developed a brief intervention to transition ineligible veterans to permanent community treatment and provide them with additional resources to meet their varied needs. The brief 1 to 3 session intervention combines practices from brief cognitive behavioral therapy (BCBT) for suicide prevention, crisis response planning (CRP), and intensive case management within a Zero Suicide framework. Both the 2019 VA/DoD suicide prevention clinical practice guidelines and Zero Suicide recommend using cognitive behavioral therapy (CBT)-based interventions for suicide prevention.11,32 These interventions are packaged into a single intervention delivered by a PSCI-SPC therapist, typically a licensed clinical social worker, a licensed clinical psychologist, or an unlicensed psychologist under the supervision of a licensed clinical psychologist.
BCBT is one type of CBT that has shown initial efficacy in reducing suicide attempts.37 BCBT reduces the risk for suicide attempts both at the conclusion of treatment and at 24-month follow-up.37 BCBT is boiled down to its most essential components so it can be delivered in a distilled format. An essential element of BCBT that will remain is the CRP. A CRP11,37,38 entails collaboratively identifying effective, appropriate coping strategies and specific individuals to contact during a crisis. CRPs demonstrated efficacy as a stand-alone intervention to existing suicide prevention methods in a randomized clinical trial, such that individuals who received CRP had faster reductions in suicidal ideation and were 76% less likely to make a suicide attempt during the 6-month follow-up period.39 These results demonstrate that use of a CRP is connected to a decrease in suicidal behavior among suicidal patients.
The VHA has developed and is piloting a new initiative focused on restructuring its intensive case management services. RACETIME to Integrated Care (eg, Risk stratification, Assessment of complexity, Coordinator of lead assignment, Evaluate whole health needs, Trusting partnerships, Integrate care, Monitor progress, Experience of the veteran and employee) is a framework that assists VHA case managers in transitioning from a traditional case management mind-set to a more integrated and holistic method of care.36 RACETIME intensive case management practices will be incorporated into the intervention. However, RACETIME focuses on case management internally to the VHA. A modification for this treatment will be to focus on intensive case management from a mental health perspective and connecting to external community resources. Community referrals are mapped within a structured process and stored on a shared drive. This improves continuity between suicide prevention coordinators when they leave for a new position.
This intervention is conducted within a Zero Suicide framework. Pertinent to PSCI-SPC innovation to enhance care for non-VHA veterans is the care transitions element within the Zero Suicide framework, which has developed comprehensive suicide prevention guidance, including a pathway to care.32 This pathway refers a process to conduct follow-up supportive contacts that are tracked and recorded.
The PSCI-SPC pilot program incorporates the elements of CRP and brief CBT within a Zero Suicide framework. The PSCI-SPC team is developing and testing a protocol for providing brief treatment and community referrals to ineligible veterans that integrates these programming elements (Figure 2). A PSCI-SPC social worker will coordinate with the eligibility office to determine VHA eligibility. Ineligible veterans are referred to community partners and nonenrolled, eligible veterans are linked to VHA HCPs if they desire. These transitions will be coordinated, closely monitored, and verified.
Once the eligibility is determined, and the veteran’s preference is assessed, the team will perform a warm handoff to a VHA representative for enrollment into VHA care or to a community placement. We have sourced multiple community placements at varied payor levels. All veterans who are ineligible for care or who do not desire to be enrolled in VHA care will be provided the intervention package described above. After the veteran is placed in community care, PSCI-SPC team will follow up regularly with the veteran for 3 months to ensure continuity of care. If additional sessions are needed while the veteran needs a community placement, the PSCI team can accommodate this and will track the number of participants who needed additional sessions. If the veteran is deemed to be at imminent risk for suicide at any time during the pilot, he/she is transferred to emergency care. The veteran is allowed to participate once stabilized.
Findings from the pilot program will inform a manual intended for dissemination to patient safety and suicide prevention coordinators nationally across the VHA. The products from this objective will be integrated with the other objectives in training that will be provided on how to develop a local collaborative (Objective 1), disseminate the toolkit (Objective 2), and receive referrals into VHA or refer veterans to community clinical partners through the pilot program (Objective 3). Products developed and disseminated throughout PSCI-SPC aim to create momentum to reduce rates of suicide in veterans who are not connected to the VHA at the local community level.
Discussion
Improving suicide prevention for veterans who receive non-VHA health care is essential to significantly reduce veteran suicide rates. For the past decade, VHA suicide prevention initiatives have largely focused on veterans eligible for care, although the fastest increase in veteran suicide rates has occurred among veterans not connected to VHA services. Currently, if a veteran is deemed ineligible for care, it is up to the veteran to find other health care services in his or her community. There is not always a clear next step for the veteran to take, nor clear guidance provided to the VHA registration staff to assist with this care transition. This is particularly concerning for veterans at high risk for suicide as this could further thwart the veteran’s sense of belongingness and increase perceived burdensomeness, both suicide risk factors, and discourage them from attaining help.40 Overall, while the VHA has successfully implemented diverse suicide prevention initiatives and services, the need for continued system improvement focused on non-VHA veterans remains. PSCI-SPC was developed for this purpose.
By creating a collaborative that will connect VHA and community organizations, there will be better utilization of resources and more appropriate referrals throughout systems that interact with veterans. Sharing suicide prevention best practices between VHA and community partners is expected to increase access to mental health treatment to all veterans. Finally, by allowing best practices for suicide prevention in the VHA to serve as a guide in the development of best practices for suicide prevention between the VHA and the local health and behavioral health care community, PSCI-SPC will create a new suicide prevention intervention for veterans with mental health needs. Through these initiatives, PSCI-SPC will support providers’ and concerned citizens’ efforts to ensure that fewer veterans fall through the cracks of disjointed systems and will promote healthier communities where, regardless of VHA enrollment status, veterans receive suicide prevention care.
Conclusions
PSCI-SPC is a novel center for the innovation and dissemination of the nation’s best practices in suicide prevention for veterans who are ineligible for or otherwise not engaged in VHA services and who turn to their community for health care. PSCI-SPC not only seeks to create, develop, and measure various solutions to reduce suicide among veterans who receive non-VHA care, but also seeks to facilitate the overall quality of existing practices for suicide prevention and care coordination for enrolled veterans who use community resources. By bridging the gap between the VHA, civilian health care systems, and other community partners striving to prevent veteran suicides, we can create better access to care and a more seamless path of communication among these important entities that impact the lives of our veterans daily
1. US Department of Veterans Affairs. National strategy for preventing veteran suicide 2018-2028. https://www.mentalhealth.va.gov/suicide_prevention/docs/Office-of-Mental-Health-and-Suicide-Prevention-National-Strategy-for-Preventing-Veterans-Suicide.pdf. Published September 2018. Accessed October 14, 2020.
2. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. National veteran suicide prevention annual report. https://www.mentalhealth.va.gov/suicide_prevention/data.asp. Accessed October 14, 2020.
3. Centers for Disease Control and Prevention. Web-based injury statistics query and reporting system (WISQARS). 2014. https://www.cdc.gov/injury/wisqars/index.html. Updated July 1, 2020. Accessed October 14, 2020.
4. Lemle RB. Choice program expansion jeopardizes high-quality VHA mental health services. Fed Pract. 2018;35(3):18-24.
5. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. VA national suicide data report 2005-2016. https://www.mentalhealth.va.gov/docs/data-sheets/OMHSP_National_Suicide_Data_Report_2005-2016_508.pdf. Published September 2018. Accessed October 14, 2020.
6. US Department of Veterans Affairs, Office of Suicide Prevention. VA national suicide data report 2005-2015. https://www.mentalhealth.va.gov/docs/data-sheets/2015/OMHSP_National_Suicide_Data_Report_2005-2015_06-14-18_508.pdf. Published June 2018. Accessed October 14, 2020.
7. US Department of Veterans Affairs. National strategy for preventing veteran suicide 2018-2028. https://www.mentalhealth.va.gov/suicide_prevention/docs/Office-of-Mental-Health-and-Suicide-Prevention-National-Strategy-for-Preventing-Veterans-Suicide.pdf. Published 2018. Accessed October 30, 2020.
8. Gordon RS. An operational classification of disease prevention. Public Health Rep. 1983;98(2):107-109.
9. National Research Council and Institute of Medicine. O’Connell ME, Boat T, Warner KE, eds. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington, DC: National Academies Press; 2009.
10. US Department of Health and Human Services, National Institute on Drug Abuse, Office of Science Policy and Communications. Drug Abuse Prevention: What Works. Rockville, MD: National Institutes of Health; 1997.
11. US Department of Veterans Affairs, US Department of Defense. VA/DoD clinical practice guideline for the assessment and management of patients at risk for suicide. https://www.healthquality.va.gov/guidelines/MH/srb. Published 2019. Updated July 30, 2020. Accessed October 14, 2020.
12. US Department of Veterans Affairs. Veterans Access, Choice and Accountability Act of 2014. https://www.govinfo.gov/content/pkg/PLAW-113publ146/pdf/PLAW-113publ146.pdf. Accessed October 14, 2020.
13. US Department of Veterans Affairs. Strategic Health Care. VA MISSION Act: Extension of the VA choice program. https://strategichealthcare.net/wp-content/uploads/2018/05/052718-VA-MISSION-Act-Summary.pdf. Accessed October 14, 2020.
14. US Congress. H.R.5674—VA MISSION Act of 2018. https://www.congress.gov/bill/115th-congress/house-bill/5674. Accessed October 15, 2020.
15. Grumet JG, Hogan MF, Chu A, Covington DW, Johnson KE. Compliance standards pave the way for reducing suicide in health care systems. J Health Care Compliance. 2019;17-26.
16. Hillestad R, Bigelow J, Bower A, et al. Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Aff (Millwood). 2005;24(5):1103-1117. doi:10.1377/hlthaff.24.5.110
17. Porter ME, Pabo EA, Lee TH. Redesigning primary care: a strategic vision to improve value by organizing around patients’ needs. Health Aff (Millwood). 2013;32(3):516-525. doi:10.1377/hlthaff.2012.0961
18. Nevedal AL, Wagner TH, Ellerbe LS, Asch SM, Koenig CJ. A qualitative study of primary care providers’ experiences with the Veterans Choice Program. J Gen Intern Med. 2019;34:598-603. doi:10.1007/s11606-018-4810-2
19. Tanielian T, Farris C, Epley C, et al. Ready to serve: community-based provider capacity to deliver culturally competent, quality mental health care to veterans and their families. https://www.rand.org/content/dam/rand/pubs/research_reports/RR800/RR806/RAND_RR806.pdf. Published 2014. Accessed October 15, 2020.
20. White House. Executive Order 13861: President’s roadmap to empower veterans and end the national tragedy of suicide (PREVENTS). https://www.va.gov/PREVENTS/docs/PRE-007-The-PREVENTS-Roadmap-1-2_508.pdf. Published June 17, 2020. Accessed October 15, 2020.
21. US Department of Veterans Affairs, Office of the Under Secretary for Health. Memorandum. VA continues community suicide prevention challenge at another mayor’s challenge policy academy. https://www.blogs.va.gov/VAntage/58468/va-continues-community-suicide-prevention-challenge-another-mayors-challenge-policy-academy. Published April 4, 2019. Accessed October 15, 2020.
22. US Department of Veterans Affairs, Veterans Health Administration (VHA) Veterans Health Administration (VHA) Fiscal Year (FY) 2018-2019 Operational Plan. www.navao.org/wp-content/uploads/2018/06/USH-Memo-10-2018-03-VHA_FY_2018-2019_Operational_Plan-4-19-18.pdf. Published April 19, 2018. Accessed October 15, 2020.
23. US Department of Veterans Affairs. VA, Health and Human Services announce governor’s challenge to prevent suicide. https://www.blogs.va.gov/VAntage/55707/va-health-human-services-announce-governors-challenge-prevent-suicide. Published January 17, 2019. Accessed October 15, 2020.
24. VA’s suicide prevention campaign “Be There’’ kicks off in Times Square. https://www.blogs.va.gov/VAntage/57272/vas-suicide-prevention-campaign-kicks-off-times-square. Published March 6, 2019. Accessed October 15, 2020.
25. US Department of Veterans Affairs, Office of Public Affairs Media Relations. Emergent mental health care for former service members. https://www.mentalhealth.va.gov/docs/Fact_Sheet-Emergent_Mental_Health_Care_Former_Service_Members.pdf. Published 2017. Accessed October 15, 2020.
26. US Department of Veterans Affairs. VA secretary formalizes expansion of emergency mental health care to former service members with other-than-honorable discharges. https://www.blogs.va.gov/VAntage/39092/va-secretary-formalizes-expansion-emergency-mental-health-care-former-service-members-honorable-discharges. Published June 27, 2017. Accessed October 15, 2020.
27. Shane L. New veteran suicide numbers raise concerns among experts hoping for positive news. Military Times. https://www.militarytimes.com/news/pentagon-congress/2019/10/09/new-veteran-suicide-numbers-raise-concerns-among-experts-hoping-for-positive-news. Published October 9, 2019. Accessed October 15, 2020.
28. US Department of Veterans Affairs. Department of Veterans Affairs FY 2018-2024 Strategic Plan. https://www.va.gov/oei/docs/VA2018-2024strategicPlan.pdf. Updated May 31, 2019. Accessed October 15, 2020.
29. Komaie G, Goodman M, McCall A, et al. Training community members in public health research: development and implementation of a community participatory research pilot project. Health Equity. 2018;2(1):282-287. doi:10.1089/heq.2018.0043
30. Wang KH, Ray NJ, Berg DN, et al. Using community-based participatory research and organizational diagnosis to characterize relationships between community leaders and academic researchers. Prev Med Reports. 2017;7:180-186. doi:10.1016/j.pmedr.2017.06.007
31. Institute for Healthcare Improvement. The breakthrough series: IHI’s collaborative model for achieving breakthrough improvement. http://www.ihi.org/resources/Pages/IHIWhitePapers/TheBreakthroughSeriesIHIsCollaborativeModelforAchievingBreakthroughImprovement.aspx. Published 2003. Accessed October 15, 2020.
32. Zero Suicide in Health and Behavioral Health Care Institute. Zero suicide toolkit. https://zerosuicide.sprc.org/toolkit. Accessed October 15, 2020.

33. Preventing suicide: a technical package of policy, programs, and practices. https://www.cdc.gov/violenceprevention/pdf/suicideTechnicalPackage.pdf. Published 2017. Accessed October 30, 2020.
34. US Department of Veterans Affairs. VA Office of Mental Health and Suicide Prevention guidebook. https://www.mentalhealth.va.gov/docs/VA-Office-of-Mental-Health-and-Suicide-Prevention-Guidebook-June-2018-FINAL-508.pdf. Published June 2018. Accessed October 15, 2020.
35. US Department of Health and Human Services, Substance Abuse and Mental Health Services, Administration Center for Substance Abuse Prevention. Focus on prevention: strategies and programs to prevent substance abuse. HHS Publication No. (SMA) 10-4120. https://helpandhopewv.org/docs/Focus%20on%20Prevention.pdf. Revised 2017. Accessed October 15, 2020.
36. Misiti R, Risinger A. RACETIME: an organizational care coordination approach to improving patient outcomes in a complex healthcare setting. Presentation at the Military Social Work & Behavioral Health Conference Austin, Texas. July 23, 2020. https://sites.utexas.edu/military-social-work-conference/misiti-risinger. Accessed October 23, 2020.
37. Rudd MD, Bryan CJ, Wertenberger EG, et al. Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up. Am J Psychiatry. 2015;172(5):441-449. doi:10.1176/appi.ajp.2014.14070843
38. Rudd MD, Mandrusiak M, Joiner TE Jr. The case against no-suicide contracts: The commitment to treatment statement as a practice alternative. Clin Psychol. 2006;62(2):243-251.
39. Bryan CJ, Mintz J, Clemans TA, et al. Effect of crisis response planning vs. contracts for safety on suicide risk in US Army soldiers: a randomized clinical trial. J Affect Disord. 2017;212:64-72. doi:10.1016/j.jad.2017.01.028
40. Joiner TE. Why People Die by Suicide. Cambridge, MA: First Harvard University Press; 2005:27.
41. Office of the Under Secretary of Defense for Personnel and Readiness. DoD Instruction 6490.16: Defense suicide prevention program. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/649016p.pdf?ver=2020-09-11-122632-850. Published November 6, 2017. Updated September 11, 2020. Accessed October 14, 2020.
42. Zero Suicide in Health and Behavioral Health Care Institute. Engage: engaging patients. http://zerosuicide.edc.org/toolkit/engage#quicktabs-engage=0. Accessed October 14, 2020.
43. Stone D, Holland K, Bartholow B, Crosby A, Davis S, Wilkins N. Preventing Suicide: A technical package of policy, programs, and practices. https://www.cdc.gov/violenceprevention/pdf/suicidetechnicalpackage.pdf. Published 2017. Accessed October 14, 2020.
44. Mills PD, Watts BV, Miller S, et al. A checklist to identify inpatient suicide hazards in veterans affairs hospitals. Jt Comm J Qual Patient Saf. 2010;36(2):87-93. doi:10.1016/s1553-7250(10)36015-6
45. US Department of Veterans Affairs, Office of Research and Development. Crisis prevention: study evaluates VA program that identifies vets at highest risk for suicide. https://www.research.va.gov/currents/0918-Study-evaluates-VA-program-that-identifies-Vets-at-highest-risk-for-suicide.cfm. Updated September, 20, 2018. Accessed October 14, 2020.
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47. Zero Suicide in Health and Behavioral Health Care Institute. Train: training for all. http://zerosuicide.sprc.org/toolkit/train. Accessed October 14, 2020.
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50. Office of the Under Secretary of Defense for Personnel and Readiness. DoD Instruction 6490.04: Mental health evaluations of members of the military services. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/649004p.pdf. Published March 4, 2013. Updated April 22, 2020. Accessed October 14, 2020.
51. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention Frequently asked questions: VA National Suicide Data Report. https://www.mentalhealth.va.gov/docs/data-sheets/2015_Data_Release_FAQs_508.pdf. Published September 2018. Updated June 22, 2018. Accessed October 14, 2020.
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1. US Department of Veterans Affairs. National strategy for preventing veteran suicide 2018-2028. https://www.mentalhealth.va.gov/suicide_prevention/docs/Office-of-Mental-Health-and-Suicide-Prevention-National-Strategy-for-Preventing-Veterans-Suicide.pdf. Published September 2018. Accessed October 14, 2020.
2. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. National veteran suicide prevention annual report. https://www.mentalhealth.va.gov/suicide_prevention/data.asp. Accessed October 14, 2020.
3. Centers for Disease Control and Prevention. Web-based injury statistics query and reporting system (WISQARS). 2014. https://www.cdc.gov/injury/wisqars/index.html. Updated July 1, 2020. Accessed October 14, 2020.
4. Lemle RB. Choice program expansion jeopardizes high-quality VHA mental health services. Fed Pract. 2018;35(3):18-24.
5. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. VA national suicide data report 2005-2016. https://www.mentalhealth.va.gov/docs/data-sheets/OMHSP_National_Suicide_Data_Report_2005-2016_508.pdf. Published September 2018. Accessed October 14, 2020.
6. US Department of Veterans Affairs, Office of Suicide Prevention. VA national suicide data report 2005-2015. https://www.mentalhealth.va.gov/docs/data-sheets/2015/OMHSP_National_Suicide_Data_Report_2005-2015_06-14-18_508.pdf. Published June 2018. Accessed October 14, 2020.
7. US Department of Veterans Affairs. National strategy for preventing veteran suicide 2018-2028. https://www.mentalhealth.va.gov/suicide_prevention/docs/Office-of-Mental-Health-and-Suicide-Prevention-National-Strategy-for-Preventing-Veterans-Suicide.pdf. Published 2018. Accessed October 30, 2020.
8. Gordon RS. An operational classification of disease prevention. Public Health Rep. 1983;98(2):107-109.
9. National Research Council and Institute of Medicine. O’Connell ME, Boat T, Warner KE, eds. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington, DC: National Academies Press; 2009.
10. US Department of Health and Human Services, National Institute on Drug Abuse, Office of Science Policy and Communications. Drug Abuse Prevention: What Works. Rockville, MD: National Institutes of Health; 1997.
11. US Department of Veterans Affairs, US Department of Defense. VA/DoD clinical practice guideline for the assessment and management of patients at risk for suicide. https://www.healthquality.va.gov/guidelines/MH/srb. Published 2019. Updated July 30, 2020. Accessed October 14, 2020.
12. US Department of Veterans Affairs. Veterans Access, Choice and Accountability Act of 2014. https://www.govinfo.gov/content/pkg/PLAW-113publ146/pdf/PLAW-113publ146.pdf. Accessed October 14, 2020.
13. US Department of Veterans Affairs. Strategic Health Care. VA MISSION Act: Extension of the VA choice program. https://strategichealthcare.net/wp-content/uploads/2018/05/052718-VA-MISSION-Act-Summary.pdf. Accessed October 14, 2020.
14. US Congress. H.R.5674—VA MISSION Act of 2018. https://www.congress.gov/bill/115th-congress/house-bill/5674. Accessed October 15, 2020.
15. Grumet JG, Hogan MF, Chu A, Covington DW, Johnson KE. Compliance standards pave the way for reducing suicide in health care systems. J Health Care Compliance. 2019;17-26.
16. Hillestad R, Bigelow J, Bower A, et al. Can electronic medical record systems transform health care? Potential health benefits, savings, and costs. Health Aff (Millwood). 2005;24(5):1103-1117. doi:10.1377/hlthaff.24.5.110
17. Porter ME, Pabo EA, Lee TH. Redesigning primary care: a strategic vision to improve value by organizing around patients’ needs. Health Aff (Millwood). 2013;32(3):516-525. doi:10.1377/hlthaff.2012.0961
18. Nevedal AL, Wagner TH, Ellerbe LS, Asch SM, Koenig CJ. A qualitative study of primary care providers’ experiences with the Veterans Choice Program. J Gen Intern Med. 2019;34:598-603. doi:10.1007/s11606-018-4810-2
19. Tanielian T, Farris C, Epley C, et al. Ready to serve: community-based provider capacity to deliver culturally competent, quality mental health care to veterans and their families. https://www.rand.org/content/dam/rand/pubs/research_reports/RR800/RR806/RAND_RR806.pdf. Published 2014. Accessed October 15, 2020.
20. White House. Executive Order 13861: President’s roadmap to empower veterans and end the national tragedy of suicide (PREVENTS). https://www.va.gov/PREVENTS/docs/PRE-007-The-PREVENTS-Roadmap-1-2_508.pdf. Published June 17, 2020. Accessed October 15, 2020.
21. US Department of Veterans Affairs, Office of the Under Secretary for Health. Memorandum. VA continues community suicide prevention challenge at another mayor’s challenge policy academy. https://www.blogs.va.gov/VAntage/58468/va-continues-community-suicide-prevention-challenge-another-mayors-challenge-policy-academy. Published April 4, 2019. Accessed October 15, 2020.
22. US Department of Veterans Affairs, Veterans Health Administration (VHA) Veterans Health Administration (VHA) Fiscal Year (FY) 2018-2019 Operational Plan. www.navao.org/wp-content/uploads/2018/06/USH-Memo-10-2018-03-VHA_FY_2018-2019_Operational_Plan-4-19-18.pdf. Published April 19, 2018. Accessed October 15, 2020.
23. US Department of Veterans Affairs. VA, Health and Human Services announce governor’s challenge to prevent suicide. https://www.blogs.va.gov/VAntage/55707/va-health-human-services-announce-governors-challenge-prevent-suicide. Published January 17, 2019. Accessed October 15, 2020.
24. VA’s suicide prevention campaign “Be There’’ kicks off in Times Square. https://www.blogs.va.gov/VAntage/57272/vas-suicide-prevention-campaign-kicks-off-times-square. Published March 6, 2019. Accessed October 15, 2020.
25. US Department of Veterans Affairs, Office of Public Affairs Media Relations. Emergent mental health care for former service members. https://www.mentalhealth.va.gov/docs/Fact_Sheet-Emergent_Mental_Health_Care_Former_Service_Members.pdf. Published 2017. Accessed October 15, 2020.
26. US Department of Veterans Affairs. VA secretary formalizes expansion of emergency mental health care to former service members with other-than-honorable discharges. https://www.blogs.va.gov/VAntage/39092/va-secretary-formalizes-expansion-emergency-mental-health-care-former-service-members-honorable-discharges. Published June 27, 2017. Accessed October 15, 2020.
27. Shane L. New veteran suicide numbers raise concerns among experts hoping for positive news. Military Times. https://www.militarytimes.com/news/pentagon-congress/2019/10/09/new-veteran-suicide-numbers-raise-concerns-among-experts-hoping-for-positive-news. Published October 9, 2019. Accessed October 15, 2020.
28. US Department of Veterans Affairs. Department of Veterans Affairs FY 2018-2024 Strategic Plan. https://www.va.gov/oei/docs/VA2018-2024strategicPlan.pdf. Updated May 31, 2019. Accessed October 15, 2020.
29. Komaie G, Goodman M, McCall A, et al. Training community members in public health research: development and implementation of a community participatory research pilot project. Health Equity. 2018;2(1):282-287. doi:10.1089/heq.2018.0043
30. Wang KH, Ray NJ, Berg DN, et al. Using community-based participatory research and organizational diagnosis to characterize relationships between community leaders and academic researchers. Prev Med Reports. 2017;7:180-186. doi:10.1016/j.pmedr.2017.06.007
31. Institute for Healthcare Improvement. The breakthrough series: IHI’s collaborative model for achieving breakthrough improvement. http://www.ihi.org/resources/Pages/IHIWhitePapers/TheBreakthroughSeriesIHIsCollaborativeModelforAchievingBreakthroughImprovement.aspx. Published 2003. Accessed October 15, 2020.
32. Zero Suicide in Health and Behavioral Health Care Institute. Zero suicide toolkit. https://zerosuicide.sprc.org/toolkit. Accessed October 15, 2020.

33. Preventing suicide: a technical package of policy, programs, and practices. https://www.cdc.gov/violenceprevention/pdf/suicideTechnicalPackage.pdf. Published 2017. Accessed October 30, 2020.
34. US Department of Veterans Affairs. VA Office of Mental Health and Suicide Prevention guidebook. https://www.mentalhealth.va.gov/docs/VA-Office-of-Mental-Health-and-Suicide-Prevention-Guidebook-June-2018-FINAL-508.pdf. Published June 2018. Accessed October 15, 2020.
35. US Department of Health and Human Services, Substance Abuse and Mental Health Services, Administration Center for Substance Abuse Prevention. Focus on prevention: strategies and programs to prevent substance abuse. HHS Publication No. (SMA) 10-4120. https://helpandhopewv.org/docs/Focus%20on%20Prevention.pdf. Revised 2017. Accessed October 15, 2020.
36. Misiti R, Risinger A. RACETIME: an organizational care coordination approach to improving patient outcomes in a complex healthcare setting. Presentation at the Military Social Work & Behavioral Health Conference Austin, Texas. July 23, 2020. https://sites.utexas.edu/military-social-work-conference/misiti-risinger. Accessed October 23, 2020.
37. Rudd MD, Bryan CJ, Wertenberger EG, et al. Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up. Am J Psychiatry. 2015;172(5):441-449. doi:10.1176/appi.ajp.2014.14070843
38. Rudd MD, Mandrusiak M, Joiner TE Jr. The case against no-suicide contracts: The commitment to treatment statement as a practice alternative. Clin Psychol. 2006;62(2):243-251.
39. Bryan CJ, Mintz J, Clemans TA, et al. Effect of crisis response planning vs. contracts for safety on suicide risk in US Army soldiers: a randomized clinical trial. J Affect Disord. 2017;212:64-72. doi:10.1016/j.jad.2017.01.028
40. Joiner TE. Why People Die by Suicide. Cambridge, MA: First Harvard University Press; 2005:27.
41. Office of the Under Secretary of Defense for Personnel and Readiness. DoD Instruction 6490.16: Defense suicide prevention program. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/649016p.pdf?ver=2020-09-11-122632-850. Published November 6, 2017. Updated September 11, 2020. Accessed October 14, 2020.
42. Zero Suicide in Health and Behavioral Health Care Institute. Engage: engaging patients. http://zerosuicide.edc.org/toolkit/engage#quicktabs-engage=0. Accessed October 14, 2020.
43. Stone D, Holland K, Bartholow B, Crosby A, Davis S, Wilkins N. Preventing Suicide: A technical package of policy, programs, and practices. https://www.cdc.gov/violenceprevention/pdf/suicidetechnicalpackage.pdf. Published 2017. Accessed October 14, 2020.
44. Mills PD, Watts BV, Miller S, et al. A checklist to identify inpatient suicide hazards in veterans affairs hospitals. Jt Comm J Qual Patient Saf. 2010;36(2):87-93. doi:10.1016/s1553-7250(10)36015-6
45. US Department of Veterans Affairs, Office of Research and Development. Crisis prevention: study evaluates VA program that identifies vets at highest risk for suicide. https://www.research.va.gov/currents/0918-Study-evaluates-VA-program-that-identifies-Vets-at-highest-risk-for-suicide.cfm. Updated September, 20, 2018. Accessed October 14, 2020.
46. Zero Suicide in Health and Behavioral Health Care Institute. Engage: active engagement for safer suicide care--reducing access to lethal means. http://zerosuicide.edc.org/toolkit/engage#quicktabs-engage=1. Published 2017. Accessed October 14, 2020.
47. Zero Suicide in Health and Behavioral Health Care Institute. Train: training for all. http://zerosuicide.sprc.org/toolkit/train. Accessed October 14, 2020.
48. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention (OMHSP). Facts about veteran suicide. https://www.mentalhealth.va.gov/docs/FINAL_VA_OMHSP_Suicide_Prevention_Fact_Sheet_508.pdf. Published June 2018. Accessed October 14, 2020.
49. Zero Suicide in Health and Behavioral Health Care Institute. Treat: direct treatment. http://zerosuicide.edc.org/toolkit/treat. Accessed October 14, 2020.
50. Office of the Under Secretary of Defense for Personnel and Readiness. DoD Instruction 6490.04: Mental health evaluations of members of the military services. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/649004p.pdf. Published March 4, 2013. Updated April 22, 2020. Accessed October 14, 2020.
51. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention Frequently asked questions: VA National Suicide Data Report. https://www.mentalhealth.va.gov/docs/data-sheets/2015_Data_Release_FAQs_508.pdf. Published September 2018. Updated June 22, 2018. Accessed October 14, 2020.
52. Zero Suicide in Health and Behavioral Health Care Institute. ZERO Suicide engage: active engagement for safer suicide care safety planning. http://zerosuicide.edc.org/toolkit/engage#quicktabs-engage=1. Accessed October 14, 2020.
Evaluation of Metabolic Monitoring and Diabetes Incidence in the First Year for Veterans Newly Started on an Atypical Antipsychotic
Atypical antipsychotic use may result in metabolic abnormalities, such as hyperglycemia, dyslipidemia, weight gain, and metabolic syndrome. These adverse effects (AEs) can cause progression to type 2 diabetes mellitus (T2DM) as well as increased risk of cardiovascular disease and cardiac mortality. Individuals diagnosed with T2DM have medical expenses that are about 2.3 times higher than individuals without diabetes.1,2 The risk of experiencing metabolic abnormalities is likely elevated for patients who were antipsychotic-naïve prior to initiation.3
In response to an increased awareness of atypical antipsychotic-related AEs, the American Diabetes Association (ADA) and American Psychiatric Association (APA) released a consensus statement in 2004 with a metabolic monitoring protocol for patients initiating or changing to a new antipsychotic medication.4 Within the first year after initiation, the ADA/APA consensus statements recommends that clinicians acquire a personal and family history, weight, body mass index (BMI), waist circumference, blood pressure (BP), fasting plasma glucose, and fasting lipid profile at the initial patient visit. Patient weight is recommended to be collected at 4 weeks and again 8 weeks later. Twelve weeks after the initial visit, weight, BMI, BP, fasting plasma glucose and a fasting lipid profile are recommended to be collected and assessed for abnormalities. Weight is then recommended to be assessed every 3 months thereafter. Review of personal and family history, waist circumference, BP, and a fasting plasma glucose is recommended to occur annually. Finally, a fasting lipid profile is to be collected every 5 years.
Since the initial consensus statement release, metabolic monitoring of patients prescribed antipsychotic medications has been found to be inadequate within several large health care organizations.5,6 Mittal and colleagues reviewed metabolic monitoring practices occurring in 32 facilities within the Veterans Health Administration (VHA) and found that monitoring practices in the first 90 days after antipsychotic initiation were largely nonadherent to the ADA/APA consensus statement recommendations.6 Medical staff in Veterans Integrated Service Network 21 (VISN 21) currently serve about 268,000 veterans actively receiving care across California, Nevada, and the Pacific Islands.To support veteran care in the fields of mental health and medication safety, the VISN 21 pharmacy benefits manager office created a clinical dashboard that identifies veterans who are currently prescribed an antipsychotic and have not completed at least 1 annual blood glucose test. While this dashboard is a valuable tool for tracking patient care for those who have been prescribed an antipsychotic > 1 year, it does not consider the ADA/APA recommendations for more frequent monitoring in the first year after initiation. A literature review found no citations of a systematic evaluation of adherence to ADA/APA monitoring recommendations or patient progression to T2DM in the first year after antipsychotic initiation for an antipsychotic-naïve veteran population. The goal of this quality improvement project is to assess VHA health care provider and patient adherence to the 2004 consensus statement recommendations within the first year after initiation for previously antipsychotic-naïve patients receiving an atypical antipsychotic and determine rate of progression to T2DM.
Methods
The project was reviewed by the University of Nevada-Reno Institutional Review Board and determined to be a nonresearch quality improvement project. This was a retrospective chart analysis that included patients receiving their first-ever atypical antipsychotic across 8 US Department of Veterans Affairs (VA) medical centers within VISN 21. Clinical patient data, including prescription, vital sign, and laboratory information, were extracted from the VA Corporate Data Warehouse using transact sequential query language.
Veterans were included in the final cohort if they met the following criteria: aged ≥ 18 years at antipsychotic initiation, initiated their first-ever atypical antipsychotic within the VHA between February 2014 and February 2019, continued the antipsychotic for ≥ 1 year, had a medication possession ratio (MPR) > 80%, and had previously established care within VHA as evidenced by having ≥ 1 primary care or outpatient mental health visit in the 6 months prior to initiation. The MPR is defined as the sum of the day’s supply of all dispensed medications in the project time frame divided by the total number of days in the project time frame.
Veterans were excluded if they initiated any other antipsychotic during the first course, had a prior diagnosis of T2DM, had any prior use of antidiabetic medications, or had a hemoglobin A1c (HbA1c) > 6.4 in the year prior to initiation.
The primary outcome was completion of all recommended metabolic monitoring time points in the first year after atypical antipsychotic initiation. The secondary outcome was incidence of T2DM as evidenced by either a HbA1c > 6.4 or diagnosis of T2DM entered into the electronic health record. Baseline monitoring for BP, blood glucose, and lipids were considered complete if a data point was collected between 3 months prior and 1 month after atypical antipsychotic initiation. Baseline monitoring for weight was considered complete if a data point was collected between 3 months prior and 2 weeks after initiation. Follow-up monitoring for BP, blood glucose, and lipids were considered completed if a data point was collected at 3 and 12 months (mean, 1 month). Follow-up monitoring for weight was considered completed if collected at 1, 2, and 3 months (mean, 2 weeks) and at 6, 9, and 12 months (mean, 1 month). Waist circumference data and patient and family history are not collected as capturable data points. Therefore, the authors were unable to include these in the final data extraction.
Results
The final cohort consisted of 1,651 veterans who met the inclusion criteria. Overall, at antipsychotic initiation the cohort had a mean (SD) age of 55 (14.6) years, was largely male (88%), and was considered overweight with a mean (SD) BMI of 29.1 (6.4) (Table 1).
Appropriate BP monitoring was completed most often with 492 patients (30%) meeting ADA/APA recommendations followed by HbA1c and/or blood glucose monitoring with 203 patients (12%) completing all time points. Recommended lipid monitoring was completed by 96 patients (6%). Weight monitoring was completed least often with 47 patients (3%) completing all recommended time points. Regarding completion of all metabolic monitoring time points, 3 (0.2%) patients in the final cohort were found to have completed all recommended monitoring. Ninety-nine patients (6%) were found to have progressed to T2DM as indicated by an HbA1c > 6.4 and/or entry of a T2DM ninth or tenth edition International Statistical Classification of Diseases code into the chart (Table 2).
Discussion
No previous literature exists that reviews adherence to recommended metabolic monitoring guidance up to 1 year after antipsychotic initiation in a previously antipsychotic-naïve cohort within the VHA. Metabolic monitoring was overall incomplete with 0.2% of the cohort completing all recommended monitoring time points. Weight was the parameter that was least completed. Based on these findings, the authors concluded that efforts are needed to improve completion rates of atypical antipsychotic metabolic monitoring. In the final cohort, 6% of patients were noted to have progressed to T2DM in the first year after atypical antipsychotic initiation. The actual number of patients progressing to T2DM may be larger because not all received adequate blood glucose monitoring. For comparison, the Centers for Disease Control and Prevention released information in 2015 that stated that the US population has an annual T2DM incidence of about 1% for adults aged 45 to 64 years.7
We understand that individuals with mental health disorders are at increased risk of T2DM compared with that of the general population and hope that this comparison only serves to drive home the point that appropriate metabolic monitoring is vital for this subgroup. The strengths of this project include identification of an area for improvement and encouraging evidence-based monitoring. Utilization of clinical data is a cost-effective and efficient method to improve patient care.
Limitations
Limitations of this study include the data’s dependence on accuracy of entry by the end-user and a lack of available data regarding prescriptions dispensed outside of the VHA. Vital signs data may have been entered into patient notes and not documented in the vitals section of the current medical record causing the appearance of missing data. Access to VHA health services and patient adherence to follow-up appointments were not assessed in this project and could affect patient ability to complete follow-up. The final analysis included only patients who remained on 1 atypical antipsychotic for a year and were considered adherent with an MPR > 80% and did not consider less adherent patients. It is also possible that health care providers who closely monitor metabolic parameters after atypical antipsychotic initiation more frequently switch patients to an alternative atypical antipsychotic while others who monitor less also switch medications less frequently. This could lead to selection of patients with health care providers who are less adherent to metabolic monitoring recommendations.
Conclusions
As a result of this study, in VISN 21 several strategies will be implemented to improve monitoring. First, the results of this project will be shared with the subject matter experts of the VISN 21 Mental Health Task Force. This task force serves as a venue for clinicians to meet virtually, discuss clinical topics, as well as to create and distribute strategies to improve patient care. Clinicians at this forum will be encouraged to implement monitoring protocols into routine practice, share best practices with colleagues, and increase patient awareness about the importance of metabolic monitoring. Second, modifications may be applied to the electronic health record to guide metabolic monitoring order entry at the time of prescription entry, which includes development of clinical reminders and laboratory order sets. Third, the clinical data manager team may be leveraged to create an electronic report identifying patients currently receiving suboptimal monitoring in the first year after antipsychotic initiation. The patients identified in this report will be discussed at the recurring VISN 21 Mental Health Task Force meeting, and strong practices will be shared with the medical centers across VISN 21. Other strategies under consideration include requiring proof of metabolic monitoring completion prior to allowing further atypical antipsychotic refills and providing direct provider education regarding the ADA/APA metabolic monitoring recommendations via the academic detailing service in effort to standardize clinical care.
1. Goff DC, Sullivan LM, McEvoy JP, et al. A comparison of ten-year cardiac risk estimates in schizophrenia patients from the CATIE study and matched controls. Schizophr Res. 2005;80(1):45-53. doi:10.1016/j.schres.2005.08.010
2. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033-1046. doi:10.2337/dc12-2625
3. Rajkumar AP, Horsdal HT, Wimberley T, et al. Endogenous and antipsychotic-related risks for diabetes mellitus in young people with schizophrenia: a Danish population-based cohort study. Am J Psychiatry. 2017;174(7):686-694. doi:10.1176/appi.ajp.2016.16040442
4. American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27(2):596-601. doi:10.2337/diacare.27.2.596
5. Morrato EH, Druss B, Hartung DM, et al. Metabolic testing rates in 3 state Medicaid programs after FDA warnings and ADA/APA recommendations for second-generation antipsychotic drugs. Arch Gen Psychiatry. 2010;67(1):17-24. doi:10.1001/archgenpsychiatry.2009.179
6. Mittal D, Li C, Williams JS, Viverito K, Landes RD, Owen RR. Monitoring veterans for metabolic side effects when prescribing antipsychotics. Psychiatr Serv. 2013;64(1):28-35. doi:10.1176/appi.ps.201100445
7. Centers for Disease Control and Prevention. National diabetes statistics report, 2020. https://www.cdc.gov/diabetes/data/statistics-report/index.html. Updated August 28, 2020. Accessed October 9, 2020.
Atypical antipsychotic use may result in metabolic abnormalities, such as hyperglycemia, dyslipidemia, weight gain, and metabolic syndrome. These adverse effects (AEs) can cause progression to type 2 diabetes mellitus (T2DM) as well as increased risk of cardiovascular disease and cardiac mortality. Individuals diagnosed with T2DM have medical expenses that are about 2.3 times higher than individuals without diabetes.1,2 The risk of experiencing metabolic abnormalities is likely elevated for patients who were antipsychotic-naïve prior to initiation.3
In response to an increased awareness of atypical antipsychotic-related AEs, the American Diabetes Association (ADA) and American Psychiatric Association (APA) released a consensus statement in 2004 with a metabolic monitoring protocol for patients initiating or changing to a new antipsychotic medication.4 Within the first year after initiation, the ADA/APA consensus statements recommends that clinicians acquire a personal and family history, weight, body mass index (BMI), waist circumference, blood pressure (BP), fasting plasma glucose, and fasting lipid profile at the initial patient visit. Patient weight is recommended to be collected at 4 weeks and again 8 weeks later. Twelve weeks after the initial visit, weight, BMI, BP, fasting plasma glucose and a fasting lipid profile are recommended to be collected and assessed for abnormalities. Weight is then recommended to be assessed every 3 months thereafter. Review of personal and family history, waist circumference, BP, and a fasting plasma glucose is recommended to occur annually. Finally, a fasting lipid profile is to be collected every 5 years.
Since the initial consensus statement release, metabolic monitoring of patients prescribed antipsychotic medications has been found to be inadequate within several large health care organizations.5,6 Mittal and colleagues reviewed metabolic monitoring practices occurring in 32 facilities within the Veterans Health Administration (VHA) and found that monitoring practices in the first 90 days after antipsychotic initiation were largely nonadherent to the ADA/APA consensus statement recommendations.6 Medical staff in Veterans Integrated Service Network 21 (VISN 21) currently serve about 268,000 veterans actively receiving care across California, Nevada, and the Pacific Islands.To support veteran care in the fields of mental health and medication safety, the VISN 21 pharmacy benefits manager office created a clinical dashboard that identifies veterans who are currently prescribed an antipsychotic and have not completed at least 1 annual blood glucose test. While this dashboard is a valuable tool for tracking patient care for those who have been prescribed an antipsychotic > 1 year, it does not consider the ADA/APA recommendations for more frequent monitoring in the first year after initiation. A literature review found no citations of a systematic evaluation of adherence to ADA/APA monitoring recommendations or patient progression to T2DM in the first year after antipsychotic initiation for an antipsychotic-naïve veteran population. The goal of this quality improvement project is to assess VHA health care provider and patient adherence to the 2004 consensus statement recommendations within the first year after initiation for previously antipsychotic-naïve patients receiving an atypical antipsychotic and determine rate of progression to T2DM.
Methods
The project was reviewed by the University of Nevada-Reno Institutional Review Board and determined to be a nonresearch quality improvement project. This was a retrospective chart analysis that included patients receiving their first-ever atypical antipsychotic across 8 US Department of Veterans Affairs (VA) medical centers within VISN 21. Clinical patient data, including prescription, vital sign, and laboratory information, were extracted from the VA Corporate Data Warehouse using transact sequential query language.
Veterans were included in the final cohort if they met the following criteria: aged ≥ 18 years at antipsychotic initiation, initiated their first-ever atypical antipsychotic within the VHA between February 2014 and February 2019, continued the antipsychotic for ≥ 1 year, had a medication possession ratio (MPR) > 80%, and had previously established care within VHA as evidenced by having ≥ 1 primary care or outpatient mental health visit in the 6 months prior to initiation. The MPR is defined as the sum of the day’s supply of all dispensed medications in the project time frame divided by the total number of days in the project time frame.
Veterans were excluded if they initiated any other antipsychotic during the first course, had a prior diagnosis of T2DM, had any prior use of antidiabetic medications, or had a hemoglobin A1c (HbA1c) > 6.4 in the year prior to initiation.
The primary outcome was completion of all recommended metabolic monitoring time points in the first year after atypical antipsychotic initiation. The secondary outcome was incidence of T2DM as evidenced by either a HbA1c > 6.4 or diagnosis of T2DM entered into the electronic health record. Baseline monitoring for BP, blood glucose, and lipids were considered complete if a data point was collected between 3 months prior and 1 month after atypical antipsychotic initiation. Baseline monitoring for weight was considered complete if a data point was collected between 3 months prior and 2 weeks after initiation. Follow-up monitoring for BP, blood glucose, and lipids were considered completed if a data point was collected at 3 and 12 months (mean, 1 month). Follow-up monitoring for weight was considered completed if collected at 1, 2, and 3 months (mean, 2 weeks) and at 6, 9, and 12 months (mean, 1 month). Waist circumference data and patient and family history are not collected as capturable data points. Therefore, the authors were unable to include these in the final data extraction.
Results
The final cohort consisted of 1,651 veterans who met the inclusion criteria. Overall, at antipsychotic initiation the cohort had a mean (SD) age of 55 (14.6) years, was largely male (88%), and was considered overweight with a mean (SD) BMI of 29.1 (6.4) (Table 1).
Appropriate BP monitoring was completed most often with 492 patients (30%) meeting ADA/APA recommendations followed by HbA1c and/or blood glucose monitoring with 203 patients (12%) completing all time points. Recommended lipid monitoring was completed by 96 patients (6%). Weight monitoring was completed least often with 47 patients (3%) completing all recommended time points. Regarding completion of all metabolic monitoring time points, 3 (0.2%) patients in the final cohort were found to have completed all recommended monitoring. Ninety-nine patients (6%) were found to have progressed to T2DM as indicated by an HbA1c > 6.4 and/or entry of a T2DM ninth or tenth edition International Statistical Classification of Diseases code into the chart (Table 2).
Discussion
No previous literature exists that reviews adherence to recommended metabolic monitoring guidance up to 1 year after antipsychotic initiation in a previously antipsychotic-naïve cohort within the VHA. Metabolic monitoring was overall incomplete with 0.2% of the cohort completing all recommended monitoring time points. Weight was the parameter that was least completed. Based on these findings, the authors concluded that efforts are needed to improve completion rates of atypical antipsychotic metabolic monitoring. In the final cohort, 6% of patients were noted to have progressed to T2DM in the first year after atypical antipsychotic initiation. The actual number of patients progressing to T2DM may be larger because not all received adequate blood glucose monitoring. For comparison, the Centers for Disease Control and Prevention released information in 2015 that stated that the US population has an annual T2DM incidence of about 1% for adults aged 45 to 64 years.7
We understand that individuals with mental health disorders are at increased risk of T2DM compared with that of the general population and hope that this comparison only serves to drive home the point that appropriate metabolic monitoring is vital for this subgroup. The strengths of this project include identification of an area for improvement and encouraging evidence-based monitoring. Utilization of clinical data is a cost-effective and efficient method to improve patient care.
Limitations
Limitations of this study include the data’s dependence on accuracy of entry by the end-user and a lack of available data regarding prescriptions dispensed outside of the VHA. Vital signs data may have been entered into patient notes and not documented in the vitals section of the current medical record causing the appearance of missing data. Access to VHA health services and patient adherence to follow-up appointments were not assessed in this project and could affect patient ability to complete follow-up. The final analysis included only patients who remained on 1 atypical antipsychotic for a year and were considered adherent with an MPR > 80% and did not consider less adherent patients. It is also possible that health care providers who closely monitor metabolic parameters after atypical antipsychotic initiation more frequently switch patients to an alternative atypical antipsychotic while others who monitor less also switch medications less frequently. This could lead to selection of patients with health care providers who are less adherent to metabolic monitoring recommendations.
Conclusions
As a result of this study, in VISN 21 several strategies will be implemented to improve monitoring. First, the results of this project will be shared with the subject matter experts of the VISN 21 Mental Health Task Force. This task force serves as a venue for clinicians to meet virtually, discuss clinical topics, as well as to create and distribute strategies to improve patient care. Clinicians at this forum will be encouraged to implement monitoring protocols into routine practice, share best practices with colleagues, and increase patient awareness about the importance of metabolic monitoring. Second, modifications may be applied to the electronic health record to guide metabolic monitoring order entry at the time of prescription entry, which includes development of clinical reminders and laboratory order sets. Third, the clinical data manager team may be leveraged to create an electronic report identifying patients currently receiving suboptimal monitoring in the first year after antipsychotic initiation. The patients identified in this report will be discussed at the recurring VISN 21 Mental Health Task Force meeting, and strong practices will be shared with the medical centers across VISN 21. Other strategies under consideration include requiring proof of metabolic monitoring completion prior to allowing further atypical antipsychotic refills and providing direct provider education regarding the ADA/APA metabolic monitoring recommendations via the academic detailing service in effort to standardize clinical care.
Atypical antipsychotic use may result in metabolic abnormalities, such as hyperglycemia, dyslipidemia, weight gain, and metabolic syndrome. These adverse effects (AEs) can cause progression to type 2 diabetes mellitus (T2DM) as well as increased risk of cardiovascular disease and cardiac mortality. Individuals diagnosed with T2DM have medical expenses that are about 2.3 times higher than individuals without diabetes.1,2 The risk of experiencing metabolic abnormalities is likely elevated for patients who were antipsychotic-naïve prior to initiation.3
In response to an increased awareness of atypical antipsychotic-related AEs, the American Diabetes Association (ADA) and American Psychiatric Association (APA) released a consensus statement in 2004 with a metabolic monitoring protocol for patients initiating or changing to a new antipsychotic medication.4 Within the first year after initiation, the ADA/APA consensus statements recommends that clinicians acquire a personal and family history, weight, body mass index (BMI), waist circumference, blood pressure (BP), fasting plasma glucose, and fasting lipid profile at the initial patient visit. Patient weight is recommended to be collected at 4 weeks and again 8 weeks later. Twelve weeks after the initial visit, weight, BMI, BP, fasting plasma glucose and a fasting lipid profile are recommended to be collected and assessed for abnormalities. Weight is then recommended to be assessed every 3 months thereafter. Review of personal and family history, waist circumference, BP, and a fasting plasma glucose is recommended to occur annually. Finally, a fasting lipid profile is to be collected every 5 years.
Since the initial consensus statement release, metabolic monitoring of patients prescribed antipsychotic medications has been found to be inadequate within several large health care organizations.5,6 Mittal and colleagues reviewed metabolic monitoring practices occurring in 32 facilities within the Veterans Health Administration (VHA) and found that monitoring practices in the first 90 days after antipsychotic initiation were largely nonadherent to the ADA/APA consensus statement recommendations.6 Medical staff in Veterans Integrated Service Network 21 (VISN 21) currently serve about 268,000 veterans actively receiving care across California, Nevada, and the Pacific Islands.To support veteran care in the fields of mental health and medication safety, the VISN 21 pharmacy benefits manager office created a clinical dashboard that identifies veterans who are currently prescribed an antipsychotic and have not completed at least 1 annual blood glucose test. While this dashboard is a valuable tool for tracking patient care for those who have been prescribed an antipsychotic > 1 year, it does not consider the ADA/APA recommendations for more frequent monitoring in the first year after initiation. A literature review found no citations of a systematic evaluation of adherence to ADA/APA monitoring recommendations or patient progression to T2DM in the first year after antipsychotic initiation for an antipsychotic-naïve veteran population. The goal of this quality improvement project is to assess VHA health care provider and patient adherence to the 2004 consensus statement recommendations within the first year after initiation for previously antipsychotic-naïve patients receiving an atypical antipsychotic and determine rate of progression to T2DM.
Methods
The project was reviewed by the University of Nevada-Reno Institutional Review Board and determined to be a nonresearch quality improvement project. This was a retrospective chart analysis that included patients receiving their first-ever atypical antipsychotic across 8 US Department of Veterans Affairs (VA) medical centers within VISN 21. Clinical patient data, including prescription, vital sign, and laboratory information, were extracted from the VA Corporate Data Warehouse using transact sequential query language.
Veterans were included in the final cohort if they met the following criteria: aged ≥ 18 years at antipsychotic initiation, initiated their first-ever atypical antipsychotic within the VHA between February 2014 and February 2019, continued the antipsychotic for ≥ 1 year, had a medication possession ratio (MPR) > 80%, and had previously established care within VHA as evidenced by having ≥ 1 primary care or outpatient mental health visit in the 6 months prior to initiation. The MPR is defined as the sum of the day’s supply of all dispensed medications in the project time frame divided by the total number of days in the project time frame.
Veterans were excluded if they initiated any other antipsychotic during the first course, had a prior diagnosis of T2DM, had any prior use of antidiabetic medications, or had a hemoglobin A1c (HbA1c) > 6.4 in the year prior to initiation.
The primary outcome was completion of all recommended metabolic monitoring time points in the first year after atypical antipsychotic initiation. The secondary outcome was incidence of T2DM as evidenced by either a HbA1c > 6.4 or diagnosis of T2DM entered into the electronic health record. Baseline monitoring for BP, blood glucose, and lipids were considered complete if a data point was collected between 3 months prior and 1 month after atypical antipsychotic initiation. Baseline monitoring for weight was considered complete if a data point was collected between 3 months prior and 2 weeks after initiation. Follow-up monitoring for BP, blood glucose, and lipids were considered completed if a data point was collected at 3 and 12 months (mean, 1 month). Follow-up monitoring for weight was considered completed if collected at 1, 2, and 3 months (mean, 2 weeks) and at 6, 9, and 12 months (mean, 1 month). Waist circumference data and patient and family history are not collected as capturable data points. Therefore, the authors were unable to include these in the final data extraction.
Results
The final cohort consisted of 1,651 veterans who met the inclusion criteria. Overall, at antipsychotic initiation the cohort had a mean (SD) age of 55 (14.6) years, was largely male (88%), and was considered overweight with a mean (SD) BMI of 29.1 (6.4) (Table 1).
Appropriate BP monitoring was completed most often with 492 patients (30%) meeting ADA/APA recommendations followed by HbA1c and/or blood glucose monitoring with 203 patients (12%) completing all time points. Recommended lipid monitoring was completed by 96 patients (6%). Weight monitoring was completed least often with 47 patients (3%) completing all recommended time points. Regarding completion of all metabolic monitoring time points, 3 (0.2%) patients in the final cohort were found to have completed all recommended monitoring. Ninety-nine patients (6%) were found to have progressed to T2DM as indicated by an HbA1c > 6.4 and/or entry of a T2DM ninth or tenth edition International Statistical Classification of Diseases code into the chart (Table 2).
Discussion
No previous literature exists that reviews adherence to recommended metabolic monitoring guidance up to 1 year after antipsychotic initiation in a previously antipsychotic-naïve cohort within the VHA. Metabolic monitoring was overall incomplete with 0.2% of the cohort completing all recommended monitoring time points. Weight was the parameter that was least completed. Based on these findings, the authors concluded that efforts are needed to improve completion rates of atypical antipsychotic metabolic monitoring. In the final cohort, 6% of patients were noted to have progressed to T2DM in the first year after atypical antipsychotic initiation. The actual number of patients progressing to T2DM may be larger because not all received adequate blood glucose monitoring. For comparison, the Centers for Disease Control and Prevention released information in 2015 that stated that the US population has an annual T2DM incidence of about 1% for adults aged 45 to 64 years.7
We understand that individuals with mental health disorders are at increased risk of T2DM compared with that of the general population and hope that this comparison only serves to drive home the point that appropriate metabolic monitoring is vital for this subgroup. The strengths of this project include identification of an area for improvement and encouraging evidence-based monitoring. Utilization of clinical data is a cost-effective and efficient method to improve patient care.
Limitations
Limitations of this study include the data’s dependence on accuracy of entry by the end-user and a lack of available data regarding prescriptions dispensed outside of the VHA. Vital signs data may have been entered into patient notes and not documented in the vitals section of the current medical record causing the appearance of missing data. Access to VHA health services and patient adherence to follow-up appointments were not assessed in this project and could affect patient ability to complete follow-up. The final analysis included only patients who remained on 1 atypical antipsychotic for a year and were considered adherent with an MPR > 80% and did not consider less adherent patients. It is also possible that health care providers who closely monitor metabolic parameters after atypical antipsychotic initiation more frequently switch patients to an alternative atypical antipsychotic while others who monitor less also switch medications less frequently. This could lead to selection of patients with health care providers who are less adherent to metabolic monitoring recommendations.
Conclusions
As a result of this study, in VISN 21 several strategies will be implemented to improve monitoring. First, the results of this project will be shared with the subject matter experts of the VISN 21 Mental Health Task Force. This task force serves as a venue for clinicians to meet virtually, discuss clinical topics, as well as to create and distribute strategies to improve patient care. Clinicians at this forum will be encouraged to implement monitoring protocols into routine practice, share best practices with colleagues, and increase patient awareness about the importance of metabolic monitoring. Second, modifications may be applied to the electronic health record to guide metabolic monitoring order entry at the time of prescription entry, which includes development of clinical reminders and laboratory order sets. Third, the clinical data manager team may be leveraged to create an electronic report identifying patients currently receiving suboptimal monitoring in the first year after antipsychotic initiation. The patients identified in this report will be discussed at the recurring VISN 21 Mental Health Task Force meeting, and strong practices will be shared with the medical centers across VISN 21. Other strategies under consideration include requiring proof of metabolic monitoring completion prior to allowing further atypical antipsychotic refills and providing direct provider education regarding the ADA/APA metabolic monitoring recommendations via the academic detailing service in effort to standardize clinical care.
1. Goff DC, Sullivan LM, McEvoy JP, et al. A comparison of ten-year cardiac risk estimates in schizophrenia patients from the CATIE study and matched controls. Schizophr Res. 2005;80(1):45-53. doi:10.1016/j.schres.2005.08.010
2. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033-1046. doi:10.2337/dc12-2625
3. Rajkumar AP, Horsdal HT, Wimberley T, et al. Endogenous and antipsychotic-related risks for diabetes mellitus in young people with schizophrenia: a Danish population-based cohort study. Am J Psychiatry. 2017;174(7):686-694. doi:10.1176/appi.ajp.2016.16040442
4. American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27(2):596-601. doi:10.2337/diacare.27.2.596
5. Morrato EH, Druss B, Hartung DM, et al. Metabolic testing rates in 3 state Medicaid programs after FDA warnings and ADA/APA recommendations for second-generation antipsychotic drugs. Arch Gen Psychiatry. 2010;67(1):17-24. doi:10.1001/archgenpsychiatry.2009.179
6. Mittal D, Li C, Williams JS, Viverito K, Landes RD, Owen RR. Monitoring veterans for metabolic side effects when prescribing antipsychotics. Psychiatr Serv. 2013;64(1):28-35. doi:10.1176/appi.ps.201100445
7. Centers for Disease Control and Prevention. National diabetes statistics report, 2020. https://www.cdc.gov/diabetes/data/statistics-report/index.html. Updated August 28, 2020. Accessed October 9, 2020.
1. Goff DC, Sullivan LM, McEvoy JP, et al. A comparison of ten-year cardiac risk estimates in schizophrenia patients from the CATIE study and matched controls. Schizophr Res. 2005;80(1):45-53. doi:10.1016/j.schres.2005.08.010
2. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033-1046. doi:10.2337/dc12-2625
3. Rajkumar AP, Horsdal HT, Wimberley T, et al. Endogenous and antipsychotic-related risks for diabetes mellitus in young people with schizophrenia: a Danish population-based cohort study. Am J Psychiatry. 2017;174(7):686-694. doi:10.1176/appi.ajp.2016.16040442
4. American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27(2):596-601. doi:10.2337/diacare.27.2.596
5. Morrato EH, Druss B, Hartung DM, et al. Metabolic testing rates in 3 state Medicaid programs after FDA warnings and ADA/APA recommendations for second-generation antipsychotic drugs. Arch Gen Psychiatry. 2010;67(1):17-24. doi:10.1001/archgenpsychiatry.2009.179
6. Mittal D, Li C, Williams JS, Viverito K, Landes RD, Owen RR. Monitoring veterans for metabolic side effects when prescribing antipsychotics. Psychiatr Serv. 2013;64(1):28-35. doi:10.1176/appi.ps.201100445
7. Centers for Disease Control and Prevention. National diabetes statistics report, 2020. https://www.cdc.gov/diabetes/data/statistics-report/index.html. Updated August 28, 2020. Accessed October 9, 2020.
Can an ‘unheard of’ approach up adherence to public health advice?
Using principles of psychoanalysis to craft public health messaging may be a novel and effective way of increasing adherence to public health advice during the COVID-19 pandemic, experts say.
In a letter published online Oct. 19 in The Lancet, coauthors Austin Ratner, MD, and Nisarg Gandhi, believe that, as expert communicators, psychoanalysts should be part of the public health care team to help battle the pandemic.
“The idea of using psychoanalysis in a public health setting is relatively unheard of,” Ratner, the author of a book titled “The Psychoanalyst’s Aversion to Proof,” told Medscape Medical News. Ratner earned his MD at John Hopkins School of Medicine but left medicine to become an author. Gandhi is a clinical research intern at Saint Barnabas Medical Center in Livingston, New Jersey.
Psychoanalysis postulates that defense mechanisms, such as denial, may play an important role in nonadherence to public health guidance regarding the pandemic, Ratner said.
including nonadherence to medical advice regarding COVID-19, as well as climate change and politics.
“By understanding that fear and anxiety underpin a lot of denial, the psychoanalytic viewpoint can help influence public health officials in recognizing the fear and anxiety, how to talk about the threat [of the pandemic], and what can be done about it,” he added.
“A new partnership”
“Psychoanalysts have historically resisted collaboration with disciplines such as social and experimental psychology,” Ratner said. This “insularity” results in “lost opportunities on the path for psychoanalysis to become part of the conversation regarding mass denial and mass nonadherence to medical advice.”
He noted that change is afoot in the psychoanalytic community. The American Psychoanalytic Association (APsaA) has begun to “empower constituents” who seek greater “integration with experimental science and greater involvement with public health.”
To that end, Ratner suggests a “new partnership” between three fields that have until now been disparate: experimental psychology, public health, and psychoanalysis.
Cognitive scientists have studied and documented denial, attributing it to “anxiety’s power to compromise rational thought,” but their approach has not focused on the psychoanalytic model of denial as a defense mechanism, Ratner observed.
Mark Smaller, PhD, past president of APsaA and board member of the International Psychoanalytical Association, elaborated.
“From a psychoanalytic perspective, I am interested in how a defense mechanism functions for individuals and groups,” Smaller told Medscape Medical News.
Denial as a defense mechanism often arises, whether in individuals or groups, from a sense of helplessness, explained Smaller, who is also the chair of the department of public advocacy at APsaA.
“People can only tolerate a certain amount of helplessness – in fact, I would suggest as an analyst that helplessness is the most difficult feeling for humans to come to terms with,” he said.
Helplessness can contribute to trauma and “I think we have a mass case of traumatic helplessness in our country right now because of the pandemic.”
Some people respond to a sense of helplessness with depression or hopelessness, while others “try to integrate the impact of the pandemic by focusing on things over which they have control, like wearing a mask, social distancing, and avoiding places with large numbers of people where the virus can be easily transmitted,” said Smaller.
However, “what seems to have occurred in our country is that, although many people have focused on what we do have control of, a large segment of our population are acting as if COVID-19 doesn’t exist, and we have leadership supporting this denial,” he added.
Is “denial” evidence-based?
Commenting for Medscape Medical News, Richard McAnulty, PhD, associate professor of psychology at the University of North Carolina at Charlotte expressed skepticism about the psychoanalytic view of denial, and its potential role in addressing the pandemic.
“A key criticism of psychoanalytic and psychodynamic viewpoints is that many – including the concept of a subconscious mind – are theoretical, not open to empirical research, and not measurable; and one of the most fundamental requirements in science is that all your constructs are measurable.”
For this reason, this approach is “limited in usefulness, although it might be an interesting source of speculation,” said McAnulty.
Ratner disagreed, noting that there is research corroborating the existence of an unconscious mind. Noted analyst Carl Jung, Ratner pointed out, conducted “some great experiments to prove some of the central tenets of psychoanalysis using word associations.”
Jung found that, if individuals were challenged with words that evoked painful associations, it took them longer to arrive at the answer to the test. They also made more mistakes.
Jung’s research “goes back to a core idea of psychoanalysis, which is that painful or difficult thoughts and feelings get distorted, pushed out of consciousness, forgotten, delayed, or suppressed,” Ratner said. These responses might account for “what we’re seeing the U.S. that people are resorting to irrational thinking without being aware of it.”
McAnulty suggested that the psychodynamic idea of denial as a defense mechanism is not relevant to mass nonadherence to pandemic-related medical advice.
Rather, the denial stems from “schemas and belief systems about the world, how people should operate and behave, and the role of government and the medical establishment,” he said.
“When certain recommendations are discrepant with the world view, it creates dissonance or a mismatch and the person will try to reconcile the mismatch,” McAnulty continued. “One way to do that is to say that these recommendations are invalid because they violate the individual’s political beliefs, world view, or religious ideas.”
Ultimately, “it depends on how we define denial,” said McAnulty. “If it means dismissing information that doesn’t fit an existing belief system, that’s denial, but the psychodynamic meaning of ‘denial’ is much deeper than that.”
Smaller, the past president of APsaA, emphasized the importance of empathy when addressing the public. “Psychoanalysts bring empathy to irrationality. Having a psychoanalyst as a team member can help public health officials to communicate better and craft the understanding of anxiety and fear into their message.”
Ratner said he is “not proposing a simplistic silver bullet as an answer to a very complex, multifaceted problem of nonadherence to medical advice.”
Instead, he is “proposing something that hasn’t happened yet, which is more research and more conversation, with psychoanalysis as part of the conversation, because the notion of denial is so relevant, despite how many other factors are involved.”
Ratner, Gandhi, Smaller, and McAnulty have disclosed no relevant financial relationships. Ratner is the author of The Psychoanalyst’s Aversion to Proof and the medical textbook Concepts in Medical Physiology.
This article first appeared on Medscape.com.
Using principles of psychoanalysis to craft public health messaging may be a novel and effective way of increasing adherence to public health advice during the COVID-19 pandemic, experts say.
In a letter published online Oct. 19 in The Lancet, coauthors Austin Ratner, MD, and Nisarg Gandhi, believe that, as expert communicators, psychoanalysts should be part of the public health care team to help battle the pandemic.
“The idea of using psychoanalysis in a public health setting is relatively unheard of,” Ratner, the author of a book titled “The Psychoanalyst’s Aversion to Proof,” told Medscape Medical News. Ratner earned his MD at John Hopkins School of Medicine but left medicine to become an author. Gandhi is a clinical research intern at Saint Barnabas Medical Center in Livingston, New Jersey.
Psychoanalysis postulates that defense mechanisms, such as denial, may play an important role in nonadherence to public health guidance regarding the pandemic, Ratner said.
including nonadherence to medical advice regarding COVID-19, as well as climate change and politics.
“By understanding that fear and anxiety underpin a lot of denial, the psychoanalytic viewpoint can help influence public health officials in recognizing the fear and anxiety, how to talk about the threat [of the pandemic], and what can be done about it,” he added.
“A new partnership”
“Psychoanalysts have historically resisted collaboration with disciplines such as social and experimental psychology,” Ratner said. This “insularity” results in “lost opportunities on the path for psychoanalysis to become part of the conversation regarding mass denial and mass nonadherence to medical advice.”
He noted that change is afoot in the psychoanalytic community. The American Psychoanalytic Association (APsaA) has begun to “empower constituents” who seek greater “integration with experimental science and greater involvement with public health.”
To that end, Ratner suggests a “new partnership” between three fields that have until now been disparate: experimental psychology, public health, and psychoanalysis.
Cognitive scientists have studied and documented denial, attributing it to “anxiety’s power to compromise rational thought,” but their approach has not focused on the psychoanalytic model of denial as a defense mechanism, Ratner observed.
Mark Smaller, PhD, past president of APsaA and board member of the International Psychoanalytical Association, elaborated.
“From a psychoanalytic perspective, I am interested in how a defense mechanism functions for individuals and groups,” Smaller told Medscape Medical News.
Denial as a defense mechanism often arises, whether in individuals or groups, from a sense of helplessness, explained Smaller, who is also the chair of the department of public advocacy at APsaA.
“People can only tolerate a certain amount of helplessness – in fact, I would suggest as an analyst that helplessness is the most difficult feeling for humans to come to terms with,” he said.
Helplessness can contribute to trauma and “I think we have a mass case of traumatic helplessness in our country right now because of the pandemic.”
Some people respond to a sense of helplessness with depression or hopelessness, while others “try to integrate the impact of the pandemic by focusing on things over which they have control, like wearing a mask, social distancing, and avoiding places with large numbers of people where the virus can be easily transmitted,” said Smaller.
However, “what seems to have occurred in our country is that, although many people have focused on what we do have control of, a large segment of our population are acting as if COVID-19 doesn’t exist, and we have leadership supporting this denial,” he added.
Is “denial” evidence-based?
Commenting for Medscape Medical News, Richard McAnulty, PhD, associate professor of psychology at the University of North Carolina at Charlotte expressed skepticism about the psychoanalytic view of denial, and its potential role in addressing the pandemic.
“A key criticism of psychoanalytic and psychodynamic viewpoints is that many – including the concept of a subconscious mind – are theoretical, not open to empirical research, and not measurable; and one of the most fundamental requirements in science is that all your constructs are measurable.”
For this reason, this approach is “limited in usefulness, although it might be an interesting source of speculation,” said McAnulty.
Ratner disagreed, noting that there is research corroborating the existence of an unconscious mind. Noted analyst Carl Jung, Ratner pointed out, conducted “some great experiments to prove some of the central tenets of psychoanalysis using word associations.”
Jung found that, if individuals were challenged with words that evoked painful associations, it took them longer to arrive at the answer to the test. They also made more mistakes.
Jung’s research “goes back to a core idea of psychoanalysis, which is that painful or difficult thoughts and feelings get distorted, pushed out of consciousness, forgotten, delayed, or suppressed,” Ratner said. These responses might account for “what we’re seeing the U.S. that people are resorting to irrational thinking without being aware of it.”
McAnulty suggested that the psychodynamic idea of denial as a defense mechanism is not relevant to mass nonadherence to pandemic-related medical advice.
Rather, the denial stems from “schemas and belief systems about the world, how people should operate and behave, and the role of government and the medical establishment,” he said.
“When certain recommendations are discrepant with the world view, it creates dissonance or a mismatch and the person will try to reconcile the mismatch,” McAnulty continued. “One way to do that is to say that these recommendations are invalid because they violate the individual’s political beliefs, world view, or religious ideas.”
Ultimately, “it depends on how we define denial,” said McAnulty. “If it means dismissing information that doesn’t fit an existing belief system, that’s denial, but the psychodynamic meaning of ‘denial’ is much deeper than that.”
Smaller, the past president of APsaA, emphasized the importance of empathy when addressing the public. “Psychoanalysts bring empathy to irrationality. Having a psychoanalyst as a team member can help public health officials to communicate better and craft the understanding of anxiety and fear into their message.”
Ratner said he is “not proposing a simplistic silver bullet as an answer to a very complex, multifaceted problem of nonadherence to medical advice.”
Instead, he is “proposing something that hasn’t happened yet, which is more research and more conversation, with psychoanalysis as part of the conversation, because the notion of denial is so relevant, despite how many other factors are involved.”
Ratner, Gandhi, Smaller, and McAnulty have disclosed no relevant financial relationships. Ratner is the author of The Psychoanalyst’s Aversion to Proof and the medical textbook Concepts in Medical Physiology.
This article first appeared on Medscape.com.
Using principles of psychoanalysis to craft public health messaging may be a novel and effective way of increasing adherence to public health advice during the COVID-19 pandemic, experts say.
In a letter published online Oct. 19 in The Lancet, coauthors Austin Ratner, MD, and Nisarg Gandhi, believe that, as expert communicators, psychoanalysts should be part of the public health care team to help battle the pandemic.
“The idea of using psychoanalysis in a public health setting is relatively unheard of,” Ratner, the author of a book titled “The Psychoanalyst’s Aversion to Proof,” told Medscape Medical News. Ratner earned his MD at John Hopkins School of Medicine but left medicine to become an author. Gandhi is a clinical research intern at Saint Barnabas Medical Center in Livingston, New Jersey.
Psychoanalysis postulates that defense mechanisms, such as denial, may play an important role in nonadherence to public health guidance regarding the pandemic, Ratner said.
including nonadherence to medical advice regarding COVID-19, as well as climate change and politics.
“By understanding that fear and anxiety underpin a lot of denial, the psychoanalytic viewpoint can help influence public health officials in recognizing the fear and anxiety, how to talk about the threat [of the pandemic], and what can be done about it,” he added.
“A new partnership”
“Psychoanalysts have historically resisted collaboration with disciplines such as social and experimental psychology,” Ratner said. This “insularity” results in “lost opportunities on the path for psychoanalysis to become part of the conversation regarding mass denial and mass nonadherence to medical advice.”
He noted that change is afoot in the psychoanalytic community. The American Psychoanalytic Association (APsaA) has begun to “empower constituents” who seek greater “integration with experimental science and greater involvement with public health.”
To that end, Ratner suggests a “new partnership” between three fields that have until now been disparate: experimental psychology, public health, and psychoanalysis.
Cognitive scientists have studied and documented denial, attributing it to “anxiety’s power to compromise rational thought,” but their approach has not focused on the psychoanalytic model of denial as a defense mechanism, Ratner observed.
Mark Smaller, PhD, past president of APsaA and board member of the International Psychoanalytical Association, elaborated.
“From a psychoanalytic perspective, I am interested in how a defense mechanism functions for individuals and groups,” Smaller told Medscape Medical News.
Denial as a defense mechanism often arises, whether in individuals or groups, from a sense of helplessness, explained Smaller, who is also the chair of the department of public advocacy at APsaA.
“People can only tolerate a certain amount of helplessness – in fact, I would suggest as an analyst that helplessness is the most difficult feeling for humans to come to terms with,” he said.
Helplessness can contribute to trauma and “I think we have a mass case of traumatic helplessness in our country right now because of the pandemic.”
Some people respond to a sense of helplessness with depression or hopelessness, while others “try to integrate the impact of the pandemic by focusing on things over which they have control, like wearing a mask, social distancing, and avoiding places with large numbers of people where the virus can be easily transmitted,” said Smaller.
However, “what seems to have occurred in our country is that, although many people have focused on what we do have control of, a large segment of our population are acting as if COVID-19 doesn’t exist, and we have leadership supporting this denial,” he added.
Is “denial” evidence-based?
Commenting for Medscape Medical News, Richard McAnulty, PhD, associate professor of psychology at the University of North Carolina at Charlotte expressed skepticism about the psychoanalytic view of denial, and its potential role in addressing the pandemic.
“A key criticism of psychoanalytic and psychodynamic viewpoints is that many – including the concept of a subconscious mind – are theoretical, not open to empirical research, and not measurable; and one of the most fundamental requirements in science is that all your constructs are measurable.”
For this reason, this approach is “limited in usefulness, although it might be an interesting source of speculation,” said McAnulty.
Ratner disagreed, noting that there is research corroborating the existence of an unconscious mind. Noted analyst Carl Jung, Ratner pointed out, conducted “some great experiments to prove some of the central tenets of psychoanalysis using word associations.”
Jung found that, if individuals were challenged with words that evoked painful associations, it took them longer to arrive at the answer to the test. They also made more mistakes.
Jung’s research “goes back to a core idea of psychoanalysis, which is that painful or difficult thoughts and feelings get distorted, pushed out of consciousness, forgotten, delayed, or suppressed,” Ratner said. These responses might account for “what we’re seeing the U.S. that people are resorting to irrational thinking without being aware of it.”
McAnulty suggested that the psychodynamic idea of denial as a defense mechanism is not relevant to mass nonadherence to pandemic-related medical advice.
Rather, the denial stems from “schemas and belief systems about the world, how people should operate and behave, and the role of government and the medical establishment,” he said.
“When certain recommendations are discrepant with the world view, it creates dissonance or a mismatch and the person will try to reconcile the mismatch,” McAnulty continued. “One way to do that is to say that these recommendations are invalid because they violate the individual’s political beliefs, world view, or religious ideas.”
Ultimately, “it depends on how we define denial,” said McAnulty. “If it means dismissing information that doesn’t fit an existing belief system, that’s denial, but the psychodynamic meaning of ‘denial’ is much deeper than that.”
Smaller, the past president of APsaA, emphasized the importance of empathy when addressing the public. “Psychoanalysts bring empathy to irrationality. Having a psychoanalyst as a team member can help public health officials to communicate better and craft the understanding of anxiety and fear into their message.”
Ratner said he is “not proposing a simplistic silver bullet as an answer to a very complex, multifaceted problem of nonadherence to medical advice.”
Instead, he is “proposing something that hasn’t happened yet, which is more research and more conversation, with psychoanalysis as part of the conversation, because the notion of denial is so relevant, despite how many other factors are involved.”
Ratner, Gandhi, Smaller, and McAnulty have disclosed no relevant financial relationships. Ratner is the author of The Psychoanalyst’s Aversion to Proof and the medical textbook Concepts in Medical Physiology.
This article first appeared on Medscape.com.
COVID-19 in pregnancy raises risk of preterm birth and severe disease
based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.
The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.
Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.
Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”
Address disparities that amplify risk
The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.
“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.
Severe disease and death increased in pregnant women
In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.
After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).
“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).
The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”
“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”
More data needed for informed counseling
“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.
“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.
Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”
“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.
“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”
Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”
The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.
SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.
based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.
The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.
Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.
Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”
Address disparities that amplify risk
The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.
“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.
Severe disease and death increased in pregnant women
In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.
After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).
“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).
The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”
“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”
More data needed for informed counseling
“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.
“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.
Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”
“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.
“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”
Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”
The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.
SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.
based on data from two studies published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
In a study of birth and infant outcomes, rates of preterm birth (less than 37 weeks’ gestational age) were higher among women with confirmed SARS-CoV-2 infections compared with the national average (12.9% vs. 10.2%) wrote Kate R. Woodworth, MD, and colleagues of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team.
The researchers collected information on pregnancy and infant outcomes from 16 jurisdictions through the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). The study included 5,252 women with laboratory-confirmed SARS-CoV-2 infection reported during March 29–Oct. 14, 2020.
Overall, 12.9% of the 3,912 live births with known gestational age were preterm. A total of 610 infants were tested for SARS-CoV-2, and 2.6% were positive. Most of these perinatal infections (85%) occurred among infants born to women with SARS-CoV-2 infection within 1 week of delivery.
Half of the infants with positive test results were preterm, possibly reflecting higher screening rates in the ICU, the researchers said. “These findings also support the growing evidence that although severe COVID-19 does occur in neonates the majority of term neonates experience asymptomatic infection or mild disease; however, information on long term outcomes among exposed infants is unknown.”
Address disparities that amplify risk
The study findings were limited by several factors including inconsistent symptom reporting, overrepresentation of Hispanic women, and incomplete information on pregnancy loss, Dr. Woodworth and associates noted. However, the results add to the knowledge about the impact of COVID-19 disease on pregnancy by providing a large, population-based cohort with completed pregnancy outcomes as well as infant testing.
“SET-NET will continue to follow pregnancies affected by SARS-CoV-2 through completion of pregnancy and infants until age 6 months to guide clinical and public health practice,” the researchers noted. “Longer-term investigation into solutions to alleviate underlying inequities in social determinants of health associated with disparities in maternal morbidity, mortality, and adverse pregnancy outcomes, and effectively addressing these inequities, could reduce the prevalence of conditions and experiences that might amplify risks from COVID-19,” they added.
Severe disease and death increased in pregnant women
In a second study published in the MMWR, Laura D. Zambrano, PhD, and colleagues, also of the CDC COVID-19 Response Pregnancy and Linked Outcomes Team, compared data on 23,434 reportedly pregnant and 386,028 nonpregnant women of reproductive age (15-44 years) with confirmed and symptomatic SARS-CoV-2 infections reported to the CDC between Jan. 22, 2020, and Oct. 3, 2020.
After adjustment for age, race, and underlying medical conditions, pregnant women with COVID-19 disease were significantly more likely than were nonpregnant women to be admitted to intensive care (10.5 per 1,000 cases vs. 3.9 per 1,000 cases), to receive invasive ventilation (2.9 vs. 1.1), receive extracorporeal membrane oxygenation (0.7 vs. 0.3) and to die (1.5 vs. 1.2).
“Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35-44 years than among those aged 15-24 years,” Dr. Zambrano and associates noted. In addition, non-Hispanic Black and Black women comprised 14.1% of the study population but accounted for 36.6% of deaths overall (9 in pregnant women and 167 in nonpregnant women).
The findings in the study of characteristics were limited by several factors including the voluntary reporting of COVID-19 cases, potential reporting bias, and inadequate time to assess severe cases, the researchers noted. However, “data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy.”
“Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19,” Dr. Zambrano and associates said. “Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy.”
More data needed for informed counseling
“It is important to conduct research trials involving pregnant women so that we have reliable data regarding outcomes with which to counsel women,” Angela Bianco, MD, a maternal fetal medicine specialist at Mount Sinai Hospital in New York, said in an interview.
“Often pregnant women are excluded from research trials, but the impact of the current public health crisis affects all persons regardless of pregnancy status,” she said.
Dr. Bianco said that she was not surprised by the findings of either study. “In fact, our own research produced similar results.”
“These recent publications found that age-matched pregnant versus nonpregnant women had more severe manifestations of COVID-19, and specifically that pregnant women had a higher risk of requiring ventilation and intensive care admission, as well as higher risk of death,” she said. “Previous studies examining the effect of other SARS viruses have demonstrated that pregnancy is associated with worse outcomes; these findings are likely attributable to the relative state of immunosuppression in pregnancy.” Also, “one of these trials found a greater risk of premature birth in women with COVID-19; this may largely be attributable to iatrogenic delivery due to maternal illness as opposed to spontaneous preterm birth,” Dr. Bianco explained.
“Data are emerging regarding the impact of SARS-CoV-2 on pregnancy outcomes, however information remains limited,” Dr. Bianco noted. “Clinicians need to make patients aware that SARS-CoV-2 infection during pregnancy is associated with a greater risk of severe illness requiring intensive care and/or ventilatory support and even death; however, the precise rates remain unknown. “COVID-19 during pregnancy may result in a preterm birth, but at this time the rate of fetal infection remains unknown,” she said. “Clinicians need to reinforce the importance of physical distancing, mask use, and proper hand hygiene, particularly in this vulnerable population.”
Dr. Bianco emphasized: “Longitudinal studies assessing the impact of SARS-CoV-2 infection at various gestational age periods are needed, as at this time most of the available data includes women with SARS-CoV-2 infection around the time of delivery. Long-term infant outcomes are needed, as well as studies assessing the risk of fetal infection.”
The studies were supported by the Centers for Disease Control and Prevention. The researchers had no financial conflicts to disclose. Dr. Bianco had no relevant financial disclosures.
SOURCE: Woodworth KR et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e2; Zambrano LD et al. MMWR. 2020 Nov 2. doi: 10.15585/mmwr.mm6944e3.
FROM MMWR
New case suggestive of in utero SARS-CoV-2 transmission
A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.
Further,
The data
In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.
Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.
The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.
“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.
Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”
The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
Some perspective
In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.
With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”
Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.
SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127
A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.
Further,
The data
In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.
Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.
The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.
“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.
Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”
The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
Some perspective
In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.
With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”
Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.
SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127
A new report of mother-to-fetus transmission of SARS-CoV-2 through umbilical cord blood adds to a small but growing body of evidence that the virus can be transmitted in utero.
Further,
The data
In a report published in the Journal of The Pediatric Infectious Diseases Society, Isabelle Von Kohorn, MD, PhD, of Holy Cross Health in Silver Spring, Md., and colleagues, described a case of neonatal infection with SARS-CoV-2 in a boy delivered by C-section at 34 weeks to a mother diagnosed with COVID-19 some 14 hours before. The newborn was immediately removed to a neonatal ICU and reunited with his mother a week later, once the mother had recovered.
Dr. Von Kohorn and colleagues reported that, while the infant’s nasopharyngeal swab test for SARS-CoV-2 was negative at 24 hours after birth, repeat molecular tests (using different assays) from 49 hours on were positive and indicated an increasing viral burden, although the infant never developed symptoms of COVID-19. In addition to being found in the nasopharynx, viral RNA also was detected in cord blood and in urine. No viral RNA was found in the placenta.
The circumstances of the birth, and the care taken to keep mother and her infant at a safe distance along with masking of the mother, made it “extremely unlikely” that the infant acquired his infection by the respiratory route, Dr. Von Kohorn and colleagues wrote.
“While we cannot rule out microscopic maternal blood contamination of cord blood in this or any other delivery, cord blood collection procedures are designed to avoid gross contamination with maternal blood. Microscopic contamination would not explain the RNA levels observed in our patient’s cord blood,” they wrote.
Clinicians should note that a neonate born to a mother with COVID-19 may take time to test positive for SARS-CoV-2 , the investigators argued, though the current recommendation of the American Academy of Pediatrics is to test nasopharyngeal secretions of well newborns at 24 and 48 hours but not again in the absence of symptoms. “This case suggests that some cases of SARS-CoV-2 in newborns may be detectable only after 48 hours of life.”
The authors hypothesized that virus transmitted by cord blood “seeded the nasopharynx and required 2 days for incubation and replication sufficient for detection.”
Some perspective
In an interview, Andrea Edlow, MD, A maternal-fetal medicine specialist at Massachusetts General Hospital in Boston, called the findings provocative if not definitive in establishing in utero or vertical transmission of SARS-CoV-2 in the same way that a Nature Communications case report did in July 2020. In that case, of a baby born to a mother with COVID-19, virus was seen at high levels in the placenta.
With the current case, “the absence of detectable virus in the placenta is certainly inconsistent/confusing if the authors claim hematogenous spread from mother to baby,” Dr. Edlow commented, “but the authors do offer plausible explanations, such as examination of limited areas within the placenta (when we know infection is likely to be patchy) and possible degradation of RNA prior to attempting to measure placental viral presence.”
Dr. Von Kohorn and colleagues’ study was funded by the National Institutes of Health, and the investigators disclosed no financial conflicts of interest. Dr. Edlow had no relevant financial disclosures.
SOURCE: Von Kohorn I et al. J Pediat Inf Dis Soc. 2020 Oct 22. doi: 10.1093/jpids/piaa127
FROM THE JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY
Home spirometry improved monitoring of cystic fibrosis patients during COVID-19 pandemic
Home spirometry has become increasingly used among cystic fibrosis patients during the COVID-19 pandemic, and new research suggests that home devices perform reasonably well. Forced expiratory volume in 1 second (FEV1) values were a bit lower than values seen in clinical spirometry performed in the same patient at a nearby time point, but the procedure reliably picked up decreases in FEV1, potentially helping patients and clinicians spot exacerbations early.
“Home spirometry was sort of a curiosity that was slowly working its way into cystic fibrosis research in 2019, and then all of a sudden in 2020 it became front and center as the only way to continue with clinical monitoring and research in many cases,” Alexander Paynter, MS, a biostatistician at the Cystic Fibrosis Foundation’s Therapeutic Development Network Coordinating Center, said during a talk at the virtual North American Cystic Fibrosis Conference.
To better determine how closely home spirometry matches clinical spirometry, Mr. Paynter and his colleagues analyzed data from the eICE study, which included 267 cystic fibrosis patients aged 14 and over at 14 cystic fibrosis centers. They were randomized to use home spirometry as an early intervention to detect exacerbations, or to continue usual clinic care with visits to the clinic every 3 months. The dataset includes twice-weekly home spirometry values, with a full-year of follow-up data. The researchers compared the home spirometry data to the clinical data closest in time to it. Clinic spirometry data with no corresponding home data within 7 days were discarded.
There was an estimated difference of –2.01 mL between home and clinic tests, with home spirometry producing lower values (95% confidence interval, –3.56 to –0.45). “There is actually a bias in home spirometry as compared to clinic spirometry,” concluded Mr. Paynter.
One explanation for lower values in home spirometry is that users are inexperienced with the device. If that’s true, then agreement should improve over time, but the researchers didn’t see strong evidence of that. Among 44 patients who completed five clinical visits, there was a difference of –2.97 (standard deviation [SD], 10.51) at baseline, –1.66 at 3 months (SD, 13.49), –3.7 at 6 months (SD, 12.44), –0.86 at 9 months (SD, 13.73), and –0.53 at 12 months (SD, 13.35). Though there was improvement over time, “we don’t find a lot of evidence that this bias completely resolves,” said Mr. Paynter.
In fact, a more likely explanation is the presence of coaching by a technician during clinical spirometry, according to Robert J. Giusti, MD, clinical professor of pediatrics and director of the Pediatric Cystic Fibrosis Center at New York University. “When they’re doing it at home, they don’t do it with the same effort, so I think that coaching through telemedicine during the home spirometry would make that difference disappear,” he said when asked to comment on the study.
The researchers found that change-based endpoints were similar between clinic and at-home spirometry. Compared to baseline, the two showed similar declines over time. “The clinic and home observations tend to track each other pretty well. At 6 months, for instance, it’s about a change of three points decrease (in both). But the bad news is that the variability is much greater in home devices,” said Mr. Paynter, noting larger confidence intervals and standard deviation values associated with home spirometry. That could influence future clinical designs that may rely on home spirometry, since a larger confidence interval means reduced power, which could double or even quadruple the number of participants needed to achieve the required power, he said.
But from a clinical standpoint, the ability of home spirometry to consistently detect a change from baseline could be quite valuable to future patient management, according to Dr. Giusti. “It looks like home spirometry will show that kind of a decrease, so that it’s still sensitive to pick up the concern that a patient is getting worse at home,” he said.
That could be useful even after the COVID-19 pandemic passes, as patients continue to embrace home monitoring. Physicians could keep track of patients and keep them focused on their care and treatment through frequent telemedicine visits combined with home spirometry. “I really think home spirometry will keep us more focused on how the patients are doing and make for better outcomes,” said Dr. Giusti.
Mr. Paynter and Dr. Giusti have no relevant financial disclosures.
SOURCE: Alex Paynter et al. NACFC 2020. Poster 643.
Home spirometry has become increasingly used among cystic fibrosis patients during the COVID-19 pandemic, and new research suggests that home devices perform reasonably well. Forced expiratory volume in 1 second (FEV1) values were a bit lower than values seen in clinical spirometry performed in the same patient at a nearby time point, but the procedure reliably picked up decreases in FEV1, potentially helping patients and clinicians spot exacerbations early.
“Home spirometry was sort of a curiosity that was slowly working its way into cystic fibrosis research in 2019, and then all of a sudden in 2020 it became front and center as the only way to continue with clinical monitoring and research in many cases,” Alexander Paynter, MS, a biostatistician at the Cystic Fibrosis Foundation’s Therapeutic Development Network Coordinating Center, said during a talk at the virtual North American Cystic Fibrosis Conference.
To better determine how closely home spirometry matches clinical spirometry, Mr. Paynter and his colleagues analyzed data from the eICE study, which included 267 cystic fibrosis patients aged 14 and over at 14 cystic fibrosis centers. They were randomized to use home spirometry as an early intervention to detect exacerbations, or to continue usual clinic care with visits to the clinic every 3 months. The dataset includes twice-weekly home spirometry values, with a full-year of follow-up data. The researchers compared the home spirometry data to the clinical data closest in time to it. Clinic spirometry data with no corresponding home data within 7 days were discarded.
There was an estimated difference of –2.01 mL between home and clinic tests, with home spirometry producing lower values (95% confidence interval, –3.56 to –0.45). “There is actually a bias in home spirometry as compared to clinic spirometry,” concluded Mr. Paynter.
One explanation for lower values in home spirometry is that users are inexperienced with the device. If that’s true, then agreement should improve over time, but the researchers didn’t see strong evidence of that. Among 44 patients who completed five clinical visits, there was a difference of –2.97 (standard deviation [SD], 10.51) at baseline, –1.66 at 3 months (SD, 13.49), –3.7 at 6 months (SD, 12.44), –0.86 at 9 months (SD, 13.73), and –0.53 at 12 months (SD, 13.35). Though there was improvement over time, “we don’t find a lot of evidence that this bias completely resolves,” said Mr. Paynter.
In fact, a more likely explanation is the presence of coaching by a technician during clinical spirometry, according to Robert J. Giusti, MD, clinical professor of pediatrics and director of the Pediatric Cystic Fibrosis Center at New York University. “When they’re doing it at home, they don’t do it with the same effort, so I think that coaching through telemedicine during the home spirometry would make that difference disappear,” he said when asked to comment on the study.
The researchers found that change-based endpoints were similar between clinic and at-home spirometry. Compared to baseline, the two showed similar declines over time. “The clinic and home observations tend to track each other pretty well. At 6 months, for instance, it’s about a change of three points decrease (in both). But the bad news is that the variability is much greater in home devices,” said Mr. Paynter, noting larger confidence intervals and standard deviation values associated with home spirometry. That could influence future clinical designs that may rely on home spirometry, since a larger confidence interval means reduced power, which could double or even quadruple the number of participants needed to achieve the required power, he said.
But from a clinical standpoint, the ability of home spirometry to consistently detect a change from baseline could be quite valuable to future patient management, according to Dr. Giusti. “It looks like home spirometry will show that kind of a decrease, so that it’s still sensitive to pick up the concern that a patient is getting worse at home,” he said.
That could be useful even after the COVID-19 pandemic passes, as patients continue to embrace home monitoring. Physicians could keep track of patients and keep them focused on their care and treatment through frequent telemedicine visits combined with home spirometry. “I really think home spirometry will keep us more focused on how the patients are doing and make for better outcomes,” said Dr. Giusti.
Mr. Paynter and Dr. Giusti have no relevant financial disclosures.
SOURCE: Alex Paynter et al. NACFC 2020. Poster 643.
Home spirometry has become increasingly used among cystic fibrosis patients during the COVID-19 pandemic, and new research suggests that home devices perform reasonably well. Forced expiratory volume in 1 second (FEV1) values were a bit lower than values seen in clinical spirometry performed in the same patient at a nearby time point, but the procedure reliably picked up decreases in FEV1, potentially helping patients and clinicians spot exacerbations early.
“Home spirometry was sort of a curiosity that was slowly working its way into cystic fibrosis research in 2019, and then all of a sudden in 2020 it became front and center as the only way to continue with clinical monitoring and research in many cases,” Alexander Paynter, MS, a biostatistician at the Cystic Fibrosis Foundation’s Therapeutic Development Network Coordinating Center, said during a talk at the virtual North American Cystic Fibrosis Conference.
To better determine how closely home spirometry matches clinical spirometry, Mr. Paynter and his colleagues analyzed data from the eICE study, which included 267 cystic fibrosis patients aged 14 and over at 14 cystic fibrosis centers. They were randomized to use home spirometry as an early intervention to detect exacerbations, or to continue usual clinic care with visits to the clinic every 3 months. The dataset includes twice-weekly home spirometry values, with a full-year of follow-up data. The researchers compared the home spirometry data to the clinical data closest in time to it. Clinic spirometry data with no corresponding home data within 7 days were discarded.
There was an estimated difference of –2.01 mL between home and clinic tests, with home spirometry producing lower values (95% confidence interval, –3.56 to –0.45). “There is actually a bias in home spirometry as compared to clinic spirometry,” concluded Mr. Paynter.
One explanation for lower values in home spirometry is that users are inexperienced with the device. If that’s true, then agreement should improve over time, but the researchers didn’t see strong evidence of that. Among 44 patients who completed five clinical visits, there was a difference of –2.97 (standard deviation [SD], 10.51) at baseline, –1.66 at 3 months (SD, 13.49), –3.7 at 6 months (SD, 12.44), –0.86 at 9 months (SD, 13.73), and –0.53 at 12 months (SD, 13.35). Though there was improvement over time, “we don’t find a lot of evidence that this bias completely resolves,” said Mr. Paynter.
In fact, a more likely explanation is the presence of coaching by a technician during clinical spirometry, according to Robert J. Giusti, MD, clinical professor of pediatrics and director of the Pediatric Cystic Fibrosis Center at New York University. “When they’re doing it at home, they don’t do it with the same effort, so I think that coaching through telemedicine during the home spirometry would make that difference disappear,” he said when asked to comment on the study.
The researchers found that change-based endpoints were similar between clinic and at-home spirometry. Compared to baseline, the two showed similar declines over time. “The clinic and home observations tend to track each other pretty well. At 6 months, for instance, it’s about a change of three points decrease (in both). But the bad news is that the variability is much greater in home devices,” said Mr. Paynter, noting larger confidence intervals and standard deviation values associated with home spirometry. That could influence future clinical designs that may rely on home spirometry, since a larger confidence interval means reduced power, which could double or even quadruple the number of participants needed to achieve the required power, he said.
But from a clinical standpoint, the ability of home spirometry to consistently detect a change from baseline could be quite valuable to future patient management, according to Dr. Giusti. “It looks like home spirometry will show that kind of a decrease, so that it’s still sensitive to pick up the concern that a patient is getting worse at home,” he said.
That could be useful even after the COVID-19 pandemic passes, as patients continue to embrace home monitoring. Physicians could keep track of patients and keep them focused on their care and treatment through frequent telemedicine visits combined with home spirometry. “I really think home spirometry will keep us more focused on how the patients are doing and make for better outcomes,” said Dr. Giusti.
Mr. Paynter and Dr. Giusti have no relevant financial disclosures.
SOURCE: Alex Paynter et al. NACFC 2020. Poster 643.
FROM NACFC 2020