A new proposal aims to move clinicians away from the keyboard and back to face time with patients. Also today, diuretics are linked to diabetic amputations in type 2 diabetes, pausing direct acting oral anticoagulants show favorable outcomes for atrial fibrillation, and while therapy has matured for patients with HCV, there are still issues with access.

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A new proposal aims to move clinicians away from the keyboard and back to face time with patients. Also today, diuretics are linked to diabetic amputations in type 2 diabetes, pausing direct acting oral anticoagulants show favorable outcomes for atrial fibrillation, and while therapy has matured for patients with HCV, there are still issues with access.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

A new proposal aims to move clinicians away from the keyboard and back to face time with patients. Also today, diuretics are linked to diabetic amputations in type 2 diabetes, pausing direct acting oral anticoagulants show favorable outcomes for atrial fibrillation, and while therapy has matured for patients with HCV, there are still issues with access.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Photo by Jen Smith

SAN DIEGO—An algorithm has proven effective for identifying differentiation syndrome (DS) in patients taking ivosidenib or enasidenib, according to a speaker at the 2018 ASH Annual Meeting.

The U.S. Food and Drug Administration (FDA) recently announced that DS is going unnoticed in some patients with acute myeloid leukemia (AML) who are taking the IDH2 inhibitor enasidenib (Idhifa) or the IDH1 inhibitor ivosidenib (Tibsovo).

Though both drug labels include boxed warnings detailing the risk of DS, the FDA found evidence to suggest that DS is underdiagnosed, which can result in fatalities.

The FDA performed a systematic analysis of DS in AML patients taking either drug to determine if an algorithm could uncover a higher incidence of DS than was previously reported.

Kelly J. Norsworthy, MD, of the FDA, described the results of this analysis at ASH as abstract 288.

The analysis included patients with relapsed/refractory AML treated on a phase 1 study of ivosidenib (NCT02074839, AG120-C-001) and a phase 1/2 study of enasidenib (NCT01915498, AG221-C-001).

There were 179 patients treated with the approved dose of ivosidenib and 214 treated with the approved dose of enasidenib.

The researchers searched for DS events in the first 90 days of therapy. Patients were categorized as having DS if they had at least one investigator-reported DS event (IDH DS or retinoic acid syndrome) or if they had at least two signs or symptoms of DS, according to revised Montesinos criteria, within 7 days.

The signs/symptoms included:

• Dyspnea
• Unexplained fever
• Weight gain
• Unexplained hypotension
• Acute renal failure
• Pulmonary infiltrates or pleuropericardial effusion
• Multiple organ dysfunction.

“We added an event for multiple organ dysfunction since this adverse event could satisfy multiple Montesinos criteria,” Dr. Norsworthy said.

“Although leukocytosis is not a diagnostic criterion for DS, it is frequently seen in association with DS, so we performed an additional query for concomitant leukocytosis,” she added.

The researchers looked for adverse events of leukocytosis, hyperleukocytosis, white blood cell count increase, and leukocyte count greater than 10 Gi/L within 7 days of clinical signs/symptoms.

DS incidence

The algorithm suggested 40% of patients in each treatment group had potential DS—72 of 179 patients treated with ivosidenib and 86 of 214 patients treated with enasidenib.

“We reviewed case narratives and laboratory data from the algorithmically defined cases of DS to adjudicate whether cases were DS or unlikely DS due to an alternative explanation, most commonly due to a clinical course inconsistent with DS or confirmed infection,” Dr. Norsworthy said.

The reviewer-adjudicated incidence of DS was 19% in both groups—34 patients on ivosidenib and 41 patients on enasidenib.

“This contrasts with the DS incidence of 11% to 14% reported by investigators,” Dr. Norsworthy said. “Thus, there was a subset of patients where the syndrome was not recognized by investigators.”

Characteristics of DS

The median time to DS onset in this analysis was 20 days (range, 1 to 78) in the ivosidenib group and 19 days in the enasidenib group (range, 1 to 86).

In both treatment groups, most patients had moderate DS—71% (n=24) in the ivosidenib group and 80% (n=33) in the enasidenib group. Moderate DS was defined as meeting two to three of the aforementioned criteria for DS.

Fewer patients had severe DS (four or more criteria)—24% (n=8) in the ivosidenib group and 12% (n=5) in the enasidenib group.

For the remaining patients, DS severity could not be determined—6% (n=2) in the ivosidenib group and 10% (n=4) in the enasidenib group. These were investigator-reported cases of DS.

Most DS cases in the ivosidenib and enasidenib groups—68% (n=23) and 66% (n=27), respectively— included grade 3 or higher adverse reactions.

Two patients in each group died of DS—6% and 5%, respectively. Only one of these cases was recognized as DS and treated with steroids, Dr. Norsworthy noted.

She also pointed out that most patients with DS had leukocytosis—79% (n=27) in the ivosidenib group and 61% (n=25) in the enasidenib group.

In addition, rates of complete response (CR) and CR with incomplete hematologic recovery (CRh) were numerically lower among patients with DS, although the confidence intervals (CI) overlap.

Among patients on ivosidenib, the CR/CRh rate was 18% (95% CI, 7-35) in those with DS and 36% (95% CI, 28-45) in those without DS.

Among patients on enasidenib, the CR/CRh rate was 18% (95% CI, 7-33) in those with DS and 25% (95% CI, 18-32) in those without DS.

“[F]irm conclusions regarding the impact on response cannot be inferred based on this post-hoc subgroup analysis,” Dr. Norsworthy stressed.

Predicting DS

Dr. Norsworthy noted that baseline patient and disease characteristics were similar between patients with and without DS.

The researchers did see a trend toward higher blasts in the marrow and peripheral blood as well as higher white blood cell counts at baseline among patients with DS.

“However, there did not appear to be a distinct baseline white blood cell count or absolute blast cell count cutoff above which DS was more common,” Dr. Norsworthy said.

She added that the patient numbers are small, so it’s not possible to make firm conclusions about prognostic factors for DS.

In closing, Dr. Norsworthy said the algorithmic approach used here “led to the recognition of additional cases of DS not identified by investigators or review committee determination for patients treated with the IDH inhibitors ivo and ena.”

“Increased recognition of the signs and symptoms of DS through the framework of the Montesinos criteria may lead to early diagnosis and treatment, which may decrease severe complications and mortality. Furthermore, integration of the algorithm into clinical trials of differentiating therapies, in a prospective fashion, may help to systematically monitor the incidence and severity of DS.”

Dr. Norsworthy declared no conflicts of interest.

Photo by Jen Smith

SAN DIEGO—An algorithm has proven effective for identifying differentiation syndrome (DS) in patients taking ivosidenib or enasidenib, according to a speaker at the 2018 ASH Annual Meeting.

The U.S. Food and Drug Administration (FDA) recently announced that DS is going unnoticed in some patients with acute myeloid leukemia (AML) who are taking the IDH2 inhibitor enasidenib (Idhifa) or the IDH1 inhibitor ivosidenib (Tibsovo).

Though both drug labels include boxed warnings detailing the risk of DS, the FDA found evidence to suggest that DS is underdiagnosed, which can result in fatalities.

The FDA performed a systematic analysis of DS in AML patients taking either drug to determine if an algorithm could uncover a higher incidence of DS than was previously reported.

Kelly J. Norsworthy, MD, of the FDA, described the results of this analysis at ASH as abstract 288.

The analysis included patients with relapsed/refractory AML treated on a phase 1 study of ivosidenib (NCT02074839, AG120-C-001) and a phase 1/2 study of enasidenib (NCT01915498, AG221-C-001).

There were 179 patients treated with the approved dose of ivosidenib and 214 treated with the approved dose of enasidenib.

The researchers searched for DS events in the first 90 days of therapy. Patients were categorized as having DS if they had at least one investigator-reported DS event (IDH DS or retinoic acid syndrome) or if they had at least two signs or symptoms of DS, according to revised Montesinos criteria, within 7 days.

The signs/symptoms included:

• Dyspnea
• Unexplained fever
• Weight gain
• Unexplained hypotension
• Acute renal failure
• Pulmonary infiltrates or pleuropericardial effusion
• Multiple organ dysfunction.

“We added an event for multiple organ dysfunction since this adverse event could satisfy multiple Montesinos criteria,” Dr. Norsworthy said.

“Although leukocytosis is not a diagnostic criterion for DS, it is frequently seen in association with DS, so we performed an additional query for concomitant leukocytosis,” she added.

The researchers looked for adverse events of leukocytosis, hyperleukocytosis, white blood cell count increase, and leukocyte count greater than 10 Gi/L within 7 days of clinical signs/symptoms.

DS incidence

The algorithm suggested 40% of patients in each treatment group had potential DS—72 of 179 patients treated with ivosidenib and 86 of 214 patients treated with enasidenib.

“We reviewed case narratives and laboratory data from the algorithmically defined cases of DS to adjudicate whether cases were DS or unlikely DS due to an alternative explanation, most commonly due to a clinical course inconsistent with DS or confirmed infection,” Dr. Norsworthy said.

The reviewer-adjudicated incidence of DS was 19% in both groups—34 patients on ivosidenib and 41 patients on enasidenib.

“This contrasts with the DS incidence of 11% to 14% reported by investigators,” Dr. Norsworthy said. “Thus, there was a subset of patients where the syndrome was not recognized by investigators.”

Characteristics of DS

The median time to DS onset in this analysis was 20 days (range, 1 to 78) in the ivosidenib group and 19 days in the enasidenib group (range, 1 to 86).

In both treatment groups, most patients had moderate DS—71% (n=24) in the ivosidenib group and 80% (n=33) in the enasidenib group. Moderate DS was defined as meeting two to three of the aforementioned criteria for DS.

Fewer patients had severe DS (four or more criteria)—24% (n=8) in the ivosidenib group and 12% (n=5) in the enasidenib group.

For the remaining patients, DS severity could not be determined—6% (n=2) in the ivosidenib group and 10% (n=4) in the enasidenib group. These were investigator-reported cases of DS.

Most DS cases in the ivosidenib and enasidenib groups—68% (n=23) and 66% (n=27), respectively— included grade 3 or higher adverse reactions.

Two patients in each group died of DS—6% and 5%, respectively. Only one of these cases was recognized as DS and treated with steroids, Dr. Norsworthy noted.

She also pointed out that most patients with DS had leukocytosis—79% (n=27) in the ivosidenib group and 61% (n=25) in the enasidenib group.

In addition, rates of complete response (CR) and CR with incomplete hematologic recovery (CRh) were numerically lower among patients with DS, although the confidence intervals (CI) overlap.

Among patients on ivosidenib, the CR/CRh rate was 18% (95% CI, 7-35) in those with DS and 36% (95% CI, 28-45) in those without DS.

Among patients on enasidenib, the CR/CRh rate was 18% (95% CI, 7-33) in those with DS and 25% (95% CI, 18-32) in those without DS.

“[F]irm conclusions regarding the impact on response cannot be inferred based on this post-hoc subgroup analysis,” Dr. Norsworthy stressed.

Predicting DS

Dr. Norsworthy noted that baseline patient and disease characteristics were similar between patients with and without DS.

The researchers did see a trend toward higher blasts in the marrow and peripheral blood as well as higher white blood cell counts at baseline among patients with DS.

“However, there did not appear to be a distinct baseline white blood cell count or absolute blast cell count cutoff above which DS was more common,” Dr. Norsworthy said.

She added that the patient numbers are small, so it’s not possible to make firm conclusions about prognostic factors for DS.

In closing, Dr. Norsworthy said the algorithmic approach used here “led to the recognition of additional cases of DS not identified by investigators or review committee determination for patients treated with the IDH inhibitors ivo and ena.”

“Increased recognition of the signs and symptoms of DS through the framework of the Montesinos criteria may lead to early diagnosis and treatment, which may decrease severe complications and mortality. Furthermore, integration of the algorithm into clinical trials of differentiating therapies, in a prospective fashion, may help to systematically monitor the incidence and severity of DS.”

Dr. Norsworthy declared no conflicts of interest.

Photo by Jen Smith

SAN DIEGO—An algorithm has proven effective for identifying differentiation syndrome (DS) in patients taking ivosidenib or enasidenib, according to a speaker at the 2018 ASH Annual Meeting.

The U.S. Food and Drug Administration (FDA) recently announced that DS is going unnoticed in some patients with acute myeloid leukemia (AML) who are taking the IDH2 inhibitor enasidenib (Idhifa) or the IDH1 inhibitor ivosidenib (Tibsovo).

Though both drug labels include boxed warnings detailing the risk of DS, the FDA found evidence to suggest that DS is underdiagnosed, which can result in fatalities.

The FDA performed a systematic analysis of DS in AML patients taking either drug to determine if an algorithm could uncover a higher incidence of DS than was previously reported.

Kelly J. Norsworthy, MD, of the FDA, described the results of this analysis at ASH as abstract 288.

The analysis included patients with relapsed/refractory AML treated on a phase 1 study of ivosidenib (NCT02074839, AG120-C-001) and a phase 1/2 study of enasidenib (NCT01915498, AG221-C-001).

There were 179 patients treated with the approved dose of ivosidenib and 214 treated with the approved dose of enasidenib.

The researchers searched for DS events in the first 90 days of therapy. Patients were categorized as having DS if they had at least one investigator-reported DS event (IDH DS or retinoic acid syndrome) or if they had at least two signs or symptoms of DS, according to revised Montesinos criteria, within 7 days.

The signs/symptoms included:

• Dyspnea
• Unexplained fever
• Weight gain
• Unexplained hypotension
• Acute renal failure
• Pulmonary infiltrates or pleuropericardial effusion
• Multiple organ dysfunction.

“We added an event for multiple organ dysfunction since this adverse event could satisfy multiple Montesinos criteria,” Dr. Norsworthy said.

“Although leukocytosis is not a diagnostic criterion for DS, it is frequently seen in association with DS, so we performed an additional query for concomitant leukocytosis,” she added.

The researchers looked for adverse events of leukocytosis, hyperleukocytosis, white blood cell count increase, and leukocyte count greater than 10 Gi/L within 7 days of clinical signs/symptoms.

DS incidence

The algorithm suggested 40% of patients in each treatment group had potential DS—72 of 179 patients treated with ivosidenib and 86 of 214 patients treated with enasidenib.

“We reviewed case narratives and laboratory data from the algorithmically defined cases of DS to adjudicate whether cases were DS or unlikely DS due to an alternative explanation, most commonly due to a clinical course inconsistent with DS or confirmed infection,” Dr. Norsworthy said.

The reviewer-adjudicated incidence of DS was 19% in both groups—34 patients on ivosidenib and 41 patients on enasidenib.

“This contrasts with the DS incidence of 11% to 14% reported by investigators,” Dr. Norsworthy said. “Thus, there was a subset of patients where the syndrome was not recognized by investigators.”

Characteristics of DS

The median time to DS onset in this analysis was 20 days (range, 1 to 78) in the ivosidenib group and 19 days in the enasidenib group (range, 1 to 86).

In both treatment groups, most patients had moderate DS—71% (n=24) in the ivosidenib group and 80% (n=33) in the enasidenib group. Moderate DS was defined as meeting two to three of the aforementioned criteria for DS.

Fewer patients had severe DS (four or more criteria)—24% (n=8) in the ivosidenib group and 12% (n=5) in the enasidenib group.

For the remaining patients, DS severity could not be determined—6% (n=2) in the ivosidenib group and 10% (n=4) in the enasidenib group. These were investigator-reported cases of DS.

Most DS cases in the ivosidenib and enasidenib groups—68% (n=23) and 66% (n=27), respectively— included grade 3 or higher adverse reactions.

Two patients in each group died of DS—6% and 5%, respectively. Only one of these cases was recognized as DS and treated with steroids, Dr. Norsworthy noted.

She also pointed out that most patients with DS had leukocytosis—79% (n=27) in the ivosidenib group and 61% (n=25) in the enasidenib group.

In addition, rates of complete response (CR) and CR with incomplete hematologic recovery (CRh) were numerically lower among patients with DS, although the confidence intervals (CI) overlap.

Among patients on ivosidenib, the CR/CRh rate was 18% (95% CI, 7-35) in those with DS and 36% (95% CI, 28-45) in those without DS.

Among patients on enasidenib, the CR/CRh rate was 18% (95% CI, 7-33) in those with DS and 25% (95% CI, 18-32) in those without DS.

“[F]irm conclusions regarding the impact on response cannot be inferred based on this post-hoc subgroup analysis,” Dr. Norsworthy stressed.

Predicting DS

Dr. Norsworthy noted that baseline patient and disease characteristics were similar between patients with and without DS.

The researchers did see a trend toward higher blasts in the marrow and peripheral blood as well as higher white blood cell counts at baseline among patients with DS.

“However, there did not appear to be a distinct baseline white blood cell count or absolute blast cell count cutoff above which DS was more common,” Dr. Norsworthy said.

She added that the patient numbers are small, so it’s not possible to make firm conclusions about prognostic factors for DS.

In closing, Dr. Norsworthy said the algorithmic approach used here “led to the recognition of additional cases of DS not identified by investigators or review committee determination for patients treated with the IDH inhibitors ivo and ena.”

“Increased recognition of the signs and symptoms of DS through the framework of the Montesinos criteria may lead to early diagnosis and treatment, which may decrease severe complications and mortality. Furthermore, integration of the algorithm into clinical trials of differentiating therapies, in a prospective fashion, may help to systematically monitor the incidence and severity of DS.”

Dr. Norsworthy declared no conflicts of interest.

Photo courtesy of ASH

SAN DIEGO—A recurrent mutation in BCL2, the therapeutic target of venetoclax, appears to be a major contributor to drug resistance in patients with chronic lymphocytic leukemia (CLL), investigators reported.

The mutation has been detected in some patients with CLL up to 2 years before resistance to venetoclax actually develops, according to Piers Blombery, MBBS, of the Peter MacCallum Cancer Center in Melbourne, Victoria, Australia.

“We have identified the first acquired BCL2 mutation developed in patients clinically treated with venetoclax,” he said during the late-breaking abstracts session at the 2018 ASH Annual Meeting.

The mutation, which the investigators have labeled BCL2 Gly101Val, “is a recurrent and frequent mediator of resistance and may be detected years before clinical relapse occurs,” Dr. Blombery added.

A paper on the mutation was published in Cancer Discovery to coincide with the presentation at ASH (abstract LBA-7).

Despite the demonstrated efficacy of venetoclax as continuous therapy in patients with relapsed or refractory CLL, the majority of patients experience disease progression, prompting the investigators to explore molecular mechanisms of secondary resistance.

To do this, they analyzed paired samples from 15 patients with CLL, enrolled in clinical trials of venetoclax, collected both before the start of venetoclax therapy and at the time of disease progression.

In seven patients, the investigators identified a novel mutation that showed up at the time of progression but was absent from the pre-venetoclax samples.

The mutation first became detectable from about 19 to 42 months after the start of therapy and preceded clinical progression by as much as 25 months, the investigators found.

They pinned the mutation down to the BH3-binding groove on BCL2, the same molecular site targeted by venetoclax. They found the mutation was not present in samples from 96 patients with venetoclax-naive CLL nor in any other B-cell malignancies.

Searches for references to the mutation in both a cancer database (COSMIC) and a population database (gnomAD) came up empty.

In other experiments, the investigators determined that cell lines overexpressing BCL2 Gly101Val are resistant to venetoclax, and, in the presence of venetoclax in vitro, BCL2 Gly101Val-expressing cells have a growth advantage compared with wild-type cells.

Additionally, they showed that the mutation results in impaired venetoclax binding in vitro.

“BCL2 Gly101Val is observed subclonally, implicating multiple mechanisms of venetoclax resistance in the same patient,” Dr. Blombery said.

He added that the identification of the resistance mutation is a strong rationale for using combination therapy to treat patients with relapsed or refractory CLL to help prevent or attenuate selection pressures that lead to resistance.

Dr. Blombery reported having no relevant disclosures. The investigators were supported by the Wilson Center for Lymphoma Genomics, Snowdome Foundation, National Health Medical Research Council, Leukemia and Lymphoma Society, Leukemia Foundation, Cancer Council of Victoria, and Australian Cancer Research Foundation.

Photo courtesy of ASH

SAN DIEGO—A recurrent mutation in BCL2, the therapeutic target of venetoclax, appears to be a major contributor to drug resistance in patients with chronic lymphocytic leukemia (CLL), investigators reported.

The mutation has been detected in some patients with CLL up to 2 years before resistance to venetoclax actually develops, according to Piers Blombery, MBBS, of the Peter MacCallum Cancer Center in Melbourne, Victoria, Australia.

“We have identified the first acquired BCL2 mutation developed in patients clinically treated with venetoclax,” he said during the late-breaking abstracts session at the 2018 ASH Annual Meeting.

The mutation, which the investigators have labeled BCL2 Gly101Val, “is a recurrent and frequent mediator of resistance and may be detected years before clinical relapse occurs,” Dr. Blombery added.

A paper on the mutation was published in Cancer Discovery to coincide with the presentation at ASH (abstract LBA-7).

Despite the demonstrated efficacy of venetoclax as continuous therapy in patients with relapsed or refractory CLL, the majority of patients experience disease progression, prompting the investigators to explore molecular mechanisms of secondary resistance.

To do this, they analyzed paired samples from 15 patients with CLL, enrolled in clinical trials of venetoclax, collected both before the start of venetoclax therapy and at the time of disease progression.

In seven patients, the investigators identified a novel mutation that showed up at the time of progression but was absent from the pre-venetoclax samples.

The mutation first became detectable from about 19 to 42 months after the start of therapy and preceded clinical progression by as much as 25 months, the investigators found.

They pinned the mutation down to the BH3-binding groove on BCL2, the same molecular site targeted by venetoclax. They found the mutation was not present in samples from 96 patients with venetoclax-naive CLL nor in any other B-cell malignancies.

Searches for references to the mutation in both a cancer database (COSMIC) and a population database (gnomAD) came up empty.

In other experiments, the investigators determined that cell lines overexpressing BCL2 Gly101Val are resistant to venetoclax, and, in the presence of venetoclax in vitro, BCL2 Gly101Val-expressing cells have a growth advantage compared with wild-type cells.

Additionally, they showed that the mutation results in impaired venetoclax binding in vitro.

“BCL2 Gly101Val is observed subclonally, implicating multiple mechanisms of venetoclax resistance in the same patient,” Dr. Blombery said.

He added that the identification of the resistance mutation is a strong rationale for using combination therapy to treat patients with relapsed or refractory CLL to help prevent or attenuate selection pressures that lead to resistance.

Dr. Blombery reported having no relevant disclosures. The investigators were supported by the Wilson Center for Lymphoma Genomics, Snowdome Foundation, National Health Medical Research Council, Leukemia and Lymphoma Society, Leukemia Foundation, Cancer Council of Victoria, and Australian Cancer Research Foundation.

Photo courtesy of ASH

SAN DIEGO—A recurrent mutation in BCL2, the therapeutic target of venetoclax, appears to be a major contributor to drug resistance in patients with chronic lymphocytic leukemia (CLL), investigators reported.

The mutation has been detected in some patients with CLL up to 2 years before resistance to venetoclax actually develops, according to Piers Blombery, MBBS, of the Peter MacCallum Cancer Center in Melbourne, Victoria, Australia.

“We have identified the first acquired BCL2 mutation developed in patients clinically treated with venetoclax,” he said during the late-breaking abstracts session at the 2018 ASH Annual Meeting.

The mutation, which the investigators have labeled BCL2 Gly101Val, “is a recurrent and frequent mediator of resistance and may be detected years before clinical relapse occurs,” Dr. Blombery added.

A paper on the mutation was published in Cancer Discovery to coincide with the presentation at ASH (abstract LBA-7).

Despite the demonstrated efficacy of venetoclax as continuous therapy in patients with relapsed or refractory CLL, the majority of patients experience disease progression, prompting the investigators to explore molecular mechanisms of secondary resistance.

To do this, they analyzed paired samples from 15 patients with CLL, enrolled in clinical trials of venetoclax, collected both before the start of venetoclax therapy and at the time of disease progression.

In seven patients, the investigators identified a novel mutation that showed up at the time of progression but was absent from the pre-venetoclax samples.

The mutation first became detectable from about 19 to 42 months after the start of therapy and preceded clinical progression by as much as 25 months, the investigators found.

They pinned the mutation down to the BH3-binding groove on BCL2, the same molecular site targeted by venetoclax. They found the mutation was not present in samples from 96 patients with venetoclax-naive CLL nor in any other B-cell malignancies.

Searches for references to the mutation in both a cancer database (COSMIC) and a population database (gnomAD) came up empty.

In other experiments, the investigators determined that cell lines overexpressing BCL2 Gly101Val are resistant to venetoclax, and, in the presence of venetoclax in vitro, BCL2 Gly101Val-expressing cells have a growth advantage compared with wild-type cells.

Additionally, they showed that the mutation results in impaired venetoclax binding in vitro.

“BCL2 Gly101Val is observed subclonally, implicating multiple mechanisms of venetoclax resistance in the same patient,” Dr. Blombery said.

He added that the identification of the resistance mutation is a strong rationale for using combination therapy to treat patients with relapsed or refractory CLL to help prevent or attenuate selection pressures that lead to resistance.

Dr. Blombery reported having no relevant disclosures. The investigators were supported by the Wilson Center for Lymphoma Genomics, Snowdome Foundation, National Health Medical Research Council, Leukemia and Lymphoma Society, Leukemia Foundation, Cancer Council of Victoria, and Australian Cancer Research Foundation.

Photo by Jen Smith

SAN DIEGO—Preliminary trial results suggest re-treatment with dasatinib is feasible and safe for a second attempt at tyrosine kinase inhibitor (TKI) discontinuation in chronic myeloid leukemia (CML) patients who fail to achieve treatment-free remission (TFR) after discontinuing imatinib.

However, investigators reported the rate of second TFR (TFR2) was 21% at 6 months, which was not enough to confirm, at this time, that dasatinib could improve the TFR2 rate after imatinib discontinuation failure.

Dennis Kim, MD, of the University of Toronto in Ontario, Canada, presented these results at the 2018 ASH Annual Meeting (abstract 787).

The design of this trial (NCT02268370) includes three phases: the imatinib discontinuation phase, the dasatinib re-challenge phase to achieve a molecular response of ≥ 4.5-log reduction in BCR-ABL1 transcripts (MR4.5), and the dasatinib discontinuation phase.

The primary objective of the trial is to determine the proportion of patients who remain in deep molecular remission (> MR4.5) after discontinuing dasatinib following a failed attempt at discontinuation of imatinib.

If patients had a confirmed molecular relapse after discontinuing imatinib, they were started on 100 mg of dasatinib daily, and, after achieving MR4.5 or greater for 12 months, they discontinued dasatinib for a try at the second TFR.

Investigators defined loss of molecular response, or relapse, as a loss of a major molecular response (MMR) once or loss of MR4.0 on two consecutive occasions.

Patient characteristics

The 131 enrolled CML patients were a median age of 61 (range, 21 to 84), and 62% were male.

Patients had a median 9.36 years of disease duration, 9.18 years of imatinib treatment, 6.82 years of MR4 duration, and 5.08 years of MR4.5 duration.

“The cohort has a very long history of imatinib treatment as well as MR4 duration,” Dr. Kim pointed out, “which also can affect our TFR1 rate, and I think, also, it can affect our TFR2 rate.”

TFR1 and TFR2 rates

As of October 25, the TFR1 rate using loss of MMR as the measure was 69.9% at 12 months from imatinib discontinuation. Relapse-free survival was 57.2% at that time.

Of the 53 patients who lost response, 51 patients received dasatinib. At 3 months of treatment, 97.7% achieved an MMR, 89.9% achieved MR4, and 84.6% achieved MR4.5.

Twenty-five of 51 patients treated with dasatinib attained MR4.5 for 12 months or longer and discontinued treatment for a second attempt at TFR.

Twenty-one patients are still receiving dasatinib and have attained MR4.5, but not for the 12-month duration yet.

Dr. Kim noted that the median time to achievement of molecular response after dasatinib re-challenge ranged from 2.76 months for MR4.5 to 1.71 months for MMR.

Twenty-one of 25 patients (84.0%) who discontinued dasatinib lost their molecular response at a median of 3.7 months.

The estimated TFR2 rate after dasatinib discontinuation is 21.0% to 24.4% at 6 months, which means the investigators cannot reject the null hypothesis of 28% or more patients remaining in remission.

Patients who lost response rapidly after dasatinib discontinuation also tended to lose response rapidly after imatinib discontinuation, Dr. Kim pointed out.

“However, you see some patients who do not lose their response after dasatinib discontinuation or who lose the response but later after the dasatinib discontinuation, they tend to lose their imatinib response also in a later time point,” he said. “So we started to look at the risk factors.”

Risk factor analysis

Out of seven potential risk factors, the investigators were able to demonstrate that time to molecular relapse after imatinib discontinuation, molecular relapse pattern after imatinib discontinuation, and BCR-ABL1 quantitative polymerase chain reaction (qPCR) value prior to dasatinib discontinuation “seemed to be very significant,” Dr. Kim said.

Time to molecular relapse after discontinuation of imatinib correlates with TFR2. The group of patients who relapsed in 3 to 6 months of stopping imatinib had a significantly longer TFR2 than patients who relapsed within 3 months of stopping imatinib (P=0.018).

The molecular relapse pattern also correlates with TFR2. The group with a single loss of MMR after imatinib discontinuation had a significantly shorter TFR2 than those who lost MR4 twice after imatinib discontinuation (P=0.043).

And 0% of the patients who had qPCR transcript levels between a 4.5 and 5.4 log reduction maintained TFR2 at 6 months. However, 28.7% who had qPCR deeper than 5.5 logs prior to dasatinib discontinuation had TFR2 at 6 months (P=0.017).

The risk factor analysis shed light, in part, on the reason the trial thus far failed to satisfy the null hypothesis.

“In other words, because we have selected a really good-risk group for TFR1, the remaining patients are actually a high-risk group for TFR2,” Dr. Kim said. “Because of that, the TFR2 rate might be somewhat lower than we had expected.”

“Or is it related to our conservative treatment with dasatinib, which is 12 months after achieving MR4.5 or deeper response? That may affect our TFR2 rate. We still have to think about that.”

Dr. Kim suggested stricter criteria be considered for attempting TFR2, such as achieving a 5.5 log reduction or deeper in BCR-ABL1 qPCR levels prior to the second TKI discontinuation attempt, and/or an MR4 duration of more than 12 months.

Dr. Kim disclosed receiving honoraria and research funding from Novartis and Bristol-Myers Squibb and serving as a consultant for Pfizer, Paladin, Novartis, and Bristol-Myers Squibb. 

Photo by Jen Smith

SAN DIEGO—Preliminary trial results suggest re-treatment with dasatinib is feasible and safe for a second attempt at tyrosine kinase inhibitor (TKI) discontinuation in chronic myeloid leukemia (CML) patients who fail to achieve treatment-free remission (TFR) after discontinuing imatinib.

However, investigators reported the rate of second TFR (TFR2) was 21% at 6 months, which was not enough to confirm, at this time, that dasatinib could improve the TFR2 rate after imatinib discontinuation failure.

Dennis Kim, MD, of the University of Toronto in Ontario, Canada, presented these results at the 2018 ASH Annual Meeting (abstract 787).

The design of this trial (NCT02268370) includes three phases: the imatinib discontinuation phase, the dasatinib re-challenge phase to achieve a molecular response of ≥ 4.5-log reduction in BCR-ABL1 transcripts (MR4.5), and the dasatinib discontinuation phase.

The primary objective of the trial is to determine the proportion of patients who remain in deep molecular remission (> MR4.5) after discontinuing dasatinib following a failed attempt at discontinuation of imatinib.

If patients had a confirmed molecular relapse after discontinuing imatinib, they were started on 100 mg of dasatinib daily, and, after achieving MR4.5 or greater for 12 months, they discontinued dasatinib for a try at the second TFR.

Investigators defined loss of molecular response, or relapse, as a loss of a major molecular response (MMR) once or loss of MR4.0 on two consecutive occasions.

Patient characteristics

The 131 enrolled CML patients were a median age of 61 (range, 21 to 84), and 62% were male.

Patients had a median 9.36 years of disease duration, 9.18 years of imatinib treatment, 6.82 years of MR4 duration, and 5.08 years of MR4.5 duration.

“The cohort has a very long history of imatinib treatment as well as MR4 duration,” Dr. Kim pointed out, “which also can affect our TFR1 rate, and I think, also, it can affect our TFR2 rate.”

TFR1 and TFR2 rates

As of October 25, the TFR1 rate using loss of MMR as the measure was 69.9% at 12 months from imatinib discontinuation. Relapse-free survival was 57.2% at that time.

Of the 53 patients who lost response, 51 patients received dasatinib. At 3 months of treatment, 97.7% achieved an MMR, 89.9% achieved MR4, and 84.6% achieved MR4.5.

Twenty-five of 51 patients treated with dasatinib attained MR4.5 for 12 months or longer and discontinued treatment for a second attempt at TFR.

Twenty-one patients are still receiving dasatinib and have attained MR4.5, but not for the 12-month duration yet.

Dr. Kim noted that the median time to achievement of molecular response after dasatinib re-challenge ranged from 2.76 months for MR4.5 to 1.71 months for MMR.

Twenty-one of 25 patients (84.0%) who discontinued dasatinib lost their molecular response at a median of 3.7 months.

The estimated TFR2 rate after dasatinib discontinuation is 21.0% to 24.4% at 6 months, which means the investigators cannot reject the null hypothesis of 28% or more patients remaining in remission.

Patients who lost response rapidly after dasatinib discontinuation also tended to lose response rapidly after imatinib discontinuation, Dr. Kim pointed out.

“However, you see some patients who do not lose their response after dasatinib discontinuation or who lose the response but later after the dasatinib discontinuation, they tend to lose their imatinib response also in a later time point,” he said. “So we started to look at the risk factors.”

Risk factor analysis

Out of seven potential risk factors, the investigators were able to demonstrate that time to molecular relapse after imatinib discontinuation, molecular relapse pattern after imatinib discontinuation, and BCR-ABL1 quantitative polymerase chain reaction (qPCR) value prior to dasatinib discontinuation “seemed to be very significant,” Dr. Kim said.

Time to molecular relapse after discontinuation of imatinib correlates with TFR2. The group of patients who relapsed in 3 to 6 months of stopping imatinib had a significantly longer TFR2 than patients who relapsed within 3 months of stopping imatinib (P=0.018).

The molecular relapse pattern also correlates with TFR2. The group with a single loss of MMR after imatinib discontinuation had a significantly shorter TFR2 than those who lost MR4 twice after imatinib discontinuation (P=0.043).

And 0% of the patients who had qPCR transcript levels between a 4.5 and 5.4 log reduction maintained TFR2 at 6 months. However, 28.7% who had qPCR deeper than 5.5 logs prior to dasatinib discontinuation had TFR2 at 6 months (P=0.017).

The risk factor analysis shed light, in part, on the reason the trial thus far failed to satisfy the null hypothesis.

“In other words, because we have selected a really good-risk group for TFR1, the remaining patients are actually a high-risk group for TFR2,” Dr. Kim said. “Because of that, the TFR2 rate might be somewhat lower than we had expected.”

“Or is it related to our conservative treatment with dasatinib, which is 12 months after achieving MR4.5 or deeper response? That may affect our TFR2 rate. We still have to think about that.”

Dr. Kim suggested stricter criteria be considered for attempting TFR2, such as achieving a 5.5 log reduction or deeper in BCR-ABL1 qPCR levels prior to the second TKI discontinuation attempt, and/or an MR4 duration of more than 12 months.

Dr. Kim disclosed receiving honoraria and research funding from Novartis and Bristol-Myers Squibb and serving as a consultant for Pfizer, Paladin, Novartis, and Bristol-Myers Squibb. 

Photo by Jen Smith

SAN DIEGO—Preliminary trial results suggest re-treatment with dasatinib is feasible and safe for a second attempt at tyrosine kinase inhibitor (TKI) discontinuation in chronic myeloid leukemia (CML) patients who fail to achieve treatment-free remission (TFR) after discontinuing imatinib.

However, investigators reported the rate of second TFR (TFR2) was 21% at 6 months, which was not enough to confirm, at this time, that dasatinib could improve the TFR2 rate after imatinib discontinuation failure.

Dennis Kim, MD, of the University of Toronto in Ontario, Canada, presented these results at the 2018 ASH Annual Meeting (abstract 787).

The design of this trial (NCT02268370) includes three phases: the imatinib discontinuation phase, the dasatinib re-challenge phase to achieve a molecular response of ≥ 4.5-log reduction in BCR-ABL1 transcripts (MR4.5), and the dasatinib discontinuation phase.

The primary objective of the trial is to determine the proportion of patients who remain in deep molecular remission (> MR4.5) after discontinuing dasatinib following a failed attempt at discontinuation of imatinib.

If patients had a confirmed molecular relapse after discontinuing imatinib, they were started on 100 mg of dasatinib daily, and, after achieving MR4.5 or greater for 12 months, they discontinued dasatinib for a try at the second TFR.

Investigators defined loss of molecular response, or relapse, as a loss of a major molecular response (MMR) once or loss of MR4.0 on two consecutive occasions.

Patient characteristics

The 131 enrolled CML patients were a median age of 61 (range, 21 to 84), and 62% were male.

Patients had a median 9.36 years of disease duration, 9.18 years of imatinib treatment, 6.82 years of MR4 duration, and 5.08 years of MR4.5 duration.

“The cohort has a very long history of imatinib treatment as well as MR4 duration,” Dr. Kim pointed out, “which also can affect our TFR1 rate, and I think, also, it can affect our TFR2 rate.”

TFR1 and TFR2 rates

As of October 25, the TFR1 rate using loss of MMR as the measure was 69.9% at 12 months from imatinib discontinuation. Relapse-free survival was 57.2% at that time.

Of the 53 patients who lost response, 51 patients received dasatinib. At 3 months of treatment, 97.7% achieved an MMR, 89.9% achieved MR4, and 84.6% achieved MR4.5.

Twenty-five of 51 patients treated with dasatinib attained MR4.5 for 12 months or longer and discontinued treatment for a second attempt at TFR.

Twenty-one patients are still receiving dasatinib and have attained MR4.5, but not for the 12-month duration yet.

Dr. Kim noted that the median time to achievement of molecular response after dasatinib re-challenge ranged from 2.76 months for MR4.5 to 1.71 months for MMR.

Twenty-one of 25 patients (84.0%) who discontinued dasatinib lost their molecular response at a median of 3.7 months.

The estimated TFR2 rate after dasatinib discontinuation is 21.0% to 24.4% at 6 months, which means the investigators cannot reject the null hypothesis of 28% or more patients remaining in remission.

Patients who lost response rapidly after dasatinib discontinuation also tended to lose response rapidly after imatinib discontinuation, Dr. Kim pointed out.

“However, you see some patients who do not lose their response after dasatinib discontinuation or who lose the response but later after the dasatinib discontinuation, they tend to lose their imatinib response also in a later time point,” he said. “So we started to look at the risk factors.”

Risk factor analysis

Out of seven potential risk factors, the investigators were able to demonstrate that time to molecular relapse after imatinib discontinuation, molecular relapse pattern after imatinib discontinuation, and BCR-ABL1 quantitative polymerase chain reaction (qPCR) value prior to dasatinib discontinuation “seemed to be very significant,” Dr. Kim said.

Time to molecular relapse after discontinuation of imatinib correlates with TFR2. The group of patients who relapsed in 3 to 6 months of stopping imatinib had a significantly longer TFR2 than patients who relapsed within 3 months of stopping imatinib (P=0.018).

The molecular relapse pattern also correlates with TFR2. The group with a single loss of MMR after imatinib discontinuation had a significantly shorter TFR2 than those who lost MR4 twice after imatinib discontinuation (P=0.043).

And 0% of the patients who had qPCR transcript levels between a 4.5 and 5.4 log reduction maintained TFR2 at 6 months. However, 28.7% who had qPCR deeper than 5.5 logs prior to dasatinib discontinuation had TFR2 at 6 months (P=0.017).

The risk factor analysis shed light, in part, on the reason the trial thus far failed to satisfy the null hypothesis.

“In other words, because we have selected a really good-risk group for TFR1, the remaining patients are actually a high-risk group for TFR2,” Dr. Kim said. “Because of that, the TFR2 rate might be somewhat lower than we had expected.”

“Or is it related to our conservative treatment with dasatinib, which is 12 months after achieving MR4.5 or deeper response? That may affect our TFR2 rate. We still have to think about that.”

Dr. Kim suggested stricter criteria be considered for attempting TFR2, such as achieving a 5.5 log reduction or deeper in BCR-ABL1 qPCR levels prior to the second TKI discontinuation attempt, and/or an MR4 duration of more than 12 months.

Dr. Kim disclosed receiving honoraria and research funding from Novartis and Bristol-Myers Squibb and serving as a consultant for Pfizer, Paladin, Novartis, and Bristol-Myers Squibb. 

We live in an ever-changing, fast-paced, and transitional world, and our health care system is no different. It’s hardly surprising, then, that digital health apps are becoming more commonplace in clinical practice. Need a useful tool to help you manage or monitor your patient’s chronic condition or educate them on preventive health and wellness measures? There’s an app for that.

If you question or lament this continual digital creep—or think it has no bearing on your patient population—you may be surprised to know that 77% of Americans have a smartphone with texting and/or mobile application abilities, creating innovative opportunities for health care providers to incorporate health apps into patient care.¹ And the benefits are not just a sales pitch on the part of manufacturers—in fact, the American Diabetes Association’s 2018 Standards of Care include a recommendation for use of mobile apps for the prevention and delayed progression of type 2 diabetes.² Of course, research shows that clinicians are more likely to adopt digital health tools if those tools improve practice efficiency, increase patient safety, improve diagnostic ability, help reduce burnout, and enhance patient-provider relationships.³

So maybe you see a role for apps in patient care. But the sheer volume and continuous proliferation of apps present an obstacle to effective evaluation and recommendation. With more than 318,000 health apps on the market and another 200 added every day, how do you know which ones are clinically sound and useful for your patients?⁴ Fortunately, there are two strategies that can help you integrate digital health apps into patient care.

1 HEALTH APPS AS MEDICATIONS

Viewing health apps as if they were medications can be helpful. Think about the process we as clinicians use when we’re thinking about prescribing a medication to a particular patient: we evaluate, manage, and prescribe.

Evaluate: As clinicians, we learn about the newest biopharmaceutical agents on the market to effectively govern our personal repertoire of medications and provide the best care for our patients. In this process, we evaluate clinical efficacy, safety, costs, benefits, barriers, contextual elements, caregiver impact, clinical studies, and more. This type of vetting process is also an effective approach to selecting and recommending health apps for your patients.

Manage: We each have a personal catalog of medications with which we become well versed, and comfortable, to effectively manage and help our patients with a multitude of medical conditions. This registry of medications represents our very special and individual “favorites,” per se. So, create a personal repertoire of health apps to improve and manage patient care.

Prescribe: Similar to medications, many digital health apps have demonstrated impressive patient outcomes with supporting clinical evidence. So why not get comfortable with prescribing digital health applications for behavior modifications or common medical conditions, just as you would with a medication?

Continue to: 2 BUILD YOUR PERSONAL APP LIBRARY

2 BUILD YOUR PERSONAL APP LIBRARY

Another strategy—touched upon in the “Manage” section earlier—is to create a personal library of highly regarded, well-vetted health apps to address common patient care matters. These could be recommended to a broad audience and will form the cornerstone of your digital compendium.

To get you started, Table 1 outlines a handful of health apps every primary care clinician should know about. These apps are supported by clinical research, endorsed or ranked by health care/industry expert organizations, and come recommended by clinical colleagues, students, or myself. The presented health apps are easily accessible via the App Store or Google Play and offer free versions, so you can assess and recommend them to your patients at no cost.

I hope you find these apps helpful with your future patient care efforts.

The author would like to acknowledge The Pace-Lenox Hill Hospital PA Program Class of 2019 for their research, evaluation, and feedback on a variety of digital health apps, and Jean Covino, DHSc, MPA , PA-C , for her encouragement to write and teach about my passion for health innovation.

We live in an ever-changing, fast-paced, and transitional world, and our health care system is no different. It’s hardly surprising, then, that digital health apps are becoming more commonplace in clinical practice. Need a useful tool to help you manage or monitor your patient’s chronic condition or educate them on preventive health and wellness measures? There’s an app for that.

If you question or lament this continual digital creep—or think it has no bearing on your patient population—you may be surprised to know that 77% of Americans have a smartphone with texting and/or mobile application abilities, creating innovative opportunities for health care providers to incorporate health apps into patient care.¹ And the benefits are not just a sales pitch on the part of manufacturers—in fact, the American Diabetes Association’s 2018 Standards of Care include a recommendation for use of mobile apps for the prevention and delayed progression of type 2 diabetes.² Of course, research shows that clinicians are more likely to adopt digital health tools if those tools improve practice efficiency, increase patient safety, improve diagnostic ability, help reduce burnout, and enhance patient-provider relationships.³

So maybe you see a role for apps in patient care. But the sheer volume and continuous proliferation of apps present an obstacle to effective evaluation and recommendation. With more than 318,000 health apps on the market and another 200 added every day, how do you know which ones are clinically sound and useful for your patients?⁴ Fortunately, there are two strategies that can help you integrate digital health apps into patient care.

1 HEALTH APPS AS MEDICATIONS

Viewing health apps as if they were medications can be helpful. Think about the process we as clinicians use when we’re thinking about prescribing a medication to a particular patient: we evaluate, manage, and prescribe.

Evaluate: As clinicians, we learn about the newest biopharmaceutical agents on the market to effectively govern our personal repertoire of medications and provide the best care for our patients. In this process, we evaluate clinical efficacy, safety, costs, benefits, barriers, contextual elements, caregiver impact, clinical studies, and more. This type of vetting process is also an effective approach to selecting and recommending health apps for your patients.

Manage: We each have a personal catalog of medications with which we become well versed, and comfortable, to effectively manage and help our patients with a multitude of medical conditions. This registry of medications represents our very special and individual “favorites,” per se. So, create a personal repertoire of health apps to improve and manage patient care.

Prescribe: Similar to medications, many digital health apps have demonstrated impressive patient outcomes with supporting clinical evidence. So why not get comfortable with prescribing digital health applications for behavior modifications or common medical conditions, just as you would with a medication?

Continue to: 2 BUILD YOUR PERSONAL APP LIBRARY

2 BUILD YOUR PERSONAL APP LIBRARY

Another strategy—touched upon in the “Manage” section earlier—is to create a personal library of highly regarded, well-vetted health apps to address common patient care matters. These could be recommended to a broad audience and will form the cornerstone of your digital compendium.

To get you started, Table 1 outlines a handful of health apps every primary care clinician should know about. These apps are supported by clinical research, endorsed or ranked by health care/industry expert organizations, and come recommended by clinical colleagues, students, or myself. The presented health apps are easily accessible via the App Store or Google Play and offer free versions, so you can assess and recommend them to your patients at no cost.

I hope you find these apps helpful with your future patient care efforts.

The author would like to acknowledge The Pace-Lenox Hill Hospital PA Program Class of 2019 for their research, evaluation, and feedback on a variety of digital health apps, and Jean Covino, DHSc, MPA , PA-C , for her encouragement to write and teach about my passion for health innovation.

We live in an ever-changing, fast-paced, and transitional world, and our health care system is no different. It’s hardly surprising, then, that digital health apps are becoming more commonplace in clinical practice. Need a useful tool to help you manage or monitor your patient’s chronic condition or educate them on preventive health and wellness measures? There’s an app for that.

If you question or lament this continual digital creep—or think it has no bearing on your patient population—you may be surprised to know that 77% of Americans have a smartphone with texting and/or mobile application abilities, creating innovative opportunities for health care providers to incorporate health apps into patient care.¹ And the benefits are not just a sales pitch on the part of manufacturers—in fact, the American Diabetes Association’s 2018 Standards of Care include a recommendation for use of mobile apps for the prevention and delayed progression of type 2 diabetes.² Of course, research shows that clinicians are more likely to adopt digital health tools if those tools improve practice efficiency, increase patient safety, improve diagnostic ability, help reduce burnout, and enhance patient-provider relationships.³

So maybe you see a role for apps in patient care. But the sheer volume and continuous proliferation of apps present an obstacle to effective evaluation and recommendation. With more than 318,000 health apps on the market and another 200 added every day, how do you know which ones are clinically sound and useful for your patients?⁴ Fortunately, there are two strategies that can help you integrate digital health apps into patient care.

1 HEALTH APPS AS MEDICATIONS

Viewing health apps as if they were medications can be helpful. Think about the process we as clinicians use when we’re thinking about prescribing a medication to a particular patient: we evaluate, manage, and prescribe.

Evaluate: As clinicians, we learn about the newest biopharmaceutical agents on the market to effectively govern our personal repertoire of medications and provide the best care for our patients. In this process, we evaluate clinical efficacy, safety, costs, benefits, barriers, contextual elements, caregiver impact, clinical studies, and more. This type of vetting process is also an effective approach to selecting and recommending health apps for your patients.

Manage: We each have a personal catalog of medications with which we become well versed, and comfortable, to effectively manage and help our patients with a multitude of medical conditions. This registry of medications represents our very special and individual “favorites,” per se. So, create a personal repertoire of health apps to improve and manage patient care.

Prescribe: Similar to medications, many digital health apps have demonstrated impressive patient outcomes with supporting clinical evidence. So why not get comfortable with prescribing digital health applications for behavior modifications or common medical conditions, just as you would with a medication?

Continue to: 2 BUILD YOUR PERSONAL APP LIBRARY

2 BUILD YOUR PERSONAL APP LIBRARY

Another strategy—touched upon in the “Manage” section earlier—is to create a personal library of highly regarded, well-vetted health apps to address common patient care matters. These could be recommended to a broad audience and will form the cornerstone of your digital compendium.

To get you started, Table 1 outlines a handful of health apps every primary care clinician should know about. These apps are supported by clinical research, endorsed or ranked by health care/industry expert organizations, and come recommended by clinical colleagues, students, or myself. The presented health apps are easily accessible via the App Store or Google Play and offer free versions, so you can assess and recommend them to your patients at no cost.

I hope you find these apps helpful with your future patient care efforts.

The author would like to acknowledge The Pace-Lenox Hill Hospital PA Program Class of 2019 for their research, evaluation, and feedback on a variety of digital health apps, and Jean Covino, DHSc, MPA , PA-C , for her encouragement to write and teach about my passion for health innovation.

The American College of Rheumatology and the National Psoriasis Foundation have released a joint treatment guideline for psoriatic arthritis that, for the first time, includes a conditional recommendation to use tumor necrosis factor–inhibitor(TNFi) biologics over methotrexate and other oral small molecules as a first-line therapy in patients with active disease.

“The available low-quality evidence is inconclusive regarding the efficacy of OSMs [oral small molecules] in management of PsA, whereas there is moderate-quality evidence of the benefits of TNFi biologics, in particular regarding their impact on the prevention of disease progression and joint damage,” wrote the panel of authors, who were led by Jasvinder A. Singh, MD, of the University of Alabama at Birmingham. “In making their recommendation, the panel recognized the cost implications, but put considerations of quality of evidence for benefit over other considerations. This guideline provides recommendations for early and aggressive therapy in patients with newly diagnosed PsA.”

The 28-page guideline, published online Nov. 30 in the Journal of Psoriasis and Psoriatic Arthritis and also in Arthritis Care & Research and Arthritis & Rheumatology, is the first set of PsA-specific recommendations to be assembled using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology that the ACR has used for RA and other conditions. GRADE uses systematic reviews of the scientific literature available to evaluate and grade the quality of evidence in a particular domain. The evidence reviews are then used to create guideline recommendations for or against particular therapy options that range from strong to conditional, depending on the quality of evidence available.

Based on the GRADE methodology and consensus building, the guideline authors crafted recommendations for eight different clinical scenarios, including the initial treatment of patients with active PsA who have not received either OSMs or other treatments; treatment of patients with active PsA despite treatment with an OSM; treatment of patients with active PsA despite treatment with a TNFi biologic either as monotherapy or in combination with methotrexate; treatment of patients with active PsA despite treatment with an interleukin (IL)-17 inhibitor or IL-12/23 inhibitor monotherapy; treatment of patients with active PsA including treat-to-target, active axial disease, enthesitis, or active inflammatory bowel disease; treatment of patients with active PsA and comorbidities, including concomitant diabetes and recurrent serious infections; vaccination in patients with active PsA; and treatment of patients with active PsA with nonpharmacologic interventions such as yoga and weight loss. Most of the treatment recommendations are conditional based on very low to moderate quality evidence. “Health care providers and patients must take into consideration all active disease domains, comorbidities, and the patient’s functional status in choosing the optimal therapy for an individual at a given point in time,” the authors emphasized.

Only five of the recommendations are listed as strong, including smoking cessation. Three of the strong recommendations concern adult patients with active PsA and concomitant active inflammatory bowel disease despite treatment with an OSM. They are “switch to a monoclonal antibody TNFi biologic over a TNFi biologic soluble receptor biologic,” “switch to a TNFi monoclonal antibody biologic over an IL-7i biologic,” and “switch to an IL-12/23i biologic over switching to an IL-17i biologic.”

The process of creating the guideline included input from a panel of nine adults who provided the authors with perspective on their values and preferences. “The concept of treat-to-target was challenging for patients,” the authors noted. “Although they saw value in improved outcomes, they also thought this strategy could increase costs to the patient (e.g., copayments, time traveling to more frequent appointments, etc.) and potentially increase adverse events. Therefore, a detailed conversation with the patient is needed to make decisions regarding treat-to-target.”

The authors concluded the guideline by calling for more comparative data to inform treatment selection in the future. “Several ongoing trials, including a trial to compare a TNFi biologic combination therapy with a TNFi biologic monotherapy and MTX monotherapy, will inform treatment decisions,” they wrote. “We anticipate future updates to the guideline when new evidence is available.”

Dr. Singh, who is also a staff rheumatologist at the Birmingham (Ala.) Veterans Affairs Medical Center, led development of the 2012 and 2015 ACR treatment guidelines for RA. He has received consulting fees from a variety of companies marketing rheumatologic drugs as well as research support from Takeda and Savient. The other guideline authors reported having numerous financial ties to industry.

[email protected]

SOURCE: Singh J et al. Arthritis Care Res. 2018 Nov 30. doi: 10.1002/acr.23789.

The American College of Rheumatology and the National Psoriasis Foundation have released a joint treatment guideline for psoriatic arthritis that, for the first time, includes a conditional recommendation to use tumor necrosis factor–inhibitor(TNFi) biologics over methotrexate and other oral small molecules as a first-line therapy in patients with active disease.

“The available low-quality evidence is inconclusive regarding the efficacy of OSMs [oral small molecules] in management of PsA, whereas there is moderate-quality evidence of the benefits of TNFi biologics, in particular regarding their impact on the prevention of disease progression and joint damage,” wrote the panel of authors, who were led by Jasvinder A. Singh, MD, of the University of Alabama at Birmingham. “In making their recommendation, the panel recognized the cost implications, but put considerations of quality of evidence for benefit over other considerations. This guideline provides recommendations for early and aggressive therapy in patients with newly diagnosed PsA.”

The 28-page guideline, published online Nov. 30 in the Journal of Psoriasis and Psoriatic Arthritis and also in Arthritis Care & Research and Arthritis & Rheumatology, is the first set of PsA-specific recommendations to be assembled using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology that the ACR has used for RA and other conditions. GRADE uses systematic reviews of the scientific literature available to evaluate and grade the quality of evidence in a particular domain. The evidence reviews are then used to create guideline recommendations for or against particular therapy options that range from strong to conditional, depending on the quality of evidence available.

Based on the GRADE methodology and consensus building, the guideline authors crafted recommendations for eight different clinical scenarios, including the initial treatment of patients with active PsA who have not received either OSMs or other treatments; treatment of patients with active PsA despite treatment with an OSM; treatment of patients with active PsA despite treatment with a TNFi biologic either as monotherapy or in combination with methotrexate; treatment of patients with active PsA despite treatment with an interleukin (IL)-17 inhibitor or IL-12/23 inhibitor monotherapy; treatment of patients with active PsA including treat-to-target, active axial disease, enthesitis, or active inflammatory bowel disease; treatment of patients with active PsA and comorbidities, including concomitant diabetes and recurrent serious infections; vaccination in patients with active PsA; and treatment of patients with active PsA with nonpharmacologic interventions such as yoga and weight loss. Most of the treatment recommendations are conditional based on very low to moderate quality evidence. “Health care providers and patients must take into consideration all active disease domains, comorbidities, and the patient’s functional status in choosing the optimal therapy for an individual at a given point in time,” the authors emphasized.

Only five of the recommendations are listed as strong, including smoking cessation. Three of the strong recommendations concern adult patients with active PsA and concomitant active inflammatory bowel disease despite treatment with an OSM. They are “switch to a monoclonal antibody TNFi biologic over a TNFi biologic soluble receptor biologic,” “switch to a TNFi monoclonal antibody biologic over an IL-7i biologic,” and “switch to an IL-12/23i biologic over switching to an IL-17i biologic.”

The process of creating the guideline included input from a panel of nine adults who provided the authors with perspective on their values and preferences. “The concept of treat-to-target was challenging for patients,” the authors noted. “Although they saw value in improved outcomes, they also thought this strategy could increase costs to the patient (e.g., copayments, time traveling to more frequent appointments, etc.) and potentially increase adverse events. Therefore, a detailed conversation with the patient is needed to make decisions regarding treat-to-target.”

The authors concluded the guideline by calling for more comparative data to inform treatment selection in the future. “Several ongoing trials, including a trial to compare a TNFi biologic combination therapy with a TNFi biologic monotherapy and MTX monotherapy, will inform treatment decisions,” they wrote. “We anticipate future updates to the guideline when new evidence is available.”

Dr. Singh, who is also a staff rheumatologist at the Birmingham (Ala.) Veterans Affairs Medical Center, led development of the 2012 and 2015 ACR treatment guidelines for RA. He has received consulting fees from a variety of companies marketing rheumatologic drugs as well as research support from Takeda and Savient. The other guideline authors reported having numerous financial ties to industry.

[email protected]

SOURCE: Singh J et al. Arthritis Care Res. 2018 Nov 30. doi: 10.1002/acr.23789.

The American College of Rheumatology and the National Psoriasis Foundation have released a joint treatment guideline for psoriatic arthritis that, for the first time, includes a conditional recommendation to use tumor necrosis factor–inhibitor(TNFi) biologics over methotrexate and other oral small molecules as a first-line therapy in patients with active disease.

“The available low-quality evidence is inconclusive regarding the efficacy of OSMs [oral small molecules] in management of PsA, whereas there is moderate-quality evidence of the benefits of TNFi biologics, in particular regarding their impact on the prevention of disease progression and joint damage,” wrote the panel of authors, who were led by Jasvinder A. Singh, MD, of the University of Alabama at Birmingham. “In making their recommendation, the panel recognized the cost implications, but put considerations of quality of evidence for benefit over other considerations. This guideline provides recommendations for early and aggressive therapy in patients with newly diagnosed PsA.”

The 28-page guideline, published online Nov. 30 in the Journal of Psoriasis and Psoriatic Arthritis and also in Arthritis Care & Research and Arthritis & Rheumatology, is the first set of PsA-specific recommendations to be assembled using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology that the ACR has used for RA and other conditions. GRADE uses systematic reviews of the scientific literature available to evaluate and grade the quality of evidence in a particular domain. The evidence reviews are then used to create guideline recommendations for or against particular therapy options that range from strong to conditional, depending on the quality of evidence available.

Based on the GRADE methodology and consensus building, the guideline authors crafted recommendations for eight different clinical scenarios, including the initial treatment of patients with active PsA who have not received either OSMs or other treatments; treatment of patients with active PsA despite treatment with an OSM; treatment of patients with active PsA despite treatment with a TNFi biologic either as monotherapy or in combination with methotrexate; treatment of patients with active PsA despite treatment with an interleukin (IL)-17 inhibitor or IL-12/23 inhibitor monotherapy; treatment of patients with active PsA including treat-to-target, active axial disease, enthesitis, or active inflammatory bowel disease; treatment of patients with active PsA and comorbidities, including concomitant diabetes and recurrent serious infections; vaccination in patients with active PsA; and treatment of patients with active PsA with nonpharmacologic interventions such as yoga and weight loss. Most of the treatment recommendations are conditional based on very low to moderate quality evidence. “Health care providers and patients must take into consideration all active disease domains, comorbidities, and the patient’s functional status in choosing the optimal therapy for an individual at a given point in time,” the authors emphasized.

Only five of the recommendations are listed as strong, including smoking cessation. Three of the strong recommendations concern adult patients with active PsA and concomitant active inflammatory bowel disease despite treatment with an OSM. They are “switch to a monoclonal antibody TNFi biologic over a TNFi biologic soluble receptor biologic,” “switch to a TNFi monoclonal antibody biologic over an IL-7i biologic,” and “switch to an IL-12/23i biologic over switching to an IL-17i biologic.”

The process of creating the guideline included input from a panel of nine adults who provided the authors with perspective on their values and preferences. “The concept of treat-to-target was challenging for patients,” the authors noted. “Although they saw value in improved outcomes, they also thought this strategy could increase costs to the patient (e.g., copayments, time traveling to more frequent appointments, etc.) and potentially increase adverse events. Therefore, a detailed conversation with the patient is needed to make decisions regarding treat-to-target.”

The authors concluded the guideline by calling for more comparative data to inform treatment selection in the future. “Several ongoing trials, including a trial to compare a TNFi biologic combination therapy with a TNFi biologic monotherapy and MTX monotherapy, will inform treatment decisions,” they wrote. “We anticipate future updates to the guideline when new evidence is available.”

Dr. Singh, who is also a staff rheumatologist at the Birmingham (Ala.) Veterans Affairs Medical Center, led development of the 2012 and 2015 ACR treatment guidelines for RA. He has received consulting fees from a variety of companies marketing rheumatologic drugs as well as research support from Takeda and Savient. The other guideline authors reported having numerous financial ties to industry.

[email protected]

SOURCE: Singh J et al. Arthritis Care Res. 2018 Nov 30. doi: 10.1002/acr.23789.

There will be 53 million older adults in the US by 2020.¹ Increasing age often brings medical comorbidities and prescriptions for multiple medications. An increasing number of prescribed medications combined with age-related changes in the ability to metabolize drugs makes older adults highly vulnerable to adverse drug events (ADEs).² In addition, older adults often have difficulty self-managing their medications and adhering to prescribed regimens.³ As a result, ADEs can lead to poor health outcomes, including hospitalizations, in older adults.

Medication errors and ADEs are particularly common during transitions from hospital to home and can lead to unnecessary readmissions,a major cause of wasteful health care spending in the US.^4,5 More than $25 billion are estimated to be spent annually on hospital readmissions, with Medicare picking up the bill for $17 billion of the total.^6,7 Researchers have found that the majority of ADEs following hospital discharge are either entirely preventable or at least ameliorable (ie, the negative impact or harm resulting from the ADE could have been reduced).⁸

To address these issues, we undertook a clinical demonstration project that implemented a new transitional care program to improve the quality of care for older veterans transitioning from the Audie L. Murphy Veterans Memorial Hospital of the South Texas Veterans Health Care System (STVHCS) in San Antonio to home. The Geriatrics Medication Education at Discharge project (GMED) falls under the auspices of the San Antonio Geriatrics Research Education and Clinical Center (GRECC). Clinical demonstration projects are mandated for US Department of Veterans Affairs (VA) GRECCs to create and promote innovative models of care for older veterans. Dissemination of successful clinical demonstration projects to other VA sites is strongly encouraged. The GMED program was modeled after the Boston GRECC Pharmacological Intervention in Late Life (PILL) program.⁹ The PILL program, which focuses on serving older veterans with cognitive impairment, demonstrated that a postdischarge pharmacist telephone visit for medication reconciliation leads to a reduction in readmission within 60 days of discharge.⁹ The goals of the GMED program were to reduce polypharmacy, inappropriate prescribing and 30-day readmissions.

Methods

The project was conducted when a full-time clinical pharmacy specialist (CPS) was available (May-September 2013 and April 2014-March 2015). This project was approved as nonresearch/quality improvement by the University of Texas Health Science Center Institutional Review Board, which serves the STVHCS. Consent was not required.

Eligibility

Patients were identified via a daily hospital database query of all adults aged ≥ 65 years admitted to the hospital through Inpatient Medicine, Neurology, or Cardiology services within the prior 24 hours. Patients meeting any of the following criteria based on review of the Computerized Patient Record System (CPRS) by the team geriatrician and CPS were considered eligible: (1) aged ≥ 70 years prescribed ≥ 12 outpatient medications; (2) aged ≥ 65 years with a medical history of dementia; (3) aged ≥ 65 years prescribed outpatient medications meeting Beers criteria¹⁰; (4) age ≥ 65 years with ≥ 2 hospital admissions (including the current, index admission) within the past calendar year; or (5) aged ≥ 65 years with ≥ 3 emergency department visits within the past calendar year. For the first polypharmacy criterion, patients aged ≥ 70 years were selected instead of aged ≥ 65 years so as not to exceed the capacity of 1 CPS. Twelve or more medications were used as a cutoff for polypharmacy based on prior quality improvement information gathered from our VA geriatrics clinic examining the average number of medications taken by older veterans in the outpatient setting.

Related: Reducing COPD Readmission Rates: Using a COPD Care Service During Care Transitions

Patients were excluded if they were expected to be discharged to any facility where the patient and/or the caregiver were not primarily responsible for medication administration after discharge. Patients who met eligibility criteria but were not seen by the transitional program pharmacist (due to staff capacity) were included in this analysis as a convenience comparison group of patients who received usual care. Patients were not randomized. All communication occurred in English, but this project did not exclude patients with limited English proficiency.

A program support assistant conducted the daily query of the hospital database. The pharmacist conducted the chart review to determine eligibility and delivered the intervention. Eligible patients were selected at random for the intervention with the intention of providing the intervention to as many veterans as possible.

The GMED Intervention

The GMED program included 2 phases, which were both conducted by a CPS with oversight from a senior CPS with geriatric pharmacology expertise and an internist/geriatrician. 

The first phase of the transitional care program included an individual, face-to-face meeting between the CPS and the patient during the hospitalization. If a veteran was not present in the room at the time of an attempted visit, the pharmacist made 2 additional attempts (3 total) to include the patient in the transitional care program during the hospitalization. 

The second component of the transitional care program included a telephone visit within 2 to 3 days of discharge, conducted by the same CPS who performed the face-to-face visit. The purpose of the telephone visit was to perform medication reconciliation, identify and rectify medication errors, provide further patient education, and assist in facilitating appropriate follow-up by the patient’s primary care provider (PCP), if required. At a minimum, veterans were asked a series of questions pertaining to their concerns about medication regimens, receipt of newly prescribed medications at discharge, additional education regarding medications after the CPS encounter during hospitalization, and whether the veteran required assistance with the medication regimen in the home setting. Follow-up questions were asked as needed to clarify and identify potential medication problems. All information from this telephone encounter was communicated to the PCP through CPRS documentation and by telephone as needed.

Related: Initiative to Minimize Pharmaceutical Risk in Older Veterans (IMPROVE) Polypharmacy Clinic

Data Collection

A standardized questionnaire was used prospectively for patients in the transitional care program group to assess patient education, primary residence, presence of a caregiver, fall history, medication adherence, and cognitive status (using Mini-Cog).¹³ Additional information (patient age, number of outpatient medications prior to and following the admission, presence of Beers criteria outpatient medications prior to and following the admission, new outpatient prescriptions, and changes to existing prescriptions as a result of the hospitalization) was gathered prospectively from patient interviews or from chart review.

For patients included in the comparison group, a retrospective administrative chart review was conducted to collect information such as age, sex, ethnic group, admission within 1 year prior to index admission, frailty, and Charlson Comorbidity Index (CCI) score, a method of categorizing comorbidities of patients based on the diagnosis codes found in administrative data.¹⁴ Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient (0 indicates no comorbidities; higher scores predict greater risk of mortality or increased resource use).

We used the index developed from 17 disease categories. The range for CCI was 0 to 25. Frailty was defined as the presence of any of the following frailty-related diagnoses: anemia; fall, head injury, other injury; coagulopathy; electrolyte disturbance; or gait disorder. These diagnoses are either primary frailty characteristics within the frailty phenotype or have been shown in prior studies to be associated with the frailty phenotype.^15-18 While more widely accepted frailty definitions exist,these other definitions require direct examination of the patient and could not be used in this project because we did not directly interact with the comparison group.^16,19 The frailty definition used has been previously identified as a predictor of health care utilization and 30-day readmission in a veteran population.²⁰ Whether or not the CPS detected a postdischarge medication error was recorded. All CPS recommendations were documented.

An index admission was defined as a hospital admission that occurred during the project period. Thirty-day readmission was defined as a hospital admission that occurred within 30 days of the discharge date of an index admission. Each index admission was considered individually for readmission (yes vs no) even if it occurred in the same patient over the project period. A 30-day readmission was not considered an index admission. An admission that occurred after a 30-day readmission was considered a subsequent index admission. Patients who died in the hospital were not included in this analysis, as they would not have participated in the entire intervention.

Statistical Analysis

We compared characteristics between patients who received GMED and patients who never received GMED (comparison group). Generalized estimating equations (GEE) were used to determine whether the rate of 30-day readmission (yes vs no) in the transitional care program group differed from that of the comparison group. In our GEE analysis, we assumed a binomial distribution and the logit link to model the log-odds of readmission as a linear function of transitional care program status (yes vs no) and other covariates, including age, frailty, hospital admission within 1 year prior to the index admission, and CCI score as covariates. Thirty-day readmission status associated with each index admission was coded as 1 for a readmission within 30 days of the discharge date of the index admission, or 0 for no readmission within 30 days.

Transitional care program status was determined whether or not the individual received the transitional care program for each index admission. This analysis allowed us to model repeated measures of index admissions as a function of the project period and whether the patient was seen by the GMED CPS during the index admission. The patient identifier was used as a cluster variable in the GEE analysis. Inverse propensity scores of receiving GMED at the index admission were adjusted as weights in the GEE analysis to minimize confounding and, hence, to strengthen the causal interpretation of the effect of the transitional care program. If there was ≥ 1 index admission, the GMED status (yes vs no) at the initial index admission was used as the dependent variable to calculate propensity scores. The propensity scores of transitional care program status were derived from the logistic regression analysis that modeled the log-odds of receiving the transitional care program at the index admission as a linear function of age, CCI, frailty, and prior hospitalization during the 1-year period prior to the index admission.

Related: Development and Implementation of a Geriatric Walking Clinic

Results

The GMED CPS saw 435 patients during the project period; 47 (10.8%) died prior to 30 days and were excluded, leaving 388 patients who received the transitional care program included in this evaluation. 

Data from the CPS-patient interviews and chart reviews were available for 378 of the 388 patients (Table 2). Patients were primarily male, non-Hispanic white, with a high school education. More than half (65%) the patients were admitted for a new diagnosis or clinical condition. 

The 30-day readmission rate was 15.6% for the transitional care program group and 21.9% for the comparison group. Three hundred seventy-one patients received the transitional care program only once, 16 patients received the transitional care program twice (ie, they had 2 index admissions during the study period and received the intervention both times), and 1 patient received the transitional care program 3 times.

In an unadjusted GEE model, the odds ratio (OR) for readmission in the transitional care program group was 0.74 (95% CI, 0.54-1.0, P = .06) compared with the usual care group (Table 3). 

Thirty-five percent of patients had ≥ 1 CPS-recommended change in their treatment at the time of the inpatient admission (Table 4). 

Discussion

We developed a transitional care program for hospitalized older veterans to improve the transition from hospital to home. After adjusting for clinical factors, GMED was associated with 26% lower odds of readmission within 30 days of discharge compared with that of the control group. The GMED CPS made changes to the medical regimen both during the inpatient admission as well as after discharge to correct medication errors and educate patients.

In addition, GMED led to a reduction in the number of prescribed medications, which impacts inappropriate polypharmacy—a significant problem in older adults, which contributes to ADEs.²¹ Our intervention was patient centered, as all decisions and education regarding medication management were tailored to each patient, taking into account medical and psychosocial factors.

Studies of similar programs have shown that a pharmacist-based program can improve outcomes in patients transitioning from hospital to home. A meta-analysis of 19 studies that evaluated the effectiveness of pharmacy-led medication reconciliation interventions at the time of a care transition showed that compared with usual care a pharmacist intervention led to reduced medication discrepancies.²² In this meta-analysis, medication discrepancies of higher clinical impact were more easily identified through pharmacy-led interventions than with usual care, suggesting improved safety. Although not all studies have shown a clear reduction in readmission rates or other health care utilization, the addition of clinical pharmacist services in the care of inpatients has generally resulted in improved care with no evidence of harm.²³

Based on these findings and collaboration with another GRECC, we designed our program to focus on older adults with polypharmacy, cognitive impairment, high-risk medication usage, and/or a history of high health care use.⁹ Our findings add to the growing body of evidence that a CPS-led transitional care program results in reduced polypharmacy and reduced unnecessary hospital readmissions. Further, our findings have demonstrated the effectiveness of this type of program in a practical, clinical setting with veteran patients.

At the time of project inception, we believed that the majority of our interventions would occur postdischarge. We were somewhat surprised that a major component of GMED was suggested interventions by our pharmacist at the time of admission. We believe that because the CPS made suggestions during admission, we prevented postdischarge ADEs. A frequent intervention corrected the medication reconciliation on file at admission. This finding also was seen in another study by Gleason and colleagues, which examined medication errors at admission for 651 adult medicine inpatients.²⁴ This study found that more than one-third of patients had medication reconciliation errors. Further, older age (≥ 65 years) was associated with increased odds of medication errors in this study.

Of note, a survey of hospital-based pharmacists indicated medication reconciliation is the most important role of the pharmacist in improving care transitions.²⁵ The pharmacists stated that detection of errors at the time of admission is very important. The pharmacists further reported that additional education and counseling for patients with poor understanding of their medications was also important. Our findings support these findings and the use of a pharmacist as part of the medical team to improve medication reconciliation and education.

Limitations

A limitation of GMED is that we monitored only admissions to our hospital; therefore, we did not account for any hospitalizations that may have occurred outside the STVHCS. Another limitation is that this was not a randomized controlled trial, and we used a convenience sample of patients who met our criteria for eligibility but were not seen due to time constraints. This introduces potential bias such that patients admitted and discharged on nights or weekends when the CPS was not available were not included in the transitional care program group, and these patients may fundamentally differ from those admitted and discharged Monday through Friday.

However, Khanna and colleagues found that night or weekend admission was not associated with 30-day readmission or other worse outcomes (such as length of stay, 30-day emergency department visit, or intensive care unit transfer) in 857 general medicine admissions at a tertiary care hospital.²⁶ Every effort was made to include as many eligible patients as possible in the transitional program group, and we were able to demonstrate that the patients in the 2 groups were similar. Frailty and prior hospital admission were more prevalent, although not significantly so, in the transitional program group, suggesting that any selection bias would have actually attenuated—not enhanced—the observed effect of the transitional program. Although the transitional program group patients were slightly younger by 0.3 years, they were similar in frailty status and CCI score.

Conclusion

The GMED program was associated with reduced 30-day hospital readmission, discontinuation of unnecessary medications, and corrected medication errors and discrepancies. We propose that a CPS-based transitional care program can improve the quality of care for older patients being discharged to home.

Acknowledgments

Supported by funding from the Veterans Health Administration T21 Non-Institutional Long-Term Care Initiative and VA Office of Rural Health and the San Antonio Geriatrics Research, Education, and Clinical Center. The sponsor did not have any role in the design, methods, data collection, or analysis, and preparation.

Author Contributions

R. Rottman-Sagebiel developed the transitional program concept and design and executed the program implementation, interpretation of data, and preparation of the manuscript. S. Pastewait, N. Cupples, A. Conde, M. Moris, and E. Gonzalez assisted with program design and implementation. S. Cope assisted with interpretation of data and preparation of the manuscript. H. Braden assisted with interpretation of data. D. MacCarthy assisted with data management and statistical analysis. C. Wang and S. Espinoza developed the program concept and design, performed statistical analysis and interpretation of data, and helped prepare the manuscript.

Advances in Geriatrics

Advances in Geriatrics features articles focused on quality improvement/quality assurance initiatives, pilot studies, best practices, research, patient education, and patient-centered care written by health care providers associated with Veteran Health Administration Geriatric Research Education and Clinical Centers. Interested authors can submit articles at editorialmanager.com/fedprac or send a brief 2 to 3 sentence abstract to [email protected] for feedback and publication recommendations.

There will be 53 million older adults in the US by 2020.¹ Increasing age often brings medical comorbidities and prescriptions for multiple medications. An increasing number of prescribed medications combined with age-related changes in the ability to metabolize drugs makes older adults highly vulnerable to adverse drug events (ADEs).² In addition, older adults often have difficulty self-managing their medications and adhering to prescribed regimens.³ As a result, ADEs can lead to poor health outcomes, including hospitalizations, in older adults.

Medication errors and ADEs are particularly common during transitions from hospital to home and can lead to unnecessary readmissions,a major cause of wasteful health care spending in the US.^4,5 More than $25 billion are estimated to be spent annually on hospital readmissions, with Medicare picking up the bill for $17 billion of the total.^6,7 Researchers have found that the majority of ADEs following hospital discharge are either entirely preventable or at least ameliorable (ie, the negative impact or harm resulting from the ADE could have been reduced).⁸

To address these issues, we undertook a clinical demonstration project that implemented a new transitional care program to improve the quality of care for older veterans transitioning from the Audie L. Murphy Veterans Memorial Hospital of the South Texas Veterans Health Care System (STVHCS) in San Antonio to home. The Geriatrics Medication Education at Discharge project (GMED) falls under the auspices of the San Antonio Geriatrics Research Education and Clinical Center (GRECC). Clinical demonstration projects are mandated for US Department of Veterans Affairs (VA) GRECCs to create and promote innovative models of care for older veterans. Dissemination of successful clinical demonstration projects to other VA sites is strongly encouraged. The GMED program was modeled after the Boston GRECC Pharmacological Intervention in Late Life (PILL) program.⁹ The PILL program, which focuses on serving older veterans with cognitive impairment, demonstrated that a postdischarge pharmacist telephone visit for medication reconciliation leads to a reduction in readmission within 60 days of discharge.⁹ The goals of the GMED program were to reduce polypharmacy, inappropriate prescribing and 30-day readmissions.

Methods

The project was conducted when a full-time clinical pharmacy specialist (CPS) was available (May-September 2013 and April 2014-March 2015). This project was approved as nonresearch/quality improvement by the University of Texas Health Science Center Institutional Review Board, which serves the STVHCS. Consent was not required.

Eligibility

Patients were identified via a daily hospital database query of all adults aged ≥ 65 years admitted to the hospital through Inpatient Medicine, Neurology, or Cardiology services within the prior 24 hours. Patients meeting any of the following criteria based on review of the Computerized Patient Record System (CPRS) by the team geriatrician and CPS were considered eligible: (1) aged ≥ 70 years prescribed ≥ 12 outpatient medications; (2) aged ≥ 65 years with a medical history of dementia; (3) aged ≥ 65 years prescribed outpatient medications meeting Beers criteria¹⁰; (4) age ≥ 65 years with ≥ 2 hospital admissions (including the current, index admission) within the past calendar year; or (5) aged ≥ 65 years with ≥ 3 emergency department visits within the past calendar year. For the first polypharmacy criterion, patients aged ≥ 70 years were selected instead of aged ≥ 65 years so as not to exceed the capacity of 1 CPS. Twelve or more medications were used as a cutoff for polypharmacy based on prior quality improvement information gathered from our VA geriatrics clinic examining the average number of medications taken by older veterans in the outpatient setting.

Related: Reducing COPD Readmission Rates: Using a COPD Care Service During Care Transitions

Patients were excluded if they were expected to be discharged to any facility where the patient and/or the caregiver were not primarily responsible for medication administration after discharge. Patients who met eligibility criteria but were not seen by the transitional program pharmacist (due to staff capacity) were included in this analysis as a convenience comparison group of patients who received usual care. Patients were not randomized. All communication occurred in English, but this project did not exclude patients with limited English proficiency.

A program support assistant conducted the daily query of the hospital database. The pharmacist conducted the chart review to determine eligibility and delivered the intervention. Eligible patients were selected at random for the intervention with the intention of providing the intervention to as many veterans as possible.

The GMED Intervention

The GMED program included 2 phases, which were both conducted by a CPS with oversight from a senior CPS with geriatric pharmacology expertise and an internist/geriatrician. 

The first phase of the transitional care program included an individual, face-to-face meeting between the CPS and the patient during the hospitalization. If a veteran was not present in the room at the time of an attempted visit, the pharmacist made 2 additional attempts (3 total) to include the patient in the transitional care program during the hospitalization. 

The second component of the transitional care program included a telephone visit within 2 to 3 days of discharge, conducted by the same CPS who performed the face-to-face visit. The purpose of the telephone visit was to perform medication reconciliation, identify and rectify medication errors, provide further patient education, and assist in facilitating appropriate follow-up by the patient’s primary care provider (PCP), if required. At a minimum, veterans were asked a series of questions pertaining to their concerns about medication regimens, receipt of newly prescribed medications at discharge, additional education regarding medications after the CPS encounter during hospitalization, and whether the veteran required assistance with the medication regimen in the home setting. Follow-up questions were asked as needed to clarify and identify potential medication problems. All information from this telephone encounter was communicated to the PCP through CPRS documentation and by telephone as needed.

Related: Initiative to Minimize Pharmaceutical Risk in Older Veterans (IMPROVE) Polypharmacy Clinic

Data Collection

A standardized questionnaire was used prospectively for patients in the transitional care program group to assess patient education, primary residence, presence of a caregiver, fall history, medication adherence, and cognitive status (using Mini-Cog).¹³ Additional information (patient age, number of outpatient medications prior to and following the admission, presence of Beers criteria outpatient medications prior to and following the admission, new outpatient prescriptions, and changes to existing prescriptions as a result of the hospitalization) was gathered prospectively from patient interviews or from chart review.

For patients included in the comparison group, a retrospective administrative chart review was conducted to collect information such as age, sex, ethnic group, admission within 1 year prior to index admission, frailty, and Charlson Comorbidity Index (CCI) score, a method of categorizing comorbidities of patients based on the diagnosis codes found in administrative data.¹⁴ Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient (0 indicates no comorbidities; higher scores predict greater risk of mortality or increased resource use).

We used the index developed from 17 disease categories. The range for CCI was 0 to 25. Frailty was defined as the presence of any of the following frailty-related diagnoses: anemia; fall, head injury, other injury; coagulopathy; electrolyte disturbance; or gait disorder. These diagnoses are either primary frailty characteristics within the frailty phenotype or have been shown in prior studies to be associated with the frailty phenotype.^15-18 While more widely accepted frailty definitions exist,these other definitions require direct examination of the patient and could not be used in this project because we did not directly interact with the comparison group.^16,19 The frailty definition used has been previously identified as a predictor of health care utilization and 30-day readmission in a veteran population.²⁰ Whether or not the CPS detected a postdischarge medication error was recorded. All CPS recommendations were documented.

An index admission was defined as a hospital admission that occurred during the project period. Thirty-day readmission was defined as a hospital admission that occurred within 30 days of the discharge date of an index admission. Each index admission was considered individually for readmission (yes vs no) even if it occurred in the same patient over the project period. A 30-day readmission was not considered an index admission. An admission that occurred after a 30-day readmission was considered a subsequent index admission. Patients who died in the hospital were not included in this analysis, as they would not have participated in the entire intervention.

Statistical Analysis

We compared characteristics between patients who received GMED and patients who never received GMED (comparison group). Generalized estimating equations (GEE) were used to determine whether the rate of 30-day readmission (yes vs no) in the transitional care program group differed from that of the comparison group. In our GEE analysis, we assumed a binomial distribution and the logit link to model the log-odds of readmission as a linear function of transitional care program status (yes vs no) and other covariates, including age, frailty, hospital admission within 1 year prior to the index admission, and CCI score as covariates. Thirty-day readmission status associated with each index admission was coded as 1 for a readmission within 30 days of the discharge date of the index admission, or 0 for no readmission within 30 days.

Transitional care program status was determined whether or not the individual received the transitional care program for each index admission. This analysis allowed us to model repeated measures of index admissions as a function of the project period and whether the patient was seen by the GMED CPS during the index admission. The patient identifier was used as a cluster variable in the GEE analysis. Inverse propensity scores of receiving GMED at the index admission were adjusted as weights in the GEE analysis to minimize confounding and, hence, to strengthen the causal interpretation of the effect of the transitional care program. If there was ≥ 1 index admission, the GMED status (yes vs no) at the initial index admission was used as the dependent variable to calculate propensity scores. The propensity scores of transitional care program status were derived from the logistic regression analysis that modeled the log-odds of receiving the transitional care program at the index admission as a linear function of age, CCI, frailty, and prior hospitalization during the 1-year period prior to the index admission.

Related: Development and Implementation of a Geriatric Walking Clinic

Results

The GMED CPS saw 435 patients during the project period; 47 (10.8%) died prior to 30 days and were excluded, leaving 388 patients who received the transitional care program included in this evaluation. 

Data from the CPS-patient interviews and chart reviews were available for 378 of the 388 patients (Table 2). Patients were primarily male, non-Hispanic white, with a high school education. More than half (65%) the patients were admitted for a new diagnosis or clinical condition. 

The 30-day readmission rate was 15.6% for the transitional care program group and 21.9% for the comparison group. Three hundred seventy-one patients received the transitional care program only once, 16 patients received the transitional care program twice (ie, they had 2 index admissions during the study period and received the intervention both times), and 1 patient received the transitional care program 3 times.

In an unadjusted GEE model, the odds ratio (OR) for readmission in the transitional care program group was 0.74 (95% CI, 0.54-1.0, P = .06) compared with the usual care group (Table 3). 

Thirty-five percent of patients had ≥ 1 CPS-recommended change in their treatment at the time of the inpatient admission (Table 4). 

Discussion

We developed a transitional care program for hospitalized older veterans to improve the transition from hospital to home. After adjusting for clinical factors, GMED was associated with 26% lower odds of readmission within 30 days of discharge compared with that of the control group. The GMED CPS made changes to the medical regimen both during the inpatient admission as well as after discharge to correct medication errors and educate patients.

In addition, GMED led to a reduction in the number of prescribed medications, which impacts inappropriate polypharmacy—a significant problem in older adults, which contributes to ADEs.²¹ Our intervention was patient centered, as all decisions and education regarding medication management were tailored to each patient, taking into account medical and psychosocial factors.

Studies of similar programs have shown that a pharmacist-based program can improve outcomes in patients transitioning from hospital to home. A meta-analysis of 19 studies that evaluated the effectiveness of pharmacy-led medication reconciliation interventions at the time of a care transition showed that compared with usual care a pharmacist intervention led to reduced medication discrepancies.²² In this meta-analysis, medication discrepancies of higher clinical impact were more easily identified through pharmacy-led interventions than with usual care, suggesting improved safety. Although not all studies have shown a clear reduction in readmission rates or other health care utilization, the addition of clinical pharmacist services in the care of inpatients has generally resulted in improved care with no evidence of harm.²³

Based on these findings and collaboration with another GRECC, we designed our program to focus on older adults with polypharmacy, cognitive impairment, high-risk medication usage, and/or a history of high health care use.⁹ Our findings add to the growing body of evidence that a CPS-led transitional care program results in reduced polypharmacy and reduced unnecessary hospital readmissions. Further, our findings have demonstrated the effectiveness of this type of program in a practical, clinical setting with veteran patients.

At the time of project inception, we believed that the majority of our interventions would occur postdischarge. We were somewhat surprised that a major component of GMED was suggested interventions by our pharmacist at the time of admission. We believe that because the CPS made suggestions during admission, we prevented postdischarge ADEs. A frequent intervention corrected the medication reconciliation on file at admission. This finding also was seen in another study by Gleason and colleagues, which examined medication errors at admission for 651 adult medicine inpatients.²⁴ This study found that more than one-third of patients had medication reconciliation errors. Further, older age (≥ 65 years) was associated with increased odds of medication errors in this study.

Of note, a survey of hospital-based pharmacists indicated medication reconciliation is the most important role of the pharmacist in improving care transitions.²⁵ The pharmacists stated that detection of errors at the time of admission is very important. The pharmacists further reported that additional education and counseling for patients with poor understanding of their medications was also important. Our findings support these findings and the use of a pharmacist as part of the medical team to improve medication reconciliation and education.

Limitations

A limitation of GMED is that we monitored only admissions to our hospital; therefore, we did not account for any hospitalizations that may have occurred outside the STVHCS. Another limitation is that this was not a randomized controlled trial, and we used a convenience sample of patients who met our criteria for eligibility but were not seen due to time constraints. This introduces potential bias such that patients admitted and discharged on nights or weekends when the CPS was not available were not included in the transitional care program group, and these patients may fundamentally differ from those admitted and discharged Monday through Friday.

However, Khanna and colleagues found that night or weekend admission was not associated with 30-day readmission or other worse outcomes (such as length of stay, 30-day emergency department visit, or intensive care unit transfer) in 857 general medicine admissions at a tertiary care hospital.²⁶ Every effort was made to include as many eligible patients as possible in the transitional program group, and we were able to demonstrate that the patients in the 2 groups were similar. Frailty and prior hospital admission were more prevalent, although not significantly so, in the transitional program group, suggesting that any selection bias would have actually attenuated—not enhanced—the observed effect of the transitional program. Although the transitional program group patients were slightly younger by 0.3 years, they were similar in frailty status and CCI score.

Conclusion

The GMED program was associated with reduced 30-day hospital readmission, discontinuation of unnecessary medications, and corrected medication errors and discrepancies. We propose that a CPS-based transitional care program can improve the quality of care for older patients being discharged to home.

Acknowledgments

Supported by funding from the Veterans Health Administration T21 Non-Institutional Long-Term Care Initiative and VA Office of Rural Health and the San Antonio Geriatrics Research, Education, and Clinical Center. The sponsor did not have any role in the design, methods, data collection, or analysis, and preparation.

Author Contributions

R. Rottman-Sagebiel developed the transitional program concept and design and executed the program implementation, interpretation of data, and preparation of the manuscript. S. Pastewait, N. Cupples, A. Conde, M. Moris, and E. Gonzalez assisted with program design and implementation. S. Cope assisted with interpretation of data and preparation of the manuscript. H. Braden assisted with interpretation of data. D. MacCarthy assisted with data management and statistical analysis. C. Wang and S. Espinoza developed the program concept and design, performed statistical analysis and interpretation of data, and helped prepare the manuscript.

Advances in Geriatrics

Advances in Geriatrics features articles focused on quality improvement/quality assurance initiatives, pilot studies, best practices, research, patient education, and patient-centered care written by health care providers associated with Veteran Health Administration Geriatric Research Education and Clinical Centers. Interested authors can submit articles at editorialmanager.com/fedprac or send a brief 2 to 3 sentence abstract to [email protected] for feedback and publication recommendations.

There will be 53 million older adults in the US by 2020.¹ Increasing age often brings medical comorbidities and prescriptions for multiple medications. An increasing number of prescribed medications combined with age-related changes in the ability to metabolize drugs makes older adults highly vulnerable to adverse drug events (ADEs).² In addition, older adults often have difficulty self-managing their medications and adhering to prescribed regimens.³ As a result, ADEs can lead to poor health outcomes, including hospitalizations, in older adults.

Medication errors and ADEs are particularly common during transitions from hospital to home and can lead to unnecessary readmissions,a major cause of wasteful health care spending in the US.^4,5 More than $25 billion are estimated to be spent annually on hospital readmissions, with Medicare picking up the bill for $17 billion of the total.^6,7 Researchers have found that the majority of ADEs following hospital discharge are either entirely preventable or at least ameliorable (ie, the negative impact or harm resulting from the ADE could have been reduced).⁸

To address these issues, we undertook a clinical demonstration project that implemented a new transitional care program to improve the quality of care for older veterans transitioning from the Audie L. Murphy Veterans Memorial Hospital of the South Texas Veterans Health Care System (STVHCS) in San Antonio to home. The Geriatrics Medication Education at Discharge project (GMED) falls under the auspices of the San Antonio Geriatrics Research Education and Clinical Center (GRECC). Clinical demonstration projects are mandated for US Department of Veterans Affairs (VA) GRECCs to create and promote innovative models of care for older veterans. Dissemination of successful clinical demonstration projects to other VA sites is strongly encouraged. The GMED program was modeled after the Boston GRECC Pharmacological Intervention in Late Life (PILL) program.⁹ The PILL program, which focuses on serving older veterans with cognitive impairment, demonstrated that a postdischarge pharmacist telephone visit for medication reconciliation leads to a reduction in readmission within 60 days of discharge.⁹ The goals of the GMED program were to reduce polypharmacy, inappropriate prescribing and 30-day readmissions.

Methods

The project was conducted when a full-time clinical pharmacy specialist (CPS) was available (May-September 2013 and April 2014-March 2015). This project was approved as nonresearch/quality improvement by the University of Texas Health Science Center Institutional Review Board, which serves the STVHCS. Consent was not required.

Eligibility

Patients were identified via a daily hospital database query of all adults aged ≥ 65 years admitted to the hospital through Inpatient Medicine, Neurology, or Cardiology services within the prior 24 hours. Patients meeting any of the following criteria based on review of the Computerized Patient Record System (CPRS) by the team geriatrician and CPS were considered eligible: (1) aged ≥ 70 years prescribed ≥ 12 outpatient medications; (2) aged ≥ 65 years with a medical history of dementia; (3) aged ≥ 65 years prescribed outpatient medications meeting Beers criteria¹⁰; (4) age ≥ 65 years with ≥ 2 hospital admissions (including the current, index admission) within the past calendar year; or (5) aged ≥ 65 years with ≥ 3 emergency department visits within the past calendar year. For the first polypharmacy criterion, patients aged ≥ 70 years were selected instead of aged ≥ 65 years so as not to exceed the capacity of 1 CPS. Twelve or more medications were used as a cutoff for polypharmacy based on prior quality improvement information gathered from our VA geriatrics clinic examining the average number of medications taken by older veterans in the outpatient setting.

Related: Reducing COPD Readmission Rates: Using a COPD Care Service During Care Transitions

Patients were excluded if they were expected to be discharged to any facility where the patient and/or the caregiver were not primarily responsible for medication administration after discharge. Patients who met eligibility criteria but were not seen by the transitional program pharmacist (due to staff capacity) were included in this analysis as a convenience comparison group of patients who received usual care. Patients were not randomized. All communication occurred in English, but this project did not exclude patients with limited English proficiency.

A program support assistant conducted the daily query of the hospital database. The pharmacist conducted the chart review to determine eligibility and delivered the intervention. Eligible patients were selected at random for the intervention with the intention of providing the intervention to as many veterans as possible.

The GMED Intervention

The GMED program included 2 phases, which were both conducted by a CPS with oversight from a senior CPS with geriatric pharmacology expertise and an internist/geriatrician. 

The first phase of the transitional care program included an individual, face-to-face meeting between the CPS and the patient during the hospitalization. If a veteran was not present in the room at the time of an attempted visit, the pharmacist made 2 additional attempts (3 total) to include the patient in the transitional care program during the hospitalization. 

The second component of the transitional care program included a telephone visit within 2 to 3 days of discharge, conducted by the same CPS who performed the face-to-face visit. The purpose of the telephone visit was to perform medication reconciliation, identify and rectify medication errors, provide further patient education, and assist in facilitating appropriate follow-up by the patient’s primary care provider (PCP), if required. At a minimum, veterans were asked a series of questions pertaining to their concerns about medication regimens, receipt of newly prescribed medications at discharge, additional education regarding medications after the CPS encounter during hospitalization, and whether the veteran required assistance with the medication regimen in the home setting. Follow-up questions were asked as needed to clarify and identify potential medication problems. All information from this telephone encounter was communicated to the PCP through CPRS documentation and by telephone as needed.

Related: Initiative to Minimize Pharmaceutical Risk in Older Veterans (IMPROVE) Polypharmacy Clinic

Data Collection

A standardized questionnaire was used prospectively for patients in the transitional care program group to assess patient education, primary residence, presence of a caregiver, fall history, medication adherence, and cognitive status (using Mini-Cog).¹³ Additional information (patient age, number of outpatient medications prior to and following the admission, presence of Beers criteria outpatient medications prior to and following the admission, new outpatient prescriptions, and changes to existing prescriptions as a result of the hospitalization) was gathered prospectively from patient interviews or from chart review.

For patients included in the comparison group, a retrospective administrative chart review was conducted to collect information such as age, sex, ethnic group, admission within 1 year prior to index admission, frailty, and Charlson Comorbidity Index (CCI) score, a method of categorizing comorbidities of patients based on the diagnosis codes found in administrative data.¹⁴ Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient (0 indicates no comorbidities; higher scores predict greater risk of mortality or increased resource use).

We used the index developed from 17 disease categories. The range for CCI was 0 to 25. Frailty was defined as the presence of any of the following frailty-related diagnoses: anemia; fall, head injury, other injury; coagulopathy; electrolyte disturbance; or gait disorder. These diagnoses are either primary frailty characteristics within the frailty phenotype or have been shown in prior studies to be associated with the frailty phenotype.^15-18 While more widely accepted frailty definitions exist,these other definitions require direct examination of the patient and could not be used in this project because we did not directly interact with the comparison group.^16,19 The frailty definition used has been previously identified as a predictor of health care utilization and 30-day readmission in a veteran population.²⁰ Whether or not the CPS detected a postdischarge medication error was recorded. All CPS recommendations were documented.

An index admission was defined as a hospital admission that occurred during the project period. Thirty-day readmission was defined as a hospital admission that occurred within 30 days of the discharge date of an index admission. Each index admission was considered individually for readmission (yes vs no) even if it occurred in the same patient over the project period. A 30-day readmission was not considered an index admission. An admission that occurred after a 30-day readmission was considered a subsequent index admission. Patients who died in the hospital were not included in this analysis, as they would not have participated in the entire intervention.

Statistical Analysis

We compared characteristics between patients who received GMED and patients who never received GMED (comparison group). Generalized estimating equations (GEE) were used to determine whether the rate of 30-day readmission (yes vs no) in the transitional care program group differed from that of the comparison group. In our GEE analysis, we assumed a binomial distribution and the logit link to model the log-odds of readmission as a linear function of transitional care program status (yes vs no) and other covariates, including age, frailty, hospital admission within 1 year prior to the index admission, and CCI score as covariates. Thirty-day readmission status associated with each index admission was coded as 1 for a readmission within 30 days of the discharge date of the index admission, or 0 for no readmission within 30 days.

Transitional care program status was determined whether or not the individual received the transitional care program for each index admission. This analysis allowed us to model repeated measures of index admissions as a function of the project period and whether the patient was seen by the GMED CPS during the index admission. The patient identifier was used as a cluster variable in the GEE analysis. Inverse propensity scores of receiving GMED at the index admission were adjusted as weights in the GEE analysis to minimize confounding and, hence, to strengthen the causal interpretation of the effect of the transitional care program. If there was ≥ 1 index admission, the GMED status (yes vs no) at the initial index admission was used as the dependent variable to calculate propensity scores. The propensity scores of transitional care program status were derived from the logistic regression analysis that modeled the log-odds of receiving the transitional care program at the index admission as a linear function of age, CCI, frailty, and prior hospitalization during the 1-year period prior to the index admission.

Related: Development and Implementation of a Geriatric Walking Clinic

Results

The GMED CPS saw 435 patients during the project period; 47 (10.8%) died prior to 30 days and were excluded, leaving 388 patients who received the transitional care program included in this evaluation. 

Data from the CPS-patient interviews and chart reviews were available for 378 of the 388 patients (Table 2). Patients were primarily male, non-Hispanic white, with a high school education. More than half (65%) the patients were admitted for a new diagnosis or clinical condition. 

The 30-day readmission rate was 15.6% for the transitional care program group and 21.9% for the comparison group. Three hundred seventy-one patients received the transitional care program only once, 16 patients received the transitional care program twice (ie, they had 2 index admissions during the study period and received the intervention both times), and 1 patient received the transitional care program 3 times.

In an unadjusted GEE model, the odds ratio (OR) for readmission in the transitional care program group was 0.74 (95% CI, 0.54-1.0, P = .06) compared with the usual care group (Table 3). 

Thirty-five percent of patients had ≥ 1 CPS-recommended change in their treatment at the time of the inpatient admission (Table 4). 

Discussion

We developed a transitional care program for hospitalized older veterans to improve the transition from hospital to home. After adjusting for clinical factors, GMED was associated with 26% lower odds of readmission within 30 days of discharge compared with that of the control group. The GMED CPS made changes to the medical regimen both during the inpatient admission as well as after discharge to correct medication errors and educate patients.

In addition, GMED led to a reduction in the number of prescribed medications, which impacts inappropriate polypharmacy—a significant problem in older adults, which contributes to ADEs.²¹ Our intervention was patient centered, as all decisions and education regarding medication management were tailored to each patient, taking into account medical and psychosocial factors.

Studies of similar programs have shown that a pharmacist-based program can improve outcomes in patients transitioning from hospital to home. A meta-analysis of 19 studies that evaluated the effectiveness of pharmacy-led medication reconciliation interventions at the time of a care transition showed that compared with usual care a pharmacist intervention led to reduced medication discrepancies.²² In this meta-analysis, medication discrepancies of higher clinical impact were more easily identified through pharmacy-led interventions than with usual care, suggesting improved safety. Although not all studies have shown a clear reduction in readmission rates or other health care utilization, the addition of clinical pharmacist services in the care of inpatients has generally resulted in improved care with no evidence of harm.²³

Based on these findings and collaboration with another GRECC, we designed our program to focus on older adults with polypharmacy, cognitive impairment, high-risk medication usage, and/or a history of high health care use.⁹ Our findings add to the growing body of evidence that a CPS-led transitional care program results in reduced polypharmacy and reduced unnecessary hospital readmissions. Further, our findings have demonstrated the effectiveness of this type of program in a practical, clinical setting with veteran patients.

At the time of project inception, we believed that the majority of our interventions would occur postdischarge. We were somewhat surprised that a major component of GMED was suggested interventions by our pharmacist at the time of admission. We believe that because the CPS made suggestions during admission, we prevented postdischarge ADEs. A frequent intervention corrected the medication reconciliation on file at admission. This finding also was seen in another study by Gleason and colleagues, which examined medication errors at admission for 651 adult medicine inpatients.²⁴ This study found that more than one-third of patients had medication reconciliation errors. Further, older age (≥ 65 years) was associated with increased odds of medication errors in this study.

Of note, a survey of hospital-based pharmacists indicated medication reconciliation is the most important role of the pharmacist in improving care transitions.²⁵ The pharmacists stated that detection of errors at the time of admission is very important. The pharmacists further reported that additional education and counseling for patients with poor understanding of their medications was also important. Our findings support these findings and the use of a pharmacist as part of the medical team to improve medication reconciliation and education.

Limitations

A limitation of GMED is that we monitored only admissions to our hospital; therefore, we did not account for any hospitalizations that may have occurred outside the STVHCS. Another limitation is that this was not a randomized controlled trial, and we used a convenience sample of patients who met our criteria for eligibility but were not seen due to time constraints. This introduces potential bias such that patients admitted and discharged on nights or weekends when the CPS was not available were not included in the transitional care program group, and these patients may fundamentally differ from those admitted and discharged Monday through Friday.

However, Khanna and colleagues found that night or weekend admission was not associated with 30-day readmission or other worse outcomes (such as length of stay, 30-day emergency department visit, or intensive care unit transfer) in 857 general medicine admissions at a tertiary care hospital.²⁶ Every effort was made to include as many eligible patients as possible in the transitional program group, and we were able to demonstrate that the patients in the 2 groups were similar. Frailty and prior hospital admission were more prevalent, although not significantly so, in the transitional program group, suggesting that any selection bias would have actually attenuated—not enhanced—the observed effect of the transitional program. Although the transitional program group patients were slightly younger by 0.3 years, they were similar in frailty status and CCI score.

Conclusion

The GMED program was associated with reduced 30-day hospital readmission, discontinuation of unnecessary medications, and corrected medication errors and discrepancies. We propose that a CPS-based transitional care program can improve the quality of care for older patients being discharged to home.

Acknowledgments

Supported by funding from the Veterans Health Administration T21 Non-Institutional Long-Term Care Initiative and VA Office of Rural Health and the San Antonio Geriatrics Research, Education, and Clinical Center. The sponsor did not have any role in the design, methods, data collection, or analysis, and preparation.

Author Contributions

R. Rottman-Sagebiel developed the transitional program concept and design and executed the program implementation, interpretation of data, and preparation of the manuscript. S. Pastewait, N. Cupples, A. Conde, M. Moris, and E. Gonzalez assisted with program design and implementation. S. Cope assisted with interpretation of data and preparation of the manuscript. H. Braden assisted with interpretation of data. D. MacCarthy assisted with data management and statistical analysis. C. Wang and S. Espinoza developed the program concept and design, performed statistical analysis and interpretation of data, and helped prepare the manuscript.

Advances in Geriatrics

Advances in Geriatrics features articles focused on quality improvement/quality assurance initiatives, pilot studies, best practices, research, patient education, and patient-centered care written by health care providers associated with Veteran Health Administration Geriatric Research Education and Clinical Centers. Interested authors can submit articles at editorialmanager.com/fedprac or send a brief 2 to 3 sentence abstract to [email protected] for feedback and publication recommendations.

This article is part of a series that illustrates strategies intended to redesign primary care education at the Veterans Health Administration (VHA), using interprofessional workplace learning. All have been implemented in the VA Centers of Excellence in Primary Care Education (CoEPCE). These models embody visionary transformation of clinical and educational environments that have potential for replication and dissemination throughout VA and other primary care clinical educational environments. For an introduction to the series see Klink K. Transforming primary care clinical learning environments to optimize education, outcomes, and satisfaction. Fed Pract. 2018;35(9):8-10.

Background

In 2011, 5 US Department of Veterans Affairs (VA) medical centers (VAMCs) were selected by the Office of Academic Affiliations (OAA) to establish CoEPCE. Part of the VA New Models of Care initiative, the 5 Centers of Excellence (CoE) in Boise, Idaho; Cleveland, Ohio; San Francisco, California; Seattle, Washington; and West Haven, Connecticut, are utilizing VA primary care settings to develop and test innovative approaches to prepare physician residents and students, advanced practice nurse residents and undergraduate nursing students, and other professions of health trainees (eg, pharmacy, social work, psychology, physician assistants [PAs]) for primary care practice in the 21st century.

The Boise CoE developed and implemented a practice-based learning model. Nurse practitioner (NP) students and residents, physician residents, pharmacy residents, psychology interns, and psychology postdoctoral fellows participate in a comprehensive curriculum and practice together for 1 to 3 years. The goal is to produce providers who are able to lead and practice health care in patient-centered primary care and rural care environments. All core curricula are interprofessionally coauthored and cotaught.¹

Methods

In 2015, OAA evaluators reviewed background documents and conducted open-ended interviews with 10 CoE staff, participating trainees, VA faculty, VA facility leadership, and affiliate faculty. In response to questions focused on their experiences, informants described lessons learned, challenges encountered, and benefits for participants, veterans, and the VA. Using a qualitative and quantitative approach, this case study draws on those interviews, surveys of PACT ICU (patient aligned care team interprofessional care update) participants, and analysis of presented patients to examine PACT ICU outcomes.

Related: Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA1c Goals

Interprofessional Education and Care

A key CoEPCE aim is to create more clinical opportunities for CoE trainees from a variety of professions to work as a team in ways that anticipate and address the care needs of veterans. This emphasis on workplace learning is needed since most current health care professional education programs lack settings where trainees from different professions can learn and work together with their clinic partners to provide care for patients. With the emphasis on patient-centered medical homes (PCMH) and team-based care in the Affordable Care Act, there is an imperative to develop new training models that address this gap in the preparation of future health professionals. Along with this imperative, clinicians are increasingly required to optimize the health of complex patients who consequently require a multidisciplinary approach to care, particularly high-risk, high-needs patients inappropriately using services, such as frequent emergency department (ED) use.

Addressing Complex Needs

In 2010, the Boise VA Medical Center (VAMC) phased in patient aligned care teams (PACTs), the VA-mandated version of PCMH that consist of a physician or NP primary care provider (PCP), a registered nurse (RN) care manager, a licensed vocational nurse (LVN), and a medical support assistant (MSA). 

The PACT ICU also serves as a venue in which trainees and supervisors from different professions use a patient-centered framework to collaborate on these specific patient cases. The PACT ICU is easily applied to a range of health conditions, such as diabetes mellitus (DM), mental and behavioral health, lack of social support, and delivery system issues, such as ED use. The goals of PACT ICU are to improve the quality and satisfaction of patient care for high-risk patients; encourage appropriate use of health care resources by prioritizing continuity with the PACT team; and enhance interprofessional PACT team function, decreasing PCP and staff stress.

Planning and Implementation

In January 2013, Boise VAMC and the Caldwell, Idaho community-based outpatient clinic (CBOC) implemented PACT ICU. Other nonteaching clinics followed later in the year. Planning and executing PACT ICU took about 10 hours of CoE staff time and required no change in Boise VAMC policy. Program leadership approval was necessary for participation of CoE residents and postdocs. Service-line leadership support was required to protect clinic staff time (nurse care manager, social workers, chaplaincy, and ethics service). At the Caldwell CBOC, the section chief approved the program, and it took about 1 month to initiate a similar version of PACT ICU.

Curriculum

PACT ICU is a workplace clinical activity with roots in the case conference model, specifically the EFECT model (Elicit the narrative of illness, Facilitate a group meeting, Evidence-based gap analysis, Care plan, and Track changes).³ PACT ICU emphasizes a patient-centered approach to developing care plans. Staff review the 5 highest risk patients who are identified by the VA Care Assessment Need (CAN) registry. The CAN is an analytic tool that is available throughout VA and estimates patients’ risk of mortality or hospitalization in the following 90 days. Physician and NP residents choose 1 of the 5 patients to discuss in PACT ICU, while the remaining 4 serve as case-control comparisons to examine long-term patient outcomes. All trainees, faculty, and staff are provided patient data that can be discussed on a secure website.

The PACT ICU combines didactic teaching with workplace learning. For example, the patient’s medical issues may lead to a formal presentation about a topic, such as secondary stroke medication prophylaxis. The workplace learning occurs as the trainees observe and participate in the decision making toward a treatment plan. Interprofessional interactions are role-modeled by clinical faculty and staff during these discussions, and the result impact the patients care. PACT ICU embodies the core domains that shape the CoEPCE curriculum: Interprofessional collaboration (IPC), performance improvement (PI), sustained relationships (SR), and shared decision making (SDM) (Table 1). 

There have been some changes to the PACT ICU model over time. Initially, conferences took place on a weekly basis, to build momentum among the team and to normalize processes. After about 2 years, this decreased to every other week to reduce the time burden. Additionally, the CoE has strengthened the “tracking changes” component of the EFECT model—trainees now present a 5-minute update on the last patient they presented at the prior PACT ICU case conference. Most recently, psychology postdoctoral candidates have instituted preconference calls with patients to further improve the teams understanding of the patients’ perspective and narrative.

Related: Improving Team-Based Care Coordination Delivery and Documentation in the Health Record

Resources

The CoE faculty participate in an education program concerning facilitation of interprofessional meetings. All faculty are expected to role model collaborative behavior and mentor trainees on the cases they present.

The PACT ICU requires a room large enough to accommodate at least 12 people. One staff member is required to review patient cases prior to the case conferences (usually about 1 hour of preparation per case conference). Another staff person creates and shares a spreadsheet stored with VA-approved information security with data fields to include the site, PACT ICU date, patient identifier, the CAN score, and a checkbox for whether the patient was selected or part of a control group. Logistic support is required for reserving the room and sending information to presenters. A clinic-based RN with training in interprofessional care case management uses an online schedule to facilitate selection and review of patients. The RN care managers can use a secure management tool to track patient care and outreach.

The RN care manager also needs to be available to attend the PACT ICU case conferences. The Boise CoE built a website to share and standardize resources, such as a presenter schedule, PACT ICU worksheet, and provider questionnaire. (Contact Boise CoE staff for access.) For the initial evaluation of impact, PACT ICU utilized staff data support in the form of a data manager and biostatistician to identify, collect, and analyze data. While optional, this was helpful in refining the approach and demonstrating the impact of the project. Other resource-related requirements for exporting PACT ICU include:

• Staff members, usually RN care managers who coordinate meetings with participants and identify appropriate patients using a registry, such as CAN;
• Meeting facilitators who enforce use of the EFECT model and interprofessional participation to ensure that the interprofessional care plan is carried out by the presenting provider; and
• Interprofessional trainees and faculty who participate in PACT ICU and complete surveys after the first conference.

Monitoring and Assessment

The CoE staff have analyzed the evaluation of PACT ICU with participant self-evaluation, consultation referral patterns, and utilization data, combination of ED and episodic care visits along with hospitalizations).⁴ Pharmacy faculty are exploring the use polypharmacy registries, and psychology will use registries of poor psychosocial function.

Partnerships

Beyond support and engagement from VA CoEPCE and affiliate faculty, PACT ICU has greatly benefited from partnerships with VA facility department and CBOC leadership. The CoEPCE codirector and faculty are in facility committees, such as the PACT Strategic Planning Committee.

Academic affiliates are integral partners who assist with NP student and resident recruitment as well as participate in the planning and refinement of CoEPCE components. PACT ICU supports their mandate to encourage interprofessional teamwork. Faculty members from Gonzaga University (NP affiliate) were involved in the initial discussion on PACT ICU and consider it a “learning laboratory” to work through challenging problems. Gonzaga CoEPCE NP trainees are asked to talk about their PACT ICU experience—its strengths, weaknesses, and challenges—to other Gonzaga students who don’t have exposure to the team experience.

Challenges and Solutions

The demand for direct patient care puts pressure on indirect patient care approaches like PACT ICU, which is a time-intensive process with high impact on only a small number of patients. The argument for deploying strategies such as PACT ICU is that managing chronic conditions and encouraging appropriate use of services will improve outcomes for the highest risk patients and save important system resources in the long-run. However, in the short-term, a strong case must be made for the diversion of resources from usual clinic flow, particularly securing recurring blocks of provider time and clinic staff members. In addition, issues about team communication and understanding of appropriate team-based care can overflow to complex patients not presented in the PACT ICU conference.

Providing a facilitated interprofessional venue to discuss how to appropriately coordinate care improves the participation and perceived value of different team members. This approach has led to improved engagement of the team for patients discussed in the PACT ICU, as well as in general care within the participating clinic. With recent changes, the VA does see a workload benefit, and participants get encounter credit through “Non face-to-face prolonged service” codes (CPT 99358/99359), and other possibilities exist related to clinical team conference codes (CPT 99367-8) and complex chronic care management codes (CPT 99487-89). More information on documentation, scheduling and encountering/billing can be found at boisevacoe.org under Products. Other challenges include logistic challenges of finding appropriate patients and distributing sensitive patient information among the team. Additionally, PACT ICU has to wrestle with staffing shortages and episodic participation by some professions that are chronically understaffed. We have addressed many of these problems by receiving buy-in from both leadership and participants. Leadership have allowed time for participation in clinic staff schedules, and each participant has committed to recruiting a substitute in case of a schedule conflict.

Factors for Success

The commitment from the Boise VAMC facility, primary care clinic leadership and affiliated training programs to support staff and trainee participation also has been critical. Additionally, VA facility leadership commitment to ongoing improvements to PACT implementation was a key facilitating factor. Colocation of trainees and clinic staff on the academic PACT team facilitates communication between PACT ICU case conferences, while also supporting team dynamics and sustained relationships with patients. Many of these patients can and will typically seek care using the interdisciplinary trainees, and trainees were motivated to proactively coordinate warm handoffs and other models of transfer of care. PACT ICU has been successfully replicated and sustained at 4 of the 5 CoEPCE sites. The Caldwell CBOC PACT ICU has been up and running for 2 years, and 2 other nonacademic clinics have piloted PACT ICU managed care conferences thus far. Experience regarding the implementation at other academic sites has been published.⁵

Accomplishments and Benefits

There is evidence that PACT ICU is achieving its goals of improving trainee learning and patient outcomes. Trainees are using team skills to provide patient-centered care; trainees are strengthening their overall clinical skills by learning how to improve their responses to high-risk patients. There is also evidence of an increase in interprofessional warm handoffs within the clinic, in which “a clinician directly introduces a patient to another clinician at the time of the patient’s visit, and often a brief encounter between the patient and the health care professional occurs.”^4,6

Unlike a traditional didactic with classroom case conferences on interprofessional collaboration, PACT ICU is an opportunity for health care professionals to both learn and work together providing care in a clinic. Moreover, colocation of diverse trainee and faculty professions during the case conferences better prepares trainees to work with other professions and supports all participants to work and communicate as a team.

CoE staff have assessed educational outcomes before and after attendance in PACT ICU. On average, trainees (n = 30) said they found the PACT ICU case conferences to be “very helpful” in developing treatment plans. 

Interprofessional Collaboration

Team building and colocating trainees, faculty, and clinic staff from different professions are a primary focus of PACT ICU. The case conferences are designed to break down silos and foster a team approach to care. Trainees learn how the team works and the ways other professionals can help them take care of the patient. For example, trainees learn early about the contributions and expertise that the pharmacist and psychologist offer in terms of their scope of practice and referral opportunities. Additionally, the RN care manager increases the integration with the PACT clinical team by sharing pertinent information on individual patients. Based on recent trainee survey findings, the CoE has observed a positive change in the team dynamic and trainee ability to interface between professions. PACT ICU participants were more likely to make referrals to other members within the PACT team, such as a warm handoff during a clinic appointment, while they were less likely to seek a consult outside the team.⁷

Clinical Performance

The PACT ICU is an opportunity for a trainee to increase clinical expertise. It provides exposure to a variety of patientsand their care needs and serves as an opportunity to present a high-risk, challenging patient to colleagues of various professions. As of June 2018, 96 physician resident and NP residents have presented complex patient cases.

In addition, a structured forum for discussing patients and their care options strengthens team clinical performance, which supports people to work to the full scope of their practice. Trainees learn and apply team skills, such as communication and the warm handoff.

An interprofessional care plan that is delineated during the meeting supports the trainee and is carried out with help from consultants as needed. These consultants often facilitate plans for a covisit or warm handoff at the next clinic visit, a call from the RN care manager, a virtual clinic appointment, or other nontraditional visits. The clinic staff can get information from PCPs about patient’s plan of care, and PCPs get a more complete picture of a patient’s situation (eg, history, communications, and life-style factors). In addition, surveys of PACT ICU participants suggest the curriculum’s effectiveness at encouraging use of PACT principles within the clinic team and improving appropriate referrals to other members of the PACT team, such as pharmacy and behavioral health.

Patients presented at PACT ICU can be particularly challenging, so there may be a psychological benefit to working with a team to develop a new care plan. The PCPs who feel they are overwhelmed and have exhausted every option step back, get input, and look at the patient in a new light.

Related: Interprofessional Education in Patient Aligned Care Team Primary Care-Mental Health Integration

CoEPCE Function

The PACT ICU is flexible and has been adapted to different ambulatory care settings. Currently, PACT ICU case conferences take place at Boise VAMC, the Caldwell CBOCs, and more recently at a smaller CBOC in Burns, Oregon. The PACT ICU structure is slightly different in the clinic settings since the VA primary care clinic has different resources to draw upon, such as hospital and specialty services. The Caldwell CBOC was unable to protect time for PCPs, so it holds a monthly PACT ICU case conference. In addition to continuing expansion in other nonacademic PACT clinics and collaboration with other CoEPCE sites, work is underway to disseminate generalizable principles for interprofessional education, as well as exporting the model for implementation in non-VA settings.

Primary Care Services

The PACT ICU has the potential to create efficiencies in busy clinic settings. It strengthens communication between PCPs and is an opportunity to touch base on the patient, delegate care, and keep track of high-risk patients who might otherwise receive attention only when having an acute problem. Nurses gain a deeper understanding of the patients presented at PACT ICU.

PACT ICU leverages and builds on existing PACT resources in an achievable and sustainable manner benefiting primary care. CoE trainees, who are part of the Silver Team, tap in to the information that team nurses gain from checking in with these high-risk patients biweekly. Moreover, the integration with the Silver Team improves continuity, which helps enhance a patient’s level of trust. The relationship strengthened between primary care and behavioral health at the Caldwell CBOC, providing improved patient access and increased professional sharing.

Patient Outcomes

The PACT ICU provides a forum for input beyond that of the PCP. This feature results in a more robust treatment plan than might be developed by individual PCPs who might not have time to consider options that are outside their scope of practice. Formulating an enriched care plan, informed by multiple professions, has the potential to improve utilization and provide better care.

The Boise VAMC PACT ICU has presented 219 patients as of June 2018. While clinical outcomes data are difficult to collect, the CoE has data on utilization differences on all patients presented at the PACT ICU case conferences. This includes 4 control patients from the same PCP, with similarly high risk based on CAN scores at the time of selection. A single control patient is selected based on gender, closest age, and CAN score; this serves as a comparator for subsequent utilization analysis.

Data from the first 2 years of this study demonstrate that compared with the high-risk control group, there was an increase in contacts with PACT team members, including behavioral health, clinical pharmacists, and nurse care management, persisting up to 6 months following the PACT ICU presentation.⁴ However, PACT ICU participation did not increase the number of visits with the PCP, indicating better engagement with the entire team. Participation was associated with significantly decreased hospitalizations and a trend toward decreased ED visits. These findings persisted when compared with controls in the PCP’s panel with similar CAN scores, making “regression to the mean” often seen in these studies much less likely.

Analysis of patients early in the project suggests the possibility of improved glycemic control in patients with DM and improved blood pressure control in hypertensive patients presented at the PACT ICU compared with that of non-PACT ICU patients.⁸ Another potential benefit includes better team-based coordination. Because the patient now has a team focusing on care, this new dynamic results in improving outreach, identifying patients who could receive care by a telephone, and better preparing team members to establish rapport when the patient calls or comes in for a visit.

The Future

In stage 2 of the CoEPCE program, a multi-site trial of PACT ICU was completed to better understand which elements are critical to success, with the goal of facilitating broader exportability.⁵ The trial focused on 3 intertwined elements: structure, delivery, and evaluation. Using local implementation and the multisite trial, the most effective practices have been documented as part of an implementation kit, available at boisevacoe.org. The goal of the implementation kit is to facilitate step-by-step implementation of PACT ICU to other settings beyond the multisite study. Since the open-ended structure of PACT ICU enables accommodating different professions and specialties beyond the model’s Boise VAMC participants, it could be easily adapted to potentially support a variety of implementations elsewhere (Appendix).

Another opportunity for expansion is increased patient involvement. Currently, PACT ICU patients have the opportunity to review and ask questions about their multidisciplinary care plans before starting. 

This article is part of a series that illustrates strategies intended to redesign primary care education at the Veterans Health Administration (VHA), using interprofessional workplace learning. All have been implemented in the VA Centers of Excellence in Primary Care Education (CoEPCE). These models embody visionary transformation of clinical and educational environments that have potential for replication and dissemination throughout VA and other primary care clinical educational environments. For an introduction to the series see Klink K. Transforming primary care clinical learning environments to optimize education, outcomes, and satisfaction. Fed Pract. 2018;35(9):8-10.

Background

In 2011, 5 US Department of Veterans Affairs (VA) medical centers (VAMCs) were selected by the Office of Academic Affiliations (OAA) to establish CoEPCE. Part of the VA New Models of Care initiative, the 5 Centers of Excellence (CoE) in Boise, Idaho; Cleveland, Ohio; San Francisco, California; Seattle, Washington; and West Haven, Connecticut, are utilizing VA primary care settings to develop and test innovative approaches to prepare physician residents and students, advanced practice nurse residents and undergraduate nursing students, and other professions of health trainees (eg, pharmacy, social work, psychology, physician assistants [PAs]) for primary care practice in the 21st century.

The Boise CoE developed and implemented a practice-based learning model. Nurse practitioner (NP) students and residents, physician residents, pharmacy residents, psychology interns, and psychology postdoctoral fellows participate in a comprehensive curriculum and practice together for 1 to 3 years. The goal is to produce providers who are able to lead and practice health care in patient-centered primary care and rural care environments. All core curricula are interprofessionally coauthored and cotaught.¹

Methods

In 2015, OAA evaluators reviewed background documents and conducted open-ended interviews with 10 CoE staff, participating trainees, VA faculty, VA facility leadership, and affiliate faculty. In response to questions focused on their experiences, informants described lessons learned, challenges encountered, and benefits for participants, veterans, and the VA. Using a qualitative and quantitative approach, this case study draws on those interviews, surveys of PACT ICU (patient aligned care team interprofessional care update) participants, and analysis of presented patients to examine PACT ICU outcomes.

Related: Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA1c Goals

Interprofessional Education and Care

A key CoEPCE aim is to create more clinical opportunities for CoE trainees from a variety of professions to work as a team in ways that anticipate and address the care needs of veterans. This emphasis on workplace learning is needed since most current health care professional education programs lack settings where trainees from different professions can learn and work together with their clinic partners to provide care for patients. With the emphasis on patient-centered medical homes (PCMH) and team-based care in the Affordable Care Act, there is an imperative to develop new training models that address this gap in the preparation of future health professionals. Along with this imperative, clinicians are increasingly required to optimize the health of complex patients who consequently require a multidisciplinary approach to care, particularly high-risk, high-needs patients inappropriately using services, such as frequent emergency department (ED) use.

Addressing Complex Needs

In 2010, the Boise VA Medical Center (VAMC) phased in patient aligned care teams (PACTs), the VA-mandated version of PCMH that consist of a physician or NP primary care provider (PCP), a registered nurse (RN) care manager, a licensed vocational nurse (LVN), and a medical support assistant (MSA). 

The PACT ICU also serves as a venue in which trainees and supervisors from different professions use a patient-centered framework to collaborate on these specific patient cases. The PACT ICU is easily applied to a range of health conditions, such as diabetes mellitus (DM), mental and behavioral health, lack of social support, and delivery system issues, such as ED use. The goals of PACT ICU are to improve the quality and satisfaction of patient care for high-risk patients; encourage appropriate use of health care resources by prioritizing continuity with the PACT team; and enhance interprofessional PACT team function, decreasing PCP and staff stress.

Planning and Implementation

In January 2013, Boise VAMC and the Caldwell, Idaho community-based outpatient clinic (CBOC) implemented PACT ICU. Other nonteaching clinics followed later in the year. Planning and executing PACT ICU took about 10 hours of CoE staff time and required no change in Boise VAMC policy. Program leadership approval was necessary for participation of CoE residents and postdocs. Service-line leadership support was required to protect clinic staff time (nurse care manager, social workers, chaplaincy, and ethics service). At the Caldwell CBOC, the section chief approved the program, and it took about 1 month to initiate a similar version of PACT ICU.

Curriculum

PACT ICU is a workplace clinical activity with roots in the case conference model, specifically the EFECT model (Elicit the narrative of illness, Facilitate a group meeting, Evidence-based gap analysis, Care plan, and Track changes).³ PACT ICU emphasizes a patient-centered approach to developing care plans. Staff review the 5 highest risk patients who are identified by the VA Care Assessment Need (CAN) registry. The CAN is an analytic tool that is available throughout VA and estimates patients’ risk of mortality or hospitalization in the following 90 days. Physician and NP residents choose 1 of the 5 patients to discuss in PACT ICU, while the remaining 4 serve as case-control comparisons to examine long-term patient outcomes. All trainees, faculty, and staff are provided patient data that can be discussed on a secure website.

The PACT ICU combines didactic teaching with workplace learning. For example, the patient’s medical issues may lead to a formal presentation about a topic, such as secondary stroke medication prophylaxis. The workplace learning occurs as the trainees observe and participate in the decision making toward a treatment plan. Interprofessional interactions are role-modeled by clinical faculty and staff during these discussions, and the result impact the patients care. PACT ICU embodies the core domains that shape the CoEPCE curriculum: Interprofessional collaboration (IPC), performance improvement (PI), sustained relationships (SR), and shared decision making (SDM) (Table 1). 

There have been some changes to the PACT ICU model over time. Initially, conferences took place on a weekly basis, to build momentum among the team and to normalize processes. After about 2 years, this decreased to every other week to reduce the time burden. Additionally, the CoE has strengthened the “tracking changes” component of the EFECT model—trainees now present a 5-minute update on the last patient they presented at the prior PACT ICU case conference. Most recently, psychology postdoctoral candidates have instituted preconference calls with patients to further improve the teams understanding of the patients’ perspective and narrative.

Related: Improving Team-Based Care Coordination Delivery and Documentation in the Health Record

Resources

The CoE faculty participate in an education program concerning facilitation of interprofessional meetings. All faculty are expected to role model collaborative behavior and mentor trainees on the cases they present.

The PACT ICU requires a room large enough to accommodate at least 12 people. One staff member is required to review patient cases prior to the case conferences (usually about 1 hour of preparation per case conference). Another staff person creates and shares a spreadsheet stored with VA-approved information security with data fields to include the site, PACT ICU date, patient identifier, the CAN score, and a checkbox for whether the patient was selected or part of a control group. Logistic support is required for reserving the room and sending information to presenters. A clinic-based RN with training in interprofessional care case management uses an online schedule to facilitate selection and review of patients. The RN care managers can use a secure management tool to track patient care and outreach.

The RN care manager also needs to be available to attend the PACT ICU case conferences. The Boise CoE built a website to share and standardize resources, such as a presenter schedule, PACT ICU worksheet, and provider questionnaire. (Contact Boise CoE staff for access.) For the initial evaluation of impact, PACT ICU utilized staff data support in the form of a data manager and biostatistician to identify, collect, and analyze data. While optional, this was helpful in refining the approach and demonstrating the impact of the project. Other resource-related requirements for exporting PACT ICU include:

• Staff members, usually RN care managers who coordinate meetings with participants and identify appropriate patients using a registry, such as CAN;
• Meeting facilitators who enforce use of the EFECT model and interprofessional participation to ensure that the interprofessional care plan is carried out by the presenting provider; and
• Interprofessional trainees and faculty who participate in PACT ICU and complete surveys after the first conference.

Monitoring and Assessment

The CoE staff have analyzed the evaluation of PACT ICU with participant self-evaluation, consultation referral patterns, and utilization data, combination of ED and episodic care visits along with hospitalizations).⁴ Pharmacy faculty are exploring the use polypharmacy registries, and psychology will use registries of poor psychosocial function.

Partnerships

Beyond support and engagement from VA CoEPCE and affiliate faculty, PACT ICU has greatly benefited from partnerships with VA facility department and CBOC leadership. The CoEPCE codirector and faculty are in facility committees, such as the PACT Strategic Planning Committee.

Academic affiliates are integral partners who assist with NP student and resident recruitment as well as participate in the planning and refinement of CoEPCE components. PACT ICU supports their mandate to encourage interprofessional teamwork. Faculty members from Gonzaga University (NP affiliate) were involved in the initial discussion on PACT ICU and consider it a “learning laboratory” to work through challenging problems. Gonzaga CoEPCE NP trainees are asked to talk about their PACT ICU experience—its strengths, weaknesses, and challenges—to other Gonzaga students who don’t have exposure to the team experience.

Challenges and Solutions

The demand for direct patient care puts pressure on indirect patient care approaches like PACT ICU, which is a time-intensive process with high impact on only a small number of patients. The argument for deploying strategies such as PACT ICU is that managing chronic conditions and encouraging appropriate use of services will improve outcomes for the highest risk patients and save important system resources in the long-run. However, in the short-term, a strong case must be made for the diversion of resources from usual clinic flow, particularly securing recurring blocks of provider time and clinic staff members. In addition, issues about team communication and understanding of appropriate team-based care can overflow to complex patients not presented in the PACT ICU conference.

Providing a facilitated interprofessional venue to discuss how to appropriately coordinate care improves the participation and perceived value of different team members. This approach has led to improved engagement of the team for patients discussed in the PACT ICU, as well as in general care within the participating clinic. With recent changes, the VA does see a workload benefit, and participants get encounter credit through “Non face-to-face prolonged service” codes (CPT 99358/99359), and other possibilities exist related to clinical team conference codes (CPT 99367-8) and complex chronic care management codes (CPT 99487-89). More information on documentation, scheduling and encountering/billing can be found at boisevacoe.org under Products. Other challenges include logistic challenges of finding appropriate patients and distributing sensitive patient information among the team. Additionally, PACT ICU has to wrestle with staffing shortages and episodic participation by some professions that are chronically understaffed. We have addressed many of these problems by receiving buy-in from both leadership and participants. Leadership have allowed time for participation in clinic staff schedules, and each participant has committed to recruiting a substitute in case of a schedule conflict.

Factors for Success

The commitment from the Boise VAMC facility, primary care clinic leadership and affiliated training programs to support staff and trainee participation also has been critical. Additionally, VA facility leadership commitment to ongoing improvements to PACT implementation was a key facilitating factor. Colocation of trainees and clinic staff on the academic PACT team facilitates communication between PACT ICU case conferences, while also supporting team dynamics and sustained relationships with patients. Many of these patients can and will typically seek care using the interdisciplinary trainees, and trainees were motivated to proactively coordinate warm handoffs and other models of transfer of care. PACT ICU has been successfully replicated and sustained at 4 of the 5 CoEPCE sites. The Caldwell CBOC PACT ICU has been up and running for 2 years, and 2 other nonacademic clinics have piloted PACT ICU managed care conferences thus far. Experience regarding the implementation at other academic sites has been published.⁵

Accomplishments and Benefits

There is evidence that PACT ICU is achieving its goals of improving trainee learning and patient outcomes. Trainees are using team skills to provide patient-centered care; trainees are strengthening their overall clinical skills by learning how to improve their responses to high-risk patients. There is also evidence of an increase in interprofessional warm handoffs within the clinic, in which “a clinician directly introduces a patient to another clinician at the time of the patient’s visit, and often a brief encounter between the patient and the health care professional occurs.”^4,6

Unlike a traditional didactic with classroom case conferences on interprofessional collaboration, PACT ICU is an opportunity for health care professionals to both learn and work together providing care in a clinic. Moreover, colocation of diverse trainee and faculty professions during the case conferences better prepares trainees to work with other professions and supports all participants to work and communicate as a team.

CoE staff have assessed educational outcomes before and after attendance in PACT ICU. On average, trainees (n = 30) said they found the PACT ICU case conferences to be “very helpful” in developing treatment plans. 

Interprofessional Collaboration

Team building and colocating trainees, faculty, and clinic staff from different professions are a primary focus of PACT ICU. The case conferences are designed to break down silos and foster a team approach to care. Trainees learn how the team works and the ways other professionals can help them take care of the patient. For example, trainees learn early about the contributions and expertise that the pharmacist and psychologist offer in terms of their scope of practice and referral opportunities. Additionally, the RN care manager increases the integration with the PACT clinical team by sharing pertinent information on individual patients. Based on recent trainee survey findings, the CoE has observed a positive change in the team dynamic and trainee ability to interface between professions. PACT ICU participants were more likely to make referrals to other members within the PACT team, such as a warm handoff during a clinic appointment, while they were less likely to seek a consult outside the team.⁷

Clinical Performance

The PACT ICU is an opportunity for a trainee to increase clinical expertise. It provides exposure to a variety of patientsand their care needs and serves as an opportunity to present a high-risk, challenging patient to colleagues of various professions. As of June 2018, 96 physician resident and NP residents have presented complex patient cases.

In addition, a structured forum for discussing patients and their care options strengthens team clinical performance, which supports people to work to the full scope of their practice. Trainees learn and apply team skills, such as communication and the warm handoff.

An interprofessional care plan that is delineated during the meeting supports the trainee and is carried out with help from consultants as needed. These consultants often facilitate plans for a covisit or warm handoff at the next clinic visit, a call from the RN care manager, a virtual clinic appointment, or other nontraditional visits. The clinic staff can get information from PCPs about patient’s plan of care, and PCPs get a more complete picture of a patient’s situation (eg, history, communications, and life-style factors). In addition, surveys of PACT ICU participants suggest the curriculum’s effectiveness at encouraging use of PACT principles within the clinic team and improving appropriate referrals to other members of the PACT team, such as pharmacy and behavioral health.

Patients presented at PACT ICU can be particularly challenging, so there may be a psychological benefit to working with a team to develop a new care plan. The PCPs who feel they are overwhelmed and have exhausted every option step back, get input, and look at the patient in a new light.

Related: Interprofessional Education in Patient Aligned Care Team Primary Care-Mental Health Integration

CoEPCE Function

The PACT ICU is flexible and has been adapted to different ambulatory care settings. Currently, PACT ICU case conferences take place at Boise VAMC, the Caldwell CBOCs, and more recently at a smaller CBOC in Burns, Oregon. The PACT ICU structure is slightly different in the clinic settings since the VA primary care clinic has different resources to draw upon, such as hospital and specialty services. The Caldwell CBOC was unable to protect time for PCPs, so it holds a monthly PACT ICU case conference. In addition to continuing expansion in other nonacademic PACT clinics and collaboration with other CoEPCE sites, work is underway to disseminate generalizable principles for interprofessional education, as well as exporting the model for implementation in non-VA settings.

Primary Care Services

The PACT ICU has the potential to create efficiencies in busy clinic settings. It strengthens communication between PCPs and is an opportunity to touch base on the patient, delegate care, and keep track of high-risk patients who might otherwise receive attention only when having an acute problem. Nurses gain a deeper understanding of the patients presented at PACT ICU.

PACT ICU leverages and builds on existing PACT resources in an achievable and sustainable manner benefiting primary care. CoE trainees, who are part of the Silver Team, tap in to the information that team nurses gain from checking in with these high-risk patients biweekly. Moreover, the integration with the Silver Team improves continuity, which helps enhance a patient’s level of trust. The relationship strengthened between primary care and behavioral health at the Caldwell CBOC, providing improved patient access and increased professional sharing.

Patient Outcomes

The PACT ICU provides a forum for input beyond that of the PCP. This feature results in a more robust treatment plan than might be developed by individual PCPs who might not have time to consider options that are outside their scope of practice. Formulating an enriched care plan, informed by multiple professions, has the potential to improve utilization and provide better care.

The Boise VAMC PACT ICU has presented 219 patients as of June 2018. While clinical outcomes data are difficult to collect, the CoE has data on utilization differences on all patients presented at the PACT ICU case conferences. This includes 4 control patients from the same PCP, with similarly high risk based on CAN scores at the time of selection. A single control patient is selected based on gender, closest age, and CAN score; this serves as a comparator for subsequent utilization analysis.

Data from the first 2 years of this study demonstrate that compared with the high-risk control group, there was an increase in contacts with PACT team members, including behavioral health, clinical pharmacists, and nurse care management, persisting up to 6 months following the PACT ICU presentation.⁴ However, PACT ICU participation did not increase the number of visits with the PCP, indicating better engagement with the entire team. Participation was associated with significantly decreased hospitalizations and a trend toward decreased ED visits. These findings persisted when compared with controls in the PCP’s panel with similar CAN scores, making “regression to the mean” often seen in these studies much less likely.

Analysis of patients early in the project suggests the possibility of improved glycemic control in patients with DM and improved blood pressure control in hypertensive patients presented at the PACT ICU compared with that of non-PACT ICU patients.⁸ Another potential benefit includes better team-based coordination. Because the patient now has a team focusing on care, this new dynamic results in improving outreach, identifying patients who could receive care by a telephone, and better preparing team members to establish rapport when the patient calls or comes in for a visit.

The Future

In stage 2 of the CoEPCE program, a multi-site trial of PACT ICU was completed to better understand which elements are critical to success, with the goal of facilitating broader exportability.⁵ The trial focused on 3 intertwined elements: structure, delivery, and evaluation. Using local implementation and the multisite trial, the most effective practices have been documented as part of an implementation kit, available at boisevacoe.org. The goal of the implementation kit is to facilitate step-by-step implementation of PACT ICU to other settings beyond the multisite study. Since the open-ended structure of PACT ICU enables accommodating different professions and specialties beyond the model’s Boise VAMC participants, it could be easily adapted to potentially support a variety of implementations elsewhere (Appendix).

Another opportunity for expansion is increased patient involvement. Currently, PACT ICU patients have the opportunity to review and ask questions about their multidisciplinary care plans before starting. 

This article is part of a series that illustrates strategies intended to redesign primary care education at the Veterans Health Administration (VHA), using interprofessional workplace learning. All have been implemented in the VA Centers of Excellence in Primary Care Education (CoEPCE). These models embody visionary transformation of clinical and educational environments that have potential for replication and dissemination throughout VA and other primary care clinical educational environments. For an introduction to the series see Klink K. Transforming primary care clinical learning environments to optimize education, outcomes, and satisfaction. Fed Pract. 2018;35(9):8-10.

Background

In 2011, 5 US Department of Veterans Affairs (VA) medical centers (VAMCs) were selected by the Office of Academic Affiliations (OAA) to establish CoEPCE. Part of the VA New Models of Care initiative, the 5 Centers of Excellence (CoE) in Boise, Idaho; Cleveland, Ohio; San Francisco, California; Seattle, Washington; and West Haven, Connecticut, are utilizing VA primary care settings to develop and test innovative approaches to prepare physician residents and students, advanced practice nurse residents and undergraduate nursing students, and other professions of health trainees (eg, pharmacy, social work, psychology, physician assistants [PAs]) for primary care practice in the 21st century.

The Boise CoE developed and implemented a practice-based learning model. Nurse practitioner (NP) students and residents, physician residents, pharmacy residents, psychology interns, and psychology postdoctoral fellows participate in a comprehensive curriculum and practice together for 1 to 3 years. The goal is to produce providers who are able to lead and practice health care in patient-centered primary care and rural care environments. All core curricula are interprofessionally coauthored and cotaught.¹

Methods

In 2015, OAA evaluators reviewed background documents and conducted open-ended interviews with 10 CoE staff, participating trainees, VA faculty, VA facility leadership, and affiliate faculty. In response to questions focused on their experiences, informants described lessons learned, challenges encountered, and benefits for participants, veterans, and the VA. Using a qualitative and quantitative approach, this case study draws on those interviews, surveys of PACT ICU (patient aligned care team interprofessional care update) participants, and analysis of presented patients to examine PACT ICU outcomes.

Related: Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA1c Goals

Interprofessional Education and Care

A key CoEPCE aim is to create more clinical opportunities for CoE trainees from a variety of professions to work as a team in ways that anticipate and address the care needs of veterans. This emphasis on workplace learning is needed since most current health care professional education programs lack settings where trainees from different professions can learn and work together with their clinic partners to provide care for patients. With the emphasis on patient-centered medical homes (PCMH) and team-based care in the Affordable Care Act, there is an imperative to develop new training models that address this gap in the preparation of future health professionals. Along with this imperative, clinicians are increasingly required to optimize the health of complex patients who consequently require a multidisciplinary approach to care, particularly high-risk, high-needs patients inappropriately using services, such as frequent emergency department (ED) use.

Addressing Complex Needs

In 2010, the Boise VA Medical Center (VAMC) phased in patient aligned care teams (PACTs), the VA-mandated version of PCMH that consist of a physician or NP primary care provider (PCP), a registered nurse (RN) care manager, a licensed vocational nurse (LVN), and a medical support assistant (MSA). 

The PACT ICU also serves as a venue in which trainees and supervisors from different professions use a patient-centered framework to collaborate on these specific patient cases. The PACT ICU is easily applied to a range of health conditions, such as diabetes mellitus (DM), mental and behavioral health, lack of social support, and delivery system issues, such as ED use. The goals of PACT ICU are to improve the quality and satisfaction of patient care for high-risk patients; encourage appropriate use of health care resources by prioritizing continuity with the PACT team; and enhance interprofessional PACT team function, decreasing PCP and staff stress.

Planning and Implementation

In January 2013, Boise VAMC and the Caldwell, Idaho community-based outpatient clinic (CBOC) implemented PACT ICU. Other nonteaching clinics followed later in the year. Planning and executing PACT ICU took about 10 hours of CoE staff time and required no change in Boise VAMC policy. Program leadership approval was necessary for participation of CoE residents and postdocs. Service-line leadership support was required to protect clinic staff time (nurse care manager, social workers, chaplaincy, and ethics service). At the Caldwell CBOC, the section chief approved the program, and it took about 1 month to initiate a similar version of PACT ICU.

Curriculum

PACT ICU is a workplace clinical activity with roots in the case conference model, specifically the EFECT model (Elicit the narrative of illness, Facilitate a group meeting, Evidence-based gap analysis, Care plan, and Track changes).³ PACT ICU emphasizes a patient-centered approach to developing care plans. Staff review the 5 highest risk patients who are identified by the VA Care Assessment Need (CAN) registry. The CAN is an analytic tool that is available throughout VA and estimates patients’ risk of mortality or hospitalization in the following 90 days. Physician and NP residents choose 1 of the 5 patients to discuss in PACT ICU, while the remaining 4 serve as case-control comparisons to examine long-term patient outcomes. All trainees, faculty, and staff are provided patient data that can be discussed on a secure website.

The PACT ICU combines didactic teaching with workplace learning. For example, the patient’s medical issues may lead to a formal presentation about a topic, such as secondary stroke medication prophylaxis. The workplace learning occurs as the trainees observe and participate in the decision making toward a treatment plan. Interprofessional interactions are role-modeled by clinical faculty and staff during these discussions, and the result impact the patients care. PACT ICU embodies the core domains that shape the CoEPCE curriculum: Interprofessional collaboration (IPC), performance improvement (PI), sustained relationships (SR), and shared decision making (SDM) (Table 1). 

There have been some changes to the PACT ICU model over time. Initially, conferences took place on a weekly basis, to build momentum among the team and to normalize processes. After about 2 years, this decreased to every other week to reduce the time burden. Additionally, the CoE has strengthened the “tracking changes” component of the EFECT model—trainees now present a 5-minute update on the last patient they presented at the prior PACT ICU case conference. Most recently, psychology postdoctoral candidates have instituted preconference calls with patients to further improve the teams understanding of the patients’ perspective and narrative.

Related: Improving Team-Based Care Coordination Delivery and Documentation in the Health Record

Resources

The CoE faculty participate in an education program concerning facilitation of interprofessional meetings. All faculty are expected to role model collaborative behavior and mentor trainees on the cases they present.

The PACT ICU requires a room large enough to accommodate at least 12 people. One staff member is required to review patient cases prior to the case conferences (usually about 1 hour of preparation per case conference). Another staff person creates and shares a spreadsheet stored with VA-approved information security with data fields to include the site, PACT ICU date, patient identifier, the CAN score, and a checkbox for whether the patient was selected or part of a control group. Logistic support is required for reserving the room and sending information to presenters. A clinic-based RN with training in interprofessional care case management uses an online schedule to facilitate selection and review of patients. The RN care managers can use a secure management tool to track patient care and outreach.

The RN care manager also needs to be available to attend the PACT ICU case conferences. The Boise CoE built a website to share and standardize resources, such as a presenter schedule, PACT ICU worksheet, and provider questionnaire. (Contact Boise CoE staff for access.) For the initial evaluation of impact, PACT ICU utilized staff data support in the form of a data manager and biostatistician to identify, collect, and analyze data. While optional, this was helpful in refining the approach and demonstrating the impact of the project. Other resource-related requirements for exporting PACT ICU include:

• Staff members, usually RN care managers who coordinate meetings with participants and identify appropriate patients using a registry, such as CAN;
• Meeting facilitators who enforce use of the EFECT model and interprofessional participation to ensure that the interprofessional care plan is carried out by the presenting provider; and
• Interprofessional trainees and faculty who participate in PACT ICU and complete surveys after the first conference.

Monitoring and Assessment

The CoE staff have analyzed the evaluation of PACT ICU with participant self-evaluation, consultation referral patterns, and utilization data, combination of ED and episodic care visits along with hospitalizations).⁴ Pharmacy faculty are exploring the use polypharmacy registries, and psychology will use registries of poor psychosocial function.

Partnerships

Beyond support and engagement from VA CoEPCE and affiliate faculty, PACT ICU has greatly benefited from partnerships with VA facility department and CBOC leadership. The CoEPCE codirector and faculty are in facility committees, such as the PACT Strategic Planning Committee.

Academic affiliates are integral partners who assist with NP student and resident recruitment as well as participate in the planning and refinement of CoEPCE components. PACT ICU supports their mandate to encourage interprofessional teamwork. Faculty members from Gonzaga University (NP affiliate) were involved in the initial discussion on PACT ICU and consider it a “learning laboratory” to work through challenging problems. Gonzaga CoEPCE NP trainees are asked to talk about their PACT ICU experience—its strengths, weaknesses, and challenges—to other Gonzaga students who don’t have exposure to the team experience.

Challenges and Solutions

The demand for direct patient care puts pressure on indirect patient care approaches like PACT ICU, which is a time-intensive process with high impact on only a small number of patients. The argument for deploying strategies such as PACT ICU is that managing chronic conditions and encouraging appropriate use of services will improve outcomes for the highest risk patients and save important system resources in the long-run. However, in the short-term, a strong case must be made for the diversion of resources from usual clinic flow, particularly securing recurring blocks of provider time and clinic staff members. In addition, issues about team communication and understanding of appropriate team-based care can overflow to complex patients not presented in the PACT ICU conference.

Providing a facilitated interprofessional venue to discuss how to appropriately coordinate care improves the participation and perceived value of different team members. This approach has led to improved engagement of the team for patients discussed in the PACT ICU, as well as in general care within the participating clinic. With recent changes, the VA does see a workload benefit, and participants get encounter credit through “Non face-to-face prolonged service” codes (CPT 99358/99359), and other possibilities exist related to clinical team conference codes (CPT 99367-8) and complex chronic care management codes (CPT 99487-89). More information on documentation, scheduling and encountering/billing can be found at boisevacoe.org under Products. Other challenges include logistic challenges of finding appropriate patients and distributing sensitive patient information among the team. Additionally, PACT ICU has to wrestle with staffing shortages and episodic participation by some professions that are chronically understaffed. We have addressed many of these problems by receiving buy-in from both leadership and participants. Leadership have allowed time for participation in clinic staff schedules, and each participant has committed to recruiting a substitute in case of a schedule conflict.

Factors for Success

The commitment from the Boise VAMC facility, primary care clinic leadership and affiliated training programs to support staff and trainee participation also has been critical. Additionally, VA facility leadership commitment to ongoing improvements to PACT implementation was a key facilitating factor. Colocation of trainees and clinic staff on the academic PACT team facilitates communication between PACT ICU case conferences, while also supporting team dynamics and sustained relationships with patients. Many of these patients can and will typically seek care using the interdisciplinary trainees, and trainees were motivated to proactively coordinate warm handoffs and other models of transfer of care. PACT ICU has been successfully replicated and sustained at 4 of the 5 CoEPCE sites. The Caldwell CBOC PACT ICU has been up and running for 2 years, and 2 other nonacademic clinics have piloted PACT ICU managed care conferences thus far. Experience regarding the implementation at other academic sites has been published.⁵

Accomplishments and Benefits

There is evidence that PACT ICU is achieving its goals of improving trainee learning and patient outcomes. Trainees are using team skills to provide patient-centered care; trainees are strengthening their overall clinical skills by learning how to improve their responses to high-risk patients. There is also evidence of an increase in interprofessional warm handoffs within the clinic, in which “a clinician directly introduces a patient to another clinician at the time of the patient’s visit, and often a brief encounter between the patient and the health care professional occurs.”^4,6

Unlike a traditional didactic with classroom case conferences on interprofessional collaboration, PACT ICU is an opportunity for health care professionals to both learn and work together providing care in a clinic. Moreover, colocation of diverse trainee and faculty professions during the case conferences better prepares trainees to work with other professions and supports all participants to work and communicate as a team.

CoE staff have assessed educational outcomes before and after attendance in PACT ICU. On average, trainees (n = 30) said they found the PACT ICU case conferences to be “very helpful” in developing treatment plans. 

Interprofessional Collaboration

Team building and colocating trainees, faculty, and clinic staff from different professions are a primary focus of PACT ICU. The case conferences are designed to break down silos and foster a team approach to care. Trainees learn how the team works and the ways other professionals can help them take care of the patient. For example, trainees learn early about the contributions and expertise that the pharmacist and psychologist offer in terms of their scope of practice and referral opportunities. Additionally, the RN care manager increases the integration with the PACT clinical team by sharing pertinent information on individual patients. Based on recent trainee survey findings, the CoE has observed a positive change in the team dynamic and trainee ability to interface between professions. PACT ICU participants were more likely to make referrals to other members within the PACT team, such as a warm handoff during a clinic appointment, while they were less likely to seek a consult outside the team.⁷

Clinical Performance

The PACT ICU is an opportunity for a trainee to increase clinical expertise. It provides exposure to a variety of patientsand their care needs and serves as an opportunity to present a high-risk, challenging patient to colleagues of various professions. As of June 2018, 96 physician resident and NP residents have presented complex patient cases.

In addition, a structured forum for discussing patients and their care options strengthens team clinical performance, which supports people to work to the full scope of their practice. Trainees learn and apply team skills, such as communication and the warm handoff.

An interprofessional care plan that is delineated during the meeting supports the trainee and is carried out with help from consultants as needed. These consultants often facilitate plans for a covisit or warm handoff at the next clinic visit, a call from the RN care manager, a virtual clinic appointment, or other nontraditional visits. The clinic staff can get information from PCPs about patient’s plan of care, and PCPs get a more complete picture of a patient’s situation (eg, history, communications, and life-style factors). In addition, surveys of PACT ICU participants suggest the curriculum’s effectiveness at encouraging use of PACT principles within the clinic team and improving appropriate referrals to other members of the PACT team, such as pharmacy and behavioral health.

Patients presented at PACT ICU can be particularly challenging, so there may be a psychological benefit to working with a team to develop a new care plan. The PCPs who feel they are overwhelmed and have exhausted every option step back, get input, and look at the patient in a new light.

Related: Interprofessional Education in Patient Aligned Care Team Primary Care-Mental Health Integration

CoEPCE Function

The PACT ICU is flexible and has been adapted to different ambulatory care settings. Currently, PACT ICU case conferences take place at Boise VAMC, the Caldwell CBOCs, and more recently at a smaller CBOC in Burns, Oregon. The PACT ICU structure is slightly different in the clinic settings since the VA primary care clinic has different resources to draw upon, such as hospital and specialty services. The Caldwell CBOC was unable to protect time for PCPs, so it holds a monthly PACT ICU case conference. In addition to continuing expansion in other nonacademic PACT clinics and collaboration with other CoEPCE sites, work is underway to disseminate generalizable principles for interprofessional education, as well as exporting the model for implementation in non-VA settings.

Primary Care Services

The PACT ICU has the potential to create efficiencies in busy clinic settings. It strengthens communication between PCPs and is an opportunity to touch base on the patient, delegate care, and keep track of high-risk patients who might otherwise receive attention only when having an acute problem. Nurses gain a deeper understanding of the patients presented at PACT ICU.

PACT ICU leverages and builds on existing PACT resources in an achievable and sustainable manner benefiting primary care. CoE trainees, who are part of the Silver Team, tap in to the information that team nurses gain from checking in with these high-risk patients biweekly. Moreover, the integration with the Silver Team improves continuity, which helps enhance a patient’s level of trust. The relationship strengthened between primary care and behavioral health at the Caldwell CBOC, providing improved patient access and increased professional sharing.

Patient Outcomes

The PACT ICU provides a forum for input beyond that of the PCP. This feature results in a more robust treatment plan than might be developed by individual PCPs who might not have time to consider options that are outside their scope of practice. Formulating an enriched care plan, informed by multiple professions, has the potential to improve utilization and provide better care.

The Boise VAMC PACT ICU has presented 219 patients as of June 2018. While clinical outcomes data are difficult to collect, the CoE has data on utilization differences on all patients presented at the PACT ICU case conferences. This includes 4 control patients from the same PCP, with similarly high risk based on CAN scores at the time of selection. A single control patient is selected based on gender, closest age, and CAN score; this serves as a comparator for subsequent utilization analysis.

Data from the first 2 years of this study demonstrate that compared with the high-risk control group, there was an increase in contacts with PACT team members, including behavioral health, clinical pharmacists, and nurse care management, persisting up to 6 months following the PACT ICU presentation.⁴ However, PACT ICU participation did not increase the number of visits with the PCP, indicating better engagement with the entire team. Participation was associated with significantly decreased hospitalizations and a trend toward decreased ED visits. These findings persisted when compared with controls in the PCP’s panel with similar CAN scores, making “regression to the mean” often seen in these studies much less likely.

Analysis of patients early in the project suggests the possibility of improved glycemic control in patients with DM and improved blood pressure control in hypertensive patients presented at the PACT ICU compared with that of non-PACT ICU patients.⁸ Another potential benefit includes better team-based coordination. Because the patient now has a team focusing on care, this new dynamic results in improving outreach, identifying patients who could receive care by a telephone, and better preparing team members to establish rapport when the patient calls or comes in for a visit.

The Future

In stage 2 of the CoEPCE program, a multi-site trial of PACT ICU was completed to better understand which elements are critical to success, with the goal of facilitating broader exportability.⁵ The trial focused on 3 intertwined elements: structure, delivery, and evaluation. Using local implementation and the multisite trial, the most effective practices have been documented as part of an implementation kit, available at boisevacoe.org. The goal of the implementation kit is to facilitate step-by-step implementation of PACT ICU to other settings beyond the multisite study. Since the open-ended structure of PACT ICU enables accommodating different professions and specialties beyond the model’s Boise VAMC participants, it could be easily adapted to potentially support a variety of implementations elsewhere (Appendix).

Another opportunity for expansion is increased patient involvement. Currently, PACT ICU patients have the opportunity to review and ask questions about their multidisciplinary care plans before starting. 

The evaluation of acute kidney injury (AKI) often starts with the classic prerenal, renal, and postrenal causalities, delineating a practical workable approach in its differential diagnosis. Accordingly, the history, physical examination, urinalysis, and kidney-bladder sonography are standard resources in the initial approach to renal disease assessment. Ultrasonography has a well-established role as an important adjuvant for postrenal diagnosis of renal failure. Nevertheless, most of the causes of AKI are prerenal and renal.

Some etiologies of kidney injury are sequelae of systemic diseases in which sonography can be diagnostically analogous to the history and physical examination. Furthermore, ultrasonography may be informative in various clinical scenarios, for example, patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). In this narrative review, the contribution of point-of-care (POC) sonography to the evaluation and management of AKI, CKD, and associated diseases are explored beyond the traditional sonogram uses for kidney biopsy, central catheter placement, and/or screening of hydronephrosis.

Two important elements made possible the incorporation of POC sonography into nephrology practice.^1,2 First, the development of handheld reliable and portable ultrasound devices and, second, the derived capacity of POC sonography to obtain objective signs of physiologic and/or pathophysiologic phenomena. The latter clinical application is realized through the incorporation of POC protocols into the modified focused assessment with sonography for trauma (FAST) examination in conjunction with limited echocardiography and lung sonography (Figure 1). 

These protocols have allowed the evaluation of extracellular volume, which is important to measure for the diagnosis and management of renal diseases. For example, the evaluation of lung water by POC ultrasonography for patients with ESRD is emerging as a promising tool. In a study of patients with ESRD undergoing hemodialysis, POC ultrasonography detected moderate-to-severe lung congestion in 45% of patients, most of whom (71%) were asymptomatic. Two years of follow-up of patients was associated with 3 to 4 times greater risk of heart attack and death, respectively, compared with individuals without congestion on sonography.^4-6 Thus, ultrasound assessment of lung water in patients with ESRD may prove to be an essential tool to assure an adequate ultrafiltration and improve patient outcomes.

Related: Nephrogenic Systemic Fibrosis in a Patient With Multiple Inflammatory Disorders

Acute Kidney Injury

Prerenal

The physical examination provides evaluation of effective arterial circulatory flow (EACF) and is clinically useful in the evaluation of prerenal azotemia. The utility is more obvious in the extremes of EACF. However, in the case of blood volume losses of > 10% or the physiologic equivalent, heart rate, blood pressure, skin turgor, urinary output, and capillary refill may be within normal limits. Obvious changes in these parameters during the physical examination are considered relatively late manifestations.^7-10 Therefore, prerenal failure is frequently diagnosed retrospectively after correction of the EACF through use of crystalloids, blood products, vasopressors, inotropic agents, discontinuation of antihypertensive agents, or treatment of its prerenal causes. Certain sonographic maneuvers, performed at the bedside during acute renal injury, may be useful in many patients to evaluate a multitude of prerenal causes of AKI.

Sonographic inferior vena cava (IVC) luminal diameter and inspiratory collapsibility together serve as a surrogate marker of preload venous return and right side heart function. Such imaging results have been shown to be more accurate than jugular venous distension on physical examination but only modestly helpful as a surrogate for central venous pressure (CVP), with more accuracy in the lower values of the CVP.¹¹ However, this procedure can be repeated often after volume resuscitation to achieve a 1.5- to 2.5-cm diameter dimension of the IVC and < 25% inspiratory collapsibility as a goal.

An IVC with a diameter > 2.5 cm in the context of a suspected prerenal AKI is more likely the consequence of heart failure (HF) rather than hypovolemia. The caveat to this finding is that pulmonary hypertension may induce false-positive results.^12,13 Hepatic vein dilation is another sign of HF and/or pulmonary hypertension. Furthermore, sonographic images of the left ventricle either from the parasternal long axis or subxiphoid approach can identify supranormal left ventricular ejection fraction (LVEF) or hyperdynamic heart as an important clue of the absolute or relative decrease of EACF.¹⁴ Conversely, a decrease in EACF in patients with low LVEF can be assessed qualitatively at the bedside in patients with systolic HF. Supporting evidence of prerenal azotemia as the result of HF can be suggested by the presence of pleural effusions and bilateral comet/rockets tails or B lines in lung sonography.¹⁵

The easily recognizable hypoechoic ascitic fluid in the presence of small, hyperechoic gross changes in the echocardiographic texture of liver may indicate a hepatorenal component as the cause of prerenal failure. A small increase of > 20% in the diameter of the portal vein with deep inspiration indicates portal hypertension, with a sensitivity of 80% and a specificity of 100%.^15,16 Other clinical scenarios leading to AKI in association with systemic hypotension may be identified quickly with the aid of POC sonography. These scenarios include cardiac tamponade, tension pneumothorax, right ventricular dysfunction (as a surrogate of pulmonary embolism), or an acute coronary event.^16,17 Alternatively, identifying the presence of severe left ventricular hypertrophy through POC ultrasonography in a patient with AKI and normal or low normal blood pressures may alert clinicians to the diagnosis of normotensive renal failure in individuals with previously unrecognized severe hypertension. In this clinical context, keeping mean arterial pressures higher than usual with vasopressors may improve renal function while decreasing dialysis utilization.^18-21

Likewise, in clinical scenarios of shock with AKI, POC ultrasonography has proven to be an indispensable tool. For example, rapid exploration of the biliary tree demonstrating anterior gallbladder wall thickening, a stone or sludge, common bile duct dilation, or perigallbladder inflammation suggests acute cholecystitis and/or cholangitis as the cause. The presence of dyspnea in association with hypotension and unilateral signs of a higher proportion of comet tails and/or a lung consolidation suggests pneumonia. Rapid differentiation between acute respiratory distress syndrome (ARDS) and pulmonary edema from HF is possible with ultrasonography. When pleural line abnormalities are seen, ARDS is a common cause.

POC ultrasonography will be key in management of ARDS, as ultrasound results will help avoid the use of excessive diuretics, which can result in renal hypoperfusion and AKI.²² In trauma patients, the ultrasound examination will identify free fluid (bleeding) as the source of the prerenal failure, along with its cause (aortic dissection, hepatic hemorrhage, splenic hemorrhage, ectopic pregnancy, etc).²³ Sonographic free air observed in the abdomen can provide the clue of a perforated viscus.²⁴ The sonographic image of an inflamed pancreas can suggest pancreatitis as the cause of the systemic hypotension. Ultimately, intravascular losses in the hypoechoic edematous bowel wall in obstruction, ileus, pseudomembranous, or infectious or autoimmune enterocolitis can lead to significant decreases in the EACF and cause prerenal injury.

Related: Prevalence of Suspicious Ultrasound Features in Hot Thyroid Nodules

Intrinsic Renal Disease

In intrinsic AKI, acute tubular necrosis (ATN), glomerulonephritis, and interstitial nephritis are the typical causes. Although no signs are specific to each of the potential causes, a poor corticomedullary differentiation, kidney size < 9 cm, and cortex size < 1 cm help to distinguish CKD from AKI, especially if no previous serum creatinine values are available. The early diagnosis of ATN continues to be clinically relevant in the management of acute renal failure. Despite not being a practical tool for POC sonography currently, the use of bedside Doppler repetitive renal vasculature measures of resistive index predict occurrence and severity of ATN in the critical care setting and are an independent risk factor for poor survival in arterial hypertension and HF.^25-30

Other POC sonographic evaluations of intrinsic AKI have been helpful in the following clinical scenarios. The presence of an ultrasonographic sign of sinusitis in the context of nephritic sediment and a rapid decline of renal function suggest antineutrophil cytoplasmic antibody (ANCA)-related vasculitis. Likewise, in younger adults, nephritic sediment and bilateral sonographic lung interstitial fluid in the absence of infection and a normal POC echocardiogram without significant edema elsewhere suggest glomerulonephritis in the category of pulmonary lung syndrome caused by antiglomerular basement membrane antibodies.

In the elderly, a similar systemic presentation suggests an ANCA vasculitis. Pleural effusion, synovitis, proteinuria, and/or hematuria will suggest lupus nephritis. Another important cause of acute renal failure in the critical care setting is intra-abdominal compartment syndrome. Here, bladder pressure measurement protocols are the standard of care. A human model evaluated the predictive value of intra-abdominal compartment syndrome pressures using the IVC square surface. In this study, a normal surface area of the IVC of > 1 cm²/m² excluded the presence of intra-abdominal hypertension 87.5% of the time. However, the sensitivity of detection of the intra-abdominal hypertension was only 67.5% when the surface area of the IVC was < 1 cm²/m².³¹

CKD and Associated Diseases

The diagnostic validity of ultrasonography is well established in adult-onset polycystic kidney disease. Bedside visualization of a parathyroid adenoma may be an important clue for a patient with CKD, echogenic kidneys, or nephrolithiasis with or without hypercalcemia to diagnose primary hyperparathyroidism. The sonographic diagnosis of abnormal parathyroid gland compared with parathyroid surgical exploration had a sensitivity, specificity, and positive predictive value of 74%, 96%, and 90%, respectively.³² In the clinical presentation of severe hypertension with headaches, ultrasonography at bedside can provide valuable diagnostic and risk assessment information of endocranial hypertension from measuring the optic nerve sheath. Sensitivity and specificity of papilledema was 90% and 79%, respectively, when 3.3 mm was the cutoff of the nerve sheath with a 30-degrees sign.³³ The carotid artery intima media thickness measured on sonography correlates with the future development of atherogenesis, left ventricular hypertrophy, cognition deficits, CKD, and cardiovascular disease in asymptomatic patients. An intima media thickness of > 1.1 mm has been associated with a higher cardiovascular mortality.

Early initiation of antihypertensive medications and/or statins has been suggested to lower risk in these asymptomatic patients.³⁴ The size and contour (smooth or irregular) of kidneys may provide clues to reflux nephropathy, dysplastic kidneys, radiation nephritis, or chronic pyelonephritis. The presence of nephrotic syndrome and abnormal free light chains ratio with a bedside echocardiogram showing the typical refractile myocardial walls with a peculiar speckled pattern is strongly suggestive of amyloidosis.³⁵ Conditions associated with chronic hypercalcemia, medullary sponge kidney, milk alkali syndrome, sarcoidosis, and distal renal tubular acidosis are causes of nephrocalcinosis. Some degree of CKD is a constant feature in nephrocalcinosis. The initial imaging of choice in nephrocalcinosis and specially the medullary type is ultrasonography preferable to X-ray and perhaps to computed tomography.³⁶

End-Stage Renal Disease

In a patient undergoing peritoneal dialysis with exit-site infection, the presence of > 1 mm radiolucent rim around the subcutaneous catheter after antibiotics has a bad prognosis and prompts catheter removal. This sonographic sign has a positive and negative predictive value for a tunneled infection of 84.6% and 94.1%, respectively.^37,38 A risk factor for peritonitis in peritoneal dialysis is air in the peritoneum, which can be seen in one-third of patients. These individuals have 2.4 times more risk of peritonitis compared with patients without pneumoperitoneum. The sensitivity and specificity of sonographic detection of pneumoperitoneum is 94% and 100%, respectively, using the scissor technique.³⁹ Proper training in performing home peritoneal dialysis decreases the incidence of pneumoperitoneum. Although not formally assessed, patient education and change in procedure techniques may decrease the incidence of pneumoperitoneum and peritonitis. The use of prelaparoscopic ultrasonography before insertion of the peritoneal dialysis catheter has detected intra-abdominal adhesions (visceral slide sign) with a sensitivity of 90% to 92%.⁴⁰

History and physical examination are frequently helpful in the diagnosis of malfunctioning arteriovenous fistulas (AVF) for inflow or outflow disturbances, with sensitivity ranging from 70% to 100% and specificity ranging from 71% to 93% compared with angiography. Frequently, POC limited ultrasound can be helpful for a problematic AVF, either for cannulation or diagnosis. The congruence of duplex sonography with arteriogram is 85% to 96%. Various etiologies of a dysfunctional AVF (pseudo- or true aneurysm, poor development, stenosis, thrombi, or accessory veins) can be observed in the dialysis unit through limited sonography.^41-44

After placement of a hemodialysis catheter using real-time ultrasonography, pneumohemothorax can be diagnosed reliably and rapidly. Catheter misplacement outside of the right atrium was detected by thoracic echocardiogram with a sensitivity of 96%, a specificity of 83%, and a positive predictive value of 98%.^45,46 Ultimately, ultrasonography may replace chest X-ray in most cases after central vein dialysis catheter placement in the acute care setting.

Postrenal Failure

The sensitivity of ultrasonography to detect dilation to hydronephrosis of the pelvicaliceal system is well established. Sonography is the diagnostic examination of choice in pregnancy and the initial screening test for the nonpregnant patient. Computed tomography is the preferred imaging study in nephroureterolithiasis; however, due to ionizing radiation and cost, ultrasonography is gaining popularity for initial and/or follow-up evaluations. The ureteral jet is a relatively unexplored color and Doppler sonographic methodology that can provide insight into pelvicalyceal peristalsis, potentially yielding evidence of functional obstruction.^47-51 Postvoid bladder residual volumes and bladder wall hypertrophy may provide important clues as to the cause(s) of the obstructive uropathy.

Telenephrology

In our institution, sonography is used in the evaluation of IVC, lungs, and kidneys via telemedicine. The probe is handled by trained nurses at the distant site. 

Cardiac Arrest in ESRD

Patients with ESRD may have sudden cardiac arrest as a result of several etiologies. During the advance cardiac life support algorithm, there is a brief period of evaluation of the electrical rhythm in which echocardiography can be helpful with the diagnosis immediately after the 2 initial minutes of cardiopulmonary resuscitation. An enlarged right ventricular cavity (> 2/3 of the left ventricle) is a sonographic sign of a pulmonary embolism.

Bedside sonography has the potential to alter the current guidelines of advance cardiac life support management. For example, if the bedside echo shows a significant pericardial effusion, a pericardiocentesis could be performed faster as it would be diagnosed faster. In addition, at times the heart may appear to be beating rapidly but there is a small amount of fluid (blood) within the cardiac chambers. This may be from an extreme case of dehydration for which rapid administration of IV fluids may help manage. Therefore, a quick bedside point of care echocardiography may reveal a cardiac anomaly that may be able to be restored in a efficient manner. 

Related: General Applications of Ultrasound in Rheumatology Practice

Conclusion

Ultrasonography at the POC provides an important and continuously expanding tool to improve nephrological diagnostic accuracy in concert with history and physical examination. Extracellular fluid evaluation is paramount in all kidney disease conditions. Recent clinical studies in lung ultrasonography suggest that the learning curve for the medical provider is quicker than with other organs. Because POC sonography in association with limited bedside echocardiography may reveal discriminatory signs of pneumonia and differentiate between cardiogenic vs noncardiogenic pulmonary edema, such imaging may be important cost-effective strategies in the management of dyspnea and in the categorization/etiology of AKI. Therefore, incorporation of POC sonography into clinical practice will require that medical schools, residency programs, and nephrology fellowship programs design teaching strategies within their respective curricula. Research studies with outcomes regarding diagnosis, morbidity, and mortality are necessary in these areas.

The evaluation of acute kidney injury (AKI) often starts with the classic prerenal, renal, and postrenal causalities, delineating a practical workable approach in its differential diagnosis. Accordingly, the history, physical examination, urinalysis, and kidney-bladder sonography are standard resources in the initial approach to renal disease assessment. Ultrasonography has a well-established role as an important adjuvant for postrenal diagnosis of renal failure. Nevertheless, most of the causes of AKI are prerenal and renal.

Some etiologies of kidney injury are sequelae of systemic diseases in which sonography can be diagnostically analogous to the history and physical examination. Furthermore, ultrasonography may be informative in various clinical scenarios, for example, patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). In this narrative review, the contribution of point-of-care (POC) sonography to the evaluation and management of AKI, CKD, and associated diseases are explored beyond the traditional sonogram uses for kidney biopsy, central catheter placement, and/or screening of hydronephrosis.

Two important elements made possible the incorporation of POC sonography into nephrology practice.^1,2 First, the development of handheld reliable and portable ultrasound devices and, second, the derived capacity of POC sonography to obtain objective signs of physiologic and/or pathophysiologic phenomena. The latter clinical application is realized through the incorporation of POC protocols into the modified focused assessment with sonography for trauma (FAST) examination in conjunction with limited echocardiography and lung sonography (Figure 1). 

These protocols have allowed the evaluation of extracellular volume, which is important to measure for the diagnosis and management of renal diseases. For example, the evaluation of lung water by POC ultrasonography for patients with ESRD is emerging as a promising tool. In a study of patients with ESRD undergoing hemodialysis, POC ultrasonography detected moderate-to-severe lung congestion in 45% of patients, most of whom (71%) were asymptomatic. Two years of follow-up of patients was associated with 3 to 4 times greater risk of heart attack and death, respectively, compared with individuals without congestion on sonography.^4-6 Thus, ultrasound assessment of lung water in patients with ESRD may prove to be an essential tool to assure an adequate ultrafiltration and improve patient outcomes.

Related: Nephrogenic Systemic Fibrosis in a Patient With Multiple Inflammatory Disorders

Acute Kidney Injury

Prerenal

The physical examination provides evaluation of effective arterial circulatory flow (EACF) and is clinically useful in the evaluation of prerenal azotemia. The utility is more obvious in the extremes of EACF. However, in the case of blood volume losses of > 10% or the physiologic equivalent, heart rate, blood pressure, skin turgor, urinary output, and capillary refill may be within normal limits. Obvious changes in these parameters during the physical examination are considered relatively late manifestations.^7-10 Therefore, prerenal failure is frequently diagnosed retrospectively after correction of the EACF through use of crystalloids, blood products, vasopressors, inotropic agents, discontinuation of antihypertensive agents, or treatment of its prerenal causes. Certain sonographic maneuvers, performed at the bedside during acute renal injury, may be useful in many patients to evaluate a multitude of prerenal causes of AKI.

Sonographic inferior vena cava (IVC) luminal diameter and inspiratory collapsibility together serve as a surrogate marker of preload venous return and right side heart function. Such imaging results have been shown to be more accurate than jugular venous distension on physical examination but only modestly helpful as a surrogate for central venous pressure (CVP), with more accuracy in the lower values of the CVP.¹¹ However, this procedure can be repeated often after volume resuscitation to achieve a 1.5- to 2.5-cm diameter dimension of the IVC and < 25% inspiratory collapsibility as a goal.

An IVC with a diameter > 2.5 cm in the context of a suspected prerenal AKI is more likely the consequence of heart failure (HF) rather than hypovolemia. The caveat to this finding is that pulmonary hypertension may induce false-positive results.^12,13 Hepatic vein dilation is another sign of HF and/or pulmonary hypertension. Furthermore, sonographic images of the left ventricle either from the parasternal long axis or subxiphoid approach can identify supranormal left ventricular ejection fraction (LVEF) or hyperdynamic heart as an important clue of the absolute or relative decrease of EACF.¹⁴ Conversely, a decrease in EACF in patients with low LVEF can be assessed qualitatively at the bedside in patients with systolic HF. Supporting evidence of prerenal azotemia as the result of HF can be suggested by the presence of pleural effusions and bilateral comet/rockets tails or B lines in lung sonography.¹⁵

The easily recognizable hypoechoic ascitic fluid in the presence of small, hyperechoic gross changes in the echocardiographic texture of liver may indicate a hepatorenal component as the cause of prerenal failure. A small increase of > 20% in the diameter of the portal vein with deep inspiration indicates portal hypertension, with a sensitivity of 80% and a specificity of 100%.^15,16 Other clinical scenarios leading to AKI in association with systemic hypotension may be identified quickly with the aid of POC sonography. These scenarios include cardiac tamponade, tension pneumothorax, right ventricular dysfunction (as a surrogate of pulmonary embolism), or an acute coronary event.^16,17 Alternatively, identifying the presence of severe left ventricular hypertrophy through POC ultrasonography in a patient with AKI and normal or low normal blood pressures may alert clinicians to the diagnosis of normotensive renal failure in individuals with previously unrecognized severe hypertension. In this clinical context, keeping mean arterial pressures higher than usual with vasopressors may improve renal function while decreasing dialysis utilization.^18-21

Likewise, in clinical scenarios of shock with AKI, POC ultrasonography has proven to be an indispensable tool. For example, rapid exploration of the biliary tree demonstrating anterior gallbladder wall thickening, a stone or sludge, common bile duct dilation, or perigallbladder inflammation suggests acute cholecystitis and/or cholangitis as the cause. The presence of dyspnea in association with hypotension and unilateral signs of a higher proportion of comet tails and/or a lung consolidation suggests pneumonia. Rapid differentiation between acute respiratory distress syndrome (ARDS) and pulmonary edema from HF is possible with ultrasonography. When pleural line abnormalities are seen, ARDS is a common cause.

POC ultrasonography will be key in management of ARDS, as ultrasound results will help avoid the use of excessive diuretics, which can result in renal hypoperfusion and AKI.²² In trauma patients, the ultrasound examination will identify free fluid (bleeding) as the source of the prerenal failure, along with its cause (aortic dissection, hepatic hemorrhage, splenic hemorrhage, ectopic pregnancy, etc).²³ Sonographic free air observed in the abdomen can provide the clue of a perforated viscus.²⁴ The sonographic image of an inflamed pancreas can suggest pancreatitis as the cause of the systemic hypotension. Ultimately, intravascular losses in the hypoechoic edematous bowel wall in obstruction, ileus, pseudomembranous, or infectious or autoimmune enterocolitis can lead to significant decreases in the EACF and cause prerenal injury.

Related: Prevalence of Suspicious Ultrasound Features in Hot Thyroid Nodules

Intrinsic Renal Disease

In intrinsic AKI, acute tubular necrosis (ATN), glomerulonephritis, and interstitial nephritis are the typical causes. Although no signs are specific to each of the potential causes, a poor corticomedullary differentiation, kidney size < 9 cm, and cortex size < 1 cm help to distinguish CKD from AKI, especially if no previous serum creatinine values are available. The early diagnosis of ATN continues to be clinically relevant in the management of acute renal failure. Despite not being a practical tool for POC sonography currently, the use of bedside Doppler repetitive renal vasculature measures of resistive index predict occurrence and severity of ATN in the critical care setting and are an independent risk factor for poor survival in arterial hypertension and HF.^25-30

Other POC sonographic evaluations of intrinsic AKI have been helpful in the following clinical scenarios. The presence of an ultrasonographic sign of sinusitis in the context of nephritic sediment and a rapid decline of renal function suggest antineutrophil cytoplasmic antibody (ANCA)-related vasculitis. Likewise, in younger adults, nephritic sediment and bilateral sonographic lung interstitial fluid in the absence of infection and a normal POC echocardiogram without significant edema elsewhere suggest glomerulonephritis in the category of pulmonary lung syndrome caused by antiglomerular basement membrane antibodies.

In the elderly, a similar systemic presentation suggests an ANCA vasculitis. Pleural effusion, synovitis, proteinuria, and/or hematuria will suggest lupus nephritis. Another important cause of acute renal failure in the critical care setting is intra-abdominal compartment syndrome. Here, bladder pressure measurement protocols are the standard of care. A human model evaluated the predictive value of intra-abdominal compartment syndrome pressures using the IVC square surface. In this study, a normal surface area of the IVC of > 1 cm²/m² excluded the presence of intra-abdominal hypertension 87.5% of the time. However, the sensitivity of detection of the intra-abdominal hypertension was only 67.5% when the surface area of the IVC was < 1 cm²/m².³¹

CKD and Associated Diseases

The diagnostic validity of ultrasonography is well established in adult-onset polycystic kidney disease. Bedside visualization of a parathyroid adenoma may be an important clue for a patient with CKD, echogenic kidneys, or nephrolithiasis with or without hypercalcemia to diagnose primary hyperparathyroidism. The sonographic diagnosis of abnormal parathyroid gland compared with parathyroid surgical exploration had a sensitivity, specificity, and positive predictive value of 74%, 96%, and 90%, respectively.³² In the clinical presentation of severe hypertension with headaches, ultrasonography at bedside can provide valuable diagnostic and risk assessment information of endocranial hypertension from measuring the optic nerve sheath. Sensitivity and specificity of papilledema was 90% and 79%, respectively, when 3.3 mm was the cutoff of the nerve sheath with a 30-degrees sign.³³ The carotid artery intima media thickness measured on sonography correlates with the future development of atherogenesis, left ventricular hypertrophy, cognition deficits, CKD, and cardiovascular disease in asymptomatic patients. An intima media thickness of > 1.1 mm has been associated with a higher cardiovascular mortality.

Early initiation of antihypertensive medications and/or statins has been suggested to lower risk in these asymptomatic patients.³⁴ The size and contour (smooth or irregular) of kidneys may provide clues to reflux nephropathy, dysplastic kidneys, radiation nephritis, or chronic pyelonephritis. The presence of nephrotic syndrome and abnormal free light chains ratio with a bedside echocardiogram showing the typical refractile myocardial walls with a peculiar speckled pattern is strongly suggestive of amyloidosis.³⁵ Conditions associated with chronic hypercalcemia, medullary sponge kidney, milk alkali syndrome, sarcoidosis, and distal renal tubular acidosis are causes of nephrocalcinosis. Some degree of CKD is a constant feature in nephrocalcinosis. The initial imaging of choice in nephrocalcinosis and specially the medullary type is ultrasonography preferable to X-ray and perhaps to computed tomography.³⁶

End-Stage Renal Disease

In a patient undergoing peritoneal dialysis with exit-site infection, the presence of > 1 mm radiolucent rim around the subcutaneous catheter after antibiotics has a bad prognosis and prompts catheter removal. This sonographic sign has a positive and negative predictive value for a tunneled infection of 84.6% and 94.1%, respectively.^37,38 A risk factor for peritonitis in peritoneal dialysis is air in the peritoneum, which can be seen in one-third of patients. These individuals have 2.4 times more risk of peritonitis compared with patients without pneumoperitoneum. The sensitivity and specificity of sonographic detection of pneumoperitoneum is 94% and 100%, respectively, using the scissor technique.³⁹ Proper training in performing home peritoneal dialysis decreases the incidence of pneumoperitoneum. Although not formally assessed, patient education and change in procedure techniques may decrease the incidence of pneumoperitoneum and peritonitis. The use of prelaparoscopic ultrasonography before insertion of the peritoneal dialysis catheter has detected intra-abdominal adhesions (visceral slide sign) with a sensitivity of 90% to 92%.⁴⁰

History and physical examination are frequently helpful in the diagnosis of malfunctioning arteriovenous fistulas (AVF) for inflow or outflow disturbances, with sensitivity ranging from 70% to 100% and specificity ranging from 71% to 93% compared with angiography. Frequently, POC limited ultrasound can be helpful for a problematic AVF, either for cannulation or diagnosis. The congruence of duplex sonography with arteriogram is 85% to 96%. Various etiologies of a dysfunctional AVF (pseudo- or true aneurysm, poor development, stenosis, thrombi, or accessory veins) can be observed in the dialysis unit through limited sonography.^41-44

After placement of a hemodialysis catheter using real-time ultrasonography, pneumohemothorax can be diagnosed reliably and rapidly. Catheter misplacement outside of the right atrium was detected by thoracic echocardiogram with a sensitivity of 96%, a specificity of 83%, and a positive predictive value of 98%.^45,46 Ultimately, ultrasonography may replace chest X-ray in most cases after central vein dialysis catheter placement in the acute care setting.

Postrenal Failure

The sensitivity of ultrasonography to detect dilation to hydronephrosis of the pelvicaliceal system is well established. Sonography is the diagnostic examination of choice in pregnancy and the initial screening test for the nonpregnant patient. Computed tomography is the preferred imaging study in nephroureterolithiasis; however, due to ionizing radiation and cost, ultrasonography is gaining popularity for initial and/or follow-up evaluations. The ureteral jet is a relatively unexplored color and Doppler sonographic methodology that can provide insight into pelvicalyceal peristalsis, potentially yielding evidence of functional obstruction.^47-51 Postvoid bladder residual volumes and bladder wall hypertrophy may provide important clues as to the cause(s) of the obstructive uropathy.

Telenephrology

In our institution, sonography is used in the evaluation of IVC, lungs, and kidneys via telemedicine. The probe is handled by trained nurses at the distant site. 

Cardiac Arrest in ESRD

Patients with ESRD may have sudden cardiac arrest as a result of several etiologies. During the advance cardiac life support algorithm, there is a brief period of evaluation of the electrical rhythm in which echocardiography can be helpful with the diagnosis immediately after the 2 initial minutes of cardiopulmonary resuscitation. An enlarged right ventricular cavity (> 2/3 of the left ventricle) is a sonographic sign of a pulmonary embolism.

Bedside sonography has the potential to alter the current guidelines of advance cardiac life support management. For example, if the bedside echo shows a significant pericardial effusion, a pericardiocentesis could be performed faster as it would be diagnosed faster. In addition, at times the heart may appear to be beating rapidly but there is a small amount of fluid (blood) within the cardiac chambers. This may be from an extreme case of dehydration for which rapid administration of IV fluids may help manage. Therefore, a quick bedside point of care echocardiography may reveal a cardiac anomaly that may be able to be restored in a efficient manner. 

Related: General Applications of Ultrasound in Rheumatology Practice

Conclusion

Ultrasonography at the POC provides an important and continuously expanding tool to improve nephrological diagnostic accuracy in concert with history and physical examination. Extracellular fluid evaluation is paramount in all kidney disease conditions. Recent clinical studies in lung ultrasonography suggest that the learning curve for the medical provider is quicker than with other organs. Because POC sonography in association with limited bedside echocardiography may reveal discriminatory signs of pneumonia and differentiate between cardiogenic vs noncardiogenic pulmonary edema, such imaging may be important cost-effective strategies in the management of dyspnea and in the categorization/etiology of AKI. Therefore, incorporation of POC sonography into clinical practice will require that medical schools, residency programs, and nephrology fellowship programs design teaching strategies within their respective curricula. Research studies with outcomes regarding diagnosis, morbidity, and mortality are necessary in these areas.

The evaluation of acute kidney injury (AKI) often starts with the classic prerenal, renal, and postrenal causalities, delineating a practical workable approach in its differential diagnosis. Accordingly, the history, physical examination, urinalysis, and kidney-bladder sonography are standard resources in the initial approach to renal disease assessment. Ultrasonography has a well-established role as an important adjuvant for postrenal diagnosis of renal failure. Nevertheless, most of the causes of AKI are prerenal and renal.

Some etiologies of kidney injury are sequelae of systemic diseases in which sonography can be diagnostically analogous to the history and physical examination. Furthermore, ultrasonography may be informative in various clinical scenarios, for example, patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). In this narrative review, the contribution of point-of-care (POC) sonography to the evaluation and management of AKI, CKD, and associated diseases are explored beyond the traditional sonogram uses for kidney biopsy, central catheter placement, and/or screening of hydronephrosis.

Two important elements made possible the incorporation of POC sonography into nephrology practice.^1,2 First, the development of handheld reliable and portable ultrasound devices and, second, the derived capacity of POC sonography to obtain objective signs of physiologic and/or pathophysiologic phenomena. The latter clinical application is realized through the incorporation of POC protocols into the modified focused assessment with sonography for trauma (FAST) examination in conjunction with limited echocardiography and lung sonography (Figure 1). 

These protocols have allowed the evaluation of extracellular volume, which is important to measure for the diagnosis and management of renal diseases. For example, the evaluation of lung water by POC ultrasonography for patients with ESRD is emerging as a promising tool. In a study of patients with ESRD undergoing hemodialysis, POC ultrasonography detected moderate-to-severe lung congestion in 45% of patients, most of whom (71%) were asymptomatic. Two years of follow-up of patients was associated with 3 to 4 times greater risk of heart attack and death, respectively, compared with individuals without congestion on sonography.^4-6 Thus, ultrasound assessment of lung water in patients with ESRD may prove to be an essential tool to assure an adequate ultrafiltration and improve patient outcomes.

Related: Nephrogenic Systemic Fibrosis in a Patient With Multiple Inflammatory Disorders

Acute Kidney Injury

Prerenal

The physical examination provides evaluation of effective arterial circulatory flow (EACF) and is clinically useful in the evaluation of prerenal azotemia. The utility is more obvious in the extremes of EACF. However, in the case of blood volume losses of > 10% or the physiologic equivalent, heart rate, blood pressure, skin turgor, urinary output, and capillary refill may be within normal limits. Obvious changes in these parameters during the physical examination are considered relatively late manifestations.^7-10 Therefore, prerenal failure is frequently diagnosed retrospectively after correction of the EACF through use of crystalloids, blood products, vasopressors, inotropic agents, discontinuation of antihypertensive agents, or treatment of its prerenal causes. Certain sonographic maneuvers, performed at the bedside during acute renal injury, may be useful in many patients to evaluate a multitude of prerenal causes of AKI.

Sonographic inferior vena cava (IVC) luminal diameter and inspiratory collapsibility together serve as a surrogate marker of preload venous return and right side heart function. Such imaging results have been shown to be more accurate than jugular venous distension on physical examination but only modestly helpful as a surrogate for central venous pressure (CVP), with more accuracy in the lower values of the CVP.¹¹ However, this procedure can be repeated often after volume resuscitation to achieve a 1.5- to 2.5-cm diameter dimension of the IVC and < 25% inspiratory collapsibility as a goal.

An IVC with a diameter > 2.5 cm in the context of a suspected prerenal AKI is more likely the consequence of heart failure (HF) rather than hypovolemia. The caveat to this finding is that pulmonary hypertension may induce false-positive results.^12,13 Hepatic vein dilation is another sign of HF and/or pulmonary hypertension. Furthermore, sonographic images of the left ventricle either from the parasternal long axis or subxiphoid approach can identify supranormal left ventricular ejection fraction (LVEF) or hyperdynamic heart as an important clue of the absolute or relative decrease of EACF.¹⁴ Conversely, a decrease in EACF in patients with low LVEF can be assessed qualitatively at the bedside in patients with systolic HF. Supporting evidence of prerenal azotemia as the result of HF can be suggested by the presence of pleural effusions and bilateral comet/rockets tails or B lines in lung sonography.¹⁵

The easily recognizable hypoechoic ascitic fluid in the presence of small, hyperechoic gross changes in the echocardiographic texture of liver may indicate a hepatorenal component as the cause of prerenal failure. A small increase of > 20% in the diameter of the portal vein with deep inspiration indicates portal hypertension, with a sensitivity of 80% and a specificity of 100%.^15,16 Other clinical scenarios leading to AKI in association with systemic hypotension may be identified quickly with the aid of POC sonography. These scenarios include cardiac tamponade, tension pneumothorax, right ventricular dysfunction (as a surrogate of pulmonary embolism), or an acute coronary event.^16,17 Alternatively, identifying the presence of severe left ventricular hypertrophy through POC ultrasonography in a patient with AKI and normal or low normal blood pressures may alert clinicians to the diagnosis of normotensive renal failure in individuals with previously unrecognized severe hypertension. In this clinical context, keeping mean arterial pressures higher than usual with vasopressors may improve renal function while decreasing dialysis utilization.^18-21

Likewise, in clinical scenarios of shock with AKI, POC ultrasonography has proven to be an indispensable tool. For example, rapid exploration of the biliary tree demonstrating anterior gallbladder wall thickening, a stone or sludge, common bile duct dilation, or perigallbladder inflammation suggests acute cholecystitis and/or cholangitis as the cause. The presence of dyspnea in association with hypotension and unilateral signs of a higher proportion of comet tails and/or a lung consolidation suggests pneumonia. Rapid differentiation between acute respiratory distress syndrome (ARDS) and pulmonary edema from HF is possible with ultrasonography. When pleural line abnormalities are seen, ARDS is a common cause.

POC ultrasonography will be key in management of ARDS, as ultrasound results will help avoid the use of excessive diuretics, which can result in renal hypoperfusion and AKI.²² In trauma patients, the ultrasound examination will identify free fluid (bleeding) as the source of the prerenal failure, along with its cause (aortic dissection, hepatic hemorrhage, splenic hemorrhage, ectopic pregnancy, etc).²³ Sonographic free air observed in the abdomen can provide the clue of a perforated viscus.²⁴ The sonographic image of an inflamed pancreas can suggest pancreatitis as the cause of the systemic hypotension. Ultimately, intravascular losses in the hypoechoic edematous bowel wall in obstruction, ileus, pseudomembranous, or infectious or autoimmune enterocolitis can lead to significant decreases in the EACF and cause prerenal injury.

Related: Prevalence of Suspicious Ultrasound Features in Hot Thyroid Nodules

Intrinsic Renal Disease

In intrinsic AKI, acute tubular necrosis (ATN), glomerulonephritis, and interstitial nephritis are the typical causes. Although no signs are specific to each of the potential causes, a poor corticomedullary differentiation, kidney size < 9 cm, and cortex size < 1 cm help to distinguish CKD from AKI, especially if no previous serum creatinine values are available. The early diagnosis of ATN continues to be clinically relevant in the management of acute renal failure. Despite not being a practical tool for POC sonography currently, the use of bedside Doppler repetitive renal vasculature measures of resistive index predict occurrence and severity of ATN in the critical care setting and are an independent risk factor for poor survival in arterial hypertension and HF.^25-30

Other POC sonographic evaluations of intrinsic AKI have been helpful in the following clinical scenarios. The presence of an ultrasonographic sign of sinusitis in the context of nephritic sediment and a rapid decline of renal function suggest antineutrophil cytoplasmic antibody (ANCA)-related vasculitis. Likewise, in younger adults, nephritic sediment and bilateral sonographic lung interstitial fluid in the absence of infection and a normal POC echocardiogram without significant edema elsewhere suggest glomerulonephritis in the category of pulmonary lung syndrome caused by antiglomerular basement membrane antibodies.

In the elderly, a similar systemic presentation suggests an ANCA vasculitis. Pleural effusion, synovitis, proteinuria, and/or hematuria will suggest lupus nephritis. Another important cause of acute renal failure in the critical care setting is intra-abdominal compartment syndrome. Here, bladder pressure measurement protocols are the standard of care. A human model evaluated the predictive value of intra-abdominal compartment syndrome pressures using the IVC square surface. In this study, a normal surface area of the IVC of > 1 cm²/m² excluded the presence of intra-abdominal hypertension 87.5% of the time. However, the sensitivity of detection of the intra-abdominal hypertension was only 67.5% when the surface area of the IVC was < 1 cm²/m².³¹

CKD and Associated Diseases

The diagnostic validity of ultrasonography is well established in adult-onset polycystic kidney disease. Bedside visualization of a parathyroid adenoma may be an important clue for a patient with CKD, echogenic kidneys, or nephrolithiasis with or without hypercalcemia to diagnose primary hyperparathyroidism. The sonographic diagnosis of abnormal parathyroid gland compared with parathyroid surgical exploration had a sensitivity, specificity, and positive predictive value of 74%, 96%, and 90%, respectively.³² In the clinical presentation of severe hypertension with headaches, ultrasonography at bedside can provide valuable diagnostic and risk assessment information of endocranial hypertension from measuring the optic nerve sheath. Sensitivity and specificity of papilledema was 90% and 79%, respectively, when 3.3 mm was the cutoff of the nerve sheath with a 30-degrees sign.³³ The carotid artery intima media thickness measured on sonography correlates with the future development of atherogenesis, left ventricular hypertrophy, cognition deficits, CKD, and cardiovascular disease in asymptomatic patients. An intima media thickness of > 1.1 mm has been associated with a higher cardiovascular mortality.

Early initiation of antihypertensive medications and/or statins has been suggested to lower risk in these asymptomatic patients.³⁴ The size and contour (smooth or irregular) of kidneys may provide clues to reflux nephropathy, dysplastic kidneys, radiation nephritis, or chronic pyelonephritis. The presence of nephrotic syndrome and abnormal free light chains ratio with a bedside echocardiogram showing the typical refractile myocardial walls with a peculiar speckled pattern is strongly suggestive of amyloidosis.³⁵ Conditions associated with chronic hypercalcemia, medullary sponge kidney, milk alkali syndrome, sarcoidosis, and distal renal tubular acidosis are causes of nephrocalcinosis. Some degree of CKD is a constant feature in nephrocalcinosis. The initial imaging of choice in nephrocalcinosis and specially the medullary type is ultrasonography preferable to X-ray and perhaps to computed tomography.³⁶

End-Stage Renal Disease

In a patient undergoing peritoneal dialysis with exit-site infection, the presence of > 1 mm radiolucent rim around the subcutaneous catheter after antibiotics has a bad prognosis and prompts catheter removal. This sonographic sign has a positive and negative predictive value for a tunneled infection of 84.6% and 94.1%, respectively.^37,38 A risk factor for peritonitis in peritoneal dialysis is air in the peritoneum, which can be seen in one-third of patients. These individuals have 2.4 times more risk of peritonitis compared with patients without pneumoperitoneum. The sensitivity and specificity of sonographic detection of pneumoperitoneum is 94% and 100%, respectively, using the scissor technique.³⁹ Proper training in performing home peritoneal dialysis decreases the incidence of pneumoperitoneum. Although not formally assessed, patient education and change in procedure techniques may decrease the incidence of pneumoperitoneum and peritonitis. The use of prelaparoscopic ultrasonography before insertion of the peritoneal dialysis catheter has detected intra-abdominal adhesions (visceral slide sign) with a sensitivity of 90% to 92%.⁴⁰

History and physical examination are frequently helpful in the diagnosis of malfunctioning arteriovenous fistulas (AVF) for inflow or outflow disturbances, with sensitivity ranging from 70% to 100% and specificity ranging from 71% to 93% compared with angiography. Frequently, POC limited ultrasound can be helpful for a problematic AVF, either for cannulation or diagnosis. The congruence of duplex sonography with arteriogram is 85% to 96%. Various etiologies of a dysfunctional AVF (pseudo- or true aneurysm, poor development, stenosis, thrombi, or accessory veins) can be observed in the dialysis unit through limited sonography.^41-44

After placement of a hemodialysis catheter using real-time ultrasonography, pneumohemothorax can be diagnosed reliably and rapidly. Catheter misplacement outside of the right atrium was detected by thoracic echocardiogram with a sensitivity of 96%, a specificity of 83%, and a positive predictive value of 98%.^45,46 Ultimately, ultrasonography may replace chest X-ray in most cases after central vein dialysis catheter placement in the acute care setting.

Postrenal Failure

The sensitivity of ultrasonography to detect dilation to hydronephrosis of the pelvicaliceal system is well established. Sonography is the diagnostic examination of choice in pregnancy and the initial screening test for the nonpregnant patient. Computed tomography is the preferred imaging study in nephroureterolithiasis; however, due to ionizing radiation and cost, ultrasonography is gaining popularity for initial and/or follow-up evaluations. The ureteral jet is a relatively unexplored color and Doppler sonographic methodology that can provide insight into pelvicalyceal peristalsis, potentially yielding evidence of functional obstruction.^47-51 Postvoid bladder residual volumes and bladder wall hypertrophy may provide important clues as to the cause(s) of the obstructive uropathy.

Telenephrology

In our institution, sonography is used in the evaluation of IVC, lungs, and kidneys via telemedicine. The probe is handled by trained nurses at the distant site. 

Cardiac Arrest in ESRD

Patients with ESRD may have sudden cardiac arrest as a result of several etiologies. During the advance cardiac life support algorithm, there is a brief period of evaluation of the electrical rhythm in which echocardiography can be helpful with the diagnosis immediately after the 2 initial minutes of cardiopulmonary resuscitation. An enlarged right ventricular cavity (> 2/3 of the left ventricle) is a sonographic sign of a pulmonary embolism.

Bedside sonography has the potential to alter the current guidelines of advance cardiac life support management. For example, if the bedside echo shows a significant pericardial effusion, a pericardiocentesis could be performed faster as it would be diagnosed faster. In addition, at times the heart may appear to be beating rapidly but there is a small amount of fluid (blood) within the cardiac chambers. This may be from an extreme case of dehydration for which rapid administration of IV fluids may help manage. Therefore, a quick bedside point of care echocardiography may reveal a cardiac anomaly that may be able to be restored in a efficient manner. 

Related: General Applications of Ultrasound in Rheumatology Practice

Conclusion

Ultrasonography at the POC provides an important and continuously expanding tool to improve nephrological diagnostic accuracy in concert with history and physical examination. Extracellular fluid evaluation is paramount in all kidney disease conditions. Recent clinical studies in lung ultrasonography suggest that the learning curve for the medical provider is quicker than with other organs. Because POC sonography in association with limited bedside echocardiography may reveal discriminatory signs of pneumonia and differentiate between cardiogenic vs noncardiogenic pulmonary edema, such imaging may be important cost-effective strategies in the management of dyspnea and in the categorization/etiology of AKI. Therefore, incorporation of POC sonography into clinical practice will require that medical schools, residency programs, and nephrology fellowship programs design teaching strategies within their respective curricula. Research studies with outcomes regarding diagnosis, morbidity, and mortality are necessary in these areas.

Although patients with multiple myeloma (MM) have an increased risk of developing venous thromboembolism (VTE), no validated model exists that predicts VTE in MM. To help health care providers better assess the risks and the appropriateness of thromboprophylaxis, a team of researchers have developed the IMPEDE VTE risk assessment tool.

According to Kristen M. Sanfilippo, MD, of Washington University School of Medicine and the St. Louis Veterans Affairs Medical Center in Missouri, who presented the paper at the American Society of Hematology meeting last week in San Diego, this is the first effort to build a tool that is both internally and externally validated. The goal was to develop a model that outperformed current National Comprehensive Cancer Network (NCCN) guidelines for VTE that are based on expert opinion and were not specific to patients with multiple myeloma.

“We evaluated the performance of the current NCCN and International Myeloma Working Group guidelines with the VA data and our model outperformed these guidelines. Our recommendations is that our IMPEDE VTE should be considered to replace them,” said Sanfilippo. "I think we can improve our predictability of thrombosis in myeloma by adding novel predictors to the model, but that would have to be assessed in a prospective manner.”

Using the VA Central Cancer Registry, the researchers identified 4,448 patients diagnosed with MM between 1999 and 2014 and retrospectively followed the patients for 180 days after start of MM chemotherapy. Using beta coefficients, the researchers developed a risk score by dividing by a common divisor and rounding to the nearest integer. The risk score for each patient was the sum of all scores for each predictor variable.

The factors associated with VTE were combined to develop the IMPEDE VTE score. The factors were: Immunomodulatory drugs, 3 points; BMI > 25,  1 point; Pathologic fracture pelvis/femur 2 points; Erythropoiesis-stimulating agents, 1 point, Dexamethasone (High-dose 4 points; low-dose 2 points)/Doxorubicin 2 points; Asian Ethnicity, -3 points; history of VTE, 3 points; Tunneled line/ central venous catheter, 2 points). In addition, use of therapeutic anticoagulation (-5 points) with warfarin or low molecular weight heparin (LWMH) and use of prophylactic LMWH or aspirin (-2 points) were associated with a decreased risk of VTE. The risk score then identifies patients’ VTE risk as low (≤ 3), intermediate (4-6), or high (≥ 7).

According to Sanfilippo, the model showed satisfactory discrimination in both the derivation cohort (Harrell’s c-statistic = 0.66) and in the bootstrap validation, c-statistic = 0.66 (95% CI: 0.63 – 0.70). Within the first 6-months of starting chemotherapy, the rate of VTE was 3.5% compared to > 10% for high-risk patients.

The researchers hoped that the risk prediction model for VTE in MM would allow for use of thromboprophylaxis in MM patients at high-risk of VTE while sparing those at low risk. 

Although patients with multiple myeloma (MM) have an increased risk of developing venous thromboembolism (VTE), no validated model exists that predicts VTE in MM. To help health care providers better assess the risks and the appropriateness of thromboprophylaxis, a team of researchers have developed the IMPEDE VTE risk assessment tool.

According to Kristen M. Sanfilippo, MD, of Washington University School of Medicine and the St. Louis Veterans Affairs Medical Center in Missouri, who presented the paper at the American Society of Hematology meeting last week in San Diego, this is the first effort to build a tool that is both internally and externally validated. The goal was to develop a model that outperformed current National Comprehensive Cancer Network (NCCN) guidelines for VTE that are based on expert opinion and were not specific to patients with multiple myeloma.

“We evaluated the performance of the current NCCN and International Myeloma Working Group guidelines with the VA data and our model outperformed these guidelines. Our recommendations is that our IMPEDE VTE should be considered to replace them,” said Sanfilippo. "I think we can improve our predictability of thrombosis in myeloma by adding novel predictors to the model, but that would have to be assessed in a prospective manner.”

Using the VA Central Cancer Registry, the researchers identified 4,448 patients diagnosed with MM between 1999 and 2014 and retrospectively followed the patients for 180 days after start of MM chemotherapy. Using beta coefficients, the researchers developed a risk score by dividing by a common divisor and rounding to the nearest integer. The risk score for each patient was the sum of all scores for each predictor variable.

The factors associated with VTE were combined to develop the IMPEDE VTE score. The factors were: Immunomodulatory drugs, 3 points; BMI > 25,  1 point; Pathologic fracture pelvis/femur 2 points; Erythropoiesis-stimulating agents, 1 point, Dexamethasone (High-dose 4 points; low-dose 2 points)/Doxorubicin 2 points; Asian Ethnicity, -3 points; history of VTE, 3 points; Tunneled line/ central venous catheter, 2 points). In addition, use of therapeutic anticoagulation (-5 points) with warfarin or low molecular weight heparin (LWMH) and use of prophylactic LMWH or aspirin (-2 points) were associated with a decreased risk of VTE. The risk score then identifies patients’ VTE risk as low (≤ 3), intermediate (4-6), or high (≥ 7).

According to Sanfilippo, the model showed satisfactory discrimination in both the derivation cohort (Harrell’s c-statistic = 0.66) and in the bootstrap validation, c-statistic = 0.66 (95% CI: 0.63 – 0.70). Within the first 6-months of starting chemotherapy, the rate of VTE was 3.5% compared to > 10% for high-risk patients.

The researchers hoped that the risk prediction model for VTE in MM would allow for use of thromboprophylaxis in MM patients at high-risk of VTE while sparing those at low risk. 

Although patients with multiple myeloma (MM) have an increased risk of developing venous thromboembolism (VTE), no validated model exists that predicts VTE in MM. To help health care providers better assess the risks and the appropriateness of thromboprophylaxis, a team of researchers have developed the IMPEDE VTE risk assessment tool.

According to Kristen M. Sanfilippo, MD, of Washington University School of Medicine and the St. Louis Veterans Affairs Medical Center in Missouri, who presented the paper at the American Society of Hematology meeting last week in San Diego, this is the first effort to build a tool that is both internally and externally validated. The goal was to develop a model that outperformed current National Comprehensive Cancer Network (NCCN) guidelines for VTE that are based on expert opinion and were not specific to patients with multiple myeloma.

“We evaluated the performance of the current NCCN and International Myeloma Working Group guidelines with the VA data and our model outperformed these guidelines. Our recommendations is that our IMPEDE VTE should be considered to replace them,” said Sanfilippo. "I think we can improve our predictability of thrombosis in myeloma by adding novel predictors to the model, but that would have to be assessed in a prospective manner.”

Using the VA Central Cancer Registry, the researchers identified 4,448 patients diagnosed with MM between 1999 and 2014 and retrospectively followed the patients for 180 days after start of MM chemotherapy. Using beta coefficients, the researchers developed a risk score by dividing by a common divisor and rounding to the nearest integer. The risk score for each patient was the sum of all scores for each predictor variable.

The factors associated with VTE were combined to develop the IMPEDE VTE score. The factors were: Immunomodulatory drugs, 3 points; BMI > 25,  1 point; Pathologic fracture pelvis/femur 2 points; Erythropoiesis-stimulating agents, 1 point, Dexamethasone (High-dose 4 points; low-dose 2 points)/Doxorubicin 2 points; Asian Ethnicity, -3 points; history of VTE, 3 points; Tunneled line/ central venous catheter, 2 points). In addition, use of therapeutic anticoagulation (-5 points) with warfarin or low molecular weight heparin (LWMH) and use of prophylactic LMWH or aspirin (-2 points) were associated with a decreased risk of VTE. The risk score then identifies patients’ VTE risk as low (≤ 3), intermediate (4-6), or high (≥ 7).

According to Sanfilippo, the model showed satisfactory discrimination in both the derivation cohort (Harrell’s c-statistic = 0.66) and in the bootstrap validation, c-statistic = 0.66 (95% CI: 0.63 – 0.70). Within the first 6-months of starting chemotherapy, the rate of VTE was 3.5% compared to > 10% for high-risk patients.

The researchers hoped that the risk prediction model for VTE in MM would allow for use of thromboprophylaxis in MM patients at high-risk of VTE while sparing those at low risk.