Myth: Getting a Tan Helps Improve Acne

Acne has a multifaceted impact on patients, and facial acne in particular can impair self-image, psychological well-being, and ability to develop relationships. Patients cope with the clinical presentation of the disease in various ways, such as wearing makeup to cover blemishes, changing their hair color or diet, or getting regular facials. A common misconception is that a tan will help resolve acne.

A 2014 study on the burden of adult female acne (N=208) found that 5.3% of patients go to tanning salons or lay out in the sun to cope with their acne and 17% use self-tanning products to make their acne less visible. Many patients (40%) also believed that sunscreen exacerbates acne. Furthermore, a study of adolescents in Stockholm reported that those with acne, eczema, or psoriasis used sunbeds more than others without skin diseases.

The risk of developing skin cancer from sun exposure or UV light has been well established, and there is no evidence that UV light helps improve acne. A 2015 review of the literature on tanning bed use and phototherapy associated with treatment of conditions such as acne reported that experimental trials have been conducted for various light source therapies (eg, blue light, red-blue light, photodynamic therapy); however, there is no direct evidence for UV light.

In fact, acne patients should be counseled on the importance of photoprotection. Many acne therapies leave patients predisposed to UV damage, and UV damage generates free radical formation, which has been implicated in acne flares.

Expert Commentary

Often I hear from patients they feel tanning helps improve their acne. I tell them there is no evidence this is at all true. Just like cream makeup can camouflage acne, so too can tanning. But, trying to hide your blemishes does not actually help nor treat them. And moreover, tanning is so dangerous for potential skin cancer later in life.

—Lawrence J. Green, MD (Washington, DC)

Myth: Getting a Tan Helps Improve Acne

Acne has a multifaceted impact on patients, and facial acne in particular can impair self-image, psychological well-being, and ability to develop relationships. Patients cope with the clinical presentation of the disease in various ways, such as wearing makeup to cover blemishes, changing their hair color or diet, or getting regular facials. A common misconception is that a tan will help resolve acne.

A 2014 study on the burden of adult female acne (N=208) found that 5.3% of patients go to tanning salons or lay out in the sun to cope with their acne and 17% use self-tanning products to make their acne less visible. Many patients (40%) also believed that sunscreen exacerbates acne. Furthermore, a study of adolescents in Stockholm reported that those with acne, eczema, or psoriasis used sunbeds more than others without skin diseases.

The risk of developing skin cancer from sun exposure or UV light has been well established, and there is no evidence that UV light helps improve acne. A 2015 review of the literature on tanning bed use and phototherapy associated with treatment of conditions such as acne reported that experimental trials have been conducted for various light source therapies (eg, blue light, red-blue light, photodynamic therapy); however, there is no direct evidence for UV light.

In fact, acne patients should be counseled on the importance of photoprotection. Many acne therapies leave patients predisposed to UV damage, and UV damage generates free radical formation, which has been implicated in acne flares.

Expert Commentary

Often I hear from patients they feel tanning helps improve their acne. I tell them there is no evidence this is at all true. Just like cream makeup can camouflage acne, so too can tanning. But, trying to hide your blemishes does not actually help nor treat them. And moreover, tanning is so dangerous for potential skin cancer later in life.

—Lawrence J. Green, MD (Washington, DC)

Myth: Getting a Tan Helps Improve Acne

Acne has a multifaceted impact on patients, and facial acne in particular can impair self-image, psychological well-being, and ability to develop relationships. Patients cope with the clinical presentation of the disease in various ways, such as wearing makeup to cover blemishes, changing their hair color or diet, or getting regular facials. A common misconception is that a tan will help resolve acne.

A 2014 study on the burden of adult female acne (N=208) found that 5.3% of patients go to tanning salons or lay out in the sun to cope with their acne and 17% use self-tanning products to make their acne less visible. Many patients (40%) also believed that sunscreen exacerbates acne. Furthermore, a study of adolescents in Stockholm reported that those with acne, eczema, or psoriasis used sunbeds more than others without skin diseases.

The risk of developing skin cancer from sun exposure or UV light has been well established, and there is no evidence that UV light helps improve acne. A 2015 review of the literature on tanning bed use and phototherapy associated with treatment of conditions such as acne reported that experimental trials have been conducted for various light source therapies (eg, blue light, red-blue light, photodynamic therapy); however, there is no direct evidence for UV light.

In fact, acne patients should be counseled on the importance of photoprotection. Many acne therapies leave patients predisposed to UV damage, and UV damage generates free radical formation, which has been implicated in acne flares.

Expert Commentary

Often I hear from patients they feel tanning helps improve their acne. I tell them there is no evidence this is at all true. Just like cream makeup can camouflage acne, so too can tanning. But, trying to hide your blemishes does not actually help nor treat them. And moreover, tanning is so dangerous for potential skin cancer later in life.

—Lawrence J. Green, MD (Washington, DC)

WAIKOLOA, HAWAII – Check for joint tenderness and swelling routinely in your psoriasis patients, to detect psoriatic joint disease at an early stage, advised Alan Menter, MD.

About a third of patients with psoriasis will go on to develop joint involvement, and about half of those will go on to develop permanent joint destruction “if left untreated,” he noted. But early joint involvement has to be caught first, and dermatologists aren’t doing a very good job at early detection, according to Dr. Menter, clinical professor of dermatology at the University of Texas, Dallas.

The consequences, including arthritis mutilans, can be devastating. “It’s vitally important for us to prevent any permanent joint disease by” picking it up early, he said. “Our job as dermatologists is to diagnose it early.”

It’s not hard to do, just a few extra questions and a few extra steps on the physical exam, which takes a minute or two during each visit with psoriasis patients, are needed, he said.

Dr. Menter reviewed questions to ask patients, and explained how to examine patients for joint involvement and alter treatment when it’s found, in an interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

WAIKOLOA, HAWAII – Check for joint tenderness and swelling routinely in your psoriasis patients, to detect psoriatic joint disease at an early stage, advised Alan Menter, MD.

About a third of patients with psoriasis will go on to develop joint involvement, and about half of those will go on to develop permanent joint destruction “if left untreated,” he noted. But early joint involvement has to be caught first, and dermatologists aren’t doing a very good job at early detection, according to Dr. Menter, clinical professor of dermatology at the University of Texas, Dallas.

The consequences, including arthritis mutilans, can be devastating. “It’s vitally important for us to prevent any permanent joint disease by” picking it up early, he said. “Our job as dermatologists is to diagnose it early.”

It’s not hard to do, just a few extra questions and a few extra steps on the physical exam, which takes a minute or two during each visit with psoriasis patients, are needed, he said.

Dr. Menter reviewed questions to ask patients, and explained how to examine patients for joint involvement and alter treatment when it’s found, in an interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

WAIKOLOA, HAWAII – Check for joint tenderness and swelling routinely in your psoriasis patients, to detect psoriatic joint disease at an early stage, advised Alan Menter, MD.

About a third of patients with psoriasis will go on to develop joint involvement, and about half of those will go on to develop permanent joint destruction “if left untreated,” he noted. But early joint involvement has to be caught first, and dermatologists aren’t doing a very good job at early detection, according to Dr. Menter, clinical professor of dermatology at the University of Texas, Dallas.

The consequences, including arthritis mutilans, can be devastating. “It’s vitally important for us to prevent any permanent joint disease by” picking it up early, he said. “Our job as dermatologists is to diagnose it early.”

It’s not hard to do, just a few extra questions and a few extra steps on the physical exam, which takes a minute or two during each visit with psoriasis patients, are needed, he said.

Dr. Menter reviewed questions to ask patients, and explained how to examine patients for joint involvement and alter treatment when it’s found, in an interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

WAIKOLOA, HAWAII – The work up of a case of onychomycosis doesn’t end with the detection of fungal hyphae.

Trichophyton rubrum remains the most common cause of toenail fungus in the United States, but nondermatophyte molds – Scopulariopsis, Fusarium, and others – are on the rise, so it’s important to speciate, especially when patients have atypical presentations or fail to respond to the T. rubrum go-to treatment, terbinafine, according to Nathaniel Jellinek, MD, of the department of dermatology, Brown University, Providence, R.I.

Standard in-office potassium hydroxide (KOH) testing can’t distinguish one species of fungus from another, nor can pathology with Gomori methenamine silver (GMS) or Periodic acid-Schiff (PAS) staining. Both culture and polymerase chain reaction (PCR), however, do.

Since few hospitals are equipped to run those tests, Dr. Jellinek uses the Case Western Center for Medical Mycology, in Cleveland, for testing.

In an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Jellinek explained how to speciate, and the importance of doing so.

He also shared his tips on getting good nail clippings and good scrapings for debris for testing, and explained when KOH testing is enough – and when to opt for more advanced diagnostic methods, including PCR, which he said trumps all previous methods.

Terbinafine is still the best option for T. rubrum, but new topicals are better for nondermatophyte molds. There’s also a clever new dosing regimen for terbinafine, one that should put patients at ease about liver toxicity and other concerns. “If you tell them they’re getting 1 month off in the middle, it seems to go over a little easier,” Dr. Jellinek said.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
 

[email protected]

WAIKOLOA, HAWAII – The work up of a case of onychomycosis doesn’t end with the detection of fungal hyphae.

Trichophyton rubrum remains the most common cause of toenail fungus in the United States, but nondermatophyte molds – Scopulariopsis, Fusarium, and others – are on the rise, so it’s important to speciate, especially when patients have atypical presentations or fail to respond to the T. rubrum go-to treatment, terbinafine, according to Nathaniel Jellinek, MD, of the department of dermatology, Brown University, Providence, R.I.

Standard in-office potassium hydroxide (KOH) testing can’t distinguish one species of fungus from another, nor can pathology with Gomori methenamine silver (GMS) or Periodic acid-Schiff (PAS) staining. Both culture and polymerase chain reaction (PCR), however, do.

Since few hospitals are equipped to run those tests, Dr. Jellinek uses the Case Western Center for Medical Mycology, in Cleveland, for testing.

In an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Jellinek explained how to speciate, and the importance of doing so.

He also shared his tips on getting good nail clippings and good scrapings for debris for testing, and explained when KOH testing is enough – and when to opt for more advanced diagnostic methods, including PCR, which he said trumps all previous methods.

Terbinafine is still the best option for T. rubrum, but new topicals are better for nondermatophyte molds. There’s also a clever new dosing regimen for terbinafine, one that should put patients at ease about liver toxicity and other concerns. “If you tell them they’re getting 1 month off in the middle, it seems to go over a little easier,” Dr. Jellinek said.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
 

[email protected]

WAIKOLOA, HAWAII – The work up of a case of onychomycosis doesn’t end with the detection of fungal hyphae.

Trichophyton rubrum remains the most common cause of toenail fungus in the United States, but nondermatophyte molds – Scopulariopsis, Fusarium, and others – are on the rise, so it’s important to speciate, especially when patients have atypical presentations or fail to respond to the T. rubrum go-to treatment, terbinafine, according to Nathaniel Jellinek, MD, of the department of dermatology, Brown University, Providence, R.I.

Standard in-office potassium hydroxide (KOH) testing can’t distinguish one species of fungus from another, nor can pathology with Gomori methenamine silver (GMS) or Periodic acid-Schiff (PAS) staining. Both culture and polymerase chain reaction (PCR), however, do.

Since few hospitals are equipped to run those tests, Dr. Jellinek uses the Case Western Center for Medical Mycology, in Cleveland, for testing.

In an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Jellinek explained how to speciate, and the importance of doing so.

He also shared his tips on getting good nail clippings and good scrapings for debris for testing, and explained when KOH testing is enough – and when to opt for more advanced diagnostic methods, including PCR, which he said trumps all previous methods.

Terbinafine is still the best option for T. rubrum, but new topicals are better for nondermatophyte molds. There’s also a clever new dosing regimen for terbinafine, one that should put patients at ease about liver toxicity and other concerns. “If you tell them they’re getting 1 month off in the middle, it seems to go over a little easier,” Dr. Jellinek said.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
 

[email protected]

When a patient told Richard Balon, MD, that he could no longer afford to spend $300 a month on a tricyclic, Dr. Balon could not believe that the price was so high. “This is clearly unsustainable,” said Dr. Balon, professor of psychiatry and anesthesiology, and associate chair of education at Wayne State University in Detroit. In this Masterclass episode of the Psychcast from the 2018 AACP Encore meeting in Las Vegas, he lectures on the increase in the price of generic and brand name medications in the United States.

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When a patient told Richard Balon, MD, that he could no longer afford to spend $300 a month on a tricyclic, Dr. Balon could not believe that the price was so high. “This is clearly unsustainable,” said Dr. Balon, professor of psychiatry and anesthesiology, and associate chair of education at Wayne State University in Detroit. In this Masterclass episode of the Psychcast from the 2018 AACP Encore meeting in Las Vegas, he lectures on the increase in the price of generic and brand name medications in the United States.

Amazon

Apple Podcasts

Google Podcasts

Spotify


 

When a patient told Richard Balon, MD, that he could no longer afford to spend $300 a month on a tricyclic, Dr. Balon could not believe that the price was so high. “This is clearly unsustainable,” said Dr. Balon, professor of psychiatry and anesthesiology, and associate chair of education at Wayne State University in Detroit. In this Masterclass episode of the Psychcast from the 2018 AACP Encore meeting in Las Vegas, he lectures on the increase in the price of generic and brand name medications in the United States.

Amazon

Apple Podcasts

Google Podcasts

Spotify


 

SAN DIEGO – One year after implementation, a pulmonary embolism response team (PERT) is making a significant difference in care of patients with submassive pulmonary embolism and evidence of right ventricular (RV) dysfunction at the Christiana Medical Center in Delaware. An analysis of data collected showed reductions in ICU stays, early death, and overall hospital length of stay.

Andrei Malov/Thinkstock

Such patients pose a challenge to clinicians because some will go on to develop more serious pulmonary embolism (PE), yet aggressive treatment options carry their own risk. Existing guidelines, such as those by the European Society of Cardiology, recommend conservative treatment of these patients, with more aggressive measures if conditions don’t quickly improve.

However, about 12% of patients on conservative therapy die, or about 100,000 per year. Those patients who go on to have bad outcomes “are obviously intermediate high risk or high risk. This is the patient population that we’re interested in [addressing through PERT]. These aren’t really sick patients. The blood pressure is normal, but they have the risk based on comorbidities or the clot burden to do poorly over the next day or two,” said Michael Benninghoff, DO, section chief of medical critical care and director of respiratory therapy at Christiana Medical Center, Wilmington, Del. Dr. Benninghoff presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The PERT concept was developed by physicians at Massachusetts General Hospital. It establishes clinical criteria that, if met, prompt a PERT alert, which in turn triggers a meeting between the initiating provider, a pulmonary intensivist, and a vascular and interventional radiology physician within 15 minutes to review the case and make rapid clinical decisions.

A PERT alert requires either a CT diagnosis of PE or a VQ scan showing a high probability of PE, combined with one of three additional criteria: elevated B-type (brain) natriuretic peptide (BNP) and troponin; echocardiographic evidence of right ventricular dysfunction; or clinical instability as indicated by heart rate over 110 beats per minute, systolic blood pressure below 100 mm Hg, or oxygen saturation lower than 90%.

The PERT program caught Dr. Benninghoff’s attention because of institutional experience with patients deteriorating on conservative treatment, but also because the treatment of submassive PE with RV dysfunction is quite scattered. “We were seeing really conservative to really aggressive treatment. I don’t think we’ve had the data to support treating a patient whose blood pressure is normal but they have signs of right ventricular dysfunction, whether it’s echocardiographic, radiographic, or laboratory evidence of myocardial necrosis. I don’t think we have a group conscience as providers as far as how aggressive to be with those patients,” said Dr. Benninghoff.

To examine the efficacy of the PERT program after 1 year, Dr. Benninghoff’s team reviewed all PE cases from 2016 (pre-PERT, n = 717) and 2017 (post-PERT, n = 752). The mortality index declined 30%, from 1.13 to 0.79, while the percentage of early death declined 52%, from 2.51 to 1.20. The mean number of ICU days fell from 5.01 to 4.40.

When the team restricted the analysis to PE lysis patients (n = 27 in 2016; n = 33 in 2017), the mean length of ICU stay dropped from 66.1 hours to 58.8 hours, and fewer patients were transferred from a lower level of care to the ICU (6 vs. 3).

“We think we have shown that just by talking in real time, forcing physicians to communicate – it certainly doesn’t hurt, that it probably helps with ICU utilization and perhaps even mortality,” said Dr. Benninghoff. 

The results are far from definitive, and much more work needs to be done to determine how best to manage patients with submassive PEs and RV dysfunction. Dr. Benninghoff doesn’t have the answers, but he’s hopeful that the PERT program can eventually provide some. “Probably the most important thing is we’re giving back to the medical community by enrolling in the consortium, putting our data in the hands of the Boston research institute, and seeing what comes of it. Hopefully in 5 years we will have a standard of care based on the work we’re doing now,” he said.

The study was funded internally. Dr. Benninghoff declared no conflicts of interest.

SOURCE: Benninghoff M. Critical Care Congress 2019, Abstract 490.

SAN DIEGO – One year after implementation, a pulmonary embolism response team (PERT) is making a significant difference in care of patients with submassive pulmonary embolism and evidence of right ventricular (RV) dysfunction at the Christiana Medical Center in Delaware. An analysis of data collected showed reductions in ICU stays, early death, and overall hospital length of stay.

Andrei Malov/Thinkstock

Such patients pose a challenge to clinicians because some will go on to develop more serious pulmonary embolism (PE), yet aggressive treatment options carry their own risk. Existing guidelines, such as those by the European Society of Cardiology, recommend conservative treatment of these patients, with more aggressive measures if conditions don’t quickly improve.

However, about 12% of patients on conservative therapy die, or about 100,000 per year. Those patients who go on to have bad outcomes “are obviously intermediate high risk or high risk. This is the patient population that we’re interested in [addressing through PERT]. These aren’t really sick patients. The blood pressure is normal, but they have the risk based on comorbidities or the clot burden to do poorly over the next day or two,” said Michael Benninghoff, DO, section chief of medical critical care and director of respiratory therapy at Christiana Medical Center, Wilmington, Del. Dr. Benninghoff presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The PERT concept was developed by physicians at Massachusetts General Hospital. It establishes clinical criteria that, if met, prompt a PERT alert, which in turn triggers a meeting between the initiating provider, a pulmonary intensivist, and a vascular and interventional radiology physician within 15 minutes to review the case and make rapid clinical decisions.

A PERT alert requires either a CT diagnosis of PE or a VQ scan showing a high probability of PE, combined with one of three additional criteria: elevated B-type (brain) natriuretic peptide (BNP) and troponin; echocardiographic evidence of right ventricular dysfunction; or clinical instability as indicated by heart rate over 110 beats per minute, systolic blood pressure below 100 mm Hg, or oxygen saturation lower than 90%.

The PERT program caught Dr. Benninghoff’s attention because of institutional experience with patients deteriorating on conservative treatment, but also because the treatment of submassive PE with RV dysfunction is quite scattered. “We were seeing really conservative to really aggressive treatment. I don’t think we’ve had the data to support treating a patient whose blood pressure is normal but they have signs of right ventricular dysfunction, whether it’s echocardiographic, radiographic, or laboratory evidence of myocardial necrosis. I don’t think we have a group conscience as providers as far as how aggressive to be with those patients,” said Dr. Benninghoff.

To examine the efficacy of the PERT program after 1 year, Dr. Benninghoff’s team reviewed all PE cases from 2016 (pre-PERT, n = 717) and 2017 (post-PERT, n = 752). The mortality index declined 30%, from 1.13 to 0.79, while the percentage of early death declined 52%, from 2.51 to 1.20. The mean number of ICU days fell from 5.01 to 4.40.

When the team restricted the analysis to PE lysis patients (n = 27 in 2016; n = 33 in 2017), the mean length of ICU stay dropped from 66.1 hours to 58.8 hours, and fewer patients were transferred from a lower level of care to the ICU (6 vs. 3).

“We think we have shown that just by talking in real time, forcing physicians to communicate – it certainly doesn’t hurt, that it probably helps with ICU utilization and perhaps even mortality,” said Dr. Benninghoff. 

The results are far from definitive, and much more work needs to be done to determine how best to manage patients with submassive PEs and RV dysfunction. Dr. Benninghoff doesn’t have the answers, but he’s hopeful that the PERT program can eventually provide some. “Probably the most important thing is we’re giving back to the medical community by enrolling in the consortium, putting our data in the hands of the Boston research institute, and seeing what comes of it. Hopefully in 5 years we will have a standard of care based on the work we’re doing now,” he said.

The study was funded internally. Dr. Benninghoff declared no conflicts of interest.

SOURCE: Benninghoff M. Critical Care Congress 2019, Abstract 490.

SAN DIEGO – One year after implementation, a pulmonary embolism response team (PERT) is making a significant difference in care of patients with submassive pulmonary embolism and evidence of right ventricular (RV) dysfunction at the Christiana Medical Center in Delaware. An analysis of data collected showed reductions in ICU stays, early death, and overall hospital length of stay.

Andrei Malov/Thinkstock

Such patients pose a challenge to clinicians because some will go on to develop more serious pulmonary embolism (PE), yet aggressive treatment options carry their own risk. Existing guidelines, such as those by the European Society of Cardiology, recommend conservative treatment of these patients, with more aggressive measures if conditions don’t quickly improve.

However, about 12% of patients on conservative therapy die, or about 100,000 per year. Those patients who go on to have bad outcomes “are obviously intermediate high risk or high risk. This is the patient population that we’re interested in [addressing through PERT]. These aren’t really sick patients. The blood pressure is normal, but they have the risk based on comorbidities or the clot burden to do poorly over the next day or two,” said Michael Benninghoff, DO, section chief of medical critical care and director of respiratory therapy at Christiana Medical Center, Wilmington, Del. Dr. Benninghoff presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

The PERT concept was developed by physicians at Massachusetts General Hospital. It establishes clinical criteria that, if met, prompt a PERT alert, which in turn triggers a meeting between the initiating provider, a pulmonary intensivist, and a vascular and interventional radiology physician within 15 minutes to review the case and make rapid clinical decisions.

A PERT alert requires either a CT diagnosis of PE or a VQ scan showing a high probability of PE, combined with one of three additional criteria: elevated B-type (brain) natriuretic peptide (BNP) and troponin; echocardiographic evidence of right ventricular dysfunction; or clinical instability as indicated by heart rate over 110 beats per minute, systolic blood pressure below 100 mm Hg, or oxygen saturation lower than 90%.

The PERT program caught Dr. Benninghoff’s attention because of institutional experience with patients deteriorating on conservative treatment, but also because the treatment of submassive PE with RV dysfunction is quite scattered. “We were seeing really conservative to really aggressive treatment. I don’t think we’ve had the data to support treating a patient whose blood pressure is normal but they have signs of right ventricular dysfunction, whether it’s echocardiographic, radiographic, or laboratory evidence of myocardial necrosis. I don’t think we have a group conscience as providers as far as how aggressive to be with those patients,” said Dr. Benninghoff.

To examine the efficacy of the PERT program after 1 year, Dr. Benninghoff’s team reviewed all PE cases from 2016 (pre-PERT, n = 717) and 2017 (post-PERT, n = 752). The mortality index declined 30%, from 1.13 to 0.79, while the percentage of early death declined 52%, from 2.51 to 1.20. The mean number of ICU days fell from 5.01 to 4.40.

When the team restricted the analysis to PE lysis patients (n = 27 in 2016; n = 33 in 2017), the mean length of ICU stay dropped from 66.1 hours to 58.8 hours, and fewer patients were transferred from a lower level of care to the ICU (6 vs. 3).

“We think we have shown that just by talking in real time, forcing physicians to communicate – it certainly doesn’t hurt, that it probably helps with ICU utilization and perhaps even mortality,” said Dr. Benninghoff. 

The results are far from definitive, and much more work needs to be done to determine how best to manage patients with submassive PEs and RV dysfunction. Dr. Benninghoff doesn’t have the answers, but he’s hopeful that the PERT program can eventually provide some. “Probably the most important thing is we’re giving back to the medical community by enrolling in the consortium, putting our data in the hands of the Boston research institute, and seeing what comes of it. Hopefully in 5 years we will have a standard of care based on the work we’re doing now,” he said.

The study was funded internally. Dr. Benninghoff declared no conflicts of interest.

SOURCE: Benninghoff M. Critical Care Congress 2019, Abstract 490.

Patients with diabetic foot ulcers have a high incidence of associated chronic vascular disease, including kidney disease, retinopathy, and peripheral artery disease (PAD). In addition, there was statistically significant association between both diabetic retinopathy and diabetic kidney disease and PAD, according to a study reported by Magdy H. Megallaa, MD, and colleagues at Alexandria (Egypt) University.

Rebecca L. Slebodnik/MDedge News

Their cross-sectional study, published in Diabetes & Metabolic Syndrome: Clinical Research and Reviews, comprised 180 type 2 diabetic patients (aged 30-70 years) with diabetic foot ulcers (DFUs) who attended an outpatient clinic between July and December 2017.

The prevalence of diabetic kidney disease and diabetic retinopathy was 86.1% and 90.0%, respectively, with 86.7% of patients having neuropathic DFUs, 11.1% having ischemic DFUs, and 2.2% having neuroischemic DFUs. The prevalence of peripheral neuropathy and PAD was 82% and 20%, respectively.

Using albuminuria as a measure of diabetic kidney disease, the researchers found that 86.1% of the patients had albuminuria and that there was a statistically significant association between albuminuria and the patient’s vibration reception threshold (VPT), a measure of diabetic neuropathy (P less than .001), and the ankle brachial index (ABI), a measure of PAD (P less than .031).

In addition, there was a statistically significant association between diabetic retinopathy and VPT (P less than .008) and between diabetic retinopathy and ABI (P less than .001).

“Albuminuria, diabetic retinopathy and peripheral neuropathy are very common among those patients and strongly associated with risk factors of diabetic foot ulceration,” the researchers concluded.

They reported that they had no conflicts.

[email protected]

SOURCE: Megallaa MH et al. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1287-92.

Patients with diabetic foot ulcers have a high incidence of associated chronic vascular disease, including kidney disease, retinopathy, and peripheral artery disease (PAD). In addition, there was statistically significant association between both diabetic retinopathy and diabetic kidney disease and PAD, according to a study reported by Magdy H. Megallaa, MD, and colleagues at Alexandria (Egypt) University.

Rebecca L. Slebodnik/MDedge News

Their cross-sectional study, published in Diabetes & Metabolic Syndrome: Clinical Research and Reviews, comprised 180 type 2 diabetic patients (aged 30-70 years) with diabetic foot ulcers (DFUs) who attended an outpatient clinic between July and December 2017.

The prevalence of diabetic kidney disease and diabetic retinopathy was 86.1% and 90.0%, respectively, with 86.7% of patients having neuropathic DFUs, 11.1% having ischemic DFUs, and 2.2% having neuroischemic DFUs. The prevalence of peripheral neuropathy and PAD was 82% and 20%, respectively.

Using albuminuria as a measure of diabetic kidney disease, the researchers found that 86.1% of the patients had albuminuria and that there was a statistically significant association between albuminuria and the patient’s vibration reception threshold (VPT), a measure of diabetic neuropathy (P less than .001), and the ankle brachial index (ABI), a measure of PAD (P less than .031).

In addition, there was a statistically significant association between diabetic retinopathy and VPT (P less than .008) and between diabetic retinopathy and ABI (P less than .001).

“Albuminuria, diabetic retinopathy and peripheral neuropathy are very common among those patients and strongly associated with risk factors of diabetic foot ulceration,” the researchers concluded.

They reported that they had no conflicts.

[email protected]

SOURCE: Megallaa MH et al. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1287-92.

Patients with diabetic foot ulcers have a high incidence of associated chronic vascular disease, including kidney disease, retinopathy, and peripheral artery disease (PAD). In addition, there was statistically significant association between both diabetic retinopathy and diabetic kidney disease and PAD, according to a study reported by Magdy H. Megallaa, MD, and colleagues at Alexandria (Egypt) University.

Rebecca L. Slebodnik/MDedge News

Their cross-sectional study, published in Diabetes & Metabolic Syndrome: Clinical Research and Reviews, comprised 180 type 2 diabetic patients (aged 30-70 years) with diabetic foot ulcers (DFUs) who attended an outpatient clinic between July and December 2017.

The prevalence of diabetic kidney disease and diabetic retinopathy was 86.1% and 90.0%, respectively, with 86.7% of patients having neuropathic DFUs, 11.1% having ischemic DFUs, and 2.2% having neuroischemic DFUs. The prevalence of peripheral neuropathy and PAD was 82% and 20%, respectively.

Using albuminuria as a measure of diabetic kidney disease, the researchers found that 86.1% of the patients had albuminuria and that there was a statistically significant association between albuminuria and the patient’s vibration reception threshold (VPT), a measure of diabetic neuropathy (P less than .001), and the ankle brachial index (ABI), a measure of PAD (P less than .031).

In addition, there was a statistically significant association between diabetic retinopathy and VPT (P less than .008) and between diabetic retinopathy and ABI (P less than .001).

“Albuminuria, diabetic retinopathy and peripheral neuropathy are very common among those patients and strongly associated with risk factors of diabetic foot ulceration,” the researchers concluded.

They reported that they had no conflicts.

[email protected]

SOURCE: Megallaa MH et al. Diabetes Metab Syndr. 2019 Mar-Apr;13(2):1287-92.

WASHINGTON – As the rising cost of prescription drugs continues to garner heightened scrutiny from the federal government, one thing is missing from the conversation that would make any solution more effective, according to American Medical Association President Barbara L. McAneny, MD.

“We would like to see transparency from end to end in this pipeline because that is the way we will have the ability to look for savings,” she said in an interview at a national advocacy conference sponsored by the American Medical Association.

“I think we don’t have the information we need to make rational decisions,” she said. “I think the first thing we need to do is to understand the entire pipeline from the basic research that results in a drug’s clinical trials that results in a new drug to the pharmacy benefit managers and all of the ways that they have increased the cost of the drugs all the way to when the patient actually gets it.”

In particular, Dr. McAneny targeted the need for transparency in the role and financial impact pharmacy benefit managers have on the cost of prescription drugs.

“We were told at our state advocacy conference, which we held in January, by an expert who studied pharmacy benefit managers, that 42% of the cost of any drug is attributable to the profits of pharmacy benefit managers,” she said. “To me, that makes me wonder what value do they add that is worth 42% of these exorbitant costs and if they are not adding value, why do we have them in this process?”

She also called on the pharmaceutical manufacturers to be more forthcoming with their financial information regarding marketing and advertising, but she stressed that it needs to be done in a way that does not hinder future development of life-saving therapies.

“We do not want to stifle innovation.” Dr. McAneny said. “As a cancer doctor, I have seen diseases that I used to treat with morphine and sympathy now be diseases that I can treat, where I can restore people to good quality of life and buy them additional years of life because of these drugs. They are amazing and I don’t want to do without them and I want more of them. ... We want to support that research. That is probably worth a lot of the price tag. But how much of that goes to direct-to-consumer advertising? How much of that is the advertising budget? Where can we cut some of this out of the system so that we get the innovation, but we get innovation that all of our patients can afford?”

Another issue that is looming for physicians is a payment rate freeze from 2020-2025 under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program, which was created under the Medicare Access and CHIP Reauthorization Act (MACRA).

“A 5-year freeze when my expenses do not freeze is a terrifying thing and could be a practice-ending expense for a lot of practices,” Dr. McAneny warned. “I will point out that independent practices, if they sell to a hospital, the cost of care immediately doubles. The amount that is paid for it, not the cost of delivering it. So that is not a great solution. But we also have this increasing practice expense and a flat rate is not going to help practices survive. So I am very concerned.”

Related to the QPP, Dr. McAneny also wants to see the Centers for Medicare & Medicaid Services do more with physician-developed alternative payment models. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) continues to review and evaluate submissions, but to date, the CMS has yet to implement any of the committee’s recommendations.

“I read all of the PTAC submissions that went to CMS. Some of them I thought were a little on the weak side, but there are a lot of them that I thought were really good ideas. I do not know why CMS did not approve them and fund them and let them be tried,” she said, although she did offer an opinion on why the agency has yet to act on any of them.

“I read their paper saying why they didn’t approve [the recommended physician-developed alternative payment models]. It seemed to me they are waiting for one silver bullet that will fix all of health care. I don’t think a silver bullet is going to fix health care. It’s not an issue. It’s a complicated set of issues. You will not have a quick fix.”

[email protected]

WASHINGTON – As the rising cost of prescription drugs continues to garner heightened scrutiny from the federal government, one thing is missing from the conversation that would make any solution more effective, according to American Medical Association President Barbara L. McAneny, MD.

“We would like to see transparency from end to end in this pipeline because that is the way we will have the ability to look for savings,” she said in an interview at a national advocacy conference sponsored by the American Medical Association.

“I think we don’t have the information we need to make rational decisions,” she said. “I think the first thing we need to do is to understand the entire pipeline from the basic research that results in a drug’s clinical trials that results in a new drug to the pharmacy benefit managers and all of the ways that they have increased the cost of the drugs all the way to when the patient actually gets it.”

In particular, Dr. McAneny targeted the need for transparency in the role and financial impact pharmacy benefit managers have on the cost of prescription drugs.

“We were told at our state advocacy conference, which we held in January, by an expert who studied pharmacy benefit managers, that 42% of the cost of any drug is attributable to the profits of pharmacy benefit managers,” she said. “To me, that makes me wonder what value do they add that is worth 42% of these exorbitant costs and if they are not adding value, why do we have them in this process?”

She also called on the pharmaceutical manufacturers to be more forthcoming with their financial information regarding marketing and advertising, but she stressed that it needs to be done in a way that does not hinder future development of life-saving therapies.

“We do not want to stifle innovation.” Dr. McAneny said. “As a cancer doctor, I have seen diseases that I used to treat with morphine and sympathy now be diseases that I can treat, where I can restore people to good quality of life and buy them additional years of life because of these drugs. They are amazing and I don’t want to do without them and I want more of them. ... We want to support that research. That is probably worth a lot of the price tag. But how much of that goes to direct-to-consumer advertising? How much of that is the advertising budget? Where can we cut some of this out of the system so that we get the innovation, but we get innovation that all of our patients can afford?”

Another issue that is looming for physicians is a payment rate freeze from 2020-2025 under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program, which was created under the Medicare Access and CHIP Reauthorization Act (MACRA).

“A 5-year freeze when my expenses do not freeze is a terrifying thing and could be a practice-ending expense for a lot of practices,” Dr. McAneny warned. “I will point out that independent practices, if they sell to a hospital, the cost of care immediately doubles. The amount that is paid for it, not the cost of delivering it. So that is not a great solution. But we also have this increasing practice expense and a flat rate is not going to help practices survive. So I am very concerned.”

Related to the QPP, Dr. McAneny also wants to see the Centers for Medicare & Medicaid Services do more with physician-developed alternative payment models. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) continues to review and evaluate submissions, but to date, the CMS has yet to implement any of the committee’s recommendations.

“I read all of the PTAC submissions that went to CMS. Some of them I thought were a little on the weak side, but there are a lot of them that I thought were really good ideas. I do not know why CMS did not approve them and fund them and let them be tried,” she said, although she did offer an opinion on why the agency has yet to act on any of them.

“I read their paper saying why they didn’t approve [the recommended physician-developed alternative payment models]. It seemed to me they are waiting for one silver bullet that will fix all of health care. I don’t think a silver bullet is going to fix health care. It’s not an issue. It’s a complicated set of issues. You will not have a quick fix.”

[email protected]

WASHINGTON – As the rising cost of prescription drugs continues to garner heightened scrutiny from the federal government, one thing is missing from the conversation that would make any solution more effective, according to American Medical Association President Barbara L. McAneny, MD.

“We would like to see transparency from end to end in this pipeline because that is the way we will have the ability to look for savings,” she said in an interview at a national advocacy conference sponsored by the American Medical Association.

“I think we don’t have the information we need to make rational decisions,” she said. “I think the first thing we need to do is to understand the entire pipeline from the basic research that results in a drug’s clinical trials that results in a new drug to the pharmacy benefit managers and all of the ways that they have increased the cost of the drugs all the way to when the patient actually gets it.”

In particular, Dr. McAneny targeted the need for transparency in the role and financial impact pharmacy benefit managers have on the cost of prescription drugs.

“We were told at our state advocacy conference, which we held in January, by an expert who studied pharmacy benefit managers, that 42% of the cost of any drug is attributable to the profits of pharmacy benefit managers,” she said. “To me, that makes me wonder what value do they add that is worth 42% of these exorbitant costs and if they are not adding value, why do we have them in this process?”

She also called on the pharmaceutical manufacturers to be more forthcoming with their financial information regarding marketing and advertising, but she stressed that it needs to be done in a way that does not hinder future development of life-saving therapies.

“We do not want to stifle innovation.” Dr. McAneny said. “As a cancer doctor, I have seen diseases that I used to treat with morphine and sympathy now be diseases that I can treat, where I can restore people to good quality of life and buy them additional years of life because of these drugs. They are amazing and I don’t want to do without them and I want more of them. ... We want to support that research. That is probably worth a lot of the price tag. But how much of that goes to direct-to-consumer advertising? How much of that is the advertising budget? Where can we cut some of this out of the system so that we get the innovation, but we get innovation that all of our patients can afford?”

Another issue that is looming for physicians is a payment rate freeze from 2020-2025 under the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program, which was created under the Medicare Access and CHIP Reauthorization Act (MACRA).

“A 5-year freeze when my expenses do not freeze is a terrifying thing and could be a practice-ending expense for a lot of practices,” Dr. McAneny warned. “I will point out that independent practices, if they sell to a hospital, the cost of care immediately doubles. The amount that is paid for it, not the cost of delivering it. So that is not a great solution. But we also have this increasing practice expense and a flat rate is not going to help practices survive. So I am very concerned.”

Related to the QPP, Dr. McAneny also wants to see the Centers for Medicare & Medicaid Services do more with physician-developed alternative payment models. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) continues to review and evaluate submissions, but to date, the CMS has yet to implement any of the committee’s recommendations.

“I read all of the PTAC submissions that went to CMS. Some of them I thought were a little on the weak side, but there are a lot of them that I thought were really good ideas. I do not know why CMS did not approve them and fund them and let them be tried,” she said, although she did offer an opinion on why the agency has yet to act on any of them.

“I read their paper saying why they didn’t approve [the recommended physician-developed alternative payment models]. It seemed to me they are waiting for one silver bullet that will fix all of health care. I don’t think a silver bullet is going to fix health care. It’s not an issue. It’s a complicated set of issues. You will not have a quick fix.”

[email protected]

Patients with peripheral artery disease (PAD) were also more likely to have left ventricular diastolic dysfunction, according to a study published in the Journal of Cardiology.

The study enrolled 1,121 patients with preserved left ventricular (LV) systolic function. The mean age was 68 years and 56% of patients were men. A total of 200 patients (17.8%) had PAD; 33.0% of these had no symptoms, 54.5% had intermittent symptoms, and 12.5% had critical ischemia, according to Koji Yanaka, MD, and colleagues at the Hyogo College of Medicine, Nishinomiya, Japan.

Multivariate logistic regression analysis showed that PAD was an independent predictor of LV diastolic dysfunction (adjusted odds ratio, 1.77; P = .01).

“The prevalence of LV diastolic dysfunction was higher in patients with PAD than those without PAD. These findings suggest that patients with PAD should be evaluated not only for LV systolic but also diastolic function in echocardiography,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

SOURCE: Yanaka K et al. J Cardiol. 2019 Feb 18. doi: 10.1016/j.jjcc.2019.01.011.

Patients with peripheral artery disease (PAD) were also more likely to have left ventricular diastolic dysfunction, according to a study published in the Journal of Cardiology.

The study enrolled 1,121 patients with preserved left ventricular (LV) systolic function. The mean age was 68 years and 56% of patients were men. A total of 200 patients (17.8%) had PAD; 33.0% of these had no symptoms, 54.5% had intermittent symptoms, and 12.5% had critical ischemia, according to Koji Yanaka, MD, and colleagues at the Hyogo College of Medicine, Nishinomiya, Japan.

Multivariate logistic regression analysis showed that PAD was an independent predictor of LV diastolic dysfunction (adjusted odds ratio, 1.77; P = .01).

“The prevalence of LV diastolic dysfunction was higher in patients with PAD than those without PAD. These findings suggest that patients with PAD should be evaluated not only for LV systolic but also diastolic function in echocardiography,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

SOURCE: Yanaka K et al. J Cardiol. 2019 Feb 18. doi: 10.1016/j.jjcc.2019.01.011.

Patients with peripheral artery disease (PAD) were also more likely to have left ventricular diastolic dysfunction, according to a study published in the Journal of Cardiology.

The study enrolled 1,121 patients with preserved left ventricular (LV) systolic function. The mean age was 68 years and 56% of patients were men. A total of 200 patients (17.8%) had PAD; 33.0% of these had no symptoms, 54.5% had intermittent symptoms, and 12.5% had critical ischemia, according to Koji Yanaka, MD, and colleagues at the Hyogo College of Medicine, Nishinomiya, Japan.

Multivariate logistic regression analysis showed that PAD was an independent predictor of LV diastolic dysfunction (adjusted odds ratio, 1.77; P = .01).

“The prevalence of LV diastolic dysfunction was higher in patients with PAD than those without PAD. These findings suggest that patients with PAD should be evaluated not only for LV systolic but also diastolic function in echocardiography,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

SOURCE: Yanaka K et al. J Cardiol. 2019 Feb 18. doi: 10.1016/j.jjcc.2019.01.011.

The Food and Drug Administration has approved turoctocog alfa pegol (N8-GP, Esperoct), a glycopegylated recombinant factor VIII product, to treat hemophilia A.

The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.

Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.

The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.

The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.

Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).

Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).

[email protected]

The Food and Drug Administration has approved turoctocog alfa pegol (N8-GP, Esperoct), a glycopegylated recombinant factor VIII product, to treat hemophilia A.

The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.

Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.

The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.

The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.

Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).

Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).

[email protected]

The Food and Drug Administration has approved turoctocog alfa pegol (N8-GP, Esperoct), a glycopegylated recombinant factor VIII product, to treat hemophilia A.

The agency approved turoctocog alfa pegol for use as routine prophylaxis to reduce the frequency of bleeding episodes, for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in adults and children with hemophilia A.

Turoctocog alfa pegol will not be available in the United States before 2020, according to Novo Nordisk. The company cannot yet launch the product because of third-party intellectual property agreements.

The FDA’s approval of turoctocog alfa pegol was supported by results from the pathfinder 2 (NCT01480180), pathfinder 3 (NCT01489111), and pathfinder 5 (NCT01731600) trials.

The trials included children, adolescents, and adults with previously treated, severe hemophilia A and no history of inhibitors. Turoctocog alfa pegol was considered effective and well tolerated in these trials.

Pooled results from pathfinder 2 and pathfinder 5 were presented at the 2018 annual meeting of the American Society of Hematology (Blood. 2018:132:1177).

Results from pathfinder 3 were previously published in Haemophilia (2017. Sep;23[5]:689-96).

[email protected]

Individuals aged 65 years and over represent 13% of the United States population and account for nearly 40% of hospital discharges.¹ Bedrest hastens the functional decline of older patients^2-5 and is associated with risk of serious complications, such as falls, delirium, venous thrombosis, and skin breakdown.^6,7 Ambulation is widely recognized as important for improving hospital outcomes.^8-10 Observational studies suggest that increases of 600 steps per day are associated with shortened length of hospital stay.⁹ However, randomized trials of assisted ambulation have not demonstrated consistent benefit.^11-14 As a result, usual care at most hospitals in the United States does not include assisted ambulation. Even when ambulation is ordered, execution of the orders is inconsistent.^15-17

Studies have demonstrated the benefits of various exercise protocols for older patients in rehabilitation facilities,^18,19 medical intensive care units,²⁰ and medical and surgical wards.^13,18,21 These interventions are usually nursing centered; however, assisting patients with ambulation multiple times per day may be a burdensome addition to the myriad responsibilities of nurses.^19,22,23 In fact, ambulation orders are the most frequently overlooked nursing task.²⁴

We designed a graded protocol of assisted ambulation implemented by a dedicated patient care nursing assistant (PCNA) multiple times daily to increase patient mobility. The objective of this study was to assess the feasibility and effectiveness of such an intervention for older inpatients. We hypothesized that the intervention would prove feasible and improve hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay.

We conducted a single-blind randomized controlled trial of patients aged ≥60 years and admitted as medical inpatients to the Cleveland Clinic Main Campus, a tertiary care center with over 1,440 inpatient beds. The consent form and study protocol were approved by the Cleveland Clinic Institutional Review Board, and the study was registered with ClinicalTrials.gov (NCT02757131).

Patients

All patients who were admitted to study wards for a medical illness and evaluated by Physical Therapy (PT) were eligible for the study. PT evaluations were ordered by the medical team if deemed necessary on the basis of factors, such as age, estimated mobility, and concerns raised by the ancillary staff. All patients who were expected to be discharged to a skilled nursing facility placement or who required home PT received a PT evaluation. Assessment of mobility was documented via Activity Measure for Postacute Care Inpatient Basic Mobility “six-clicks” short form, hereafter abbreviated as “six-clicks.” Based on past experience, patients with scores <16 rarely go home (<20% of the time), and those with scores >20 usually go home regardless of ambulation. Therefore, only patients with scores of 16-20 were invited to participate in the study. Although patients who were not evaluated by PT might also benefit from the intervention, we required a six-clicks score to assess eligibility. The exclusion criteria included anticipated remaining length of stay less than three days, admission under observation status, admission to the intensive care unit (ICU,) patients receiving comfort care measures, and patients with medical conditions precluding ambulation, such as decompensated heart failure or unstable angina.

Randomization

Patients were randomized to “usual care” or “mobility technician” after baseline evaluation using a computerized system. A block randomization scheme with a size of four was used to ensure an approximately equal number of patients per group.

Intervention

Patients randomized to the intervention group were asked to participate in the ambulation protocol outlined by the PT three times daily under the supervision of the mobility technician. The protocol involved four exercise levels (sitting, standing, walking, and stairs), which were implemented depending on the patient’s physical capacity. The mobility technicians, who were PCNAs, were trained by the PT team. PCNAs have no specific degrees or certification. They are taught safe handling techniques during their job orientation, so they already had an understanding of how to transfer and assist a patient with ambulation. The mobility technician training consisted of one four-hour session run by the PT team in the physical therapy department and the nursing unit. The training included safe handling practices and basic mobility, such as transfers from bed to chair, bed to standing, walking with assistance, and walking independently with equipment such as cane, rolling walker, and walking belt. All instruction was demonstrated by the trainer, and the mobility technician was then able to practice. The mobility technician then shadowed the trainer and practiced the techniques under supervision. Competency was assessed by the trainer.

The cohort of patients randomized to “usual care” was not seen by the mobility technicians but was not otherwise restricted in nursing’s baseline ability to execute recommendations placed by the PT team. Compliance with the recommendations is highly variable and dependent on patient acuity during the shift, staffing issues, and competing duties. Cleveland Clinic promotes a “culture of mobility,” and nurses are encouraged to get patients out of bed and assist with ambulation.

Study Instruments—Measures of Mobility

The six-clicks instrument is a tool for measuring basic mobility. It was adapted from the Activity Measures for Post-Acute Care (AM-PAC) instrument.²⁵ Although initially created for self-report in the post-acute care setting, six-clicks has been validated for use by PTs in the acute care setting²⁶ and is currently in use at more than 1,000 US hospitals. Cleveland Clinic PTs have used this measure for routine evaluation since 2011. The instrument has high interrater reliability and can predict discharge disposition.^27-29

Each patient was provided with a tracking device (Fitbit) attached at the wrist to record daily steps for measuring mobility. The use of Fitbit has been validated in ambulatory and inpatient settings.³⁰ The device produces step counts within 3% of the observed step count for most patients but may undercount steps in patients with very slow gait.³¹ The device was provided to each enrollee and collected at discharge.

Variables

Demographic information, comorbid diagnoses, and discharge destination were extracted from the electronic medical record. Information on prehospitalization physical activity level was obtained from the initial PT assessment. Falls were tracked through the safety event reporting system.

Outcomes

The primary outcomes were discharge disposition and hospital length of stay. The secondary outcomes included average steps per day, change in six-clicks score from admission to discharge, inpatient mortality, admission to ICU, falls, deep vein thrombosis, pulmonary embolism, or pneumonia, and readmission within 30 days.

Statistical Analysis

Patient characteristics were summarized as means and standard deviations or medians and interquartile ranges for continuous variables and as frequencies and percentages for categorical variables. The t-test or Wilcoxon rank sum test was applied to compare continuous characteristics between the intervention and control groups. Chi-squared test or Fisher’s exact test was applied to compare categorical characteristics. Given its skewed distribution, the length of stay was log-transformed and compared between the two groups using Student’s t-test. Chi-squared test was used to compare categorical outcomes. The analysis of final six-clicks scores was adjusted for baseline scores, and the least-square estimates are provided. A linear mixed effects model was used to compare the number of daily steps taken because each participant had multiple steps measured. Results were adjusted for prehospital activity. In addition to comparing the total steps taken by each group, we determined the proportion of patients who exceeded a particular threshold by taking the average number of steps per day for all subjects and relating it to home discharge using the Receiver Operating Characteristics (ROC) curve. An optimal cut-off was determined to maximize the Youden index. We also compared the proportion of patients who exceeded 900 steps because this value was previously reported as an important threshold.³² All analyses were conducted using intention-to-treat principles. We also conducted a per-protocol analysis in which we limited the intervention group to those who received at least one assisted ambulation session. A dose-response analysis was also performed, in which patients were categorized as not receiving the therapy, receiving sessions on one or two days, or receiving them on more than two days.

All analyses were conducted using R-studio (Boston, MA). Statistical significance was defined as a P-value < .05. Given that this is a pilot study, the results were not adjusted for multiple comparisons.

Characteristics of patients in the intervention and control groups are shown in Table 1. The patients were mostly white and female, with an average age in the mid-70s (range 61-98). All measures evaluated were not significantly different between the intervention and control groups. However, more patients in the intervention group had a prehospital activity level classified as independent.

Table 2 demonstrates the feasibility of the intervention. Of patients randomized to the intervention group, 74% were ambulated at least once. Once enrolled, the patients successfully participated in assisted ambulation for about two-thirds of their hospital stay. However, the intervention was delivered for only one-third of the total length of stay because most patients were not enrolled on admission. On average, the mobility technicians made 11 attempts to ambulate each patient and 56% of these attempts were successful. The proportion of unsuccessful attempts did not change over the course of the study. The reasons for unsuccessful attempts included patient refusal (n = 102) or unavailability (n = 68), mobility technicians running out of time (n = 2), and other (n = 12).

In this pilot study conducted with older medical inpatients, we found that assisted ambulation provided by a dedicated mobility technician was feasible and increased the number of steps taken by patients. Not all patients in the treatment group received the intervention partly due to the fact that the program initially did not include weekends and the mobility technicians were sometimes redirected to other nursing duties. Both issues were addressed during the course of the study. In the per protocol analysis, the intervention increased the average six-clicks score and there was a nonsignificant reduction in the percentage of patients discharged to a rehabilitation facility.

A range of hospital-based mobility interventions have been described. Several of which were complex multidisciplinary interventions that included a mobility component. The compliance rates have ranged from 82% to 93.7%,12,13 although a systematic review noted that many studies do not provide this level of information.¹¹ Interventions were carried out by nursing staff and PT with support from family members and social workers.^33-35 Ambulation-specific programs have also relied on nurses and PT13,14,36 and, occasionally, on research assistants to implement assisted ambulation protocols.^12,37 A recent study that employed research assistants to deliver inhospital ambulation reported achieving 51.3% of intended walks.³⁷

In contradistinction to previous studies, we created a new role, employing PCNAs as dedicated mobility technicians. We did this for two reasons. First, the approach is less expensive than deploying registered nurses or PTs to ambulate patients and therefore more likely to be adopted by hospitals, especially if it can decrease the cost of an episode of care by avoiding subsequent inpatient rehabilitation. Mobility technicians have no degree or certification requirements and are therefore paid less than nurses or physical therapists. Second, by having a single responsibility, mobility technicians were more likely to engage in their task than nurses, who have competing responsibilities. However, when nurse staffing was short, nurse managers were tempted to recall the PCNAs for other nursing duties. It took time before PCNAs and supervisors prioritized this new responsibility. When they did, the number of attempted walks increased substantially, but the percentage of successful attempts remained constant at 56%, highlighting the difficulty of getting hospitalized patients to walk.

On average, patients who received the intervention engaged in 72 minutes of additional physical activity and averaged 990 steps per day. Observational data suggest patients accrue about 1,100 steps in the day before discharge, with older patients accruing closer to 900.21 One study found that older patients with fewer than 900 steps per day were likely to experience a functional decline.32 We also found that patients who achieved at least 900 steps were more likely to go home. However, we found that a lower threshold, namely, 400 steps, offered better discrimination between patients who go home and those who do not. Future prospective studies are needed to establish the appropriate goal for exercise interventions. A lower step goal could dramatically enhance the efficiency of the intervention.

A Cochrane review found that pooled analysis of multidisciplinary interventions that included exercise, often in the form of walking, achieved a small but significant increase in the proportion of patients discharged to home (RR 1.08, 95%CI 1.03 to 1.14).¹¹ We found no significant change in the discharge disposition, but our study was underpowered for this endpoint. The six-clicks score showed a small but significant change in the per protocol analysis. The six-clicks score has been shown to correlate with discharge disposition,^28,29 and an improvement in the score suggests that discharge disposition may be influenced.

The intervention may also not have been implemented for long enough. On average, visits were achieved for one-third of the hospital stay partly because of the delay in PT evaluation, which we required for eligibility. In practice, PT evaluation can occur just a few days before the anticipated discharge. We observed a dose dependent response among patients in the intervention group, suggesting that earlier intervention could be more effective. Earlier intervention might be achieved if the MT performed the six-clicks on potentially eligible patients.

The effects of hospitalization on mobility may be the most pronounced in the long term; one study found that 40% of hospitalized older patients manifested new ADL or IADL disability three months after discharge compared with 31% at discharge.⁷ Hospital-based mobility interventions may continue to affect subjects’ independence for weeks or months. In one RCT, an inpatient ambulation intervention improved mobility in the community one month after discharge.³⁷ A hospital-based exercise program that included ambulation achieved better functional outcomes one month later.¹³ One RCT that combined inpatient exercise with outpatient care coordination also decreased readmission rates.³⁴ We found that the intervention did not affect readmission.

This pilot study has several limitations. The sample size was small, and the findings need to be replicated in a larger randomized controlled trial. This is particularly important because the two study arms were not balanced in terms of their prehospital activity. After adjustment for prehospital activity, the differences in the step count in the intention-to-treat analysis were no longer significant. As we adjusted the intervention to hospital workflow, the intervention changed over time. The intention-to-treat analysis may therefore underestimate the effect of the intervention. This work provides a basis for future trial. Finally, discharge disposition depends on a complex interplay of factors, including social factors and preferences, which may not be affected by a mobility intervention.

In summary, an inhospital mobility protocol of attempting ambulation delivered by dedicated mobility technicians three times daily successfully increased the daily step counts and mobility scores of the patients. Studies with a larger sample size are needed to determine whether the proposed approach can affect length of hospital stay, discharge disposition, and overall cost of an episode of care.

Disclosures

Mary Stilphen reports consulting for CreCare and Adeo, which license and distribute AM-PAC short forms, including 6 clicks. All other authors report no conflicts of interest.

Funding

This study was supported by a Research Program Committee grant from the Cleveland Clinic.

Individuals aged 65 years and over represent 13% of the United States population and account for nearly 40% of hospital discharges.¹ Bedrest hastens the functional decline of older patients^2-5 and is associated with risk of serious complications, such as falls, delirium, venous thrombosis, and skin breakdown.^6,7 Ambulation is widely recognized as important for improving hospital outcomes.^8-10 Observational studies suggest that increases of 600 steps per day are associated with shortened length of hospital stay.⁹ However, randomized trials of assisted ambulation have not demonstrated consistent benefit.^11-14 As a result, usual care at most hospitals in the United States does not include assisted ambulation. Even when ambulation is ordered, execution of the orders is inconsistent.^15-17

Studies have demonstrated the benefits of various exercise protocols for older patients in rehabilitation facilities,^18,19 medical intensive care units,²⁰ and medical and surgical wards.^13,18,21 These interventions are usually nursing centered; however, assisting patients with ambulation multiple times per day may be a burdensome addition to the myriad responsibilities of nurses.^19,22,23 In fact, ambulation orders are the most frequently overlooked nursing task.²⁴

We designed a graded protocol of assisted ambulation implemented by a dedicated patient care nursing assistant (PCNA) multiple times daily to increase patient mobility. The objective of this study was to assess the feasibility and effectiveness of such an intervention for older inpatients. We hypothesized that the intervention would prove feasible and improve hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay.

We conducted a single-blind randomized controlled trial of patients aged ≥60 years and admitted as medical inpatients to the Cleveland Clinic Main Campus, a tertiary care center with over 1,440 inpatient beds. The consent form and study protocol were approved by the Cleveland Clinic Institutional Review Board, and the study was registered with ClinicalTrials.gov (NCT02757131).

Patients

All patients who were admitted to study wards for a medical illness and evaluated by Physical Therapy (PT) were eligible for the study. PT evaluations were ordered by the medical team if deemed necessary on the basis of factors, such as age, estimated mobility, and concerns raised by the ancillary staff. All patients who were expected to be discharged to a skilled nursing facility placement or who required home PT received a PT evaluation. Assessment of mobility was documented via Activity Measure for Postacute Care Inpatient Basic Mobility “six-clicks” short form, hereafter abbreviated as “six-clicks.” Based on past experience, patients with scores <16 rarely go home (<20% of the time), and those with scores >20 usually go home regardless of ambulation. Therefore, only patients with scores of 16-20 were invited to participate in the study. Although patients who were not evaluated by PT might also benefit from the intervention, we required a six-clicks score to assess eligibility. The exclusion criteria included anticipated remaining length of stay less than three days, admission under observation status, admission to the intensive care unit (ICU,) patients receiving comfort care measures, and patients with medical conditions precluding ambulation, such as decompensated heart failure or unstable angina.

Randomization

Patients were randomized to “usual care” or “mobility technician” after baseline evaluation using a computerized system. A block randomization scheme with a size of four was used to ensure an approximately equal number of patients per group.

Intervention

Patients randomized to the intervention group were asked to participate in the ambulation protocol outlined by the PT three times daily under the supervision of the mobility technician. The protocol involved four exercise levels (sitting, standing, walking, and stairs), which were implemented depending on the patient’s physical capacity. The mobility technicians, who were PCNAs, were trained by the PT team. PCNAs have no specific degrees or certification. They are taught safe handling techniques during their job orientation, so they already had an understanding of how to transfer and assist a patient with ambulation. The mobility technician training consisted of one four-hour session run by the PT team in the physical therapy department and the nursing unit. The training included safe handling practices and basic mobility, such as transfers from bed to chair, bed to standing, walking with assistance, and walking independently with equipment such as cane, rolling walker, and walking belt. All instruction was demonstrated by the trainer, and the mobility technician was then able to practice. The mobility technician then shadowed the trainer and practiced the techniques under supervision. Competency was assessed by the trainer.

The cohort of patients randomized to “usual care” was not seen by the mobility technicians but was not otherwise restricted in nursing’s baseline ability to execute recommendations placed by the PT team. Compliance with the recommendations is highly variable and dependent on patient acuity during the shift, staffing issues, and competing duties. Cleveland Clinic promotes a “culture of mobility,” and nurses are encouraged to get patients out of bed and assist with ambulation.

Study Instruments—Measures of Mobility

The six-clicks instrument is a tool for measuring basic mobility. It was adapted from the Activity Measures for Post-Acute Care (AM-PAC) instrument.²⁵ Although initially created for self-report in the post-acute care setting, six-clicks has been validated for use by PTs in the acute care setting²⁶ and is currently in use at more than 1,000 US hospitals. Cleveland Clinic PTs have used this measure for routine evaluation since 2011. The instrument has high interrater reliability and can predict discharge disposition.^27-29

Each patient was provided with a tracking device (Fitbit) attached at the wrist to record daily steps for measuring mobility. The use of Fitbit has been validated in ambulatory and inpatient settings.³⁰ The device produces step counts within 3% of the observed step count for most patients but may undercount steps in patients with very slow gait.³¹ The device was provided to each enrollee and collected at discharge.

Variables

Demographic information, comorbid diagnoses, and discharge destination were extracted from the electronic medical record. Information on prehospitalization physical activity level was obtained from the initial PT assessment. Falls were tracked through the safety event reporting system.

Outcomes

The primary outcomes were discharge disposition and hospital length of stay. The secondary outcomes included average steps per day, change in six-clicks score from admission to discharge, inpatient mortality, admission to ICU, falls, deep vein thrombosis, pulmonary embolism, or pneumonia, and readmission within 30 days.

Statistical Analysis

Patient characteristics were summarized as means and standard deviations or medians and interquartile ranges for continuous variables and as frequencies and percentages for categorical variables. The t-test or Wilcoxon rank sum test was applied to compare continuous characteristics between the intervention and control groups. Chi-squared test or Fisher’s exact test was applied to compare categorical characteristics. Given its skewed distribution, the length of stay was log-transformed and compared between the two groups using Student’s t-test. Chi-squared test was used to compare categorical outcomes. The analysis of final six-clicks scores was adjusted for baseline scores, and the least-square estimates are provided. A linear mixed effects model was used to compare the number of daily steps taken because each participant had multiple steps measured. Results were adjusted for prehospital activity. In addition to comparing the total steps taken by each group, we determined the proportion of patients who exceeded a particular threshold by taking the average number of steps per day for all subjects and relating it to home discharge using the Receiver Operating Characteristics (ROC) curve. An optimal cut-off was determined to maximize the Youden index. We also compared the proportion of patients who exceeded 900 steps because this value was previously reported as an important threshold.³² All analyses were conducted using intention-to-treat principles. We also conducted a per-protocol analysis in which we limited the intervention group to those who received at least one assisted ambulation session. A dose-response analysis was also performed, in which patients were categorized as not receiving the therapy, receiving sessions on one or two days, or receiving them on more than two days.

All analyses were conducted using R-studio (Boston, MA). Statistical significance was defined as a P-value < .05. Given that this is a pilot study, the results were not adjusted for multiple comparisons.

Characteristics of patients in the intervention and control groups are shown in Table 1. The patients were mostly white and female, with an average age in the mid-70s (range 61-98). All measures evaluated were not significantly different between the intervention and control groups. However, more patients in the intervention group had a prehospital activity level classified as independent.

Table 2 demonstrates the feasibility of the intervention. Of patients randomized to the intervention group, 74% were ambulated at least once. Once enrolled, the patients successfully participated in assisted ambulation for about two-thirds of their hospital stay. However, the intervention was delivered for only one-third of the total length of stay because most patients were not enrolled on admission. On average, the mobility technicians made 11 attempts to ambulate each patient and 56% of these attempts were successful. The proportion of unsuccessful attempts did not change over the course of the study. The reasons for unsuccessful attempts included patient refusal (n = 102) or unavailability (n = 68), mobility technicians running out of time (n = 2), and other (n = 12).

In this pilot study conducted with older medical inpatients, we found that assisted ambulation provided by a dedicated mobility technician was feasible and increased the number of steps taken by patients. Not all patients in the treatment group received the intervention partly due to the fact that the program initially did not include weekends and the mobility technicians were sometimes redirected to other nursing duties. Both issues were addressed during the course of the study. In the per protocol analysis, the intervention increased the average six-clicks score and there was a nonsignificant reduction in the percentage of patients discharged to a rehabilitation facility.

A range of hospital-based mobility interventions have been described. Several of which were complex multidisciplinary interventions that included a mobility component. The compliance rates have ranged from 82% to 93.7%,12,13 although a systematic review noted that many studies do not provide this level of information.¹¹ Interventions were carried out by nursing staff and PT with support from family members and social workers.^33-35 Ambulation-specific programs have also relied on nurses and PT13,14,36 and, occasionally, on research assistants to implement assisted ambulation protocols.^12,37 A recent study that employed research assistants to deliver inhospital ambulation reported achieving 51.3% of intended walks.³⁷

In contradistinction to previous studies, we created a new role, employing PCNAs as dedicated mobility technicians. We did this for two reasons. First, the approach is less expensive than deploying registered nurses or PTs to ambulate patients and therefore more likely to be adopted by hospitals, especially if it can decrease the cost of an episode of care by avoiding subsequent inpatient rehabilitation. Mobility technicians have no degree or certification requirements and are therefore paid less than nurses or physical therapists. Second, by having a single responsibility, mobility technicians were more likely to engage in their task than nurses, who have competing responsibilities. However, when nurse staffing was short, nurse managers were tempted to recall the PCNAs for other nursing duties. It took time before PCNAs and supervisors prioritized this new responsibility. When they did, the number of attempted walks increased substantially, but the percentage of successful attempts remained constant at 56%, highlighting the difficulty of getting hospitalized patients to walk.

On average, patients who received the intervention engaged in 72 minutes of additional physical activity and averaged 990 steps per day. Observational data suggest patients accrue about 1,100 steps in the day before discharge, with older patients accruing closer to 900.21 One study found that older patients with fewer than 900 steps per day were likely to experience a functional decline.32 We also found that patients who achieved at least 900 steps were more likely to go home. However, we found that a lower threshold, namely, 400 steps, offered better discrimination between patients who go home and those who do not. Future prospective studies are needed to establish the appropriate goal for exercise interventions. A lower step goal could dramatically enhance the efficiency of the intervention.

A Cochrane review found that pooled analysis of multidisciplinary interventions that included exercise, often in the form of walking, achieved a small but significant increase in the proportion of patients discharged to home (RR 1.08, 95%CI 1.03 to 1.14).¹¹ We found no significant change in the discharge disposition, but our study was underpowered for this endpoint. The six-clicks score showed a small but significant change in the per protocol analysis. The six-clicks score has been shown to correlate with discharge disposition,^28,29 and an improvement in the score suggests that discharge disposition may be influenced.

The intervention may also not have been implemented for long enough. On average, visits were achieved for one-third of the hospital stay partly because of the delay in PT evaluation, which we required for eligibility. In practice, PT evaluation can occur just a few days before the anticipated discharge. We observed a dose dependent response among patients in the intervention group, suggesting that earlier intervention could be more effective. Earlier intervention might be achieved if the MT performed the six-clicks on potentially eligible patients.

The effects of hospitalization on mobility may be the most pronounced in the long term; one study found that 40% of hospitalized older patients manifested new ADL or IADL disability three months after discharge compared with 31% at discharge.⁷ Hospital-based mobility interventions may continue to affect subjects’ independence for weeks or months. In one RCT, an inpatient ambulation intervention improved mobility in the community one month after discharge.³⁷ A hospital-based exercise program that included ambulation achieved better functional outcomes one month later.¹³ One RCT that combined inpatient exercise with outpatient care coordination also decreased readmission rates.³⁴ We found that the intervention did not affect readmission.

This pilot study has several limitations. The sample size was small, and the findings need to be replicated in a larger randomized controlled trial. This is particularly important because the two study arms were not balanced in terms of their prehospital activity. After adjustment for prehospital activity, the differences in the step count in the intention-to-treat analysis were no longer significant. As we adjusted the intervention to hospital workflow, the intervention changed over time. The intention-to-treat analysis may therefore underestimate the effect of the intervention. This work provides a basis for future trial. Finally, discharge disposition depends on a complex interplay of factors, including social factors and preferences, which may not be affected by a mobility intervention.

In summary, an inhospital mobility protocol of attempting ambulation delivered by dedicated mobility technicians three times daily successfully increased the daily step counts and mobility scores of the patients. Studies with a larger sample size are needed to determine whether the proposed approach can affect length of hospital stay, discharge disposition, and overall cost of an episode of care.

Disclosures

Mary Stilphen reports consulting for CreCare and Adeo, which license and distribute AM-PAC short forms, including 6 clicks. All other authors report no conflicts of interest.

Funding

This study was supported by a Research Program Committee grant from the Cleveland Clinic.

Individuals aged 65 years and over represent 13% of the United States population and account for nearly 40% of hospital discharges.¹ Bedrest hastens the functional decline of older patients^2-5 and is associated with risk of serious complications, such as falls, delirium, venous thrombosis, and skin breakdown.^6,7 Ambulation is widely recognized as important for improving hospital outcomes.^8-10 Observational studies suggest that increases of 600 steps per day are associated with shortened length of hospital stay.⁹ However, randomized trials of assisted ambulation have not demonstrated consistent benefit.^11-14 As a result, usual care at most hospitals in the United States does not include assisted ambulation. Even when ambulation is ordered, execution of the orders is inconsistent.^15-17

Studies have demonstrated the benefits of various exercise protocols for older patients in rehabilitation facilities,^18,19 medical intensive care units,²⁰ and medical and surgical wards.^13,18,21 These interventions are usually nursing centered; however, assisting patients with ambulation multiple times per day may be a burdensome addition to the myriad responsibilities of nurses.^19,22,23 In fact, ambulation orders are the most frequently overlooked nursing task.²⁴

We designed a graded protocol of assisted ambulation implemented by a dedicated patient care nursing assistant (PCNA) multiple times daily to increase patient mobility. The objective of this study was to assess the feasibility and effectiveness of such an intervention for older inpatients. We hypothesized that the intervention would prove feasible and improve hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay.

We conducted a single-blind randomized controlled trial of patients aged ≥60 years and admitted as medical inpatients to the Cleveland Clinic Main Campus, a tertiary care center with over 1,440 inpatient beds. The consent form and study protocol were approved by the Cleveland Clinic Institutional Review Board, and the study was registered with ClinicalTrials.gov (NCT02757131).

Patients

All patients who were admitted to study wards for a medical illness and evaluated by Physical Therapy (PT) were eligible for the study. PT evaluations were ordered by the medical team if deemed necessary on the basis of factors, such as age, estimated mobility, and concerns raised by the ancillary staff. All patients who were expected to be discharged to a skilled nursing facility placement or who required home PT received a PT evaluation. Assessment of mobility was documented via Activity Measure for Postacute Care Inpatient Basic Mobility “six-clicks” short form, hereafter abbreviated as “six-clicks.” Based on past experience, patients with scores <16 rarely go home (<20% of the time), and those with scores >20 usually go home regardless of ambulation. Therefore, only patients with scores of 16-20 were invited to participate in the study. Although patients who were not evaluated by PT might also benefit from the intervention, we required a six-clicks score to assess eligibility. The exclusion criteria included anticipated remaining length of stay less than three days, admission under observation status, admission to the intensive care unit (ICU,) patients receiving comfort care measures, and patients with medical conditions precluding ambulation, such as decompensated heart failure or unstable angina.

Randomization

Patients were randomized to “usual care” or “mobility technician” after baseline evaluation using a computerized system. A block randomization scheme with a size of four was used to ensure an approximately equal number of patients per group.

Intervention

Patients randomized to the intervention group were asked to participate in the ambulation protocol outlined by the PT three times daily under the supervision of the mobility technician. The protocol involved four exercise levels (sitting, standing, walking, and stairs), which were implemented depending on the patient’s physical capacity. The mobility technicians, who were PCNAs, were trained by the PT team. PCNAs have no specific degrees or certification. They are taught safe handling techniques during their job orientation, so they already had an understanding of how to transfer and assist a patient with ambulation. The mobility technician training consisted of one four-hour session run by the PT team in the physical therapy department and the nursing unit. The training included safe handling practices and basic mobility, such as transfers from bed to chair, bed to standing, walking with assistance, and walking independently with equipment such as cane, rolling walker, and walking belt. All instruction was demonstrated by the trainer, and the mobility technician was then able to practice. The mobility technician then shadowed the trainer and practiced the techniques under supervision. Competency was assessed by the trainer.

The cohort of patients randomized to “usual care” was not seen by the mobility technicians but was not otherwise restricted in nursing’s baseline ability to execute recommendations placed by the PT team. Compliance with the recommendations is highly variable and dependent on patient acuity during the shift, staffing issues, and competing duties. Cleveland Clinic promotes a “culture of mobility,” and nurses are encouraged to get patients out of bed and assist with ambulation.

Study Instruments—Measures of Mobility

The six-clicks instrument is a tool for measuring basic mobility. It was adapted from the Activity Measures for Post-Acute Care (AM-PAC) instrument.²⁵ Although initially created for self-report in the post-acute care setting, six-clicks has been validated for use by PTs in the acute care setting²⁶ and is currently in use at more than 1,000 US hospitals. Cleveland Clinic PTs have used this measure for routine evaluation since 2011. The instrument has high interrater reliability and can predict discharge disposition.^27-29

Each patient was provided with a tracking device (Fitbit) attached at the wrist to record daily steps for measuring mobility. The use of Fitbit has been validated in ambulatory and inpatient settings.³⁰ The device produces step counts within 3% of the observed step count for most patients but may undercount steps in patients with very slow gait.³¹ The device was provided to each enrollee and collected at discharge.

Variables

Demographic information, comorbid diagnoses, and discharge destination were extracted from the electronic medical record. Information on prehospitalization physical activity level was obtained from the initial PT assessment. Falls were tracked through the safety event reporting system.

Outcomes

The primary outcomes were discharge disposition and hospital length of stay. The secondary outcomes included average steps per day, change in six-clicks score from admission to discharge, inpatient mortality, admission to ICU, falls, deep vein thrombosis, pulmonary embolism, or pneumonia, and readmission within 30 days.

Statistical Analysis

Patient characteristics were summarized as means and standard deviations or medians and interquartile ranges for continuous variables and as frequencies and percentages for categorical variables. The t-test or Wilcoxon rank sum test was applied to compare continuous characteristics between the intervention and control groups. Chi-squared test or Fisher’s exact test was applied to compare categorical characteristics. Given its skewed distribution, the length of stay was log-transformed and compared between the two groups using Student’s t-test. Chi-squared test was used to compare categorical outcomes. The analysis of final six-clicks scores was adjusted for baseline scores, and the least-square estimates are provided. A linear mixed effects model was used to compare the number of daily steps taken because each participant had multiple steps measured. Results were adjusted for prehospital activity. In addition to comparing the total steps taken by each group, we determined the proportion of patients who exceeded a particular threshold by taking the average number of steps per day for all subjects and relating it to home discharge using the Receiver Operating Characteristics (ROC) curve. An optimal cut-off was determined to maximize the Youden index. We also compared the proportion of patients who exceeded 900 steps because this value was previously reported as an important threshold.³² All analyses were conducted using intention-to-treat principles. We also conducted a per-protocol analysis in which we limited the intervention group to those who received at least one assisted ambulation session. A dose-response analysis was also performed, in which patients were categorized as not receiving the therapy, receiving sessions on one or two days, or receiving them on more than two days.

All analyses were conducted using R-studio (Boston, MA). Statistical significance was defined as a P-value < .05. Given that this is a pilot study, the results were not adjusted for multiple comparisons.

Characteristics of patients in the intervention and control groups are shown in Table 1. The patients were mostly white and female, with an average age in the mid-70s (range 61-98). All measures evaluated were not significantly different between the intervention and control groups. However, more patients in the intervention group had a prehospital activity level classified as independent.

Table 2 demonstrates the feasibility of the intervention. Of patients randomized to the intervention group, 74% were ambulated at least once. Once enrolled, the patients successfully participated in assisted ambulation for about two-thirds of their hospital stay. However, the intervention was delivered for only one-third of the total length of stay because most patients were not enrolled on admission. On average, the mobility technicians made 11 attempts to ambulate each patient and 56% of these attempts were successful. The proportion of unsuccessful attempts did not change over the course of the study. The reasons for unsuccessful attempts included patient refusal (n = 102) or unavailability (n = 68), mobility technicians running out of time (n = 2), and other (n = 12).

In this pilot study conducted with older medical inpatients, we found that assisted ambulation provided by a dedicated mobility technician was feasible and increased the number of steps taken by patients. Not all patients in the treatment group received the intervention partly due to the fact that the program initially did not include weekends and the mobility technicians were sometimes redirected to other nursing duties. Both issues were addressed during the course of the study. In the per protocol analysis, the intervention increased the average six-clicks score and there was a nonsignificant reduction in the percentage of patients discharged to a rehabilitation facility.

A range of hospital-based mobility interventions have been described. Several of which were complex multidisciplinary interventions that included a mobility component. The compliance rates have ranged from 82% to 93.7%,12,13 although a systematic review noted that many studies do not provide this level of information.¹¹ Interventions were carried out by nursing staff and PT with support from family members and social workers.^33-35 Ambulation-specific programs have also relied on nurses and PT13,14,36 and, occasionally, on research assistants to implement assisted ambulation protocols.^12,37 A recent study that employed research assistants to deliver inhospital ambulation reported achieving 51.3% of intended walks.³⁷

In contradistinction to previous studies, we created a new role, employing PCNAs as dedicated mobility technicians. We did this for two reasons. First, the approach is less expensive than deploying registered nurses or PTs to ambulate patients and therefore more likely to be adopted by hospitals, especially if it can decrease the cost of an episode of care by avoiding subsequent inpatient rehabilitation. Mobility technicians have no degree or certification requirements and are therefore paid less than nurses or physical therapists. Second, by having a single responsibility, mobility technicians were more likely to engage in their task than nurses, who have competing responsibilities. However, when nurse staffing was short, nurse managers were tempted to recall the PCNAs for other nursing duties. It took time before PCNAs and supervisors prioritized this new responsibility. When they did, the number of attempted walks increased substantially, but the percentage of successful attempts remained constant at 56%, highlighting the difficulty of getting hospitalized patients to walk.

On average, patients who received the intervention engaged in 72 minutes of additional physical activity and averaged 990 steps per day. Observational data suggest patients accrue about 1,100 steps in the day before discharge, with older patients accruing closer to 900.21 One study found that older patients with fewer than 900 steps per day were likely to experience a functional decline.32 We also found that patients who achieved at least 900 steps were more likely to go home. However, we found that a lower threshold, namely, 400 steps, offered better discrimination between patients who go home and those who do not. Future prospective studies are needed to establish the appropriate goal for exercise interventions. A lower step goal could dramatically enhance the efficiency of the intervention.

A Cochrane review found that pooled analysis of multidisciplinary interventions that included exercise, often in the form of walking, achieved a small but significant increase in the proportion of patients discharged to home (RR 1.08, 95%CI 1.03 to 1.14).¹¹ We found no significant change in the discharge disposition, but our study was underpowered for this endpoint. The six-clicks score showed a small but significant change in the per protocol analysis. The six-clicks score has been shown to correlate with discharge disposition,^28,29 and an improvement in the score suggests that discharge disposition may be influenced.

The intervention may also not have been implemented for long enough. On average, visits were achieved for one-third of the hospital stay partly because of the delay in PT evaluation, which we required for eligibility. In practice, PT evaluation can occur just a few days before the anticipated discharge. We observed a dose dependent response among patients in the intervention group, suggesting that earlier intervention could be more effective. Earlier intervention might be achieved if the MT performed the six-clicks on potentially eligible patients.

The effects of hospitalization on mobility may be the most pronounced in the long term; one study found that 40% of hospitalized older patients manifested new ADL or IADL disability three months after discharge compared with 31% at discharge.⁷ Hospital-based mobility interventions may continue to affect subjects’ independence for weeks or months. In one RCT, an inpatient ambulation intervention improved mobility in the community one month after discharge.³⁷ A hospital-based exercise program that included ambulation achieved better functional outcomes one month later.¹³ One RCT that combined inpatient exercise with outpatient care coordination also decreased readmission rates.³⁴ We found that the intervention did not affect readmission.

This pilot study has several limitations. The sample size was small, and the findings need to be replicated in a larger randomized controlled trial. This is particularly important because the two study arms were not balanced in terms of their prehospital activity. After adjustment for prehospital activity, the differences in the step count in the intention-to-treat analysis were no longer significant. As we adjusted the intervention to hospital workflow, the intervention changed over time. The intention-to-treat analysis may therefore underestimate the effect of the intervention. This work provides a basis for future trial. Finally, discharge disposition depends on a complex interplay of factors, including social factors and preferences, which may not be affected by a mobility intervention.

In summary, an inhospital mobility protocol of attempting ambulation delivered by dedicated mobility technicians three times daily successfully increased the daily step counts and mobility scores of the patients. Studies with a larger sample size are needed to determine whether the proposed approach can affect length of hospital stay, discharge disposition, and overall cost of an episode of care.

Disclosures

Mary Stilphen reports consulting for CreCare and Adeo, which license and distribute AM-PAC short forms, including 6 clicks. All other authors report no conflicts of interest.

Funding

This study was supported by a Research Program Committee grant from the Cleveland Clinic.