patient engagement

December 10, 2021: Decentralized Trials: Naughty or Nice? (Adrian F. Hernandez, MD, MHS)

Posted on by terren.green@duke.edu

Speaker

Adrian F. Hernandez, MD, MHS
Executive Director, Duke Clinical Research Institute
Vice Dean, Duke University School of Medicine

Topic

Decentralized Trials: Naughty or Nice?

Keywords

Decentralized trials; Study design; Implementation; Patient engagement; Patient-reported data

Key Points

  • Decentralized trials have been occurring since the start of the internet and mobile devices to reach people where they are and collect data in places we were not able to in the past.
  • One key problem decentralized trials can help solve is the gap between those who wish to participate in research and those who actually do participate. Clinical trial deserts and lack of broadband widen the gap between those who wish to participate and those who are able.
  • Decentralized trials attempt to capture data remotely instead of at a site and virtually(patient-reported) rather than recorded by study personnel.
  • COVID-19 flipped the model for clinical trial visits from that of site-based visits and care to home based, virtual visits and care.
  • Enrollment can be a challenge for decentralized trials and requires engagement campaigns at various timepoints in the study to achieve desired enrollment numbers.
  • Decentralized trials can help ensure inclusion of diverse communities in your study population.
  • The HeartLine study, CHIEF-HF study, HERO-Together study, and ACTIV-6 study are taking advantage of various technologies to decentralize study design.

Discussion Themes

Decentralized methods may improve recruitment, but may not improve retention. We may need a hybrid model to keep a patient engaged.

Decentralized methods may require decisions about what data we should collect and what we could collect, but don’t need.

 

Read more about decentralized study design in Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010-2016: A Systematic Literature Review and Digitizing Clinical Trials.

 

Tags

#pctGR, @Collaboratory1

December 3, 2021: Primary Care-Based Behavioral Treatment for Long Term Opioid Users with Chronic Pain: Primary Results and Lessons Learned from the PPACT Pragmatic Trial (Lynn DeBar, PhD MPH)

Posted on by terren.green@duke.edu

Speaker

Lynn DeBar, PhD MPH
Senior Scientist
Kaiser Permanente Washington Health Research Institute
Seattle, WA

Keywords

PPACT, Chronic pain, Opioid use, Patient reported outcome data, Patient-centered research, Cognitive behavioral therapy

Key Points

  • Chronic Pain is responsible for far more years lived with disability than a large number of other diseases and injuries, such as COPD, diabetes, dementia, stroke and others, combined.
  • PPACT was a cluster randomized study aimed at integrating interdisciplinary pain management methods into primary care to improve care for patients with chronic pain.
  • Participants had been prescribed long-term opioids for mixed chronic pain conditions.
  • Study intervention lasted 12 weeks and included cognitive behavioral therapy, yoga-based exercises, physical therapy, a medication review, and support from a primary care provider.
  • Participants in the treatment group of the PPACT study showed a modest reduction of pain that was sustained over a 12 month period.
  • The PPACT intervention was cost effective versus usual treatment methods.

Discussion Themes

An in-person enhanced enrollment session was conducted to give potential subjects a comprehensive overview of the study procedures. This enrollment session led to fewer people enrolling in the study, but of those that did, more completed the study.

The key to successful CBT is an interactive patient-centered approach.

 

Read more about the PPACT study.

 

Tags

#pctGR, @Collaboratory1

November 19, 2021: Exploring Approaches in Using Digital and Mobile Health in Patient-oriented Research: Pearls and Pitfalls (Anish K. Agarwal MD, MPH MS)

Posted on by terren.green@duke.edu

Speaker

Anish K. Agarwal MD, MPH MS
Assistant Professor of Emergency Medicine
Clinical Innovation Manager, Penn Medicine Center for Health Care Innovation
University of Pennsylvania, Perelman School of Medicine

Topic

Exploring Approaches in Using Digital and Mobile Health in Patient-oriented Research: Pearls and Pitfalls

Keywords

Mobile health; Digital health; Patient-oriented research; Study design

Key Points

  • Digital and mobile health is a rapidly evolving field that integrates with the electronic health records in both low and high tech ways.
  • Dr. Agarwal conducted a randomized control trial of overweight veterans who had daily access to a smartphone or tablet. These participants were sent a wearable device to collect step count data.
  • An important consideration for studies using mobile health technology is participant access to a smart or mobile device. 85% of Americans have access to a Smartphone where 97% have access to a mobile device that can receive texts. 20% use a smartwatch.
  • Mobile methods are just tools to support overall study design.
  • Dr. Agrawal conducted a study on post-operative opioid prescribing and use. Data was gathered from participants via text messaging systems.
  • Simple text messages that are more conversational in nature are received better by the participant. Links in text messages should be limited. It’s important for participants to understand the privacy and security of their communications and data. Nudge a participant with a text at the right time to avoid being overbearing.

Discussion Themes

Let patients know that SMS is not secure, and frame questions to avoid patients sending HIPAA covered data via text.

A good relationship with your institutions Privacy and Safety office is fundamental to navigating IRB regulations for research with digital and mobile devices.

 

Read more about Dr. Agarwal’s studies using mobile health devices: Effect of Gamification With and Without Financial Incentives to Increase Physical Activity Among Veterans Classified as Having Obesity or Overweight: A Randomized Clinical Trial and Patient-Reported Opioid Consumption and Pain Intensity After Common Orthopedic and Urologic Surgical Procedures With Use of an Automated Text Messaging System.

 

Tags

#pctGR, @Collaboratory1

November 12, 2021: Using Financial Incentives to Increase COVID-19 Vaccine Uptake (Charlene Wong, MD MSHP; Noel T. Brewer, PhD)

Posted on by terren.green@duke.edu

Speakers

Charlene Wong, MD MSHP
Associate Professor of Pediatrics and Public Policy
Duke University School of Medicine
Chief Health Policy Officer for COVID-19
North Carolina Department of Health and Human Services

Noel T. Brewer, PhD
Gillings Distinguished Professor in Public Health
Department of Health Behavior
Gillings School of Global Public Health
University of North Carolina
Member, Lineberger Comprehensive Cancer Center
University of North Carolina

Topic

Using Financial Incentives to Increase COVID-19 Vaccine Uptake

Keywords

COVID-19; Vaccine; Incentive; North Carolina DHHS

Key Points

  • The Summer Cash Card incentive program, run by the North Carolina Department of Health and Human Services from May 26 to June 8, 2021, offered $25 gift cards as an incentive to receive a COVID-19 vaccination and an additional $25 gift card to anyone transporting individuals to a vaccination site.
  • During the time period that the Summer Cash Card incentive program was running, 2 in 10 people indicated that they were likely to get vaccinated, but remained unvaccinated for reasons such as lost wages, lack of child care, and lack of transportation.
  • Other incentive programs used in North Carolina included drawings for larger cash prizes or college scholarships for teens.
  • Recipients of $25 gift cards completed a survey asking the importance of getting the $25 gift card in their decision to get vaccinated or drive someone to get vaccinated.
  • Results from the survey showed that the financial incentive was particularly important to Hispanic individuals and individuals with an annual income below $40,000.
  • During times when vaccine administration fell, incentive sites did not see the same drop in vaccination rates.
  • Incentives are effective if they are known, valued, contingent, certain, and immediate.

Discussion Themes

For many individuals cost or transportation issues are the main barrier to vaccination.

Financial incentives could be considered coercive, but the benefits to the individual and the community are broad and the risks low. The $25 incentive is a fair amount to cover the costs of lost wages and transportation that it takes to get to the vaccine clinic.

Focus for incentives is still on the remaining people who are not vaccinated at all rather than on those who need booster vaccines.

 

Read more about the North Carolina DHHS financial incentive program for COVID-19 vaccines. Read the JAMA paper published in October 2021.

 

Tags

#pctGR, @Collaboratory1

October 8, 2021: Lessons Learned and Patient Partnership in ADAPTABLE (Schuyler Jones, MD; Madelaine Faulkner Modrow, MPH)

Posted on by terren.green@duke.edu

Speakers

Schuyler Jones, MD
Associate Professor of Medicine
Duke University School of Medicine

Madelaine Faulkner Modrow, MPH
Program Director
Department of Epidemiology and Biostatistics
University of California, San Francisco

Topic

Lessons Learned and Patient Partnership in ADAPTABLE

Keywords

Patient engagement; Pragmatic clinical trial; Aspirin; ADAPTABLE; Study design; Stakeholder engagement; Recruitment

Key Points

  • ADAPTABLE is a pragmatic clinical study of 15,000 patients to examine a simple, everyday decision, whether to take 81mg or 325mg of aspirin daily, to identify if that decision could prevent heart attacks.
  • ADAPTABLE used both pragmatic and personalized approaches to participant recruitment.
  • Pragmatic recruitment involves broad-based email and social media outreach to a large pool of potential subjects. This method of recruitment was lower cost, less time intensive, and faster paced than personalized recruitment.
  • Personalized recruitment involves traditional in-clinic or phone call personal outreach to potential participants. This method of recruitment was higher cost, time intensive, and slower paced than personalized recruitment.
  • ADAPTABLE learned a critical lesson in patient engagement: in-clinic enrollment was much higher at 81% of those approached versus e-communication enrollment at 35% of those contacted.
  • Key principles of patient engagement include trust and partnership, respect and listening, empowering patients to find solutions, and value and design the trial for the patient experience.

Discussion Themes

We are moving from a traditional model of research to a relational model with participants coming together with researchers and forming a kind of social contract where a participant’s voice is valued in the research process.

We have lessons left to learn in order to fully utilize technology for patient engagement including how to use broad outreach methods to increase enrollment of diverse populations.

Patients continue to look to their clinician or doctor for advice on whether to participate in a clinical trial. Trusted contacts will continue to play an important role in the recruitment process.

 

Read more about the ADAPTABLE trial.

Tags

#pctGR, @Collaboratory1

October 6, 2021: Patient Partnership in ADAPTABLE Featured in This Friday’s PCT Grand Rounds

Posted on by Damon Seils
Headshots of Madelaine Faulkner Modrow and Dr. Schuyler Jones
Madelaine Faulkner Modrow (left) and Dr. Schuyler Jones

In this Friday’s PCT Grand Rounds, Madelaine Faulkner Modrow of the University of California, San Francisco, and Dr. Schuyler Jones of Duke University will present “Lessons Learned and Patient Partnership in ADAPTABLE.”

The Grand Rounds session will be held on Friday, October 8, at 1:00 pm eastern. Join the online meeting.

For webinar recordings and slides from previous Grand Rounds sessions, see the Grand Rounds hub.

September 24, 2021: Enabling Patient-Reported Outcome Measures (PROMs) in Clinical Trials, Exemplified by Cardiovascular Trials (Theresa Coles, PhD; Kevin Weinfurt, PhD)

Posted on by terren.green@duke.edu

Speakers

Theresa Coles, PhD
Assistant Professor
Department of Population Health Sciences
Duke University School of Medicine

Kevin Weinfurt, PhD
Professor and Vice Chair of Research
Department of Population Health Sciences
Duke University School of Medicine

Topic

Enabling Patient-Reported Outcome Measures (PROMs) in Clinical Trials, Exemplified by Cardiovascular Trials

Keywords

Patient-reported outcomes; PROM; Validity Theory; Patient engagement

Key Points

  • Patient-reported outcome scores have value and bring different measures of outcome, such as quality of life and burden of treatment into focus in a study.
  • PROMs, or Patient Reported Outcome Measures, are not routinely collected in clinical care so they are not readily available in the electronic health record.
  • Challenges of integrating PROMs into clinical trials include the culture of the health care system, budget, time, missing information, and unclear or uncertain interpretation of scores.
  • Modern Validity Theory refers to the validity of the interpretation of test scores for the proposed use of the test, not the validity of the score itself.
  • A repository for validity arguments may help avoid redundant research and provide examples of successful validity arguments.

Discussion Themes

How do we educate regulators and researchers about interpreting validity arguments?

Validating PROMs to ensure they are appropriate for use across different cultures and population groups requires historical evidence across many different validity arguments.

PROMs offered in different formats receive better response rates.

Read more about Dr. Coles and Dr. Weinfurt’s work with PROMs in their recent publication, “Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials.”

Tags

#pctGR, @Collaboratory1

September 10, 2021: Effect of Salt Substitution on Cardiovascular Events and Death (Bruce Neal, MB ChB, PhD, FRCP, FAHA, FAHMS)

Posted on by terren.green@duke.edu

Speaker

Bruce Neal, MB ChB, PhD, FRCP, FAHA, FAHMS
Executive Director, George Institute Australia
Professor of Medicine, UNSW Sydney
Honorary Professor, Sydney Medical School, University of Sydney
Professor of Clinical Epidemiology, Imperial College London

Topic

Effect of Salt Substitution on Cardiovascular Events and Death

Keywords

Cluster randomized trial; Salt substitute; Stroke; Cardiovascular disease; SSaSS

Key Points

  • The SSaSS study is a pragmatic, cluster randomized trial on the effects of salt substitutes versus regular salt on stroke, major adverse cardiovascular events, and mortality.
  • The SSaSS study followed almost 21,000 people in 600 village clusters over 5 years. At the end of the 5 year study, 92% of the intervention group was still using salt substitute and 6% of control started using salt substitute.
  • Data from the study show evidence of lower blood pressure, lower risk of stroke, lower risk of major adverse cardiovascular events, and protection against premature death with no evidence of harm.
  • There was no evidence of any increased risk of hyperkalemia.

Discussion Themes

Successful recruitment approaches in this large, long-term trial required extensive engagement and networking with local health workers and community leaders.

Salt substitute as a method to lower stroke and cardiovascular risk is attractive because it looks and tastes the same as salt, and doesn’t ask people to change their behavior.

The use of salt substitutes to decrease the intake of discretionary sodium, the salt used in home cooking or sprinkled on food after cooking, may have more effect in developing countries.  Developed countries consume processed and packaged foods more often and have less discretionary sodium intake.  In developed countries, it may be necessary to encourage food manufacturers to decrease sodium and increase potassium in the processed and packaged foods they produce.

Many millions of lives could benefit from the effects of salt substitute if this could be implemented in developing countries around the world.

Read more about Dr. Neal’s work with the SSaSS study.

Tags

#pctGR, @Collaboratory1

August 17, 2021: Grand Rounds Podcast with Survivor Corps Now Available

Posted on by Gina Uhlenbrauck

Survivor Corp logoIn the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez interviews Diana Berrent, JD, founder of Survivor Corps, Nick Guthe, Survivor Corps member and advisor, and Natalie Lambert, PhD, of the Indiana University School of Medicine, around best practices for medical professionals treating patients experiencing the debilitating effects of long-term COVID-19.

The full July 23 Grand Rounds webinar is also available.

Podcast August 5, 2021: Survivor Corps: Long-Term COVID-19 Patient Engagement (Diana Berrent, JD; Natalie Lambert, PhD; Nick Guthe)

Posted on by Gina Uhlenbrauck

This podcast continues the discussion with Diana Berrent, JD, and Nick Guthe, both of Survivor Corps, and Natalie Lambert, PhD, of the Indiana University School of Medicine, as they describe best practices for medical professionals treating patients experiencing debilitating effects of COVID-19.

Click on the recording below to listen to the podcast.

Want to hear more? View the full Grand Rounds presentation.

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Read the transcript.