Patient engagement

Grand Rounds November 1, 2024: Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study (Thomas W. Carton, PhD, MS; Anitha S. John, MD, PhD)

Posted on by Sophia Ramirez

Speakers

Anitha S. John, MD, PhD
Medical Director
Washington Adult Congenital Heart Program
Professor of Pediatrics
Children’s National Hospital
George Washington University

Thomas W. Carton, PhD, MS
Chief Data and Strategy Officer
Louisiana Public Health Institute

Keywords

Adult Congenital Heart Disease; Registry; Patient Engagement

Key Points

  • The research team reviewed the current challenges in adult congenital heart disease (ACHD) clinical care, surveillance, and long-term outcomes research, including a demand for subspecialty care that outweighs the supply; the heterogeneity of CHD and its long-term outcomes; and changing treatment strategies.
  • Though there are several CHD registries in the U.S., very few focus on adults with CHD. The research’s teams efforts, beginning with the Congenital Heart Initiative (CHI) launch in 2020, came about in response to this gap.
  • The mission of the CHI is to create a digital hub collecting health data from patients and providers. The team seeks to involve patients in every aspect of the CHI registry, with the ultimate goal of creating a community of ACHD patients and providers with a shared understanding of research needs and medical outcomes.
  • As the registry initially lacked data from healthcare providers and the electronic health record, the team partnered with PCORnet to establish an ACHD surveillance system.
  • The CHI-RON study uses PCORnet data and patient-reported outcomes to determine whether ACHD patients who are receiving recommended care do better than those who are not and the impact of gaps in care on patient-reported outcomes.
  • Dr. Carton provided an overview of PCORnet, followed by a review of the data science innovations the team used to generate a computable phenotype, identify congenital heart providers, diversify demographic recruitment for the registry, and incorporate procedure results into the common data model for analysis.
  • One of the strengths of this project was the high degree of patient and partner engagement. This involvement led directly to programming such as the “ACHA Café,” a virtual coffee hour in which patients could engage with one another, and guided their social media content.

Discussion Themes

The ACHD patient population identified a few key topics that they hoped the CHI would explore, including long-term effects of congenital heart defects, the most effective therapeutics for treating CHD, and mental health care options. Patient partner feedback also helped the team refine their recruitment and outreach materials.

Given the tendency for some types of CHD to be given more attention than others, the research team sought to enroll a patient population that was inclusive of a variety of presentations. This presented some methodological challenges, e.g. when it came to drawing distinctions in the registry.

Grand Rounds July 19, 2024: Lessons From PRECIDENTD: A Pragmatic Comparative Effectiveness Trial (Deborah J. Wexler, MD, MSc; Brendan M Everett, MD, MPH)

Posted on by Sophia Ramirez

Speakers

Deborah J. Wexler, MD, MSc
Associate Professor of Medicine and Diabetes Unit Chief
Massachusetts General Hospital and Harvard Medical School

Brendan M. Everett, MD, MPH
Associate Professor of Medicine
Divisions of Cardiology and Preventive Medicine
Brigham and Women’s Hospital and Harvard Medical School

Keywords

Cardiovascular Health; Kidney Disease; Patient Engagement

Key Points

  • Comparative effectiveness of SGLT2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1 RA) for cardiac and kidney outcomes is a major question in cardiac-kidney-metabolic health.
  • More broadly, comparative effectiveness of on-patent medications is crucial, yet not mandated, with little incentive (and some disincentive) for pharmaceutical companies to participate.
  • The PRECIDENTD trial will seek to test one approach to evaluating the comparative effectiveness of expensive new therapies. Their primary aim is to conduct a head-to-head evaluation of SGLT2i versus GLP-1 RA for the prevention of major adverse cardiovascular/kidney events and death.
  • Partnerships with patients, providers and stakeholders will be crucial to the success of PRECIDENTD. Patient engagement strategies include Community Engagement Studios, a Center for Effective Health Communication, and an interactive text messaging system to assess adherence.
  • The research team sees the trial, which involves two expensive, brand-name drugs and requires extensive collaboration, as a true test of a pragmatic trial of branded pharmaceutical medications.
  • Obtaining informed consent isn’t going to be pragmatic; it is time-consuming, challenging, and individualized.
  • Constrained funding in the feasibility phase may hamper the growth of the trial. In a bureaucratic research environment, the administrative burden can take time and energy from a study.

Discussion Themes

Patients have been more interested in participating given that this trial compares one effective, well-understood active drug to another, so there’s no risk of being assigned to a placebo group.

The pragmatic nature of the trial means that the study team is recruiting participants who can go either way when it comes to the two treatment options. The highest-risk people won’t be enrolled.

March 18, 2022: Early Treatment of COVID-19: The TOGETHER Adaptive Platform Trial (Edward Mills, PhD, FRCP; Craig Rayner, PharmD)

Posted on by terren.green@duke.edu

Speakers

Edward Mills PhD, FRCP
Professor, McMaster University

Craig R Rayner FRCP Edin PharmD MBA
Certara Distinguished Scientist
Adjunct Associate Professor, Monash University

Keywords

COVID-19; Ivermectin; TOGETHER trial; Patient engagement; Adaptive platform trial

Key Points

  • The TOGETHER trial is a randomized adaptive platform trial investigating 11 different treatments for COVID-19 including Ivermectin.
  • Initial in vitro experiments of Ivermectin in April of 2020 showed promising results, but many of those original papers were later retracted.
  • The TOGETHER trial used PBPK modelling to determine trial dose regimen. The trial started with 1 dose and later moved to 3 doses.
  • The primary outcome of the TOGETHER trial was emergency room visits due to COVID-19 or hospitalization due to the progression of COVID-19.
  • No evidence was found of treatment effect for ivermectin compared to placebo, but a small treatment effect cannot be ruled out. It may have an effect for a subgroup of patients.

Discussion Themes

A low confidence interval could signal that the trial was stopped too early.

Building trust within the community is key to the success of a trial. Recruitment is difficult if the patients don’t trust the trial or researchers.

Read more about the TOGETHER trial.

 

 Tags

#pctGR, @Collaboratory1

February 25, 2022: The Next Generation of Patient-Centered Trials – No Site Visits, Home-delivery of Meds and Patient-reported Outcomes – The CHIEF-HF Trial (John Spertus, MD, MPH, FACC, FAHA)

Posted on by terren.green@duke.edu

Speaker

John Spertus, MD, MPH, FACC, FAHA
Daniel Lauer/Missouri Endowed Chair and Professor
University of Missouri – Kansas City
Clinical Director of Outcomes Research
Saint Luke’s Mid America Heart Institute

Keywords

Heart failure; Canagliflozin; INVOKANA; Kansas City Cardiomyopathy Questionnaire (KCCQ); tele-health; tele-trials

Key Points

  • The CHIEF-HF trial (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) was a double blind randomized clinical trial of the medication Canagliflozin for heart failure.
  • CHIEF-HF was designed to learn if patients have fewer symptoms after 3 months of treatment with Canagliflozin.
  • CHIEF-HF used a novel trial design that involved no site-visits and electronic monitoring of patient engagement. The follow up rate for this study was over 97%.
  • The Total Symptom Score on the KC Cardiomyopathy Questionnaire was the key outcome measure in the CHIEF-HF Trial.
  • Heart failure patients treated with Canagliflozin experienced a statistically significant improvements in symptoms.
  • Sites in the study chose recruitment methods that worked best for them. More personalized recruitment strategies were most successful.
  • Difficulties of electronic trials include the technology limitations of the participants, and electronic consent concerns from regulatory agencies. Positives of electronic trials are high enrollment and completion rates.

Discussion Themes

How do technology heavy studies enroll diverse and underserved populations who may not have access to smartphones and wearable technology?

Virtual studies such as this that enrolled at 6 to 8 times the rate on a traditional trial can save quite a bit of money on overhead expenses.

 

Read more about the CHIEF-HF trial.

 

Tags

#pctGR, @Collaboratory1

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

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

Grand Rounds November 19: Exploring Approaches in Using Digital and Mobile Health in Patient-oriented Research: Pearls and Pitfalls

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

Date: Friday, November 19, 2021, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

Click ‘Connect to Audio”
Choose ‘Computer Audio’ or ‘I will call in’.
If using the ‘call in option’, follow the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 2622 682 0537
Meeting Password: 12345

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 2622 682 0537

NOTE: For Toll-free users, the call-back (call me) services are also available.

October 22, 2021: The STAMP Trial: Increasing Engagement in Advance Care Planning and Lessons Learned from Partnering with Community Ambulatory Practices (Terri R. Fried, MD)

Posted on by terren.green@duke.edu

Speaker

Terri R. Fried, MD
Section Chief, Geriatrics
Professor of Medicine
Yale School of Medicine
Attending Physician
VA Connecticut Healthcare System

Topic

The STAMP Trial: Increasing Engagement in Advance Care Planning and Lessons Learned from Partnering with Community Ambulatory Practices

Keywords

STAMP Trial; Advance Care Planning; ACP; Patient engagement; Cluster randomized trial

Key Points

  • The STAMP (Sharing and Talking about My Preferences) Trial is a cluster randomized controlled trial aimed at increasing engagement in Advanced Care Planning (ACP).
  • The STAMP Trial first aimed to re-conceptualize advance care planning (ACP) to achieve the ultimate goal of enabling the patient or surrogate to make decisions in a future moment rather than making decisions in advance. In this way, ACP is a flexible act of communication that allows for in-the-moment advice of a patients care providers about the nuances of a particular clinical situation.
  • ACP is a Health Behavior that involves stages of change. The STAMP Trial uses a 10 minute survey to assess how ready a patient is to start the ACP communication process.
  • Patients are given ACP materials based on their stage of readiness as assessed by the survey.
  • Results showed a small increase in ACP planning for groups randomized to the study interventions, but that small increase applied over large numbers of patients could have a significant impact on the number of people participating in ACP.

Discussion Themes

Cluster randomized trial design is complex unless you are working with an intervention that is implemented in a whole health care system rather than individual patients.

Determining a denominator in a cluster randomized trial at the patient level was very difficult.

 

Read more about Dr. Fried’s work on the STAMP Trial.

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