patient-reported outcomes

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

November 17, 2021: PCT Grand Rounds to Explore Digital and Mobile Health in Patient-Oriented Research

Posted on by Damon Seils
Headshot of Dr. Anish Agarwal
Dr. Anish Agarwal

In this Friday’s PCT Grand Rounds session, Dr. Anish Agarwal of the University of Pennsylvania will present “Exploring Approaches in Using Digital and Mobile Health in Patient-Oriented Research: Pearls and Pitfalls.”

Dr. Agarwal is an assistant professor of emergency medicine at Penn and the clinical innovation manager at the Penn Medicine Center for Health Care Innovation.

The Grand Rounds session will be held on Friday, November 19, at 1:00 pm eastern. Join the online meeting.

November 9, 2021: PPACT Study Finds Benefits of Cognitive Behavioral Therapy in Reducing Chronic Pain and Pain-Related Disability

Posted on by terren.green@duke.edu
Photo of Dr. Lynn DeBar
Dr. Lynn DeBar, principal investigator of PPACT

Patients who participated in a cognitive behavioral therapy (CBT) intervention as part of their regular care for chronic pain showed improved function and reduced pain compared to standard treatment, according to the results of the Pain Program for Active Coping and Training (PPACT) study. Although CBT did not reduce opioid use, patients who participated in a 12-week course on pain self-management led by primary care providers showed modest but sustained benefits that persisted for 12 months after the intervention.

Study results were published this month in the Annals of Internal Medicine.

The PPACT study, an NIH Collaboratory Trial, was a pragmatic, cluster randomized trial that enrolled 850 patients receiving long-term opioid therapy for chronic pain. Patients in the intervention group participated in 12 weekly, 90-minute group sessions that taught skills of muscle relaxation, guided imagery, cognitive restructuring, and yoga-based adapted movement. Patients in the usual care group continued to receive pharmacologic and nonpharmacologic treatment.

Figure from PPACT main outcomes paper
Source: Annals of Internal Medicine 2021 Nov 2. doi: 10.7326/M21-1436

Patients were followed for 12 months with primary outcome measures of pain impact on enjoyment of life, activity levels, and sleep. Researchers also assessed secondary outcome measures of pain-related disability and opioid use.

Compared to usual care, the CBT intervention reduced self-reported pain and pain-related disability and increased satisfaction with primary healthcare providers. Opioid use and dose remained the same in both the intervention group and the usual care group.

PPACT was supported within the NIH Collaboratory by the NIH Common Fund, the National Center for Complementary and Integrative Health (NCCIH), and the National Institute of Neurological Disorders and Stroke (NINDS). Learn more about the NIH Collaboratory Trials.

October 5, 2021: New Article Identifies Challenges and Prerequisites for Using Electronic Health Record Systems for Pragmatic Research

Posted on by Karen Staman

JAMIA Cover

In a new NIH Collaboratory study, 20 NIH Collaboratory Trials responded to a survey about challenges encountered when using the electronic health record (EHR) for pragmatic clinical research. The goal of the study was to elucidate challenges and develop solutions—or prerequisites for pragmatic research—to enable healthcare system leaders, policy makers, and EHR designers to improve the national capacity for generating real-world evidence.

The article was published in the Journal of American Medical Informatics Association (JAMIA).

The challenges identified by the projects fell into 6 broad themes, including inadequate collection of patient-centered data, lack of functionality for structured data collection, lack of standardization, lack of resources to support customization, difficulties aggregating data from multiple sites, and difficult and inefficient access to EHR data.

Researchers from the NIH Collaboratory’s EHR Core and colleagues from the Patient-Centered Outcomes and the Health Care Systems Interactions Core Working Groups discussed the issues and iterated possible solutions. The authors developed the following prerequisites for the conduct of pragmatic research:

  • Integrate collection of patient-centered data into EHR systems
  • Facilitate structured research data collection by leveraging standard EHR functions, usable interfaces, and standard workflows
  • Support creation of high-quality research data by using standards
  • Ensure adequate IT staff to support embedded research
  • Create aggregate, multidata type resources for multisite trials
  • Create reusable and automated queries

The authors argue for the ability to tailor EHR systems to enable the collection of patient-centered outcomes and the extraction of high-quality, standardized data. Although the primary uses of the data are for clinical care and billing, high-quality data from the EHR also have the potential to improve clinical care and population health by providing reliable evidence and to support pragmatic research and learning within and across healthcare systems.

Read the full article.

This work was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through cooperative agreement U24AT009676 from the Office of Strategic Coordination within the Office of the NIH Director. This work was also supported by the NIH through the NIH HEAL Initiative under award number U24AT010961.

 

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 23, 2021: PCO Core Aims for Greater Consistency in Integrating Patient-Reported Outcomes in Research and Clinical Care

Posted on by Damon Seils

Leaders of the NIH Collaboratory’s Patient-Centered Outcomes (PCO) Core Working Group spoke in a recent Zoom-based interview about the Core’s latest accomplishments and ongoing collaborations with the NIH Collaboratory Trials.

“The purpose of the Core is to provide reusable and sustainable resources and tools to help project teams incorporate patient-centered outcomes and other patient-reported data in pragmatic clinical trials and the electronic health record,” said Dr. Emily O’Brien, an associate professor in population health sciences at Duke University and a cochair of the PCO Core.

“We address 3 components in any clinical research study: the needs of the clinician to provide care for the patient, the needs of the researcher, and the needs of the patient or the individual being treated,” added Dr. Christy Zigler, an assistant professor in population health sciences at Duke University and a cochair of the PCO Core. “To guide clinical researchers about PCO data collection, we usually think about 4 major considerations: adding IT infrastructure, deciding when PCOs are appropriate and choosing the best instrument, defining how to integrate PCO collection into the care process in a meaningful and appropriate way, and preparing for real-time reporting and statistical of PCO data,” Zigler said.

View the full video.

Last year, the PCO Core completed a survey of NIH Collaboratory Trials about cultural and linguistic adaptations of patient-centered outcome measures. The survey revealed significant barriers to researchers wanting to tailor instruments for their study populations.

“We wanted to know how and whether existing NIH Collaboratory Trials were adapting instruments for their populations of interest, either through translation, or cultural adaptation, or both,” said O’Brien. “This was really helpful to give us a sense of what barriers projects might encounter in the future… Planning ahead is critical, and having enough time and resources available to make these adaptations will be important for any projects that might benefit from having these adapted instruments available,” she said.

“We’re also thinking a lot about acceptability and burden of patient-centered outcomes,” said Dr. Zigler. “So we’re targeting PRISM NIH Collaboratory Trials within the first year of transition to implementation…and sending out a survey to gauge acceptability and burden at all levels, from the clinical care team, from the research side, and also from the patients themselves,” Zigler said.

Zigler and O’Brien also highlighted ongoing collaborations with the NIH Collaboratory’s other Core Working groups, including discussions with the Ethics and Regulatory Core about the ethical implications of integrating PCO data into clinical care and a consultation with the Electronic Health Records Core on integrating patient-centered and patient-reported outcomes into the electronic health record so that pragmatic clinical trial researchers can use them.

“Patient-centered outcomes data does not exist in a vacuum,” said O’Brien. “The data that are collected as part of NIH Collaboratory projects exist as part of both the larger study and also the larger health system within which the study is being conducted. So there are really clear connections between the PCO Core and the work that we do and all the other Cores, and those Cores have been a great resource for us as we’re advising projects on key issues that come up during the design and implementation phases of their studies,” she said.

View the full interview with Dr. Zigler and Dr. O’Brien.

 

Screen shot from video interview with Dr. Christy Zigler and Dr. Emily O'Brien

September 22, 2021: PCT Grand Rounds Explores Enabling Patient-Reported Outcome Measures in Clinical Trials

Posted on by Damon Seils
Headshots of Dr. Theresa Coles and Dr. Kevin Weinfurt
Dr. Theresa Coles (left) and Dr. Kevin Weinfurt

In this Friday’s PCT Grand Rounds, Dr. Theresa Coles and Dr. Kevin Weinfurt of Duke University will discuss the use of patient-reported outcome measures in clinical trials, using examples from cardiovascular trials.

The Grand Rounds session will be held on Friday, September 24, at 1:00 pm eastern. Join the online meeting.

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

July 23, 2021: Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care (Diana Berrent, JD; Natalie Lambert, PhD; Nick Guthe)

Posted on by terren.green@duke.edu

Speakers

Diana Berrent, JD
Survivor Corps, Founder

Natalie Lambert, PhD
Associate Research Professor
Indiana University School of Medicine

Nick Guthe
Survivor Corps Member and Advisor

Topic

Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care

Keywords

Long-term COVID; COVID-19 symptoms; Survivor Corps; Patient-centered outcomes; Real-world evidence; Patient engagement

Key Points

  • Survivor Corps is a 170,000 member grassroots organization founded in 2020 to support and educate people with COVID-19 and those who continue to experience long-lasting symptoms of COVID-19.
  • People who experience long-term, after-effects of COVID-19 report feeling alone and desperate due to the difficult and dissatisfying medical care they receive and their medical provider’s lack of knowledge about long-term COVID.
  • Long-term COVID patients want to be heard and believed by medical professionals who are thorough in their examination and testing methods.
  • Survivor Corps advocates for crucial research to be done on the symptoms that cause the most human pain and suffering, and not just the symptoms that are experienced most frequently.
  • COVID-19 research can be done at a faster pace if we engage citizen-scientists and quickly release NIH research funding.
  • The life-or-death struggles of people with long-term COVID illustrate the need to treat this condition as an emergency medical situation—the same as we would treat an acute case of COVID-19.

Discussion Themes

The CDC guidelines are the first-step, interim guidance; however, no treatment options have been offered. Another iteration of these guidelines needs to be released soon.

We know from people who have experienced long-lasting effects of COVID-19 that the condition can be debilitating and devastating—patients are in urgent need of understanding and help.

Medical professionals should focus on real-word evidence to develop patient-centered outcomes.

Read more about Survivor Corps, Dr. Lambert’s research, the report from the Survivor Corps COVID-19 ‘Long Hauler’ Symptom Survey, and physician resources.

Tags

#pctGR, @Collaboratory1, @Survivor_Corps

July 19, 2021: COVID-19 Grand Rounds Will Feature Survivor Corps and the Use of Real-World Evidence From Citizen-Scientists

Posted on by Damon Seils

Survivor Corp logo

In this Friday’s COVID-19 Grand Rounds session, Diana Berrent, Natalie Lambert, and Nick Guthe of Survivor Corps will present “Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care.” The Grand Rounds session will be held on Friday, July 23, at 1:00 pm eastern. Join the online meeting.

Survivor Corps is an online community of 170,000 patients affected by COVID-19 and their families and friends. The advocacy group is using its members’ collective experience to build a repository of data sets and research tools to support COVID-19 research, including studies of post-COVID conditions, or “long COVID.” The group seeks to fill the gap between real-world evidence and scientific research to advance understanding of the disease and patients’ healthcare options.

“We have been sort of the canary in the COVID coal mine from the beginning,” said Berrent, who founded Survivor Corps in March 2020 after becoming one of the first people in the United States to be diagnosed with COVID-19.

Berrent will be joined during Grand Rounds by Survivor Corps research director Dr. Natalie Lambert and by Nick Guthe, a Survivor Corps member and adviser.

Survivor Corps’s website, which has been selected by the US Library of Congress for inclusion in the nation’s Coronavirus Web Archive, serves as a hub to provide support, information, and education about COVID-19, connect patients to researchers, and facilitate the nation’s COVID-19 response.

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency. For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

April 9, 2021: Taking Research to the Participant: Experiences with TREAT NOW, a No-Touch COVID-19 Trial (Adit Ginde, MD, MPH)

Posted on by Gina Uhlenbrauck

Speaker

Adit Ginde, MD, MPH
Professor and Vice Chair for Research, Department of Emergency Medicine
Director of Clinical Research, Department of Anesthesiology
Director, Colorado CTSI Trial Innovation Network Hub
University of Colorado School of Medicine

Topic

Taking Research to the Participant: Experiences with TREAT NOW, a No-Touch COVID-19 Trial

Keywords

COVID-19; No-touch trial design; Antiviral therapy; Adaptive platform trial; Repurposed drugs; Patient-reported outcomes

Key Points

  • The TREAT NOW trial evaluated the effectiveness and safety of early treatment with antiviral agents (lopinavir/ritonavir) in outpatient adults with COVID-19 for preventing hospitalization and improving clinical outcomes.
  • The trial used an adaptive platform approach with the ability to add or remove agents, and focused on repurposed FDA-approved therapies that are rapidly scalable and easily deployed.
  • The no-touch design required that the entire trial be completed without having any physical interaction with the participant.
  • TREAT NOW shows that no-touch trials are not only feasible but also effective. However, considerable effort was needed to get the smart data systems right. The data system must accommodate many different levels of technical skill, different languages, and different modes of communication.

Discussion Themes

What is the role of a site in a no-touch trial?

What was the most effective recruitment strategy?

What is the demographic breakdown of your participants?

Read more about the TREAT NOW trial on ClinicalTrials.gov.

Tags

#pctGR, @Collaboratory1