In a recent video interview, Dr. Helene Langevin, director of the National Center for Complementary and Integrative Health at the NIH, discusses the important work of the NIH Collaboratory in sharing knowledge and lessons learned as well as in harnessing expertise across the 19 Demonstration Projects it supports. “It is very important that we understand how research can be successfully implemented and tested in real-world clinical practice.”
For more interviews about the HEAL and PRISM projects, check out the February 21 news story.
Up to 50% of patients do not take their cardiovascular medications as prescribed. Nonadherence is associated with increased cardiovascular events.
Nudges prompt small, incremental changes in behavior and can be delivered through text messaging.
The Nudge pragmatic study was piloted across 3 integrated healthcare systems. The intervention uses pharmacy data to monitor gaps in patients’ cardiovascular medication refills. Patients with gaps receive text messages on their mobile phone to remind them to refill their medication.
Discussion Themes
A “chatbot” is used in one of the study arms to interact with the patient through the mobile phone application. As part of the analytic plan, the study team will be evaluating engagement with the interactive chatbot and the dose response.
The Nudge study gives patients two opportunities to opt out of participating. The study team is tracking demographics of patients who opted out as well as their reasons for opting out.
How do you handle the roughly 10% of people who receive care from more than one health system? That is, patients may be receiving conflicting advice, including directions to discontinue their medications.
Recently, the Collaboratory Coordinating Center conducted video interviews describing the critical work being done in the NIH HEAL Initiative program to address the national opioid crisis. As part of this program, the PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) NIH Collaboratory Trials present exciting new possibilities for answering important questions along with unique challenges.
Drs. Rebecca Baker and Wendy Weber discuss the aims of the HEAL Initiative, including:
Leveraging expertise across all NIH institutes and centers to enhance pain management and improve prevention and treatment strategies for opioid use disorder and addiction
Generating evidence to help clinicians and patients make the right treatment decisions
Drs. Meyers, Hernandez, and Weber discuss aspects of collaborating with the four PRISM NIH Collaboratory Trials, including:
Leveraging broad expertise in the Collaboratory program to support embedded healthcare systems research in pain management
Developing new understanding across different care models such as physical therapy, surgery, acupuncture therapy, and primary care settings
Learning about patient-reported outcomes that will be the most meaningful to establish best practices in pain management
Learn more about the PRISM NIH Collaboratory Trials on their webpages:
AcuOA: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
FM TIPS: Fibromyalgia TENS in Physical Therapy Study
NOHARM: Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management
OPTIMUM: Group-based mindfulness for patients with chronic low back pain in the primary care setting
Mitesh S. Patel, MD, MBA
Ralph Muller Presidential Assistant Professor
Perelman School of Medicine & Wharton School
University of Pennsylvania
Director, Penn Medicine Nudge Unit
Topic
Using Nudges to Improve the Delivery of Health Care
Keywords
Motivational nudges; Medical decision-making; Behavioral economics; Nudge units; Health behaviors
Key Points
Nudges remind, guide, or motivate a decision. In a healthcare setting, medical nudges use principles of behavioral economics and psychology to “steer medical decision-making toward higher value and improved patient outcomes.”
A “nudge unit” is a behavioral design team that systematically tests ways to improve decisions and change behavior.
It is important that medical nudges be testable and rigorously evaluated. Well-designed nudges have the right fit for the context, are aligned with health system and patient care goals, are scalable, and make a significant impact.
Nudges can be used to help clinicians promote evidence-based care, and help patients increase engagement and change health behaviors.
Discussion Themes
Nudges are prevalent in other industries; for example, when asked to add trip insurance to the purchase of an airfare.
In a healthcare setting, effective nudges can help achieve care delivery priorities (for example, improved screening, follow up, adherence) as well as reduce clinician burden.
Understanding the health system’s culture and workflow is essential for the sustainability and effectiveness of nudges.
Kevin Haynes, PharmD, MSCE
Principal Scientist
HealthCore
Topic
PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research Networks
Keywords
Data linkages; PCORnet; Patient-powered research networks; Health plan research networks; Computable phenotypes
Key Points
One of the biggest challenges facing healthcare today is reducing gaps in evidence necessary to improve health outcomes. Research collaborations between health plans and patient-powered research networks (PPRNs) can help close this gap.
PCORnet enables linkages with patient groups through PPRNs, which include participating organizations and leadership teams of patients, advocacy groups, clinicians, academic centers, and practice-based research networks.
From the health plan perspective, postal mail outreach to members was more effective than email outreach around engaging patients in research opportunities.
Discussion Themes
When engaging with different patient-powered research networks, are there differences around common conditions compared with rare or stigmatized conditions?
What are participants told about the commercialization of findings, whether in terms of new treatments that might be identified, or the ways in which findings might affect health plans’ willingness to continue to cover certain treatments?
An essential aspect of collaboration is building and maintaining the trust of members in the research networks.
The GGC4H NIH Collaboratory Trial, now in its implementation phase, has begun enrollment of study participants. Congratulations to Drs. Kuklinski, Sterling, and Catalano and the entire GGC4H study team!
GGC4H is a cluster-randomized trial that is testing the feasibility and effectiveness of implementing Guiding Good Choices—a universal evidence-based anticipatory guidance curriculum for parents of early adolescents—in three large, integrated healthcare systems serving socioeconomically diverse families. In prior community trials, the Guiding Good Choices curriculum has been shown to prevent adolescent substance use, depressive symptoms, and delinquent behavior. This study offers an opportunity to test the intervention’s effectiveness with respect to improving adolescent behavioral health outcomes when implemented at scale in pediatric primary care within a pragmatic trial.
Rachel L. Winer, PhD
University of Washington
School of Public Health
Department of Epidemiology
Diana S.M. Buist, PhD, MPH
Kaiser Permanente Washington Health Research Institute
Topic
Designing & Testing the Future of Home-based Cervical Cancer Screening: Results from a Collaborative Academic-Embedded Delivery System Pragmatic Randomized Trial
Keywords
Embedded pragmatic clinical trial; Cervical cancer screening; Human papilloma virus
Key Points
The aim of the Home-Based Options to Make Screening Easier (HOME) pragmatic randomized trial was to compare the effectiveness of 2 approaches to increasing cervical cancer screening among women 30-64 years of age who are overdue for cervical cancer screening.
Challenges of embedded pragmatic trials reported by the study team include:
Discussions with lab, primary care, OB/GYN, and prevention and outreach teams
Negotiation about the target population
Aligning with evolving clinical guidelines
Engaging multiple clinical champions
Extensive back and forth with IRB for approval
The study team also conducted semi-structured interviews to understand women’s attitudes, emotional responses, and informational needs after receiving a positive kit result and completing recommended follow up.
Discussion Themes
Were you able to assess the impact of this intervention on the clinic staff?
To help move the field forward, there is a need for more publications and more education of peer reviewers and funders about the challenges of conducting embedded pragmatic trials.
Matthew T. Roe, MD, MHS
Senior Investigator, Professor of Medicine
Duke Clinical Research Institute
Topic
Transforming Medical Evidence Generation with Technology-Enabled Trials
Keywords
Mobile clinical trials; Real-world evidence; Real-world data; Study design; Regulatory oversight; Digital health; Mobile health applications; Biosensors; Electronic health records
Key Points
Digital health applications and electronic health records provide tremendous opportunities for improving trial efficiencies, broadening patient participation, and reducing cost.
Novel approaches that can help reduce data collection burden for study sites include importing EHR data directly into the trial database, collecting patient-reported outcomes through web-based portals, and incorporating digital health data from wearables and biosensors.
To realize the potential of new technology, cross-sectional partnerships are needed among research participants, researchers, biopharma device industries, professional medical associations, insurers, FDA, clinicians, health IT, contract research organizations, and health systems.
Discussion Themes
How many potential patients might we lose if having a smart phone is an inclusion criterion for a clinical study?
How can we ensure that the clinical trial infrastructure is inclusive of minority populations, especially those in rural settings?
What is the role of physicians in reaching a large number of participants who are not near an academic research center?
Ultimately, in clinical trials, the data are what matter and what decisions are based on. We need to understand data quality and standards for the data to be accepted.
Vanita R. Aroda, MD
Director of Diabetes Clinical Research
Brigham & Women’s Hospital
Harvard Medical School
Topic
Oh Yes, We Have Tons of Patients Who Can Do This Study!
Keywords
Patient engagement; Patient recruitment and retention; Clinician engagement; Health care systems; Multicenter clinical trials; Electronic health record
Key Points
Research occurs beyond the silo. Effective large-scale multicenter clinical trial recruitment requires an accessible network of potential participants.
Engage colleagues and the healthcare system as part of the collaborative journey across the trial’s lifecycle.
It is highly recommended to do a role-playing exercise with the study team to prevent fumbles when engaging and recruiting study participants.
The science, the protocols, and the data are all important, but it is the essential human element that makes it all happen.
Discussion Themes
Participant retention is really a continuation of good recruitment and engagement.
Make sure your database query makes clinical sense and is the best fit to answer your study question. Don’t spend time on the wrong data.
What other recruitment opportunities or techniques can sites use after they exhaust their patient panel?
To improve trial participation, start by understanding the user/consumer; ie, the trial participant and his or her trial experience.
Digital improvements in clinical trials can involve these incremental steps:
Study planning that is data-driven, crowdsourced, and informed by artificial intelligence
Patient engagement that implements electronic consent, flexibility in location, digital concierge support, and data ownership
Study conduct that integrates remote monitoring, digital biomarkers, and electronically sourced data
Analysis and reporting that is automated and includes dissemination to trial participants
Discussion Themes
Will digital tools in medicine development enable improvement, disruption, or displacement?
Digital tools in development focus on breaking down barriers to participation, using digital to improve existing measurement or enable new endpoints, and automating processes and tasks while improving quality.
The GGC4H NIH Collaboratory Trial, now in its implementation phase, has begun enrollment of study participants. Congratulations to Drs. Kuklinski, Sterling, and Catalano and the entire GGC4H study team!