Recruitment

July 24, 2025: Recently Launched NIH Collaboratory Trials Offer Lessons for Embedded Pragmatic Research

Posted on by Karen Staman

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Angelo Volandes, co–principal investigator (PI) of the ACP PEACE trial, led a panel of investigators who shared key challenges and lessons learned from their recently launched trials. The panelists included Stephanie Fitzpatrick, PI of the MOMs Chat & Care Study, Elizabeth Wick, co-PI of I CAN Do Surgical ACP, and ChenChen Wang and Robert Saper, co-PIs of TAICHIKNEE.

MOMs Chat & Care Study

Goal: To test the effectiveness of Northwell Health’s MOMs navigation program at 2 levels of intensity designed to facilitate timely, appropriate care for high-risk Black and Latina birthing people and reduce risk for severe maternal morbidity

Key Challenge: Low recruitment

Solutions:

  • Expanded inclusion criteria to include Hispanic/Latina patients, those with lower risk factor scores, and gestational of less than 17 weeks instead of less than 13 weeks
  • Added manual review of charts to ensure the patients they telephoned for recruitment are pregnant and to determine the number of weeks of pregnancy
  • Changed recruitment materials and general approach so that empathy is at the forefront

Learn more about the MOMs Chat & Care Study.

I CAN DO Surgical ACP

Goal: To identify a systems-based approach to help older adults undergoing major elective surgery engage in advance care planning decisions

Key Challenge: One site will finish 6 months early but will still have access to the platform for research, which provides an opportunity they do not want to waste

Solution: Use the trial infrastructure to pilot test another intervention in the remaining months of trial time. The plan is to develop and test human-in-the-loop patient-facing generative AI to assess the quality of patient–AI interactions and answer additional questions, potentially laying the groundwork for future trials.

Learn more about I CAN DO Surgical ACP.

TAICHIKNEE

Goal: To determine whether remotely delivered tai chi is feasible across the 4 partnering healthcare systems and if tai chi, compared with routine care, will improve physical health (including knee pain and function), mental health, and healthcare utilization

Key Challenge: Long delays at institutional review board due to backlogs

Solution: The PI understood that many organizations had to cut costs and reduce IRB and regulatory staff, which likely drove delays in regulatory approval. When the study leadership interacted with the IRB, they did so in a generous and curious way, asking how they could help. The regulatory staff acknowledged the problem and suggested that, as the trial is federally funded and meets the regulatory criteria to be considered minimal risk, it should take priority.

Learn more about TAICHIKNEE.

This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.

Grand Rounds March 21, 2025: Generative Artificial Intelligence in Clinical Trials: A Driver of Efficiency and Democratization of Care (Alexander J. “AJ” Blood, MD, MSc)

Posted on by Sophia Ramirez

Speaker

Alexander J. “AJ” Blood, MD, MSc
Associate Director, Accelerator for Clinical Transformation Research Group
Instructor of Medicine at Harvard Medical School
Cardiologist and Intensivist
Brigham and Women’s Hospital

Keywords

Artificial Intelligence; Cost; Large Language Models; Enrollment; Eligibility; Recruitment

Key Points

  • The Accelerator for Clinical Transformation (ACT) is a research group that seeks to use emerging technology to try and expand access to healthcare and improve quality and quantity of healthcare delivery. They focus on team-based models and scalable applications.
  • It’s becoming more expensive and time-consuming to move a drug from the clinical trial stage to approval. Patient recruitment is the leading driver of costs in clinical trials, and 55% of trials that fail to complete cite low accrual rate as the reason for study termination. There’s pressure from industry to conduct clinical trials in a way that is faster, cheaper, and better for both the patients and the research environment.
  • ACT conducted a pilot study in which they embedded a Large Language Model (LLM) tool called RECTIFIER into an active clinical trial of patients with heart failure. RECTIFIER is an AI-powered, comprehensive software application able to ask and answer questions about unstructured clinical data. In a pilot study, RECTIFIER determined patient eligibility with higher accuracy and specificity than study staff, indicating its potential to streamline screening.
  • LLMs are the engines that power the software. There are two key challenges that need to be taken into consideration to use these tools effectively: 1) there’s a content window – a limit to the amount of Electronic Health Record (EHR) data you can pull in; and 2) Using LLMs is expensive.
  • Following up on the pilot study results, ACT conducted a prospective randomized controlled trial: The Manual Versus AI-Assisted Clinical Trial Screening Using LLMs (MAPS-LLM) trial. MAPS-LLM compared two methods for analyzing a randomized pool of potentially eligible participants: manual review by study staff, and RECITIFIER-augmented review by study staff. Their primary endpoint was eligibility determination.
  • They found that AI-assisted patient screening using the RECTIFIER system significantly improved eligibility determination and enrollment compared with manual screening in a heart failure clinical trial.
  • ACT concluded that implementing AI-assisted tools like RECTIFIER can enhance clinical trial efficiency, reduce resource utilization, and promote equitable recruitment, potentially leading to faster trial completion and earlier patient access to novel therapies. Generative AI is likely to play a significant role in the future of clinical trials.

Discussion Themes

Study staff in the MAPS-LLM intervention arm were able to direct more time and effort towards contacting patients and managing patients with the time they would have spent reviewing charts and manually screening the EHR.

The rate of eligibility between the two arms was equivalent; the difference was, the AI-augmented group was able to assess twice as many potentially eligible patients.

While this tool can do a lot of analytical work, a human element will be essential to utilizing it effectively and to bringing “human intelligence” to participant enrollment.

The ACT team has started to pilot this technology in other disease areas, including cardiology more broadly, endocrinology, oncology, and gastroenterology.

Grand Rounds January 10, 2025: FM-TIPS Community Engagement Methods for Recruitment (Dana Dailey PT, PhD; Heather Schacht Reisinger, PhD)

Posted on by Sophia Ramirez

Speakers

Dana Dailey PT, PhD
Assistant Research Scientist
Physical Therapy and Rehabilitation Science
University of Iowa
Associate Professor, Physical Therapy Department
St. Ambrose University

Heather Schacht Reisinger, PhD
Director, Implementation Science Center
Associate Director for Engagement, Integration, and Implementation
Institute for Clinical and Translational Science
Professor, Division of General Internal Medicine at the University of Iowa

Keywords

Community-Engaged Research; Recruitment

Key Points

  • The Fibromyalgia TENS in Physical Therapy (FM-TIPS) study sought to test the feasibility and effectiveness of adding Transcutaneous Electrical Nerve Stimulation (TENS) to standard physical therapy (PT) care in a real-world PT setting. Their primary outcome was the change in movement pain, from baseline to 50 days.
  • By February 2022, the team had activated 25 active PT clinics across seven Midwestern states. In February 2023, the team received a diversity supplement for community engagement and brought on a Community Engagement Coordinator.
  • After developing a community engagement process and implementing six community engagement strategies, inquiries about the study increased significantly, screening rates held steady, and enrollment rates increased. These effects were more pronounced in targeted clinics.
  • Engagement with the clinics, clinicians, and community had a significant impact on the pragmatic trial. Dr. Dailey noted that clinicians felt more supported and seen as a part of both the clinic and the community. Conversations with participants were also fruitful, helping the researchers understand how participants were feeling when they weren’t in therapy.
  • Clinical research in community physical therapy clinics is not common, and there was a steep learning curve for many of the physical therapists involved. Community support helped them navigate screening and enrollment.
  • The study team developed individualized clinic plans through inquiry of clinicians and clinics. This feedback helped them identify organizations to collaborate with, local events, etc.
  • Process building, including implementation and complete documentation of outcome measures, was important to site evaluation. As a result of these activities, the research team was able to carry lessons over into low-enrolling clinics, adapt, and make productive changes.

Discussion Themes

When researchers think about pragmatic trials involving clinics, Dr. Reisinger noted, it becomes difficult to delineate the concepts of “community members” and “participants.” For example, it’s important to also think about clinicians also as community members who are living and working in those spaces, and who have a deep knowledge of and commitment to their community. All of that knowledge will be important to decision-making.

Intensive and responsive community engagement was made possible for this pragmatic trial by the diversity supplement, which enabled the team to hire two full-time community engagement coordinators. At the rate they were going before they implemented community engagement, the study team would not have hit their enrollment target; in the end, they exceeded it.

Researcher teams should always be adaptive and flexible when doing community engagement, even when it comes to documentation.

May 4, 2021: COVID-19 Grand Rounds Continues Friday With Dr. Megan Ranney on Online Recruitment in the Era of COVID-19

Posted on by Damon Seils

Dr. Megan RanneyIn this Friday’s COVID-19 Grand Rounds session, Dr. Megan Ranney of Brown University will present “Online Recruitment in the Era of COVID-19: Pitfalls and Progress.” The Grand Rounds session will be held on Friday, May 7, at 1:00 pm eastern. Join the online meeting.

Dr. Ranney is a practicing emergency physician, researcher, and advocate for innovative approaches to health. Her work focuses on the intersection between digital health, violence prevention, and population health. She also currently serves as a medical analyst for CNN.

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.

July 19, 2019: Misinformation as a Source of Complication for Clinical Trials (Brian Southwell, PhD)

Posted on by Damon Seils

Speaker

Brian Southwell, PhD
Senior Director, Science in the Public Sphere, RTI International
Duke-RTI Scholar, Duke Forge, Duke University

Topic

Misinformation as a Source of Complication for Clinical Trials

Keywords

Behavioral sciences; Health behavior; Health knowledge, attitudes, practice; Misinformation; Patient selection; Treatment refusal

Key Points

  • Both lack of information and misinformation likely reduce participation in clinical trials.
  • Many sources of misinformation engender distrust of treatment, including inaccurate online sources, questionable sources trying to sell products, some health education from advocacy organizations, and even conventional news sources.
  • It is important to understand misinformation, how it emerges, its consequences, and the unintended effects of correcting it.
  • Our needs for social connection and hope for the future make us vulnerable to medical misinformation.
  • Studies support the corrective potential of direct rebuttal and large-scale exposure to accurate information.
  • It is important for clinicians and researchers to monitor and understand patients’ information environments and to build and maintain trust between healthcare systems and patients.

Discussion Themes

Emerging literature on misinformation highlights our humanity. Our needs for social connection and hope for the future make us vulnerable to misinformation.

Correcting misinformation is difficult and requires understanding of human psychology and patients’ information environments, and promotion of the shared interests of patients and healthcare systems.

Findings from STOP CRC on Pragmatic Trial Recruitment

Posted on by Gina Uhlenbrauck
Gloria Coronado, PhD, and Beverly Green, MD, MPH, Principal Investigators, STOP CRC Trial
Gloria Coronado, PhD, and Beverly Green, MD, MPH, Principal Investigators, STOP CRC Trial

Drs. Beverly Green and Gloria Coronado and colleagues have published an article in Clinical Trials describing the challenges of recruiting participants into large, multisite pragmatic clinical trials—particularly at the health system level. STOP CRC is one of the NIH Collaboratory’s pragmatic clinical trial, which are intended to provide a framework of implementation methods and best practices to enable participation of varied health care systems in clinical research.

STOP CRC is testing a culturally tailored, health care system–based program to improve colorectal cancer screening rates in a community-based collaborative network of federally qualified health centers. The authors observed that recruiting sites to participate in pragmatic trials is time-intensive and involves both preparing materials and organizing face-to-face meetings with staff and clinic leaders. Yet little is known about the characteristics of nonparticipating sites and clinic-level factors that may influence willingness to participate in a pragmatic trial.

“Our findings underscore the importance of assessing and reporting recruitment success at the organizational and/or clinic level in order to know the external validity of the findings and may inform future efforts to select and recruit health systems to participate in pragmatic research.” (Coronado, et al. Clin Trials 2015)