January 8, 2025 Virtual Onboarding Meeting: STEP-2

NIH Pragmatic Trials Collaboratory Onboarding Meeting

January 8, 2025
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Wendy Weber
Adrian Hernandez

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Wendy Weber

Working With the NIH Collaboratory Coordinating Center
Adrian Hernandez

Brief Introduction to the Core Working Groups

New UG3 NIH Collaboratory Trial Overview
Self-Testing for Cervical Cancer in Priority Populations (STEP-2)
Rachel Winer
Amanda Petrik
Jasmin Tiro

Open Discussion
Adrian Hernandez

Closing Remarks
Wendy Weber
Adrian Hernandez

January 8, 2025: In This Week’s PCT Grand Rounds, Community Engagement Methods in the FM-TIPS Trial

Headshots of Dr. Heather Schacht Reisinger and Dr. Dana DaileyIn this Friday’s PCT Grand Rounds, Heather Schacht Reisinger and Dana Dailey of the University of Iowa will present “FM-TIPS Community Engagement Methods for Recruitment.”

The Grand Rounds session will be held on Friday, January 10, 2025, at 1:00 pm eastern.

FM-TIPS, an NIH Collaboratory Trial, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia. The trial is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases through the NIH HEAL Initiative. Learn more about FM-TIPS.

Reisinger is an associate professor of internal medicine and the associate director of engagement, integration, and implementation in the Institute for Clinical and Translational Science; and Dailey is an assistant research scientist in the Department of Physical Therapy and Rehabilitation Science—both in the University of Iowa’s Carver College of Medicine.

Join the online meeting.

December 16, 2024: Study Snapshot and Updated Ethics Documentation Available for I CAN DO Surgical ACP

Logo for the I CAN DO Surgical ACP trialA new study snapshot and updated ethics and regulatory documentation are now available for the I CAN DO Surgical ACP trial. As part of the study’s transition from the planning phase to the implementation phase this fall, the investigators reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.

I CAN DO Surgical ACP, an NIH Collaboratory Trial, is testing a system-based approach to help older adults undergoing elective surgery engage in advance care planning. Another goal of the study is to understand digital engagement, language, and social drivers of health that drive engagement in the intervention.

The study is supported by a grant award from the National Institute on Aging and is led by Elizabeth Wick and Rebecca Sudore of the University of California, San Francisco, and Genevieve Melton-Meaux of the University of Minnesota.

December 5, 2024: Nudge Pragmatic Trial Finds No Improvement in Adherence to Cardiovascular Medications at 12 Months

Headshots of Dr. Michael Ho and Dr. Sheana Bull
Dr. Michael Ho and Dr. Sheana Bull, principal investigators for Nudge

Text message–based reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care in the recently completed Nudge trial.

The results of the study were published online ahead of print in JAMA.

Nudge, an NIH Collaboratory Trial, was a randomized, pragmatic clinical trial embedded in 3 healthcare systems testing a variety of text messaging strategies to encourage patients to refill their cardiovascular medications. Poor medication adherence is common among patients with chronic conditions, and poor adherence to cardiovascular medications is associated with higher rates of adverse health outcomes, including hospitalization and mortality.

The study team randomly assigned 9501 patients who delayed refilling their cardiovascular medications to receive either usual care or 1 of 3 text message interventions: (1) a generic text message reminder to refill medication; (2) a text message reminder that incorporated “behavioral nudges”; and (3) a behavioral nudge text message reminder plus a chatbot that used preprogrammed algorithms to assess common barriers to medication adherence. The primary outcome was the proportion of days covered in the 365 days after randomization for all cardiovascular medication classes for which the patient had a refill gap at baseline.

Screenshot of the title page of the article published in JAMA.At the end of the trial, there were no statistically significant differences in the proportion of days covered with medication between the study groups. There were also no differences in emergency department visits, hospitalizations, and mortality. In a post hoc analysis exploring medication adherence in the first 3 months after a refill gap, the study team saw modest improvement in refill adherence with the text messaging strategies compared with usual care.

Read the full article.

Given that most patients refilled their medications within 30 days of receiving a reminder text message, the authors concluded that the lack of benefit after 30 days may be related to “intervention decay” that has been seen with other interventions. “Additional interventions need to be rigorously tested to try to improve adherence to chronic cardiovascular medications,” they wrote.

Nudge was supported within the NIH Pragmatic Trials Collaboratory by a grant award from the National Heart, Lung, and Blood Institute.

“The feedback and guidance from the NIH Collaboratory’s Cores were instrumental to overcoming the challenges we faced in completing this project,” said Michael Ho, co–principal investigator for Nudge and a senior clinician investigator at Kaiser Permanente Colorado’s Institute for Health Research.

Learn more about Nudge.

December 2, 2024: NCI-Supported LungSMART Trial Joins the NIH Pragmatic Trials Collaboratory

Headshots of LungSMART investigators David Wetter, Guilherme Del Fiol, and Ken Kawamoto
From left to right: Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto, principal investigators for LungSMART

The NIH Pragmatic Trials Collaboratory is pleased to welcome LungSMART (Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers) to its portfolio of innovative NIH Collaboratory Trials.

Lung cancer is the leading cause of cancer-related deaths in the United States, but only 6.5% of eligible individuals were screened for lung cancer in 2020. Moreover, there are significant disparities in lung cancer screening related to race/ethnicity and socioeconomic status.

The LungSMART team will conduct a sequential multiple-assignment randomized trial (SMART) in community health centers in Utah to test telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening. The new project is supported by a grant award from the National Cancer Institute, a first for the NIH Pragmatic Trials Collaboratory.

David Wetter, Guilherme Del Fiol, and Ken Kawamoto will serve as the principal investigators for LungSMART. Wetter is the Jon M. and Karen Huntsman Presidential Professor, director of the Center for Health Outcomes and Population Equity, senior director for cancer health equity science at the Huntsman Cancer Institute, and director of community and stakeholder engagement at the Clinical and Translational Sciences Institute; Del Fiol is professor and vice chair of biomedical informatics; and Kawamoto is professor and vice chair of clinical informatics—all at the University of Utah.

Learn more about the LungSMART trial.

November 20, 2024 Virtual Onboarding Meeting: LungSMART

NIH Pragmatic Trials Collaboratory Onboarding Meeting

November 20, 2024
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Lesley Curtis
Beda Jean-Francois

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Beda Jean-Francois

Working With the NIH Collaboratory Coordinating Center
Lesley Curtis

Brief Introduction to the Core Working Groups

New UG3 NIH Collaboratory Trial Overview
Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers (LungSMART)
David Wetter
Guilherme Del Fiol
Kensaku Kawamoto

Open Discussion
Lesley Curtis

Closing Remarks
Lesley Curtis
Beda Jean-Francois

November 26, 2024: Hybrid Methods Improve Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations

ACI

In an article published online this week, leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the collection of patient-reported outcome measures (PROMs) in medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnically minoritized groups, and rural and frontier communities.

The electronic health record and other digital modes are frequently used to collect PROM data, and engagement with these digital tools can be low among disparities-prone populations.

“Our ability to measure PROMs is hampered by patients’ limited digital proficiency, difficulty understanding PROMs as written, and access to portals and the Internet. …With low uptake among disparities prone populations, reliance on portals may inadvertently exacerbate health inequities,” the authors wrote.

Therefore, the authors recommend hybrid approaches:

  • multiple outreach modes
  • high-touch methods
  • creativity in promoting digital uptake
  • multimodal participant engagement, and
  • text messaging for the collection of PROMs

The authors draw on on experiences from 5 of the NIH Collaboratory Trials and the expertise of the Patient-Centered Outcomes Core and the Health Equity Core.

The article was published this week in Applied Clinical Informatics.

November 25, 2024: NIH Collaboratory Trial Investigators Share Lessons From Using Electronic Health Records in Pragmatic Trials

Cover of Contemporary Clinical TrialsDrawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems.

“Teams need to be aware of—and perhaps proactively investigate—possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and safety of pragmatic clinical trials,” the authors wrote.

The challenges can create delays and unanticipated work that require creativity and collaboration, and include:

  • Rapid technology evolution: Over the course of a years-long trial, technology can become outdated.
  • EHR updates: Periodic, routine updates may change the way data are represented, captured, or computed, causing the logic of the intervention delivery tool to function differently or not function at all.
  • Switching EHR systems: Smaller clinics may switch EHR systems midtrial, causing disruptions in the research.

“We have learned that preparing for changes in the EHR by anticipating their effects, adapting, and reducing impact on the intervention is an important component in conducting embedded pragmatic clinical trials,” the authors wrote.

Read the full article.

November 5, 2024: Study Snapshot and Updated Ethics Documentation Available for MOMs Chat & Care Study

MOMs Chat and Care Study logoA new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core.

The MOMs Chat and Care Study, an NIH Collaboratory Trial, is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce their risk for severe maternal morbidity. Patients in both study arms will receive close clinical and behavioral health monitoring and navigation to timely care and services. The study is being led by Stephanie Fitzpatrick at the Feinstein Institutes for Medical Research and is supported by an R01 grant award from the National Institute of Nursing Research.

October 24, 2024 Virtual Onboarding Meeting: APA-SM

NIH Pragmatic Trials Collaboratory Onboarding Meeting

October 24, 2024
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Wendy Weber

Working With the NIH Collaboratory Coordinating Center
Lesley Curtis, PhD

Brief Introduction to the Core Working Groups

Prevention and Management of Chronic Pain in Rural Populations
Karen Kehl

New UG3 NIH Collaboratory Trial Overview
Jennifer Kawi
Hulin Wu
Jane Bolin

Open Discussion
Lesley Curtis

Closing Remarks
Wendy Weber
Lesley Curtis