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.
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.
A 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.
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.
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.
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.
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.
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.
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.
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:
Drawing 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.
A 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.
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.