NIH Collaboratory Trials

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

Posted on by Damon Seils
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

Posted on by Karen Staman

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

Posted on by Karen Staman

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

Posted on by Damon Seils

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

October 24, 2024: APA-SM Trial Joins the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

APA-SM InvestigatorsThe NIH Pragmatic Trials Collaboratory is pleased to welcome APA-SM (Personalized Auricular Point Acupressure for Chronic Pain Self-Management in Rural Populations) to its portfolio of innovative NIH Collaboratory Trials. The new project is supported by an award from the National Institute of Neurological Disorders and Stroke, with administrative oversight from the National Center for Complementary and Integrative Health.

The APA-SM study team will conduct a pragmatic, hybrid effectiveness-implementation trial of a 4-week auricular point acupressure intervention for self-management of chronic pain in rural communities in Texas and South Carolina. The primary outcomes include pain intensity, pain interference, and function. Key secondary outcomes are based on the HEAL Clinical Pain Core Common Data Elements. The study team will also evaluate implementation outcomes, cost-effectiveness, and predictive factors for treatment response.

Jennifer Kawi, Jane Bolin, and Hulin Wu will serve as the principal investigators for APA-SM. Kawi is a Lee and Joseph Jamail Distinguished Professor in the Cizik School of Nursing at the University of Texas Health Science Center at Houston (UTHealth Houston). Bolin is Regents Professor Emerita and a senior professor in the College of Nursing at Texas A&M University. Wu is the Betty Wheless Trotter Professor and Chair of the Department of Biostatistics and Data Science, professor of biomedical informatics, and director of the Center for Big Data in Health Sciences at UTHealth Houston.

Funding for APA-SM is provided through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, to address the opioid crisis.

Learn more about the APA-SM trial.

October 21, 2024: BEST-ICU and Chat 4 Heart Health Have Updated Study Snapshots, Ethics and Regulatory Documentation

Posted on by Damon Seils

Updated study snapshots and ethics and regulatory documentation are now available for the BEST-ICU and Chat 4 Heart Health trials. Both of these NIH Collaboratory Trials are supported by awards from the National Heart, Lung, and Blood Institute.

BEST-ICU logoBEST-ICU transitioned from the planning phase to the implementation phase during the summer. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. BEST-ICU is evaluating 2 strategies grounded in behavioral economics theory and implementation science to increase ABCDEF bundle adoption in the intensive care unit and improve care for critically ill adults across a variety of healthcare systems, particularly those serving populations with known health disparities. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care.

Chat 4 Heart Health logoChat 4 Heart Health also transitioned from planning to implementation this summer. The trial is testing the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve individuals’ self-management health behaviors, including physical activity and medication adherence. The study will provide evidence regarding the best population-based strategy for universal delivery to engage patients in self-management to improve the American Heart Association’s “Life’s Essential 8” measures for improving and maintaining cardiovascular health.

October 17, 2024: GGC4H Pilot Finds Spanish-Language Intervention Feasible and Acceptable in Pediatric Primary Care

Posted on by Damon Seils

Headshots of Dr. Margaret Kuklinski and Dr. Stacy Sterling
Dr. Margaret Kuklinski and Dr. Stacy Sterling

In a pilot study for the GGC4H trial, researchers found that a virtual version of the Guiando Buenas Decisiones program delivered in the context of pediatric primary care was feasible, acceptable, and appealing to pediatricians and parents. The program is a Spanish-language version of the Guiding Good Choices intervention being implemented in the GGC4H trial.

The report was published online ahead of print in the Journal of Prevention.

The pediatricians and parents included in the Spanish-language feasibility pilot participated in semistructured, telephone-based, qualitative interviews in 2020 and 2021. Although Guiando Buenas Decisiones had previously been offered in community settings, pediatric primary care may offer another appealing setting for reaching Spanish-speaking families.

“By offering [the program] in a trusted setting, the stigma of parenting programs will be reduced and preventive interventions can be more sustainably funded,” the authors wrote.

Read the full article.

GGC4H, an NIH Collaboratory Trial, is a pragmatic clinical trial testing the feasibility and effectiveness of implementing within healthcare systems the Guiding Good Choices substance use prevention program for caregivers of adolescents aged 11 to 13 years. The trial is supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Center for Complementary and Integrative Health. Learn more about GGC4H.

October 15, 2024: Case Study Describes a Reassessment of Sample Size in an Ongoing Cluster Randomized Trial

Posted on by Damon Seils

FM-TIPS logoA new case study from the NIH Pragmatic Trials Collaboratory highlights an interim reassessment of sample size during an ongoing cluster randomized trial. The case study was published this week in the Living Textbook of Pragmatic Clinical Trials.

Researchers in cluster randomized trials must account for potential correlation between clusters in the design and analysis of their trial by estimating the intraclass correlation when calculating the target sample size. Often they use preliminary data from the planned enrollment sites to estimate the correlation. However, when preliminary data are unavailable at the time of study design, they may use interim data collected during the trial itself to reassess the trial’s sample size.

The contributors of the case study focus on FM-TIPS, an NIH Collaboratory Trial, to describe an approach to conducting an interim reassessment of sample size in an ongoing trial. Read the full case study.

FM-TIPS 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.

The contributors of the case study include members of the FM-TIPS study team and leaders of the NIH Collaboratory’s Biostatistics and Study Design Core. David-Erick Lafontant is a statistician, Bridget Zimmerman is a clinical professor of biostatistics, and Emine Bayman is an associate professor of biostatistics—all at the University of Iowa. Megan McCabe is an assistant professor of biostatistics at the University of Alabama at Birmingham. Patrick Heagerty is a professor of biostatistics at the University of Washington. Liz Turner is an associate professor of biostatistics and bioinformatics at Duke University.