NIH Collaboratory Trials

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.

October 3, 2024: JAMA Commentary Highlights Gap Between Research Results and Implementation Decisions

Posted on by Karen Staman

Headshots of Richard Platt, Hayden Bosworth, and Greg SimonIn a JAMA Viewpoint published online this week, leaders from the NIH Pragmatic Trials Collaboratory discuss the discordance between the results of pragmatic clinical trials and the implementation of those results in healthcare settings, even in settings that championed the work.

Coauthors Richard Platt, Hayden Bosworth, and Gregory Simon posit that, to provide evidence that healthcare systems leaders will actually use, changes are necessary:

  • Trials need to be faster (2 to 3 years)
  • Trials should consider outcomes that healthcare system leaders care about (such as costs and subgroup analyses)
  • The evidence required for change should be at the level that healthcare system leaders use (such as not necessarily rejecting the null hypothesis at P < .05 but also considering results of Bayesian methods and interim analyses)

Read the full article.

“We believe it is possible to make pragmatic clinical trials of policies and procedures more useful to delivery systems by accommodating their priorities, introducing flexibility in the level of evidence trials require, shortening the duration of planning and implementation, addressing system leaders’ interest in multiple outcomes and subgroup analyses, encouraging modification of protocols during the implementation phase, and by providing timely interim analyses that can guide decisions about continuing or modifying an intervention,” the authors wrote.

This work was based on an NIH Pragmatic Trials Collaboratory workshop held in 2023, Getting the Right Evidence to Decision-Makers Faster. The workshop explored the critical cycle of evidence generation to decision by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

Platt is a cochair of the NIH Collaboratory’s Distributed Research Network and the Harvard Pilgrim Health Care Institute Distinguished Professor of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School. Bosworth is a cochair of the Implementation Science Core and a professor in population health sciences at Duke University. Simon is the chair of the Health Care Systems Interactions Core and a senior investigator at the Kaiser Permanente Washington Health Research Institute.

View the full workshop materials.

September 24, 2024: GRACE Team Identifies Barriers to Integrating Acupuncture Into US Healthcare System

Posted on by Damon Seils

Cover of the Journal of Integrative and Complementary Medicine (JICM)In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system.

The review was published online ahead of print in the Journal of Integrative and Complementary Medicine.

Acupuncture is widely practiced in the United States and has been shown to be effective in multiple clinical applications for a variety of conditions. Yet, its integration into the healthcare system has been uneven.

In their review of the existing evidence, the authors found:

  • Understanding and addressing individual patients’ needs, awareness, concerns, and financial constraints is essential
  • Healthcare providers play an important role in communicating information about acupuncture to their patients and building trust
  • Organization-level changes are needed to address lack of space in healthcare facilities, lack of referral systems, and lack of credentialing and privileging procedures
  • Policies related to payment by both private and public insurers have been slow to change

Read the full report.

The authors stress that studies testing implementation of acupuncture interventions in real-world settings can help to address barriers to integration.

“Results of this study can be used to optimize strategies to effectively implement acupuncture into clinical practice, and ultimately influence policy changes,” they wrote.

GRACE, an NIH Collaboratory Trial, is a pragmatic clinical trial testing real-world implementation of acupuncture and guided relaxation for patients with pain associated with sickle cell disease. The trial is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative under an award administered by the National Center for Complementary and Integrative Health. Learn more about the GRACE trial.

September 16, 2024: Researchers Examine Feasibility of Enhanced TSOS Intervention for Trauma Survivors in Australia

Posted on by Damon Seils

Disability and RehabilitationResearchers in Australia examined the feasibility of implementing an enhanced version of the TSOS collaborative care intervention for patients at risk of persistent posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury. They found the intervention was highly valued by most participants and could be implemented at low cost in the trauma system in Victoria, Australia.

The report was published this month in Disability and Rehabilitation.

The TSOS study, an NIH Collaboratory Trial led by principal investigator Doug Zatzick of the University of Washington, was a stepped-wedge, cluster randomized pragmatic clinical trial testing the delivery of a stepped collaborative care intervention vs usual care for injured patients with PTSD symptoms and comorbid conditions.

In the feasibility study in Australia, the researchers enrolled patients who had a range of complex clinical and social experiences and trauma-related concerns, many of whom would have been excluded from traditional trials of psychology-informed interventions. The study offers preliminary evidence for whether the intervention led to reduced PTSD symptoms and pain-related disability. Future effectiveness and efficacy studies will be needed.

Read the full report.

TSOS was supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute of Mental Health. Learn more about the NIH Collaboratory Trials.

August 26, 2024: iPATH Trial Aims to Improve Diabetes Care in Community Health Centers

Posted on by Damon Seils

Headshot of Dr. Sara SingerThe iPATH trial, one of the newest additions to our portfolio of NIH Collaboratory Trials, is testing the implementation of a practice transformation strategy for patients with type 2 diabetes in federally qualified health centers (FQHCs) in California, Massachusetts, Ohio, and Puerto Rico.

We asked the principal investigator for iPATH, Sara Singer of Stanford University, to tell us more about her innovative study.

Please introduce yourself and tell us about your study.

I am Sara Singer, a professor of health policy and medicine at Stanford School of Medicine and professor of organizational behavior (by courtesy) at Stanford Graduate School of Business. I serve as principal investigator for iPATH, a 5-year R01 study funded by the National Institute on Minority Health and Health Disparities (NIMHD). iPATH supports a team of researchers from Stanford, Ohio State, Harvard, and Impactivo LLC. iPATH aims to identify, rigorously test, and disseminate promising care delivery innovations in FQHCs across 4 US regions (Northeast, Midwest, South, and West).

In the first phase of this project, we are conducting a multiple case comparison study of 12 FQHCs to understand how they care for patients with type 2 diabetes and to identify recent innovations. We will use these findings to refine and implement a modularized, customized practice transformation intervention in 8 FQHCs, in a stepped-wedge, randomized controlled trial.

What challenges has the study team faced, and how have you dealt with them?

We have faced 3 main challenges in the initial launch of our study.

First, we experienced a delayed start to the study. To address this, our study team has been working with a condensed timeline, and we are on track to meet the year 2 milestones on time.

Second, this is a multisite study with significant complexity, including 4 research teams with diverse experience and perspectives, complex contracting needs including comprehensive data use agreements among the 4 sites, and a single IRB. We have been able to address this complexity through regular communication, standardization, and alignment within the study team, biweekly all-team meetings, regular check-ins with our sponsored research and contracting offices, and by working closely with Advarra, our single IRB.

Third, as anticipated, we have faced challenges related to recruiting FQHCs, which we addressed by working with both the state and local primary care associations and by reaching out to more sites.

What impact do you hope your trial will have on real-world healthcare?

We hope that the lessons learned from our multiple case comparison study and iPATH practice transformation intervention will provide evidence for improving diabetes care in FQHCs and reducing health disparities across the nation and help FQHCs achieve goals that enable them to receive incentive pay.

How has being part of the NIH Pragmatic Trials Collaboratory affected your project?

It was helpful to have upfront conversations with the NIH Collaboratory at the start of our study because the discussions caused us to reflect on our proposed approach and reconsider our initial study decisions. For example, the NIH Collaboratory provided us with methodological advice that we adopted. They suggested that, for selecting sites for our randomized trial, that we ask FQHCs to identify their 2 largest locations and then randomize between those 2 so that one would serve as the intervention site and the other as the control.

What advice do you have for investigators planning a pragmatic trial?

Because pragmatic trials are not conducted in a controlled environment and the research participants have other priorities and demands on their time in addition to the trial, we recommend that investigators (1) build a generous timeline for accomplishing study milestones and (2) plan for flexibility in your study to foster inclusion and support for study participants.

Learn more about the iPATH trial.

August 12, 2024: I CAN DO Surgical ACP Seeks to Open the Door to Team-Based Surgical Care

Posted on by Damon Seils

Few of the 20 million older adults who undergo elective surgical procedures in the United States each year engage in advance care planning. I CAN DO Surgical ACP, an NIH Collaboratory Trial, aims to address this missed opportunity to align older patients’ preferences with their surgical decisions and improve patient-clinician communications.

We spoke with co–principal investigator Elizabeth Wick about the I CAN DO Surgical ACP trial at the NIH Collaboratory’s 2024 Annual Steering Committee Meeting.

“We’re really hoping that our trial will open the door to more team-based care in surgery,” Wick said.

Wick is a professor of surgery and the vice chair of quality and safety in the Department of Surgery at the University of California, San Francisco, and cochair of the department’s research committee.

The I CAN DO Surgical ACP trial will will test 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 the National Institute on Aging.

Learn more about I CAN DO Surgical ACP.

July 29, 2024: MOMs Chat & Care Study Aims to Address Crisis of Black Maternal Morbidity

Posted on by Damon Seils

Among the newest NIH Collaboratory Trials is a study of an intervention to reduce rates of severe maternal morbidity, a health crisis in the United States that disproportionately affects Black patients.

We spoke with principal investigator Stephanie Fitzpatrick about the MOMs Chat & Care Study at the NIH Collaboratory’s 2024 Annual Steering Committee Meeting.

“In the United States, we have the highest rate of maternal morbidity, particularly among Black birthing people,” Fitzpatrick explained. “With findings from our trial, we hope that we can train and support other health systems in being able to provide more intensive wraparound services to get Black birthing people the care they need when they need it to prevent complications and eventually death,” she added.

Fitzpatrick is a professor in the Institute of Health System Science in the Feinstein Institutes for Medical Research at Northwell Health.

The MOMs Chat & Care Study will test 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. This NIH Collaboratory Trial is supported by the National Institute of Nursing Research.

Learn more about the MOMs Chat & Care Study.