NIH Collaboratory Trials

March 18, 2025: ABATE Infection Analysis Explores Cost-Effectiveness of Strategies to Prevent Hospital-Acquired Infections

Posted on by Damon Seils

Logo for the ABATE Infection Demonstration ProjectIn a cost-effectiveness analysis using data from the ABATE Infection trial, a strategy of chlorhexidine bathing and nasal decolonization targeted to hospitalized adults with medical devices in non–intensive care unit (ICU) settings was cost-effective in reducing hospital-acquired infections.

The study results were published this month in JAMA Network Open.

ABATE Infection, an NIH Collaboratory Trial, was a cluster randomized pragmatic trial of universal chlorhexidine bathing and nasal decolonization compared with usual care for more than 500,000 hospitalized patients. Previous research had shown the effectiveness of the intervention in ICUs. ABATE Infection studied the intervention in non-ICU settings, finding no significant effect overall but a significant reduction in infections among patients with medical devices.

The Agency for Healthcare Research and Quality later published a toolkit to help clinical teams reduce hospital-acquired infections based on the intervention materials used in the ABATE Infection trial.

For the cost-effectiveness analysis, researchers created a decision analysis model using a simulated cohort of patients based on the ABATE Infection study population. The targeted strategy for patients with medical devices was cost-effective in a wide range of scenarios from the perspectives of both hospitals and healthcare payers. Universal decolonization for all hospitalized adults in non-ICU settings was cost-effective in some scenarios.

Read the full report.

ABATE Infection was supported within the NIH Collaboratory by the National Institute of Allergy and Infectious Diseases. Learn more about ABATE Infection.

March 11, 2025: Study Design Paper Published for MOMs Chat & Care Study

Posted on by Damon Seils

MOMs Chat and Care Study logoThe study design paper for the MOMs Chat & Care Study has been published online ahead of print in Contemporary Clinical Trials. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials!

The MOMs Chat and Care Study 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.

Read the full study design paper.

March 10, 2025: Developing Monitoring Plans Warrants Special Attention in Pragmatic Clinical Trials

Posted on by Karen Staman

Cover of Contemporary Clinical TrialsIn an article published online ahead of print, leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the importance of independent oversight by a safety office or data and safety monitoring board in pragmatic clinical trials, even for trials deemed to have minimal risk.

Challenges specific to pragmatic trials include:

  • complexity, quality, and timing of a real-world data pipeline, especially in trials with many heterogeneous sites
  • embedding of interventions in clinical workflows, so investigators have less control over treatments or interventions
  • potential for incidental and collateral findings

“We recommend regular, rigorous data quality checks, ongoing monitoring of adherence to interventions, and including someone who is knowledgeable about pragmatic clinical trials and novel research designs in the development of Data and Safety Monitoring Plans and Data and Safety Monitoring Boards,” the authors wrote.

By attempting to reflect real-world conditions, pragmatic trials are conducted in settings that cannot be closely controlled. Therefore, close monitoring is critical for a successful study that produces meaningful results, whether it be by independent monitors or data and safety monitoring boards.

The authors drew on experiences from 7 of the NIH Collaboratory Trials and the expertise of the Coordinating Center, the Ethics and Regulatory Core, the Biostatistics and Study Design Core, and the Health Care Systems Interactions Core.

The article was published in Contemporary Clinical Trials.

March 6, 2025: Enrollment Begins for Several of the Newest NIH Collaboratory Trials

Posted on by Damon Seils

In recent months, 5 of the newest NIH Collaboratory Trials have begun to enroll research participants. Congratulations to the study teams from ARBOR-Telehealth, BEST-ICU, Chat 4 Heart Health, I CAN DO Surgical ACP, and the MOMs Chat & Care Study for reaching this important project milestone!

 ARBOR-Telehealth is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. The study is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

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. The trial is supported by the National, Heart, Lung, and Blood Institute (NHLBI).

Chat 4 Heart Health 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. The project is supported by NHLBI.

I CAN DO Surgical ACP 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 trial is supported by the National Institute on Aging.

The MOMs Chat and Care Study 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 supported by the National Institute of Nursing Research.

 

March 4, 2025: PRIM-ER Team Develops Innovative Statistical Techniques for Stepped-Wedge Trials

Posted on by Damon Seils

Cover image of Statistics in MedicineResearchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The new models, which use Bayesian methods, outperformed traditional analytic methods and other Bayesian approaches in simulations and real-world applications.

The article was published online in Statistics in Medicine.

In cluster randomized trials with stepped-wedge designs, the clusters are randomized into several groups, and all groups start the trial in the control condition. Groups of clusters cross over to the intervention condition on a staggered timeline, and all groups receive the intervention before the end of the trial.

Stepped-wedge designs can be advantageous when simultaneous rollout of the intervention to all clusters is infeasible, or when withholding the intervention from any cluster would be unethical, or when there is a risk of contamination between intervention subjects and control subjects. However, stepped-wedge designs can also introduce confounding by time, as the intervention is rolled out to clusters in waves. Temporal trends during the study can influence the study’s outcomes.

(Learn more about stepped-wedge designs in the Living Textbook.)

The PRIM-ER researchers tested 2 new Bayesian hierarchical penalized spline models to improve the estimation of intervention effects in stepped-wedge trials. The first model focuses on immediate intervention effects and accounts for large numbers of clusters and time periods. The second model extends the first by accounting for time-varying intervention effects. The researchers applied both models to data from PRIM-ER.

Read the full report.

PRIM-ER tested a multidisciplinary primary palliative care intervention in a diverse mix of emergency departments in the United States to improve the delivery of goal-directed emergency care of older adults. The study was supported by the National Institute on Aging. Learn more about PRIM-ER.

March 3, 2025: Intervention Complexity a Consistent Theme Across Pragmatic Trial Collaboratories

Posted on by Damon Seils
Headshot of Lindsay Ballengee
Lindsay Ballengee

In a survey of pragmatic clinical trials across 3 NIH research networks, the complexity of delivering nonpharmacological interventions was similar between pain-related trials and non–pain-related trials. However, pain trials tended to have more intervention components, add more new tasks, and require modifications to existing workflows.

The results of the study were published online ahead of print in Contemporary Clinical Trials Communications.

The researchers surveyed study team members from trials in the NIH Pragmatic Trials Collaboratory, the IMPACT Collaboratory, and the Pain Management Collaboratory. All 3 programs support pragmatic clinical trials embedded in healthcare systems, including trials of nonpharmacological interventions for pain.

Though the trials examined in the study had similar intervention complexity, pain trials had slightly greater complexity overall, and the study teams for these trials reported needing to make more adaptations in workflows during the trial to improve the intervention’s fit or effectiveness in real-world settings.

Read the full report.

“Change in workflow was an important consideration for intervention delivery for all trials in our study,” wrote lead author Lindsay Ballengee and her coauthors. “Future research should capture detailed, real-time information about the nature of intervention delivery complexity, adaptations, and implementation success to help improve delivery of nonpharmacologic pain interventions,” she wrote. Ballengee is a research fellow with the NIH Pragmatic Trials Collaboratory.

February 26, 2025: BEST-ICU Trial to Be Featured in This Week’s PCT Grand Rounds

Posted on by Damon Seils
Headshots of Dr. Michele Balas and Dr. Eduard Vasilevskis
Dr. Michele Balas and Dr. Eduard Vasilevskis, principal investigators of BEST-ICU

In this Friday’s PCT Grand Rounds, Michele Balas and Ed Vasilevskis will present “Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST-ICU): Protocol, Challenges, and Major Updates.”

The Grand Rounds session will be held on Friday, February 28, 2025, at 1:00 pm eastern.

BEST-ICU, an NIH Collaboratory Trial supported by the National Heart, Lung, and Blood Institute, 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. The ABCDEF bundle is a multicomponent, evidence-based intervention to improve team-based care. Learn more about BEST-ICU.

Balas is the Dorothy Hodges Olson Distinguished Professor of Nursing and the associate dean of research at the University of Nebraska Medical Center College of Nursing. Vasilevskis is a professor of medicine at the University of Wisconsin-Madison.

Join the online meeting.

February 24, 2025: Study Snapshots and Updated Ethics Documentation Available for 3 NIH HEAL Initiative–Supported Trials in Rural Populations

Posted on by Damon Seils

New study snapshots and updated ethics and regulatory documentation are now available for the AIM-CP, ARBOR-Telehealth, and RAMP trials. The 3 NIH Collaboratory Trials, all supported through the NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, reflect a special emphasis on developing strategies for the management of chronic pain in rural and remote populations. The trials have transitioned from the UG3 planning phase to the UH3 implementation phase.

“There are many known disparities between urban and rural populations,” said Karen Kehl, a program director at the National Institute of Nursing Research (NINR), in an interview at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting. “And when we talk about chronic pain, we know that there’s a higher incidence and a higher severity of pain in rural populations, and yet they don’t have access to many of the effective solutions that we have,” Kehl added.

AIM-CP

 AIM-CP is testing the implementation of a care management program to address disparate access to nonpharmacological treatments for chronic pain in rural populations. The principal investigators are Sebastian Tong and Kushang Patel of the University of Washington. The study is supported by NINR.

 

ARBOR-Telehealth

 ARBOR-Telehealth is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. The principal investigators are Richard Skolasky and Kevin McLaughlin of Johns Hopkins University. The study is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

 

RAMP

 RAMP is evaluating the use of a 12-week mind-body skills training program for rural veterans with pain within the VA’s Whole Health initiative, including a one-on-one session with a Whole Health coach followed by 11 weekly group sessions to include prerecorded expert-led education videos, mind-body skills training and practice, and group discussions. The principal investigators are Diana Burgess and Roni Evans of the University of Minnesota and Katherine Hadlandsmyth of the University of Iowa. The study is supported by NINR.

 

February 19, 2025: Texting for Behavior Change to Improve Chronic Care Management, in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Chat 4 Heart Health logoIn this Friday’s PCT Grand Rounds, Michael Ho and Sheana Bull will present “Texting for Behavior Change: Lessons Learned Across 2 Interventions to Improve Chronic Care Management.”

The Grand Rounds session will be held on Friday, February 21, 2025, at 1:00 pm eastern.

This Grand Rounds session will report the results of Chat 4 Heart Health, an NIH Collaboratory Trial. The trial evaluated the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve individuals’ self-management health behaviors. The presenters will also share insights from Nudge, another NIH Collaboratory Trial, which tested a variety of text messaging strategies to encourage patients to refill their cardiovascular medications.

Ho is a senior clinician investigator at Kaiser Permanente Colorado’s Institute for Health Research. Bull is a professor of community and behavioral health at the Colorado School of Public Health.

Join the online meeting.

February 12, 2025: Results of ACP PEACE, an NIH Collaboratory Trial, in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Logo for the ACP PEACE Demonstration ProjectIn this Friday’s PCT Grand Rounds, Angelo Volandes of Dartmouth Health and James Tulsky of Dana-Farber Cancer Institute will present “A Cluster Randomized, Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults With Cancer (ACP-PEACE).”

The Grand Rounds session will be held on Friday, February 14, 2025, at 1:00 pm eastern.

ACP PEACE, an NIH Collaboratory Trial, is evaluating a comprehensive advance care planning program for older patients with advanced cancer that combines clinician communication skills training and patient video decision aids.

Volandes is a professor of medicine and the vice chair for research in the Department of Medicine at Dartmouth Health and the Geisel School of Medicine at Dartmouth. Tulsky is a professor of medicine at Harvard Medical School and the Poorvu Jaffe Chair of Supportive Oncology at the Dana-Farber Cancer Institute.

Join the online meeting.