NIH Collaboratory Trials

July 11, 2023: Chat 4 Heart Health NIH Collaboratory Trial Joins the NIH Pragmatic Trials Collaboratory

Posted on by Lauren Stewart

Headshots of Dr. Sheana Bull and Dr. Michael HoThe NIH Collaboratory is excited to announce the addition of Chat 4 Heart Health to its portfolio of innovative NIH Collaboratory Trials.

The American Heart Association (AHA) identifies Life's Essential 8 (LE8) lifestyle factors as eating better, being more active, quitting tobacco, getting healthy sleep, managing weight, controlling cholesterol, managing blood sugar, and managing blood pressure. When uncontrolled, these lifestyle factors lead to common coexisting chronic conditions, morbidity, healthcare costs, and death. Patients who experience health disparities are disproportionately affected by cardiovascular diseases, have worse disease control, and suffer greater sequelae.

Chat 4 Heart Health will use a patient-level randomized pragmatic trial to test the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve an individual's self-management health behaviors, including physical activity and medication adherence. The study findings will provide evidence regarding the best population-based strategy for universal delivery to engage all patients with health disparities in self-management to improve the AHA's LE8.

Dr. Michael Ho and Dr. Sheana Bull will serve as the co–principal investigators for Chat 4 Heart Health. Dr. Ho is a professor of medicine at the University of Colorado School of Medicine. Dr. Bull is a professor and past chair of the Department of Community and Behavioral Health at the Colorado School of Public Health, as well as the director of the mHealth Impact Lab.

The Chat 4 Heart Health NIH Collaboratory Trial is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Heart, Lung, and Blood Institute (NHLBI).

Ho and Bull are experienced investigators in the NIH Collaboratory, and both serve currently as co-PIs on the Nudge NIH Collaboratory Trial.

Grand Rounds June 16, 2023: BeatPain Utah: Partnering With Community Health Centers Within a Socio-Technical Framework (Julie Fritz, PT, PhD, FAPTA; Guilherme Del Fiol, MD, PhD)

Posted on by Damon Seils

Speakers

Julie Fritz, PT, PhD, FAPTA
Distinguished Professor, Department of Physical Therapy & Athletic Training
Associate Dean for Research, College of Health
University of Utah

Guilherme Del Fiol, MD, PhD
Professor, Biomedical Informatics
University of Utah

Keywords

Community Health Centers; Low Back Pain; Physical Therapy Modalities; Primary Care; Telemedicine

Key Points

  • Clinical practice guidelines support nonpharmacologic care as first-line management of low back pain. However, persons in low-income and rural communities have significantly higher odds of receiving a prescription opioid for a new back pain diagnosis.
  • Use of nonpharmacologic pain treatments is lower in rural settings and for persons of Hispanic/Latino ethnicity. Many of these communities are served by federally qualified health centers that often lack options to provide accessible nonpharmacologic alternatives.
  • Clinical research can exacerbate disparities, because clinical trials typically are based in urban, academic medical centers, underrepresent diverse populations, and overlook community engagement strategies in trial planning and design.
  • BeatPain Utah, an NIH Pragmatic Trials Collaboratory Trial, is an embedded pragmatic clinical trial comparing the effectiveness of nonpharmacologic intervention strategies for patients with back pain seeking care in federally qualified health centers in Utah. The interventions include a telehealth strategy that provides a brief pain teleconsult along with phone-based physical therapy, and an adaptive strategy that provides the brief pain teleconsult first, followed by phone-based physical therapy among patients who are nonresponsive to treatment.
  • BeatPain Utah is using the Community-Engaged Dissemination and Implementation (CEDI) framework, which considers both social and technical factors in the implementation of health IT strategies, decentralizes the research methods and procedures, and grounds the implementation in a systematic, iterative mapping of how both clinic staff and patients interact with health IT.
  • Although there is evidence of a significant divide in the implementation of advanced health IT functions, low-resource settings can adopt advanced health IT with some assistance. Moreover, there is considerable opportunity to reduce inequities through increased adoption of telehealth strategies, given that 96% of people in low-resource communities have at least a text and voice phone.

Discussion Themes

  • Motivating patients to engage in self-management of health conditions is a challenge, irrespective of whether the intervention is delivered in person or remotely.
  • Designing interventions that can meet everyone’s needs can be a challenge in a study that involves rural/urban and racial/ethnic diversity. Implementation mapping at the beginning of the design process is key. This includes direct assessment of patients’ needs, such as by interviewing patients who seek care in the partnering clinics to understand their expectations and how they would think about a mode of care delivery, like telehealth, that is unfamiliar to them.
  • Another crucial element of the health equity–focused model is ensuring that the question at the heart of the research is of value to the clinics and their leadership. For every trial, one of the first important tasks is to reach out to the community health center leadership and see if they are interested. The clinic’s priorities should drive the design of the trial. “We have to be very accommodating to the needs of each [community health center] and respect their needs.”
  • How quickly can these types of studies proceed from trial completion to release of results? Especially in studies involving chronic conditions, having long-term follow-up data to answer the core effectiveness question in a hybrid trial means there could be a long wait for results. Researchers must also be prepared to consider the question of sustaining a service that many clinics in the study have come to rely on, even before the results are available.

Tags

#pctGR, @Collaboratory1

July 3, 2023: Report Shares Strategies for Addressing Lack of Generalizability of EHR Data

Posted on by Damon Seils

JAMIA cover imagePragmatic research is vulnerable to differences in data capture and access to care for different subsets of the population, which, if left unaddressed, can worsen health gaps.

In a new article published online ahead of print in JAMIA, the NIH Pragmatic Trials Collaboratory's Trial teams reflect on the challenges encountered by their trials and share the specific strategies they used to increase the generalizability of research results.

“Poor generalizability can occur because detailed information about specific populations is missing, and critically, is missing not at random,” the authors cautioned.

The NIH Collaboratory Trials are implementing approaches designed to ensure inclusion and retention of all populations, and to enable the complete collection of data.

“By improving data capture, access to care, and patient technology support, ePCTs hold the potential to yield insights and estimates pertinent to the entire population, not just a subset of the population,” they wrote.

This work was a collaboration between the Community Health Improvement Core, the EHR Core, and the Patient-Centered Outcomes Core of the NIH Pragmatic Trials Collaboratory.

June 21, 2023: Results of ICD-Pieces to Be Presented in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Headshots of Dr. Miguel Vazquez and Dr. George "Holt" OliverIn this Friday’s PCT Grand Rounds, Miguel Vazquez of the University of Texas Southwestern Medical Center and George “Holt” Oliver of the Parkland Center for Clinical Innovation will present “Improving Delivery of Care for Chronic Kidney Disease, Diabetes, and Hypertension,” including results from the ICD-Pieces NIH Collaboratory Trial.

The Grand Rounds session will be held on Friday, June 23, 2023, at 1:00 pm eastern.

ICD-Pieces, an NIH Collaboratory Trial, used a novel information technology platform to identify patients with concurrent chronic kidney disease, diabetes, and hypertension and deliver evidence-based interventions to improve patient outcomes. The study is supported within the NIH Collaboratory under an award from the National Institute of Diabetes and Digestive and Kidney Diseases.

Dr. Vazquez is a professor of internal medicine at the University of Texas Southwestern Medical Center and Dr. Oliver is vice president of clinical informatics at the Parkland Center for Clinical Innovation.

Join the online meeting.

June 14, 2023: IMPACt-LBP and INSPIRE 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 IMPACt-LBP and INSPIRE trials, both NIH Pragmatic Trials Collaboratory Trials.

Logo for the IMPACt-LBP NIH Collaboratory TrialIMPACt-LBP transitioned from the planning phase to the implementation phase in August. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The study is a cluster randomized trial evaluating the effect of first-contact patient referral to physical therapists and doctors of chiropractic for the treatment of low back pain. IMPACt-LBP is supported within the NIH Collaboratory under an award from the National Center for Complementary and Integrative Health.

  • Also available is an updated study snapshot for IMPACt-LBP.

Logo for the INSPIRE NIH Collaboratory TrialINSPIRE joined the NIH Collaboratory at the beginning of its implementation phase. The study team held its initial consultation with the Ethics Regulatory Core to review their approach to consent, data privacy, and the applicability of recent FDA guidance regarding clinical decision support software functions. INSPIRE consists of 2 cluster randomized trials that are using personalized clinical decision support to improve judicious antibiotic prescribing for non–critically ill patients hospitalized with abdominal infections or skin and soft tissue infections. The project is supported within the NIH Collaboratory under an award from the National Institute of Allergy and Infectious Diseases.

  • See also the study snapshot for INSPIRE.

June 6, 2023: INSPIRE NIH Collaboratory Trial Principal Investigators Share Update at Annual Steering Committee Meeting

Posted on by Karen Staman

In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in Bethesda, Maryland, Richard Platt, MD, MS (co–principal investigator) and Shruti Gohil, MD, MPH (lead investigator) of the INSPIRE NIH Collaboratory Trial shared the status of the trials, discussed recent lessons learned, described the impact they hope their trials will have on the future of healthcare, and reflected on the impact the NIH Collaboratory has had on their trials thus far.

Status Update

Headshot of Dr. Richard Platt
Richard Platt, MD

Shruti Gohil, MD, MPH

INSPIRE (or Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) is implementing 2 separate cluster-randomized trials to study the effectiveness of a patient/infection/hospital-specific clinical decision support program in improving antibiotic prescribing for non–critically ill patients who are hospitalized with abdominal infections or skin and soft tissue infections. The purpose of the trials is to reduce unnecessary broad-spectrum antibiotic use in non–intensive care unit inpatients.

The 12-month trial is currently in month 5, and the team has already seen a downward inflection in broad-spectrum antibiotic use.

Lessons Learned

Due to the urgent public health threat of antibiotic resistance, healthcare systems are actively seeking ways to support clinicians in judicious antibiotic prescribing. As a result, although the target recruitment was 60 hospitals out of approximately 200, 92 hospitals at HCA Healthcare requested enrollment.

"We have the privilege of being with a health system that has a strong leadership structure that is patient-safety oriented, and quality improvement is a top-notch priority," Gohil said, describing the unusual overenrollment.

The INSPIRE team determined that the trial could be shortened from 18 months to 12 by using all 92 hospitals.

"We determined that the higher number of hospitals wanting to participate gave us the opportunity to understand the usefulness of this decision support tool as quickly as possible and honor the commitment of the partner health system," Platt said. "Their view is, if it works, we want to use it everywhere as soon as possible," he said.

Impact of the Trial on Real-World Healthcare

Dr. Gohil explained that she hopes not only to reduce unnecessary prescribing of broad-spectrum antibiotics, but also to learn about how digital health can transform healthcare and its delivery.

“We have a tool that not only flags a low-risk patient, but is doing it based on data from the [electronic medical record] system, and is calculating risk specific to a patient, specific to a disease, and specific to a type of bacteria, and one that is unique to a hospital. It captures all that information and presents it to a clinician to make good judgments about antibiotic selection,” Gohil said. She hopes this work will be a step towards future systems that could be “savvy enough and real-time enough deliver high precision care tailored for individual patients as  part of an embedded learning system.”

Impact of the NIH Pragmatic Trials Collaboratory on INSPIRE

The INSPIRE intervention includes a clinical decision support tool to help clinicians make a guideline-concordant decision on antibiotic use based on a patient's personalized risk. At the time of the trial’s launch, the FDA introduced a new guidance on Clinical Decision Support Software to support determinations regarding whether a software would be considered a device and therefore subject to FDA oversight.

“It was really helpful to have the Ethics and Regulatory Core do a deep dive with us on the FDA guidance on clinical decision support and help determine that our software was not considered a device,” Platt said.

The INSPIRE NIH Collaboratory Trial is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Institute of Allergy and Infectious Diseases (NIAID).

All of the materials from the 2023 Steering Committee meeting are now available.

UH3 Project: Behavioral Economic and Staffing Strategies to Increase Adoption of the ABCDEF Bundle in the ICU (BEST-ICU)

UH3 Project: Behavioral Economic and Staffing Strategies to Increase Adoption of the ABCDEF Bundle in the ICU (BEST-ICU)

Overview

Presentations

Principal Investigators:
Dr. Michele Balas

Michele Balas, PhD, RN, CCRN-K, FCCM, FAAN

Dr. Eduard Vasilevskis

Eduard Vasilevskis, MD, MPH

Sponsoring Institution: University of Nebraska Medical Center
Collaborators: 

  • Nebraska Medical Center
  • Ohio State University Wexner Medical Center
  • University of Iowa Hospitals and Clinics

NIH Institute Providing Oversight: National Heart, Lung, and Blood Institute (NHLBI)
Program Official: Ingrid Espinoza Grandon, PhD (NHLBI)
Project Scientist: Karen Kehl, PhD, RN, FPCN National Institute of Nursing Research (NINR)

Study Snapshot

Trial Summary

Survivors of critical illness frequently experience profound health impairments brought about or exacerbated by outdated mechanical ventilation and symptom management practices in the intensive care unit (ICU) and by known racial and socioeconomic disparities. This morbidity is potentially preventable through use of the ABCDEF bundle, a multicomponent, evidence-based intervention that improves team-based care in the ICU. Although the ABCDEF bundle has consistently been proven safe and effective, its adoption and performance remain poor nationwide. The BEST-ICU trial is evaluating 2 strategies grounded in behavioral economic theory and implementation science to increase ABCDEF bundle adoption. The strategies target a variety of ICU team members and known behavioral determinants of bundle performance. In the trial’s planning phase, the study team worked with the NIH Pragmatic Trials Collaboratory Coordinating Center and community partners to enhance and finalize the implementation strategies and research methods. In the implementation phase, the study team is conducting a pragmatic, stepped-wedge, cluster randomized, hybrid type 3 effectiveness-implementation trial. The participating sites include 6 matched pairs of 12 ICUs in 3 hospitals (providing care for approximately 8100 patients on mechanical ventilation). The study team will randomly assign the ICUs within each matched pair to receive either a real-time audit and feedback dashboard using data from the electronic health record, or a registered nurse implementation facilitator. The trial will compare the effectiveness of the 2 strategies on ABCDEF bundle adoption (the primary outcome) and several clinical outcomes, including duration of mechanical ventilation; ICU, hospital, and 30-day mortality; ICU and hospital length of stay; days with acute brain dysfunction; discharge disposition; use of psychoactive medications and physical therapy; and 30-day hospital readmission. The study team will also identify and describe key stakeholders’ experiences with and perspectives on the acceptability of the implementation strategies and their impact on workload. The long-term goal of BEST-ICU is to develop pragmatic, sustainable strategies to increase the delivery of evidence-based practices that improve care for critically ill adults across a variety of healthcare systems, particularly those serving populations with known health disparities, such as safety net hospitals.

NIH Project Information

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August 22, 2022: IMPACt-LBP Awarded Continuation to Implementation Phase

Posted on by Damon Seils

IMPACt-LBP investigatorsThe NIH Pragmatic Trials Collaboratory is pleased to announce that the IMPACt-LBP NIH Collaboratory Trial received approval this month to transition from the planning phase to the implementation phase. This pragmatic clinical trial embedded in healthcare systems is studying implementation of guideline-based care for low back pain, a leading cause of ambulatory care visits in the United States.

Congratulations to the IMPACt-LBP investigators and their study teams for reaching this important milestone!

IMPACt-LBP will evaluate implementation of the American College of Physicians guideline for low back pain, which involves multidisciplinary collaborative care that includes doctors of chiropractic and physical therapists. The study will measure the effects of first-contact patient referral to these clinicians on physical function, pain, opioid prescriptions, and other patient-level outcomes.

Logo for the IMPACt-LBP NIH Collaboratory TrialThe study is administered by the National Center for Complementary and Integrative Health with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development. The project is led by Drs. Christine Goertz, Adam Goode, and Hrishikesh Chakraborty of Duke University and Dr. Jon Lurie of Dartmouth Hitchcock Medical Center.

Learn more about IMPACt-LBP.

July 14, 2022: Solving Unexpected Challenges in Pragmatic Trial Data Collection

Posted on by Elizabeth Mccamic

Headshot of Dr. Keith MarsoloDuring the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, Dr. Keith Marsolo, Co-chair of the Electronic Health Records Core, moderated a panel on “Barriers and Challenges: Data Collection and Merging Datasets.” Four panelists shared their experiences collecting and aggregating data from diverse data sets and how they solved unexpected challenges.

The panelists included Drs. Ted Melnick (EMBED), Holt Oliver (ICD-Pieces), Margaret Kuklinski (GGC4H), and Andrea Cheville (NOHARM).

During the discussion, panelists shared lessons learned from collecting electronic health record (EHR) data during large pragmatic clinical trials across multiple health systems. Common challenges included:

  • Privacy concerns and not having the ability to collect deidentified patient or clinician demographic information
  • Working across health systems that use different EHR platforms and collecting data consistently across sites
  • Turnover of IT staff at participating sites and changes in site data agencies during the study period
  • Updates to the EHR that affect study algorithms and other issues with algorithms not identifying data as expected
  • Overcoming technical barriers with practice workflows and integrating with IT systems

The panelists shared solutions and possible best practices for future studies, including the need for planning, coordinating, and testing before study launch, the importance of being able to pivot and change directions as problems arise, being open to alternative data collection methods such as surveys to augment findings, and having the right team at the right time to be responsive to problems, which for one study meant having informaticists and expert EHR builders embedded in the trial team.

Panelists identified two key policy and infrastructure changes that would help trials be successful in the future. These changes include development of a national unique patient identifier across health systems and incentivizing EHR vendors to find common ground to better support research.

The Electronic Health Records Core continues to learn from experiences of the program’s NIH Collaboratory Trials and shares emerging information, resources, and EHR-related recommendations to improve future pragmatic research.

View slides from the discussion panel.

Learn more

View video collection that highlights advances in Electronic Health Records for pragmatic research.

Watch the August 2021 Interview with Electronic Health Record Core leaders Drs. Rachel Richesson and Keith Marsolo

June 30, 2022: BackInAction Is Back on Track After COVID-19 Delays

Posted on by Elizabeth Mccamic

Karen J. Sherman, PhD, MPH
Dr. Karen Sherman

In connection with the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, we sat down for an interview with Drs. Karen Sherman and Lynn DeBar to get an update on the Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction) NIH Collaboratory Trial. BackInAction is a pragmatic randomized trial to evaluate the safety and effectiveness of treatments for older adults with chronic low back pain. The study team is conducting a 3-arm trial of adults 65 years or older with low back pain to evaluate acupuncture vs usual care.

What is the current status of the BackInAction trial?
BackInAction has recruited about two-thirds of its participants and is on track to complete recruitment next fall. We also are providing acupuncture and doing follow-up interviews, so the trial is in the “ongoing phase.”

What challenges have you faced, and how have you dealt with them?
Our biggest challenges have been associated with COVID-19 impacts. Given the higher risk and vulnerability for our older adult target population and the requirement for in-person treatment (acupuncture), we delayed the start of recruitment by many months to ensure that those outreached had ample opportunity to be vaccinated beforehand and have also paused recruitment commensurate with regional surges of COVID variants at one or more of our clinical sites as needed. We also vetted the community acupuncturists who provide acupuncture to our study participants to ensure adequate COVID-safe office practices.

Lynn DeBar, PhD, MPH
Dr. Lynn DeBar

Unrelated to COVID-19, escalating thresholds for regulatory and security features resulted in a previously approved event tracking and recruitment and assessment software system not passing the Technology Resource Office (TRO) review at multiple clinical sites and the consequent need to align data collection and aggregation from site-specific systems. TRO reviews established for clinical care software and processes for our healthcare systems increasingly restrict clinical research practices as well.

What impact do you hope your trial will have on real-world healthcare?
The grant was funded as part of the NIH HEAL Initiative's PRISM program, and the specific funding opportunity announcement was issued because Medicare was interested in additional nonpharmacological treatment options for older adults with chronic low back pain. We had thought that they would be using data from the trial for a coverage decision, since few data on acupuncture existed for older adults. We hope that the trial results will assist the Centers for Medicare & Medicaid Services in any further refinements related to coverage of acupuncture for older adults with chronic low back pain.

How has being part of the NIH Pragmatic Trials Collaboratory shaped your project?
It’s helpful to have the sounding board of regular contact with principal investigators and research teams grappling with often similar issues that arise in implementing pragmatic trials (Steering Committee meetings, annual meetings, and Core Working Groups). Feedback from the Biostatistics and Study Design Core has been particularly helpful, as has the PRISM-wide help selecting and coordinating an appropriate data repository for required HEAL common data elements. Although there have been a few instances when we’ve been surprised by and needed to correct study-specific information included in cross-site dissemination products (always given ample opportunity to do so), we’re very aware and grateful for the functionality of the program’s Coordinating Center and infrastructure in contrast to some of the more recently established Coordinating Center infrastructures for related NIH sub-initiatives. The NIH Pragmatic Trials Collaboratory is much more an aid than a hindrance!