NIH Collaboratory Trials

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

Data and Resource Sharing

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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!

June 29, 2022: Pragmatic Trials Experienced Significant Impacts of COVID-19 on Trial Activities

Posted on by Damon Seils

Headshot of Dr. Emily O'Brien
Lead author Dr. Emily O’Brien

Pragmatic clinical trials experienced significant impacts of COVID-19 on trial activities, according to a survey of NIH Pragmatic Trials Collaboratory Trials published last month in Trials.

Since the beginning of the COVID-19 pandemic in March 2020, many of the NIH Collaboratory Trials have had to postpone recruitment, alter methods of participant engagement, and modify tools for research assessment and intervention delivery. Trial delays often created statistical challenges, especially for those using stepped-wedge designs.

Most of the study teams were able to work closely with healthcare system partners to adapt their study interventions. Some of the adaptations resulted in better participant outreach and the ability to study virtual intervention delivery methods. All of the NIH Collaboratory Trials were able to adapt to pandemic-related changes.

In a recent video interview, lead author Dr. Emily O’Brien praised the study teams.

“We certainly did see some degree of disruption, but I was impressed by the flexibility in the ability to adapt that all of our NIH Collaboratory Trial teams showed,” said O’Brien. “Some of them mentioned the support of having the [Core Working Groups] and consultations with experts in real time to be able to make adjustments,” she said.

The NIH Collaboratory published a tool last year to assist investigators in identifying impacts of the COVID-19 pandemic on ongoing pragmatic trials. The Statistical Analysis Plan Checklist for Addressing COVID-19 Impacts summarizes impacts on trial conduct that study teams should document, measure, analyze, and report.

June 27, 2022: EMBED Publishes Results From Study of Buprenorphine Initiation in Emergency Departments

Posted on by Elizabeth Mccamic

Headshots of Dr. Edward Melnick and Dr. Gail D'Onofrio
Dr. Ted Melnick and Dr. Gail D’Onofrio, co–principal investigators of EMBED

Implementation of a user-centered clinical decision support tool did not increase the rate of patients receiving buprenorphine for treatment of opioid use disorder in the emergency department (ED) when compared to usual care.

When the tool was used, it was associated with high rates of buprenorphine initiation, and the tool increased the number of physicians who provided ED-initiated buprenorphine and naloxone prescriptions.

The findings of EMBED were published in the BMJ on June 27.

From November 2019 to May 2021, researchers conducted EMBED, an NIH Pragmatic Trials Collaboratory Trial, in 18 clusters across 5 healthcare systems in 5 states, representing the Northeast, Southeast, and Western regions of the United States.

The 18 clusters included 21 EDs, with 3 sites paired with a second ED within the same healthcare system due to low patient volume or high physician crossover rates between the 2 sites. Each cluster received either the intervention or maintained usual care.

The study sample was made up of all patient visits to the ED during the study period. Eligible patient encounters were identified using criteria in the electronic health record. For patients with multiple ED visits during the trial, only the first ED visit was included in the analysis.

ED attending physicians caring for patients who met the trial’s inclusion criteria were the primary study subjects, but all ED clinicians practicing at intervention sites had access to the EMBED tool for all patients in their care at that site. A total of 5,047 patients (2,787 intervention and 2,260 usual care) were eligible for analysis along with the 599 physicians who cared for them (340 intervention, 259 usual care).

The intervention did not affect the patient-level rate of ED-initiated buprenorphine (which was 12.5% in the intervention arm and 12.0% in the usual care arm). The proportion of physicians who initiated buprenorphine in the ED at least once was higher at intervention sites compared to usual care sites (44.4% vs 34.0%).

In the intervention arm, the EMBED tool was launched by physicians for 261 of 2,787 eligible patients. When the tool was launched, buprenorphine was ordered for 161 patients (67% of 261 encounters).

“We built tools that work within the electronic health record that make it easier for clinicians to treat patients with addiction, using medications that physicians may initially find complex and unfamiliar,” said Dr. Edward Melnick of Yale University, co–principal investigator of the study. “We’ve tried to make that easier for clinicians to allow this practice to be adopted into routine care.”

“EMBED offers a major opportunity to accelerate adoption by offering a simple, automated, rapid solution to initiating treatment and referral for people suffering from opioid use disorder,” said Dr. Gail D’Onofrio of Yale University, co–principal investigator of the study. “Additional prompts and interventions will be needed to increase more universal implementation into the routine care of ED patients with opioid use disorder.”

Watch Dr. Melnick discuss the EMBED project in this NIH Pragmatic Trials Collaboratory interview from April 2022.

EMBED was supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.