Updated study snapshots and ethics and regulatory documentation are now available for the IMPACt-LBP and INSPIRE trials, both NIH Pragmatic Trials Collaboratory Trials.
IMPACt-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.
Read the updated ethics and regulatory documentation, including information about the study team’s approach to informed consent and collection of patient-reported outcome data.
Also available is an updated study snapshot for IMPACt-LBP.
INSPIRE 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.
The Grand Rounds session will be held on Friday, June 16, 2023, at 1:00 pm eastern.
BeatPain Utah, an NIH Collaboratory Trials, is studying real-world implementation of a telehealth physical therapy strategy for patients with chronic back pain in primary care clinics of federally qualified health centers. The study is supported by the NIH through the NIH Heal Initiative under an award from the National Institute of Nursing Research.
Dr. Fritz is a distinguished professor of physical therapy and athletic training and Dr. Del Fiol is a professor of biomedical informatics—both at the University of Utah.
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
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.
PROACT Xa was a prospective, randomized clinical trial conducted to determine whether apixaban was noninferior to warfarin in preventing valve thrombosis or valve-related thromboembolism in patients with an On-X mechanical aortic valve. The trial’s pragmatic design features enabled the investigators to conduct the the trial successfully during the COVID-19 public health emergency.
Dr. Alexander is a cardiologist and professor of medicine in the Duke University School of Medicine and a faculty member in the Duke Clinical Research Institute.
In a secondary analysis from the EMBED pragmatic clinical trial, Black patients with opioid use disorder were less likely than White patients to be initiated on buprenorphine in the emergency department.
The study’s findings were published recently in Academic Emergency Medicine.
EMBED, an NIH Collaboratory Trial, was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States. The trial evaluated a clinical decision support system for initiating buprenorphine in emergency department settings.
The racial disparity in buprenorphine initiation remained after adjustment for patient, clinician, and site characteristics. Even in emergency departments in academic hospitals, where rates of buprenorphine were higher overall, Black patients received proportionally less buprenorphine initiations than White patients. Hispanic patients were more likely to receive buprenorphine than non-Hispanic patients in both community and academic emergency departments. However, adjustment for discharge diagnosis attenuated the association between ethnicity and buprenorphine initiation.
“Attention should be focused on identifying continued disparities in [emergency department] treatment of opioid use disorder by race and ethnicity,” the authors concluded, “as well as the barriers and inequities that continue to limit patients’ ability to access the [emergency department] for treatment of opioid use disorder.”
EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and received logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn about the other NIH Collaboratory Trials.
Richelle J. Koopman, MD, MS Jack M. and Winifred S. Colwill Professor and Vice Chair
Department of Family and Community Medicine
University of Missouri
Keywords
Electronic Health Record, Pragmatic Clinical Trial
Key Points
Patients bring patient-generated home blood pressure data into the clinical workflow. It is difficult to enter and create visualizations of this data in the electronic health record (EHR), so the research team developed an EHR data visualization of home blood pressure from data entered via the patient portal.
Starting in 2015, researchers held 10 focus groups with patients, family medicine and general internal medicine physicians and 1 CMIO. Researchers assessed the effect of the data visualization on patient risk perception and the interaction of health literacy, numeracy, and graph literacy with the data visualization.
The team’s goals were to design for the primary care setting because 85% of hypertension care is in this setting. The team wanted the visualization designed for shared decision making, with an emphasis on patient information needs and comprehension and physician information needs and workflow. The visualization needed to have an intuitive design, and the team was cognizant of how data visualization can affect decision making.
The data visualization started with a basic list of information needed, including systolic and diastolic data; clinic and home data; raw data numbers, effect of medications on blood pressure; goal ranges; out of range values; customizable goal ranges; patient burden of entry; data variability relative to control, and contextual life event data. From there, the team iterated based on patient-physician needs, resulting in the COACH (Collaborative Oriented Approach to Controlling High Blood Pressure) app.
Later this year, the study team will launch the COACH trial, a pragmatic clinical trial with 550 adult primary care patients with uncontrolled hypertension who are portal users. The trial will take place across 3 sites, University of Missouri, OHSU, and Vanderbilt and across 2 EHR platforms, EPIC and Oracle. The primary outcome is blood pressure at 6 months. The trial is doing a consolidated framework for implementation research to understand the preferred workflows and concerns for patients and physicians.
Discussion Themes
-Who provided the text support for the app and how were they resourced and trained? We specified adverse events that were largely hypotension, ER visits and hospitalizations. We are evaluating the usability of the app. At MU we have a collaboratory called the Tiger Institution that does programming. They estimated 5,000 hours to put it in the EHR, and they did it for free. We are paying now. It works in the Oregon EPIC EHR, and we are working on translating it to Vanderbilt.
–Can you speak to sustainability and what you are doing with billing codes? It was data that was sitting there without alerts in our system. We need to have some way to create a better actionable alert. There is billing potential here. There are mechanisms to bill for home blood pressure monitoring for Medicare. The sustainability comes from being able to bill for these services and keeping it lean in messaging.
–What about the patients who are not in the portal? That is definitely a problem. At MU and OHSU we are at about 80-90%. You can access the portal from desktop and phones. Lots of people have smartphones but they do not have the portal. Vanderbilt has a plan for bridging this gap through care managers.
Dr. O’Toole is the chief of Orthopaedics at the R. Adams Cowley Shock Trauma Center, head of the Division of Orthopaedic Trauma, and director of clinical research in the Department of Orthopaedics at the University of Maryland School of Medicine.
Organizational culture, clinician training and support, the ability to link patients to ongoing treatment, and the ability to tailor implementation to each clinical site were key determinants of successful implementation of an intervention to promote buprenorphine initiation in emergency departments, according to a qualitative study conducted as part of the EMBED pragmatic clinical trial.
EMBED, an NIH Collaboratory Trial, was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States. The trial tested the effectiveness of a clinical decision support tool integrated into the electronic health record in improving rates of buprenorphine initiation in the emergency department for the treatment of opioid use disorder. The intervention led to a modest increase in buprenorphine initiation and little impact on patient outcomes.
A secondary aim of the study was to identify determinants of adopting, implementing, and maintaining the clinical decision support tool at the trial sites. Among the key determinants were:
establishing buprenorphine initiation as a cultural norm within healthcare organizations;
organizational commitment to implementing and sustaining the intervention;
clinician training and support on opioid use disorder and buprenorphine initiation in emergency departments;
availability of referral resources to link patients who were initiated on buprenorphine in the emergency to ongoing treatment; and
the ability to tailor the intervention to clinic workflows that fit the resources and characteristics of the local clinic.
EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and received logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn about the other NIH Collaboratory Trials.
Dr. Koopman is professor and vice chair for research and faculty affairs in family and community medicine and the Jack M. and Winifred S. Colwill Endowed Professor at the University of Missouri. The Collaboration-Oriented Approach to Controlling High Blood Pressure (COACH) is a patient-facing clinical decision support app that assists patients in self-management of high blood pressure.
The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5-day preconference workshop at the 2023 Annual Research Meeting in Seattle, Washington.
The workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings,” will cover the essentials of embedded healthcare systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Attendees will participate in facilitated, hands-on learning activities and interact with principal investigators of pragmatic clinical trials embedded in healthcare systems, including NIH Collaboratory Trials.
Firsthand experiences and case studies from the NIH Collaboratory will support and illustrate the topics presented and demonstrate how pragmatic trials embedded in real-world settings are driving tomorrow’s outcomes. Speakers will include program officers and senior staff from NIH Institutes, Centers, and Offices and senior investigators from the NIH Collaboratory Trials and the Coordinating Center leadership.
The learning objectives of the workshop include:
To clarify the definition of embedded pragmatic clinical trials and explain their utility.
To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing these trials within diverse healthcare systems.
To increase the capacity of health services researchers to address important clinical questions with pragmatic trials in real-world settings, driving tomorrow’s research outcomes.
Workshop details and registration
Friday, June 23, 2023, 8:15 a.m.-4:25 p.m.
Saturday, June 24, 2023, 8:00 a.m.-12:00 p.m.
Seattle Convention Center
Seattle, Washington