February 26, 2024
HOMERuN Collaborative: Learning Health Consortium for Hospital-Based Trials
The Hospital Medicine Reengineering Network (HOMERuN) is a rapidly growing collaborative made up of more than 50 Hospital Medicine groups from academic and non-academic hospitals across the United States.
Organizers and Facilitators: Sunil Kripalani, MD, MSc; Lana Wahid, MD; Andy Auerbach, MD, MPH

Background: HOMERuN was founded as a learning health organization and has engaged in many multi-center collaborations, but not previously in multi-center clinical trials. Conducting pragmatic randomized controlled trials (pRCTs) is a promising new strategy for HOMERuN to generate rigorous real-world evidence on topics relevant to clinical practice, while also growing research infrastructure, providing career development opportunities, and opening new funding streams. pRCTs can be conducted in a way that largely utilizes electronic procedures for patient identification, randomization, and outcome assessment. These types of pRCTs can be used to compare the effectiveness of two standards of care (e.g., the recent ACORN trial, which compared cefipime vs piperacillin-tazobactam in adults with acute infection), or compare different strategies for implementing practice change (e.g., a mentored implementation model vs clinical decision support).

At Vanderbilt, a pragmatic trials group has successfully carried out single-site pRCTs, and has spread the approach to conduct multi-center pRCTs through the Pulmonary Critical Care Research Group. At Duke, the hospitalist group has built up capacity and developed efficient procedures to perform RCTs. UCSF has built out specific research infrastructure to support EHR-based randomized trials and is helping develop multicenter RCT informatics infrastructure.  

To explore the extension of these models to HOMERuN, we conducted break out sessions during the January 12 Collaborative Call, asking participants to weigh in on a few key questions:

  • What is the level of interest in participating in a pragmatic clinical trials network?
  • What infrastructure is currently available at HOMERuN sites for pragmatic trials?
  • Does this infrastructure reside within (or is easily accessed by) hospital medicine? If not, is it available at the institution?
  • What support would be needed for successful participation in a pragmatic trials network?

Below is a summary of the major themes that emerged in the discussion.
  • Growing Interest: Over seven sites have expressed significant interest, indicating the potential for rapid network expansion.
  • Diverse Experience: Two sites boast experience with inpatient and outpatient studies, showcasing their involvement in impactful projects like COPD and the ACORN study.
  • Collaborative Infrastructure: While some sites face limitations in infrastructure, many find support from colleagues in different specialties for guidance.
  • Patient Voice: The HOMERuN PFAC emphasizes the importance of incorporating the patient's voice at every stage of trial planning and execution.
  • Broad Scientific Impact: The network sees an opportunity to answer practical questions and generate science of broad interest.
"Don't forget the patient family caregiver perspective from A-Z in the process."
  • Resource Disparities: Larger academic medical centers are better equipped, requiring special attention to community-based programs.
  • Funding Challenges: Continuous funding to maintain a research team poses a significant concern for multiple sites.
  • Data Sharing Tensions: Safety net hospitals face challenges in data sharing due to ownership by the county rather than the hospital.
  • Consent and IRB: Inconsistencies around IRB rules and knowledge gaps related to pragmatic trials and consent requirements are prevalent issues.
  • Borrowed Resources: Borrowing research staff from other specialties raises concerns about prioritization of work.
"The big issue is the funding. You have access to programmers and staff but you need to figure out the funding part of it."
  • Focused Pragmatic Trials: The network sees opportunities in pragmatic trials addressing burning clinical issues.
  • Academic Recognition: Participation offers the chance for academic recognition, publications, and establishing hospitalists as researchers.
  • Continuous Funding Model: Establishing new sources of funding (federal, foundation, or pharma/device) is identified as a key opportunity.
  • IRB Training Initiatives: Sites express interest in education on differences between central and local IRBs.
  • Leveraging Existing Tools: Utilizing EHR tools like Epic and leveraging existing infrastructure present opportunities for collaboration.
"If there were a way to have pragmatic trials where you have a seasoned researcher at the helm, but an opportunity for less seasoned people to get involved, I think that would be amazing."
  • Funding Insecurity: Fear of bringing on staff without continuous funding poses a significant threat.
  • IRB Discrepancies: Discrepancies among IRBs may result in inconsistencies in trial conduct across sites.
  • Data Hub Necessity: A central data coordinating center is important for project success.
  • EHR Differences: Challenges arise from different EHRs and obtaining approval for building EHR tools.
  • Diversity: There may be a need to balance diversity of sites and patient populations with sites that are poised to go.
  • Structural Concerns: About 2/3 of hospitalist programs have internal resources that could be deployed toward a pragmatic trial, but those resources are often spoken for and would need to be funded.
"Our internal resources are often split with needs to conduct analysis for administrative and operational purposes."
Next Steps
  1. Distribute a survey to sites to assess elements of research capacity
  2. Obtain data from the American Hospital Association survey on site characteristics
  3. Continue strategic planning discussions via HOMERuN calls and at SHM Converge
Our next meeting will be on March 8, 2024.
Image Attributions: Vector images from vecteezy.com
Check out the HOMERuN website for more information.
If you would like to join the HOMERuN Collaborative calls, please reach out to [email protected].