July 24, 2023
HOMERuN Collaborative: Participate in Two Important Studies!
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.
Using a Risk Assessment Model for VTE to Reduce Prophylaxis in Hospitalized Medical Patients—A Randomized Clinical Trial
Principal Investigators: Michael Rothberg and Matthew Pappas, Cleveland Clinic
Funding Agency (desired): National Heart, Lung, and Blood Institute (NHLBI)
Overview: Heparin products can reduce the incidence of venous thromboembolism, but many hospitals prescribe prophylaxis to many low-risk patients as well. This has potential harms, including complications (bleeding, heparin-induced thrombocytopenia), financial costs, nursing time, and unnecessary subcutaneous injections. We previously developed and validated a risk assessment model capable of accurately estimating the probability of VTE among medical inpatients using information automatically obtained from the electronic health record. In a stepped-wedge cluster randomized trial among ten Cleveland Clinic hospitals, implementation of our model reduced use of prophylaxis with no increase in VTE. However, our implementation was limited to one health system.
  • Aim 1: Incorporate our validated risk assessment model into the EHR admission order sets of X participating health systems. To ensure confident deployment, we will extract outcomes (VTE, hemorrhage, and HIT) to validate and recalibrate our model for each participating health system.
  • Aim 2: Conduct a cluster randomized trial of model-guided prophylaxis within participating health systems, with hospitals as the unit of randomization and patient-level outcomes (patient-days of prophylaxis, VTE, bleeding, HIT, and costs). We hypothesize that model-guided prophylaxis will lead to lower rates of chemoprophylaxis and no increase in the rate of VTE. We further hypothesize that model-guided prophylaxis will lead to lower rates of bleeding, lower rates of HIT, and lower costs of care.
  • Aim 3: Identify physician and hospital factors associated with successful implementation of the risk assessment model.
Site participation: Cleveland Clinic (CCF) will serve as the coordinating site. We are looking for sites interested in participating in an RCT that would begin in 2024. Our first request would be a nonbinding letter of interest, so that we can plan and power our trial appropriately and demonstrate potential sites in an NHLBI grant application.
We're looking for sites that:
  • Have a high rate of VTE prophylaxis (>60%)
  • Would be open to reducing prophylaxis
  • Would be willing to make a calculator mandatory for medical admissions
  • Have an IT department that can help extract data and with local implementation
  • (Preferably) Have two or more hospitals within their health system and use Epic
The study team will provide:
  • Our risk assessment models, code, and algorithms for validating outcomes based on EHR data
  • Expertise from deployment at our 10 hospitals
  • Opportunity to present preliminary information/data from your site (e.g., poster and/or oral presentations at the annual SHM conference)
  • Networking with other centers
  • Non-named authorship and/or acknowledgement on all resultant publications; named authorship for participants who meet ICMJE criteria; Ability to add “site lead” for this federally funded study on your CV
  • (Potentially, depending on budgeting) modest funding for implementation support and/or honoraria
  • Boilerplate text that you could use in the (nonbinding) letter of interest
If you are interested in participating, contact Michael Rothberg (rothbem@ccf.org) or Matthew Pappas (pappasm@ccf.org).
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE) Study
Purpose of RELIANCE:
Both roflumilast and azithromycin have been shown to reduce the risk of COPD exacerbations compared to placebo. However, there has not been a head-to-head comparison of these two FDA-approved medications. RELIANCE is intended to support hospital efforts to reduce the risk of all-cause hospitalization and premature deaths in individuals with COPD. 

RELIANCE is Seeking Community-Based Hospitalists:
Hospitalists are critical in the development of post-discharge care plans and medications used by people with COPD. We found from preliminary work that identification of people with COPD while they are hospitalized is an efficient recruitment method for RELIANCE.

Benefits and Compensation:
  • $500/year honorarium for being a community partner (paid after registration) plus $2,000 per patient enrolled.
  • Option to participate in clinical roundtables with COPD thought leaders.
  • Contribute topic ideas for future grant proposals or publications related to hospitalist care.
  • Community Partners will not be investigators / authors, but will be acknowledged in the RELIANCE publication. 

Please reach out to Tiffany.Lee@ucsf.edu if you are interested in participating and would like more information about RELIANCE.
Our next meeting will be on August 11, 2023.
Check out the HOMERuN website for more information.
If you would like to join the HOMERuN Collaborative calls, please reach out to Tiffany.Lee@ucsf.edu.