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Clinical Trial Summary

Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice. The MIDAS QUERI program will help providers improve the way they treat VA patients for three common conditions, using specific strategies to ensure the reliable delivery of these treatments. The first project will focus on reducing polypharmacy using the VIONE practice, developed in VA. The second project will focus on better use of drugs called direct oral anticoagulants (DOACs) for patients with a history of severe blood clots or an abnormal heart rhythm. The third project will focus on providing a highly effective therapy for patients with insomnia, which does not require the use of medications. The investigators will test three implementation approaches to improve medication use within these topics.


Clinical Trial Description

Background Sustained integration of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test three multi-component implementation strategies to sustain optimal use of three EBPs: 1) a deprescribing tool intended to reduce risk of polypharmacy; 2) inappropriate use of direct-acting anticoagulant medications (DOACs); and 3) use of cognitive behavioral therapy for insomnia as first-line treatment instead of prescribing less effective or risky medications. The investigators describe design and methods for the harmonized series of cluster-randomized control trials testing three implementation approaches to sustainably decrease inappropriate use of the three EBPs. Methods For each trial, the investigators will recruit 12 sites (36 total). All will have access to a clinical dashboard that flags patients at higher risk due to potential inappropriate use of medications. For each of the three EBPs, sites will be randomized to one of three implementation approaches to improve use of the EBPs: 1) the Learn. Engage. Act. Process. (LEAP) team-based quality improvement (QI) learning program; 2) individual-level educational outreach; or 3) both approaches. Primary outcomes is operationalized across the three trials as a dichotomous response (yes/no) indicating inappropriate use of the EBP among at-risk patients at 48 months (12 months pre-intervention plus 36 months post-intervention). This outcome will be computed using month-by-month administrative data. To compare outcomes across arms, the investigators will use generalized estimating equations (GEE) with the harmonized outcome as the dependent variable. Discussion Scientific advances in ways to deliver higher quality care are constantly evolving. Especially in light of this, it is quite challenging for healthcare systems, to sustainably change providers' clinical practices. MIDAS QUERI trials will focus on fostering sustained use of EBPs that have already had targeted but incomplete implementation. The implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates use of actionable clinical dashboard data and implementation of incremental changes, designed to be feasible within busy clinical settings. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05065502
Study type Interventional
Source VA Office of Research and Development
Contact Laura J Damschroder, MPH
Phone (734) 845-3603
Email [email protected]
Status Recruiting
Phase N/A
Start date May 3, 2021
Completion date September 30, 2025

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