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Optimization Strategies for Medication Use (MIDAS cRCT Trial)
N/A
Waitlist Available
Led By Ariel Domlyn, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-6 months pre-baseline vs. 13-18 months post-baseline
Awards & highlights
MIDAS cRCT Trial Summary
This trial will compare two approaches to changing how providers treat three common conditions in order to improve patient care.
Who is the study for?
This trial is for VA clinical settings with a team leader or champion, necessary resources, and service leadership buy-in. It aims to optimize treatment practices for overmedication, blood clots, abnormal heart rhythms, and insomnia. Individual patients are not being recruited; instead, entire clinics are the focus.Check my eligibility
What is being tested?
The MIDAS trial is testing two strategies: Academic Detailing (AD) and LEAP to improve medication use in VA healthcare systems. The goal is to reduce inappropriate medications, better manage blood thinners like DOACs in certain patients, and promote cognitive therapy over drugs for treating insomnia.See study design
What are the potential side effects?
Since this trial focuses on implementation strategies rather than direct patient interventions, it does not directly involve side effects of medications. However, improved practices may lead to reduced adverse drug reactions from overmedication or misuse.
MIDAS cRCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-6 months pre-baseline vs. 13-18 months post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-6 months pre-baseline vs. 13-18 months post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Monthly facility percent of inappropriate medication use
Secondary outcome measures
Change in mean cognitive behavioral therapy for insomnia (CBTI) sessions completed
Change in monthly medication costs for all drugs
Change in number of inappropriate medications at a patient-level
+5 moreOther outcome measures
Change in Best Places to Work Score
Change in Employee Burnout
Change in Employee Engagement in Quality Improvement
+1 moreMIDAS cRCT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AD + LEAP CombinedExperimental Treatment2 Interventions
This arm combines use of AD plus the Learn. Engage. Act. Process (LEAP) program. LEAP is a 6-month quality improvement coaching program plus a 6-month monthly follow-up.
Group II: Academic Detailing (AD) OnlyActive Control1 Intervention
One-on-one educational outreach to employees and providers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Academic Detailing (AD)
2021
N/A
~30
LEAP
2021
N/A
~74280
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,323,382 Total Patients Enrolled
Ariel Domlyn, PhDPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
Jeremy B. Sussman, MD MSPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
2 Previous Clinical Trials
47 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The necessary resources for the study are not available or accessible.Criterion: Data is easily available to track how well the new practice is being used and the effect it has.The researchers are looking for medical clinics to participate in the study, not individual patients.There is a department that has agreed to oversee and manage the changes made during the implementation process.Not applicable.You are in a leadership or champion role.
Research Study Groups:
This trial has the following groups:- Group 1: AD + LEAP Combined
- Group 2: Academic Detailing (AD) Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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