MIDAS Cluster Randomized Controlled Trial of Implementation Strategies to Optimize Use of Medications in VA Clinical Settings

NCT05065502 | Completed Results

• 1 other identifier: QUX 21-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 potentially inappropriate medication (PIM) use 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 increasing the use of cognitive behavioral therapy for insomnia as the first-line treatment for insomnia instead of sleep medications. The investigators will test two implementation approaches to improve medication use within these topics.

Conditions

Polypharmacy; Insomnia; Anticoagulants

Keywords

implementation science; implementation strategy; anticoagulation; polypharmacy; insomnia; medication safety; academic detailing; quality improvement; pragmatic trial

Outcome Measures

Primary Outcomes (1)

• Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities.

  Percentage of PIMs across AD vs. LEAP+AD facilities were modelled as the difference between post-period and pre-period, using the average from the 1-6-month pre-baseline period as "pre" and the average 13-18-month post-baseline as "post." Data was collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Clinic-month outcome was computed as: 1) VIONE; proportion of patients who possessed one or more medications from the Beers' list of patients 65 or older, actively following with the clinic, and not in hospice/palliative care; 2) DOACs; proportion of patients with flags for potentially inappropriate use on a DOAC safety dashboard of those using DOACs; 3) CBTI; proportion of patients with a new prescription for a sleep medication for insomnia who have not had CBTI of those who are actively followed by the clinic and not in hospice/palliative care. The outcome was analyzed by pooling across all three-EBPs.

  13-18 months post-baseline

Secondary Outcomes (12)

• Change in Patients With Percentage of Potentially Inappropriate Use of Medications (PIMs) Across Facilities

  13-18 months post-baseline

• Change in Monthly Medication Costs for All Drugs Across Facilities

  13-18 months post-baseline

• Change in Number of Medication Reviews Across Facilities

  13-18 months post-baseline

• Change in Number of Inappropriate Medications at a Patient-level

  13-18 months post-baseline

• Change in Percentage of Patients With High-risk Direct Oral Anticoagulant (DOAC) Use Across Facilities

  13-18 months post-baseline

Other Outcomes (4)

• Change in Employee Engagement in Quality Improvement

  18-months Post-baseline

• Change in Employee Burnout

  18-months post-baseline

• Change in Best Places to Work Score

  18-months post-baseline

Study Arms (2)

Academic Detailing (AD) Only

ACTIVE COMPARATOR

One-on-one educational outreach to employees and providers.

Behavioral: Academic Detailing (AD)

AD + LEAP Combined

EXPERIMENTAL

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.

Behavioral: Academic Detailing (AD); Behavioral: LEAP

Interventions

Academic Detailing (AD) BEHAVIORAL

The National Resource Center for Academic Detailing (NaRCAD) describes AD as "an innovative, one-on-one outreach education technique that helps clinicians provide evidence-based care to their patients. Using an accurate, up-to-date synthesis of the best clinical evidence in an engaging format, academic detailers ignite clinician behavior change, ultimately improving patient health. A successful AD visit is highly interactive, always a dialogue, and assesses a clinician's individual needs, beliefs, attitudes, issues, and concerns in order to promote better.\[practice\]."

AD + LEAP Combined; Academic Detailing (AD) Only

LEAP BEHAVIORAL

Learn. Engage. Act. Process (LEAP) program is a structured 6-month core curriculum plus 6 monthly collaborative sessions. The LEAP quality improvement program engages frontline teams in sustained incremental improvements of EBPs over a six-month period, allowing space for busy clinicians to learn and immediately apply fundamental QI skills. LEAP encompasses: 1) a structured, accessible curriculum based on the Institute for Healthcare Improvement's (IHI) Model for Improvement and Plan-Do-Study-Act cycles of change; 2) team-based, hands-on learning, and 3) coaching support and a QI network to enhance learning and accountability.

AD + LEAP Combined

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Note- the investigators are recruiting clinics - not individual patients.
• Prior to implementation, the investigators will work with sites to ensure they have met the preconditions necessary to begin sustained optimization of the EBP:
• a team leader or champion
• an identified department with service leadership buy-in and control over the processes/practices impacted by the implementation
• readily accessible data to measure process and impact of the implementation and use of the EBP
• availability of required resources

You may not qualify if:

• N/A

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Related Publications (2)

• Domlyn AM, Hooks G, Freitag M, Evans L, Stewart M, Damschroder L, Sussman JB. Core and modifiable components of academic detailing: demonstration of implementation strategy development, tailoring, and documentation process. Front Health Serv. 2025 Jun 3;5:1521504. doi: 10.3389/frhs.2025.1521504. eCollection 2025.

  PMID: 40529793 DERIVED

• Damschroder LJ, Sussman JB, Pfeiffer PN, Kurlander JE, Freitag MB, Robinson CH, Spoutz P, Christopher MLD, Battar S, Dickerson K, Sedgwick C, Wallace-Lacey AG, Barnes GD, Linsky AM, Ulmer CS, Lowery JC. Maintaining Implementation through Dynamic Adaptations (MIDAS): protocol for a cluster-randomized trial of implementation strategies to optimize and sustain use of evidence-based practices in Veteran Health Administration (VHA) patients. Implement Sci Commun. 2022 May 14;3(1):53. doi: 10.1186/s43058-022-00297-z.

  PMID: 35568903 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

This evaluation was developed by combining three smaller cluster randomized control trials on different topic areas. In the early post-coronavirus disease 2019 (COVID-19) era, site-level engagement was extremely difficult, perhaps minimizing the impact of the interventions.

Results Point of Contact

• Title: Jeremy Sussman, MD, MS, Corresponding Principal Investigator
• Organization: VA Ann Arbor Health Care System

Jeremy.Sussman@va.gov

N/A

Study Officials

• Jeremy B. Sussman, MD MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

• Ariel Domlyn, PhD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

• Jacob E Kurlander, MD MS MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

• Paul N Pfeiffer, MD MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will conduct a series of three trials to test two implementation strategies designed for sustained change. Each trial will be a two-arm, cluster-randomized trial. The results of these trials will be pooled together in a single cross-trial analysis using a dichotomous outcome for each trial. Each trial will also be analyzed independently. Two of the trials will use the same dichotomous primary outcome and the third trial will use a different primary outcome (CBTI). The two arms will both include use of clinical population health dashboards. Unit of analysis is clinic. Clinics will be randomized to one of two implementation strategies described below. Implementation strategies will be tested for effectiveness of sustained use of practices to address documented quality gaps related to (1) potentially inappropriate medications, (2) use of direct oral anticoagulation medications (DOACs), and (3) cognitive behavioral therapy as first-line treatment for insomnia (CBTI).

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: October 4, 2021
• Study Start: May 3, 2021
• Primary Completion: March 6, 2024
• Study Completion: May 14, 2024
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: For 36 months after article is published.
• Access Criteria: Upon request by researchers who provide a methodologically sound proposal. Further details will be available.

Locations

US (1)