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PolypharmacyMIDAS cRCTNCT05065502

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

A study testing Academic Detailing (AD) and LEAP in people with Polypharmacy and Insomnia, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Polypharmacy, Insomnia, Anticoagulants
What is being tested?
Academic Detailing (AD) and LEAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
3 May 2021to 14 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105-2303

Other trials in United States

About this study

Official title: Maintaining Implementation Through Dynamic Adaptations (MIDAS) (QUE 20-025)

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.

Read the detailed description

Background The adoption and sustainment 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 multi-component implementation strategies to sustain optimal use of three EBPs: 1) a deprescribing approach intended to reduce potentially inappropriate polypharmacy; 2) appropriate dosing and drug selection of direct-acting anticoagulant medications (DOACs); and 3) use of cognitive behavioral therapy as first-line treatment for insomnia before pharmacologic treatment. We describe the design and methods for a harmonized series of cluster-randomized control trials comparing two implementation strategies.

Methods For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to a clinical dashboard that flags patients who may benefit from the target EBP at that clinic and provider. For each trial, clinics will be randomized to one of two implementation strategies to improve use of the EBPs: 1) individual-level academic detailing (AD); or 2) AD plus the team-based Learn. Engage. Act. Process. (LEAP) quality improvement (QI) learning program. The primary outcomes will be operationalized across the three trials as a patient-level dichotomous response (yes/no) indicating patients with potentially inappropriate medications (PIMs) among those who may benefit from the EBP. This outcome will be computed using month-by-month administrative data. Primary comparison between the two implementation strategies will be analyzed using generalized estimating equations (GEE) with clinic-level monthly percent of PIMs as the dependent variable. Primary comparative endpoint will be at 13-18 months post-baseline. Each trial will also be analyzed independently.

Discussion MIDAS QUERI trials will focus on fostering sustained use of EBPs that previously had targeted but incomplete implementation. Our implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates use of actionable clinical dashboard data and making incremental changes, designed to be feasible within busy clinical settings.

Being tested
Academic Detailing (AD), LEAP
Keywords
implementation science, implementation strategy, anticoagulation, polypharmacy, insomnia, medication safety, academic detailing, quality improvement, pragmatic trial
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Academic Detailing (AD)Behavioural

    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]."

  • LEAPBehavioural

    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.

Study groups in NCT05065502
Study groupRoleWhat they receive
Academic Detailing (AD) OnlyActive comparatorOne-on-one educational outreach to employees and providers.
Receives: Behavioral: Academic Detailing (AD)
AD + LEAP CombinedExperimentalThis 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.
Receives: Behavioral: Academic Detailing (AD); Behavioral: LEAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 13-18 months post-baseline

Secondary outcomes (12)

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

    Medications include proton pump inhibitors (PPIs), aspirin, central nervous system (CNS) active medications (muscle relaxants, anti-psychotics, Z-drugs, and benzodiazepines), or anticholinergic drugs. This is the primary outcome for the VIONE trial when analyzed as a stand-alone trial and the VIONE sub-analysis of the overall MIDAS study primary outcome. Percentage of patients with PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations (GEE), with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using least squares (LS) means from the GEE model.

    Measured: 13-18 months post-baseline

  2. Change in Monthly Medication Costs for All Drugs Across Facilities

    Cost of all drugs without regard to appropriateness. Average monthly cost per patient across LEAP vs. LEAP + AD facilities were modelled longitudinally with a Generalized Linear Model with a Gamma Link and a three-way interaction of arm, month of follow-up and pre-, post-period. Estimates computed using LS means from the GEE model. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial.

    Measured: 13-18 months post-baseline

  3. Change in Number of Medication Reviews Across Facilities

    Number of medication reviews completed by a pharmacist. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial.

    Measured: 13-18 months post-baseline

  4. Change in Number of Inappropriate Medications at a Patient-level

    This is a measure of count of medications used at the patient (not facility) level. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial.

    Measured: 13-18 months post-baseline

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

    High-risk DOAC use will be assessed by "flags" using the algorithm from an operations DOAC dashboard. These flags were developed based on existing guidelines and advice of many anticoagulation experts. Percentage of patients with PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations, with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using LS means from the GEE model. This is the primary outcome for the DOAC trial when analyzed as a stand-alone trial and the DOAC sub-analysis of the overall MIDAS study primary outcome.

    Measured: 13-18 months post-baseline

  6. Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Chronic Kidney Disease Across Facilities

    This was the subset of patients with DOAC Population Health Management Tool (Dashboard) flags that occur when medications are given at doses that would be appropriate but are not because the patient has abnormal renal function. This has had minimal adjustments since being described in previous publications.

    Measured: 13-18 months post-baseline

  7. Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Weight Across Facilities

    This was the subset of patients with DOAC Population Health Management Tool (Dashboard) flags that occur when medications are given at doses that would be appropriate but are not because the patient has unusually high or low weight or BMI. This has had minimal adjustments since being described in previous publications.

    Measured: 13-18 months post-baseline

  8. Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Other Mis-dosing Across Facilities

    These are the remaining high-risk flags and are usually due to patients with medication interactions or doses that are incorrect due to the indication. This has had minimal adjustments since being described in previous publications.

    Measured: 13-18 months post-baseline

  9. Change in Percentage of Patient Receipt of Any Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities

    Patient receipt of any CBTI will be measured by extracting from the medical records CBTI note templates completed by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. Percentage of PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations, with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using LS means from the GEE model. This will be the primary outcome for the CBTI trial when analyzed as a stand-alone trial.

    Measured: 13-18 months post-baseline

  10. Change in Mean Cognitive Behavioral Therapy for Insomnia (CBTI) Sessions Completed

    Mean number of sessions will be measured by extracting from the medical records CBTI note templates completed by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. This will be a secondary outcome for the CBTI trial when analyzed as a stand-alone trial.

    Measured: 13-18 months post-baseline

  11. Change in the Monthly Percentage of Patients Referred to Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities

    CBTI referrals will be measured according to counts of CBTI consult requests in the medical record. For clinics that do not use medical record consult requests specific to CBTI, referrals will be measured using monthly counts provided by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. This will be a secondary outcome for the CBTI trial when analyzed as a stand-alone trial.

    Measured: 13-18 months post-baseline

  12. Change in Percentage of Patients With First Line Sleep Medication Across Facilities

    The 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. This is a CBTI sub-analysis of the overall MIDAS study primary outcome.

    Measured: 13-18 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start3 May 2021
  3. Primary completion6 Mar 2024
  4. Study completion14 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05065502
Sponsor's protocol ID
QUX 21-004
Acronym
MIDAS cRCT
Status last verified
Sep 2025
First submitted
17 Aug 2021
Last updated
15 Oct 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Site-level data that underlie results reported, after de-identification will be available.

Publications

  • 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.

    PubMed 40529793

  • 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.

    PubMed 35568903

Questions about this trial

What is this clinical trial studying?

A study testing Academic Detailing (AD) and LEAP in people with Polypharmacy and Insomnia, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities. (time frame: 13-18 months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05065502, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.

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MIDAS cRCT Clinical Trial NCT05065502 | AzTrials