Clinical trial NCT05065502: MIDAS Cluster Randomized Controlled Trial of Implementation Strategies to Optimize Use of Medications in VA Clinical Settings
Official title: Maintaining Implementation Through Dynamic Adaptations (MIDAS) (QUE 20-025)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Insomnia
Anticoagulants
Keywords: implementation science
implementation strategy
anticoagulation
polypharmacy
insomnia
medication safety
academic detailing
quality improvement
pragmatic trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-10-04
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

N/A

Primary outcomes:
measure: Change in Monthly facility percent of inappropriate medication use
timeFrame: 1-6 months pre-baseline vs. 13-18 months post-baseline
Secondary outcomes:
measure: Change in prevalence of potentially inappropriate use of specific medications
timeFrame: 1-6 months pre-baseline vs. 13-18 months post-baseline
measure: Change in monthly medication costs for all drugs
timeFrame: 1-6 months pre-baseline vs. 13-18 months post-baseline
measure: Change in number of medication reviews
timeFrame: 1-6 months pre-baseline vs. 13-18 months post-baseline
measure: Change in number of inappropriate medications at a patient-level
timeFrame: 1-6 months pre-baseline vs. 13-18 months post-baseline
measure: Change in prevalence of high-risk direct oral anticoagulant (DOAC) use
timeFrame: 1-6 months pre-baseline vs. 13-18 months post-baseline
measure: Change in prevalence of any receipt of cognitive behavioral therapy for insomnia (CBTI)
timeFrame: 1-6 months pre-baseline vs. 13-18 months post-baseline
measure: Change in mean cognitive behavioral therapy for insomnia (CBTI) sessions completed
timeFrame: 1-6 months pre-baseline vs. 13-18 months post-baseline
measure: Change in the monthly percentage of patients referred to cognitive behavioral therapy for insomnia (CBTI)
timeFrame: 1-6 months pre-baseline vs. 13-18 months post-baseline
Other outcomes:
measure: Change in Employee Engagement in Quality Improvement
timeFrame: Baseline to 18-months post-baseline
measure: Change in Employee Burnout
timeFrame: Baseline to 18-months post-baseline
measure: Change in Best Places to Work Score
timeFrame: Baseline to 18-months post-baseline
measure: Change in Workgroup Cohesion & Engagement
timeFrame: Baseline to 18-months post-baseline
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Jeremy B. Sussman, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Ariel Domlyn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Jacob E Kurlander, MD MS MS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Paul N Pfeiffer, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.