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

Study Overview
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Brief Summary
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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
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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 (13 to 36 months) percent of PIMs as the dependent variable. Primary comparative endpoint will be at 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.

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

Conditions
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Insomnia, Polypharmacy, Anticoagulants

Intervention / Treatment
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* Behavioral: Academic Detailing (AD)
* Behavioral: LEAP


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 into 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Academic Detailing (AD) Only<br>One-on-one educational outreach to employees and providers. | Behavioral: Academic Detailing (AD)<br>* 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].<br>|
| Experimental: AD + LEAP Combined<br>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)<br>* 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].<br>Behavioral: LEAP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Monthly facility percent of inappropriate medication use | Monthly facility percent of potentially inappropriate medication use for the 18-month period following baseline with months 13-18 as the post-baseline follow-up period. Lower ratios indicate better outcome. Data will be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Clinic-month outcome will be computed as: 1) VIONE; proportion of patients who possessed one or more medications from the Beers' list out 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 out of those using DOACs; 3) CBTI; proportion of patients with a new prescription for a sleep medication for insomnia who have not had CBTI, who are actively followed by the clinic and not in hospice/palliative care. Outcomes will be assessed in pooled analyses and for two of the three trials. | Baseline to 18-months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in prevalence of potentially inappropriate use of specific medications | Specific medications include proton pump inhibitors (PPIs), aspirin, CNS active medications (muscle relaxants, anti-psychotics, Z-drugs, and benzodiazepines), or anticholinergic drugs. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial. | Baseline to 18-months post-baseline | 
| Change in monthly medication costs for all drugs | Cost of all drugs without regard to appropriateness. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial. | Baseline to 18-months post-baseline | 
| Change in number of medication reviews | 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. | Baseline to 18-months post-baseline | 
| 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. | Baseline to 18-months post-baseline | 
| Change in prevalence of high-risk direct oral anticoagulant (DOAC) use | High-risk DOAC use will be assessed by flags using the algorithm from an operations DOAC dashboard. Dashboard flags include potential mis-dosing, potential medication interactions, or concern for nonadherence. This will be a secondary outcome for the DOAC trial when analyzed as a stand-alone trial. | Baseline to 18-months post-baseline | 
| Change in prevalence of any receipt of cognitive behavioral therapy for insomnia (CBTI) | 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. This will be the primary outcome for the CBTI trial when analyzed as a stand-alone trial. | Baseline to 18-months post-baseline | 
| 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. | Baseline to 18-months | 
| Change in the monthly percentage of patients referred to cognitive behavioral therapy for insomnia (CBTI) | 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. | Baseline to 18-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implementation science, implementation strategy, anticoagulation, polypharmacy, insomnia, medication safety, academic detailing, quality improvement, pragmatic trial