MIDAS Cluster Randomized Controlled Trial of Implementation Strategies to Optimize Use of Medications in VA Clinical Settings
- Conditions
- PolypharmacyAnticoagulantsInsomnia
- Interventions
- Behavioral: Academic Detailing (AD)Behavioral: LEAP
- Registration Number
- NCT05065502
- Lead Sponsor
- VA Office of Research and Development
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Academic Detailing (AD) Only Academic Detailing (AD) One-on-one educational outreach to employees and providers. AD + LEAP Combined LEAP 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. AD + LEAP Combined Academic Detailing (AD) 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.
- Primary Outcome Measures
Name Time Method Change in Monthly facility percent of inappropriate medication use 1-6 months pre-baseline vs. 13-18 months post-baseline Monthly facility percent of potentially inappropriate medication use for the time period 13-18 months post-baseline for AD vs. LEAP+AD, controlling for use in the time period 1-6 months pre-baseline. 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 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. Outcomes will be assessed in pooled analyses.
- Secondary Outcome Measures
Name Time Method Change in prevalence of potentially inappropriate use of specific medications 1-6 months pre-baseline vs. 13-18 months post-baseline 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.
Change in monthly medication costs for all drugs 1-6 months pre-baseline vs. 13-18 months post-baseline 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.
Change in number of inappropriate medications at a patient-level 1-6 months pre-baseline vs. 13-18 months post-baseline 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.
Change in prevalence of any receipt of cognitive behavioral therapy for insomnia (CBTI) 1-6 months pre-baseline vs. 13-18 months post-baseline 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.
Change in mean cognitive behavioral therapy for insomnia (CBTI) sessions completed 1-6 months pre-baseline vs. 13-18 months post-baseline 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.
Change in the monthly percentage of patients referred to cognitive behavioral therapy for insomnia (CBTI) 1-6 months pre-baseline vs. 13-18 months post-baseline 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.
Change in number of medication reviews 1-6 months pre-baseline vs. 13-18 months post-baseline 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.
Change in prevalence of high-risk direct oral anticoagulant (DOAC) use 1-6 months pre-baseline vs. 13-18 months post-baseline 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.
Trial Locations
- Locations (1)
VA Ann Arbor Healthcare System, Ann Arbor, MI
🇺🇸Ann Arbor, Michigan, United States