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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Insomnia; Polypharmacy; Anticoagulants
• Intervention / Treatment: Behavioral: Academic Detailing (AD); Behavioral: LEAP

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 (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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105-2303
      • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Employee Engagement in Quality Improvement	3-item pilot measure of the extent to which employees engage in quality improvement activities. Scores are 1-5 with higher ratings indicating more engagement in QI.	Baseline to 18-months post-baseline
Change in Employee Burnout	3-item measure comprising one item each for exhaustion, depersonalization, and reduced achievement (reverse scored). "High Burnout" measures the percent of staff who are feeling burned out on all three burnout items at a frequency of "once a week" to "every day." Scored: 0-100%, where LOWER score is more favorable.	Baseline to 18-months post-baseline
Change in Best Places to Work Score	3-item scale. "Best Places to Work" is a summary measure of the group's satisfaction with the job, organization, and likelihood to recommend VA as a good place to work. This is a measure normally administered within the All-employee Survey (AES). This score is functionally similar to those reported for Federal agencies by the Partnership for Public Service (http://bestplacestowork.org). Overall Satisfaction (% Positive), Organization Satisfaction (% Positive), and Recommend My Organization (% Positive). Score as Percent positive = "Very Satisfied/Satisfied" or "Strongly Agree/Agree."	Baseline to 18-months post-baseline
Change in Workgroup Cohesion & Engagement	7-item measure from the VA's newly developed Patient Safety Culture. Values 1 to 5 where higher values indicate more positive scores.	Baseline to 18-months post-baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Paul N Pfeiffer, MD MS, VA Ann Arbor Healthcare System, Ann Arbor, MI; Principal Investigator: Jeremy B. Sussman, MD MS, VA Ann Arbor Healthcare System, Ann Arbor, MI; Principal Investigator: Jacob E Kurlander, MD MS MS, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: insomnia; anticoagulation; polypharmacy; pragmatic trial; implementation science; quality improvement; medication safety; academic detailing; implementation strategy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: QUX 21-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Site-level data that underlie results reported, after de-identification will be available.
• IPD Sharing Time Frame: For 36 months after article is published.
• IPD Sharing Access Criteria: Upon request by researchers who provide a methodologically sound proposal. Further details will be available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No