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

Insomnia Clinical Trial

— MIDAS cRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05065502
• Other study ID #: QUX 21-004
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: May 14, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 14, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants
• Insomnia
• Polypharmacy
• Sleep Initiation and Maintenance Disorders

Intervention

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]."
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	Change in Monthly facility percent of inappropriate medication use	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.	1-6 months pre-baseline vs. 13-18 months post-baseline
Secondary	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.	1-6 months pre-baseline vs. 13-18 months post-baseline
Secondary	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.	1-6 months pre-baseline vs. 13-18 months post-baseline
Secondary	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.	1-6 months pre-baseline vs. 13-18 months post-baseline
Secondary	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.	1-6 months pre-baseline vs. 13-18 months post-baseline
Secondary	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.	1-6 months pre-baseline vs. 13-18 months post-baseline
Secondary	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.	1-6 months pre-baseline vs. 13-18 months post-baseline
Secondary	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.	1-6 months pre-baseline vs. 13-18 months post-baseline
Secondary	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.	1-6 months pre-baseline vs. 13-18 months post-baseline