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.

Academic detailing Anti-coagulation Deprescribing Implementation science Implementation strategy Insomnia Medication safety Polypharmacy Quality improvement

Journal

Implementation science communications
ISSN: 2662-2211
Titre abrégé: Implement Sci Commun
Pays: England
ID NLM: 101764360

Informations de publication

Date de publication:
14 May 2022
Historique:
received: 03 03 2022
accepted: 05 04 2022
entrez: 15 5 2022
pubmed: 16 5 2022
medline: 16 5 2022
Statut: epublish

Résumé

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 oral anticoagulants (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. For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to relevant clinical data to identify 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 the use of the EBPs: (1) individual-level academic detailing (AD) or (2) AD plus the team-based Learn. Engage. Act. (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. 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 the use of actional clinical data and making incremental changes, designed to be feasible within busy clinical settings. ClinicalTrials.gov: NCT05065502 . Registered October 4, 2021-retrospectively registered.

Sections du résumé

BACKGROUND 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 oral anticoagulants (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 METHODS
For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to relevant clinical data to identify 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 the use of the EBPs: (1) individual-level academic detailing (AD) or (2) AD plus the team-based Learn. Engage. Act.
PROCESS METHODS
(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 CONCLUSIONS
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 the use of actional clinical data and making incremental changes, designed to be feasible within busy clinical settings.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov: NCT05065502 . Registered October 4, 2021-retrospectively registered.

Identifiants

pubmed: 35568903
doi: 10.1186/s43058-022-00297-z
pii: 10.1186/s43058-022-00297-z
pmc: PMC9107220
doi:

Banques de données

ClinicalTrials.gov
['NCT05065502']

Types de publication

Journal Article

Langues

eng

Pagination

53

Subventions

Organisme : Quality Enhancement Research Initiative
ID : QUE 20-025

Informations de copyright

© 2022. The Author(s).

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Auteurs

Laura J Damschroder (LJ)

Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA. Laura.Damschroder@va.gov.

Jeremy B Sussman (JB)

Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA.
Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA.

Paul N Pfeiffer (PN)

Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA.
Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.

Jacob E Kurlander (JE)

Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA.
Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA.

Michelle B Freitag (MB)

Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA.

Claire H Robinson (CH)

Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA.

Patrick Spoutz (P)

Veterans Health Affairs VISN 20 Pharmacy Benefits Management, Vancouver, WA, USA.

Melissa L D Christopher (MLD)

Pharmacy Benefits Management Services, Veterans Health Administration, 810 Vermont Ave NW, Washington DC, 20420, USA.

Saraswathy Battar (S)

Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA.
Baylor College of Medicine, Houston, TX, USA.

Kimberly Dickerson (K)

Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.

Christopher Sedgwick (C)

Department of Veterans Affairs, VA Heartland Network (VISN 15), Kansas City, MO, USA.

Ashleigh G Wallace-Lacey (AG)

VA St Louis Medical Center John Cochran Division, St. Louis, MO, USA.

Geoffrey D Barnes (GD)

Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA.
Frankel Cardiovascular Center, University of Michigan, Ann Arbor, MI, USA.

Amy M Linsky (AM)

Section of General Medicine, VA Boston Healthcare System, Boston, MA, USA.
Center for Health Organizations and Implementation Research, VA Boston Healthcare System, Boston, MA, USA.
Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, USA.

Christi S Ulmer (CS)

Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) Durham Veterans Affairs Health Care System, Durham, NC, USA.
Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.

Julie C Lowery (JC)

Center for Clinical Management Research, VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA.

Classifications MeSH