Implementing evidence-based practices to improve primary care for high-risk patients: study protocol for the VA high-RIsk VETerans (RIVET) type III effectiveness-implementation trial.

Medication Adherence Multimorbidity Needs Assessment Primary Health Care

Journal

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

Informations de publication

Date de publication:
15 Jul 2024
Historique:
received: 30 05 2024
accepted: 08 07 2024
medline: 16 7 2024
pubmed: 16 7 2024
entrez: 15 7 2024
Statut: epublish

Résumé

Patients with significant multimorbidity and other factors that make healthcare challenging to access and coordinate are at high risk for poor health outcomes. Although most (93%) of Veterans' Health Administration (VHA) patients at high risk for hospitalization or death ("high-risk Veterans") are primarily managed by primary care teams, few of these teams have implemented evidence-based practices (EBPs) known to improve outcomes for the high-risk patient population's complex healthcare issues. Effective implementation strategies could increase adoption of these EBPs in primary care; however, the most effective implementation strategies to increase evidence-based care for high-risk patients are unknown. The high-RIsk VETerans (RIVET) Quality Enhancement Research Initiative (QUERI) will compare two variants of Evidence-Based Quality Improvement (EBQI) strategies to implement two distinct EBPs for high-risk Veterans: individual coaching (EBQI-IC; tailored training with individual implementation sites to meet site-specific needs) versus learning collaborative (EBQI-LC; implementation sites trained in groups to encourage collaboration among sites). One EBP, Comprehensive Assessment and Care Planning (CACP), guides teams in addressing patients' cognitive, functional, and social needs through a comprehensive care plan. The other EBP, Medication Adherence Assessment (MAA), addresses common challenges to medication adherence using a patient-centered approach. We will recruit and randomize 16 sites to either EBQI-IC or EBQI-LC to implement one of the EBPs, chosen by the site. Each site will have a site champion (front-line staff) who will participate in 18 months of EBQI facilitation. We will use a mixed-methods type 3 hybrid Effectiveness-Implementation trial to test EBQI-IC versus EBQI-LC versus usual care using a Concurrent Stepped Wedge design. We will use the Practical, Robust Implementation and Sustainability Model (PRISM) framework to compare and evaluate Reach, Effectiveness, Adoption, Implementation, and costs. We will then assess the maintenance/sustainment and spread of both EBPs in primary care after the 18-month implementation period. Our primary outcome will be Reach, measured by the percentage of eligible high-risk patients who received the EBP. Our study will identify which implementation strategy is most effective overall, and under various contexts, accounting for unique barriers, facilitators, EBP characteristics, and adaptations. Ultimately this study will identify ways for primary care clinics and teams to choose implementation strategies that can improve care and outcomes for patients with complex healthcare needs. ClinicalTrials.gov, NCT05050643. Registered September 9th, 2021, https://clinicaltrials.gov/study/NCT05050643 PROTOCOL VERSION: This protocol is Version 1.0 which was created on 6/3/2020.

Sections du résumé

BACKGROUND BACKGROUND
Patients with significant multimorbidity and other factors that make healthcare challenging to access and coordinate are at high risk for poor health outcomes. Although most (93%) of Veterans' Health Administration (VHA) patients at high risk for hospitalization or death ("high-risk Veterans") are primarily managed by primary care teams, few of these teams have implemented evidence-based practices (EBPs) known to improve outcomes for the high-risk patient population's complex healthcare issues. Effective implementation strategies could increase adoption of these EBPs in primary care; however, the most effective implementation strategies to increase evidence-based care for high-risk patients are unknown. The high-RIsk VETerans (RIVET) Quality Enhancement Research Initiative (QUERI) will compare two variants of Evidence-Based Quality Improvement (EBQI) strategies to implement two distinct EBPs for high-risk Veterans: individual coaching (EBQI-IC; tailored training with individual implementation sites to meet site-specific needs) versus learning collaborative (EBQI-LC; implementation sites trained in groups to encourage collaboration among sites). One EBP, Comprehensive Assessment and Care Planning (CACP), guides teams in addressing patients' cognitive, functional, and social needs through a comprehensive care plan. The other EBP, Medication Adherence Assessment (MAA), addresses common challenges to medication adherence using a patient-centered approach.
METHODS METHODS
We will recruit and randomize 16 sites to either EBQI-IC or EBQI-LC to implement one of the EBPs, chosen by the site. Each site will have a site champion (front-line staff) who will participate in 18 months of EBQI facilitation.
ANALYSIS METHODS
We will use a mixed-methods type 3 hybrid Effectiveness-Implementation trial to test EBQI-IC versus EBQI-LC versus usual care using a Concurrent Stepped Wedge design. We will use the Practical, Robust Implementation and Sustainability Model (PRISM) framework to compare and evaluate Reach, Effectiveness, Adoption, Implementation, and costs. We will then assess the maintenance/sustainment and spread of both EBPs in primary care after the 18-month implementation period. Our primary outcome will be Reach, measured by the percentage of eligible high-risk patients who received the EBP.
DISCUSSION CONCLUSIONS
Our study will identify which implementation strategy is most effective overall, and under various contexts, accounting for unique barriers, facilitators, EBP characteristics, and adaptations. Ultimately this study will identify ways for primary care clinics and teams to choose implementation strategies that can improve care and outcomes for patients with complex healthcare needs.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov, NCT05050643. Registered September 9th, 2021, https://clinicaltrials.gov/study/NCT05050643 PROTOCOL VERSION: This protocol is Version 1.0 which was created on 6/3/2020.

Identifiants

DOI: 10.1186/s43058-024-00613-9 PMID: 39010160
pubmed: 39010160
doi: 10.1186/s43058-024-00613-9
pii: 10.1186/s43058-024-00613-9
doi:

Banques de données

ClinicalTrials.gov
['NCT05050643']

Types de publication

Journal Article

Langues

eng

Pagination

75

Subventions

Organisme : U.S. Department of Veterans Affairs
ID : QUE-20-018

Informations de copyright

© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.

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Auteurs

Elvira E Jimenez (EE)

Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA, 90073, USA. elvira.jimenez@va.gov.
Department of Neurology, David Geffen School of Medicine, University of California Los Angeles (UCLA), 760 Westwood Plaza, Los Angeles, CA, 90095, USA. elvira.jimenez@va.gov.
Caring for Complex Chronic Conditions Research Center & Division of General Internal Medicine, School of Medicine, University of Pittsburgh, 3550 Terrace St, Pittsburgh, PA, 15213, USA. elvira.jimenez@va.gov.
ORCID: 0009-0009-7189-6370

Ann-Marie Rosland (AM)

Center for Health Equity Research and Promotion (CHERP), VA Pittsburgh Healthcare System, 1 University Dr, Pittsburgh, PA, 15240, USA.
Caring for Complex Chronic Conditions Research Center & Division of General Internal Medicine, School of Medicine, University of Pittsburgh, 3550 Terrace St, Pittsburgh, PA, 15213, USA.

Susan E Stockdale (SE)

Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA, 90073, USA.
Department of Neurology, David Geffen School of Medicine, University of California Los Angeles (UCLA), 760 Westwood Plaza, Los Angeles, CA, 90095, USA.

Ashok Reddy (A)

Department of Medicine, Division of General Internal Medicine, Harborview Medical Center, University of Washington, 325 Ninth Ave, Box 359780, Seattle, WA, 98104, USA.
Center for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA, 98108, USA.

Michelle S Wong (MS)

Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA, 90073, USA.

Natasha Torrence (N)

Center for Health Equity Research and Promotion (CHERP), VA Pittsburgh Healthcare System, 1 University Dr, Pittsburgh, PA, 15240, USA.
Caring for Complex Chronic Conditions Research Center & Division of General Internal Medicine, School of Medicine, University of Pittsburgh, 3550 Terrace St, Pittsburgh, PA, 15213, USA.

Alexis Huynh (A)

Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA, 90073, USA.

Evelyn T Chang (ET)

Center for the Study of Healthcare Innovation, Implementation & Policy (CSHIIP), VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd, Los Angeles, CA, 90073, USA.
Division of General Internal Medicine, Department of Medicine, David Geffen School of Medicine, UCLA, 740 Charles E Young Dr S, Los Angeles, CA, 90095, USA.

Classifications MeSH