Increasing goals of care conversations in primary care: Study protocol for a cluster randomized, pragmatic, sequential multiple assignment randomized trial.

Advance care planning Goals of care conversations Implementation science Palliative care Quality of life Sequential multiple assignment randomized trial (SMART) Serious illness conversations

Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
27 Jul 2024
Historique:
received: 14 03 2024
revised: 11 07 2024
accepted: 24 07 2024
medline: 30 7 2024
pubmed: 30 7 2024
entrez: 29 7 2024
Statut: aheadofprint

Résumé

Goals of care conversations explore seriously ill patients' values to guide medical decision making and often inform decisions about life sustaining treatments. Ideally, conversations occur before a health crisis between patients and clinicians in the outpatient setting. In the United States Veterans Affairs (VA) healthcare system, most conversations still occur in the inpatient setting. Strategies are needed to improve implementation of outpatient, primary care goals of care conversations. We plan a cluster randomized (clinician-level) sequential, multiple assignment randomized trial to evaluate the effectiveness of patient implementation strategies on the outcome of goals of care conversation documentation when delivered in combination with clinician implementation strategies. Across three VA healthcare system sites, we will enroll primary care clinicians with low rates of goals of care conversations and their patients with serious medical illness in the top 10th percentile of risk of hospitalization or death. We will compare the effectiveness of sequences of implementation strategies and explore how patient and site factors modify implementation strategy effects. Finally, we will conduct a mixed-methods evaluation to understand implementation strategy success or failure. The design includes two key innovations: (1) strategies that target both clinicians and patients and (2) sequential strategies with increased intensity for non-responders. This study aims to determine the effect of different sequences and combinations of implementation strategies on primary care documentation of goals of care conversations. Study partners, including the VA National Center for Ethics in Health Care and Office of Primary Care, can consider policies based on study findings.

Sections du résumé

BACKGROUND BACKGROUND
Goals of care conversations explore seriously ill patients' values to guide medical decision making and often inform decisions about life sustaining treatments. Ideally, conversations occur before a health crisis between patients and clinicians in the outpatient setting. In the United States Veterans Affairs (VA) healthcare system, most conversations still occur in the inpatient setting. Strategies are needed to improve implementation of outpatient, primary care goals of care conversations.
METHODS METHODS
We plan a cluster randomized (clinician-level) sequential, multiple assignment randomized trial to evaluate the effectiveness of patient implementation strategies on the outcome of goals of care conversation documentation when delivered in combination with clinician implementation strategies. Across three VA healthcare system sites, we will enroll primary care clinicians with low rates of goals of care conversations and their patients with serious medical illness in the top 10th percentile of risk of hospitalization or death. We will compare the effectiveness of sequences of implementation strategies and explore how patient and site factors modify implementation strategy effects. Finally, we will conduct a mixed-methods evaluation to understand implementation strategy success or failure. The design includes two key innovations: (1) strategies that target both clinicians and patients and (2) sequential strategies with increased intensity for non-responders.
CONCLUSION CONCLUSIONS
This study aims to determine the effect of different sequences and combinations of implementation strategies on primary care documentation of goals of care conversations. Study partners, including the VA National Center for Ethics in Health Care and Office of Primary Care, can consider policies based on study findings.

Identifiants

DOI: 10.1016/j.cct.2024.107643 PMID: 39074531
pubmed: 39074531
pii: S1551-7144(24)00226-X
doi: 10.1016/j.cct.2024.107643
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

107643

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Auteurs

David B Bekelman (DB)

VA Eastern Colorado Health Care System, Aurora, CO, USA; University of Colorado Anschutz Medical Campus, Aurora, CO, USA. Electronic address: david.bekelman@va.gov.

Karleen Giannitrapani (K)

Center for Innovation to Implementation VA Palo Alto Healthcare System, USA; Stanford University School of Medicine, Primary Care and Population Health, Palo Alto, CA, USA.

Kristin A Linn (KA)

Division of Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Paula Langner (P)

VA Eastern Colorado Health Care System, Aurora, CO, USA.

Rebecca L Sudore (RL)

San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA; Division of Geriatrics, Department of Medicine, University of California, San Francisco, CA, USA.

Borsika Rabin (B)

VA Eastern Colorado Health Care System, Aurora, CO, USA; Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, CA, USA; UC San Diego ACTRI Dissemination and Implementation Science Center, University of California San Diego, La Jolla, CA, USA.

Karl A Lorenz (KA)

Center for Innovation to Implementation VA Palo Alto Healthcare System, USA; Stanford University School of Medicine, Primary Care and Population Health, Palo Alto, CA, USA.

Mary Beth Foglia (MB)

VA National Center for Ethics in Health Care, USA; Department of Bioethics and Humanities, University of Washington School of Medicine, Seattle, WA, USA.

Amanda Glickman (A)

University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

Scott Pawlikowski (S)

Department of Bioethics and Humanities, University of Washington School of Medicine, Seattle, WA, USA.

Marilyn Sloan (M)

VA Eastern Colorado Health Care System, Aurora, CO, USA.

Raziel C Gamboa (RC)

Center for Innovation to Implementation VA Palo Alto Healthcare System, USA.

Matthew D McCaa (MD)

Center for Innovation to Implementation VA Palo Alto Healthcare System, USA.

Anne Hines (A)

VA Eastern Colorado Health Care System, Aurora, CO, USA.

Anne M Walling (AM)

University of California, Los Angeles, CA, USA; VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.

Classifications MeSH