SHARING Choices: Design and rationale for a pragmatic trial of an advance care planning intervention for older adults with and without dementia in primary care.
Advance care planning
Advance directives
Dementia
Primary care
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
08 2022
08 2022
Historique:
received:
08
02
2022
revised:
27
05
2022
accepted:
06
06
2022
pubmed:
12
6
2022
medline:
31
8
2022
entrez:
11
6
2022
Statut:
ppublish
Résumé
Advance care planning (ACP) and involving family are particularly important in dementia, and primary care is a key setting. The purpose of this trial is to examine the impact and implementation of SHARING Choices, an intervention to improve communication for older adults with and without dementia through proactively supporting ACP and family engagement in primary care. We cluster-randomized 55 diverse primary care practices across two health systems to the intervention or usual care. SHARING Choices is a multicomponent intervention that aims to improve communication through patient and family engagement in ACP, agenda setting, and shared access to the patient portal for all patients over 65 years of age. The primary outcomes include documentation of an advance directive or medical orders for life-sustaining treatment in the electronic health record (EHR) at 12 months for all patients and receipt of potentially burdensome care within 6 months of death for the subgroup of patients with serious illness. We plan a priori sub-analysis for patients with dementia. Data sources include the health system EHRs and the Maryland health information exchange. We use a mixed-methods approach to evaluate uptake, fidelity and adaptation of the intervention and implementation facilitators and barriers. This cluster-randomized pragmatic trial examines ACP with a focus on the key population of those with dementia, implementation in diverse settings and innovative approaches to trial design and outcome abstraction. Mixed-methods approaches enable understanding of intervention delivery and facilitators and barriers to implementation in rapidly changing health care systems. gov Identifier: NCT04819191.
Sections du résumé
BACKGROUND
Advance care planning (ACP) and involving family are particularly important in dementia, and primary care is a key setting. The purpose of this trial is to examine the impact and implementation of SHARING Choices, an intervention to improve communication for older adults with and without dementia through proactively supporting ACP and family engagement in primary care.
METHODS
We cluster-randomized 55 diverse primary care practices across two health systems to the intervention or usual care. SHARING Choices is a multicomponent intervention that aims to improve communication through patient and family engagement in ACP, agenda setting, and shared access to the patient portal for all patients over 65 years of age. The primary outcomes include documentation of an advance directive or medical orders for life-sustaining treatment in the electronic health record (EHR) at 12 months for all patients and receipt of potentially burdensome care within 6 months of death for the subgroup of patients with serious illness. We plan a priori sub-analysis for patients with dementia. Data sources include the health system EHRs and the Maryland health information exchange. We use a mixed-methods approach to evaluate uptake, fidelity and adaptation of the intervention and implementation facilitators and barriers.
CONCLUSIONS
This cluster-randomized pragmatic trial examines ACP with a focus on the key population of those with dementia, implementation in diverse settings and innovative approaches to trial design and outcome abstraction. Mixed-methods approaches enable understanding of intervention delivery and facilitators and barriers to implementation in rapidly changing health care systems.
CLINICALTRIALS
gov Identifier: NCT04819191.
Identifiants
pubmed: 35690262
pii: S1551-7144(22)00144-6
doi: 10.1016/j.cct.2022.106818
pmc: PMC9700199
mid: NIHMS1851888
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04819191']
Types de publication
Journal Article
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106818Subventions
Organisme : NIA NIH HHS
ID : R33 AG061882
Pays : United States
Organisme : NIA NIH HHS
ID : R61 AG061882
Pays : United States
Investigateurs
Ryan Anderson
(R)
Diane Echavarria
(D)
Tara Funkhouser
(T)
Karyn Lee Carlson Nicholson
(KLC)
Christine Rawlinson
(C)
Sri Ribala
(S)
Meena Seshamani
(M)
Laura Torres
(L)
Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.
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