Facilitating communication for critically ill patients and their family members: Study protocol for two randomized trials implemented in the U.S. and France.
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 2021
08 2021
Historique:
received:
14
03
2021
revised:
14
05
2021
accepted:
31
05
2021
pubmed:
7
6
2021
medline:
25
9
2021
entrez:
6
6
2021
Statut:
ppublish
Résumé
Critically-ill patients and their families suffer a high burden of psychological symptoms due, in part, to many transitions among clinicians and settings during and after critical illness, resulting in fragmented care. Communication facilitators may help. We are conducting two cluster-randomized trials, one in the U.S. and one in France, with the goal of evaluating a nurse facilitator trained to support, model, and teach communication strategies enabling patients and families to secure care consistent with patients' goals, beginning in ICU and continuing for 3 months. We will randomize 376 critically-ill patients in the US and 400 in France to intervention or usual care. Eligible patients have a risk of hospital mortality of greater than15% or a chronic illness with a median survival of approximately 2 years or less. We assess effectiveness with patient- and family-centered outcomes, including symptoms of depression, anxiety, and post-traumatic stress, as well as assessments of goal-concordant care, at 1-, 3-, and 6-months post-randomization. The primary outcome is family symptoms of depression over 6 months. We also evaluate whether the intervention improves value by reducing utilization while improving outcomes. Finally, we use mixed methods to explore implementation factors associated with implementation outcomes (acceptability, fidelity, acceptability, penetration) to inform dissemination. Conducting the trial in U.S. and France will provide insights into differences and similarities between countries. We describe the design of two randomized trials of a communication facilitator for improving outcomes for critically ill patients and their families in two countries.
Sections du résumé
BACKGROUND
Critically-ill patients and their families suffer a high burden of psychological symptoms due, in part, to many transitions among clinicians and settings during and after critical illness, resulting in fragmented care. Communication facilitators may help.
DESIGN AND INTERVENTION
We are conducting two cluster-randomized trials, one in the U.S. and one in France, with the goal of evaluating a nurse facilitator trained to support, model, and teach communication strategies enabling patients and families to secure care consistent with patients' goals, beginning in ICU and continuing for 3 months.
PARTICIPANTS
We will randomize 376 critically-ill patients in the US and 400 in France to intervention or usual care. Eligible patients have a risk of hospital mortality of greater than15% or a chronic illness with a median survival of approximately 2 years or less.
OUTCOMES
We assess effectiveness with patient- and family-centered outcomes, including symptoms of depression, anxiety, and post-traumatic stress, as well as assessments of goal-concordant care, at 1-, 3-, and 6-months post-randomization. The primary outcome is family symptoms of depression over 6 months. We also evaluate whether the intervention improves value by reducing utilization while improving outcomes. Finally, we use mixed methods to explore implementation factors associated with implementation outcomes (acceptability, fidelity, acceptability, penetration) to inform dissemination. Conducting the trial in U.S. and France will provide insights into differences and similarities between countries.
CONCLUSIONS
We describe the design of two randomized trials of a communication facilitator for improving outcomes for critically ill patients and their families in two countries.
Identifiants
pubmed: 34091062
pii: S1551-7144(21)00201-9
doi: 10.1016/j.cct.2021.106465
pmc: PMC8429114
mid: NIHMS1714103
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106465Subventions
Organisme : NINR NIH HHS
ID : R01 NR018161
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
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