» Articles » PMID: 34091062

Facilitating Communication for Critically Ill Patients and Their Family Members: Study Protocol for Two Randomized Trials Implemented in the U.S. and France

Abstract

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.

Citing Articles

Barriers and Strategies to Effective Serious Illness Communication for Patients with End-Stage Liver Disease in the Intensive Care Setting.

Brown C, Khan S, Parekh T, Muir A, Sudore R J Intensive Care Med. 2024; :8850666241280892.

PMID: 39247992 PMC: 11890205. DOI: 10.1177/08850666241280892.


"It's all about setting the stage." The nurse facilitator trial: perceived outcomes and implementation issues. A qualitative study among ICU clinicians and nurse facilitators.

Renet A, Azoulay E, Reignier J, Cariou A, Renault A, Huet O Intensive Care Med. 2024; 50(10):1657-1667.

PMID: 39158706 DOI: 10.1007/s00134-024-07589-z.


Financial Hardship: A Qualitative Study Exploring Perspectives of Seriously Ill Patients and Their Family.

Dotolo D, Pytel C, Nielsen E, Im J, Engelberg R, Khandelwal N J Pain Symptom Manage. 2024; 68(5):e382-e391.

PMID: 39147110 PMC: 11471371. DOI: 10.1016/j.jpainsymman.2024.08.001.


A randomised controlled trial of a nurse facilitator to promote communication for family members of critically ill patients.

Kentish-Barnes N, Azoulay E, Reignier J, Cariou A, Lafarge A, Huet O Intensive Care Med. 2024; 50(5):712-724.

PMID: 38573403 DOI: 10.1007/s00134-024-07390-y.


Tailored implementation of the FICUS multicomponent family support intervention in adult intensive care units: findings from a mixed methods contextual analysis.

Verweij L, Oesch S, Naef R BMC Health Serv Res. 2023; 23(1):1339.

PMID: 38041092 PMC: 10693161. DOI: 10.1186/s12913-023-10285-1.


References
1.
Hough C, Curtis J . Long-term sequelae of critical illness: memories and health-related quality of life. Crit Care. 2005; 9(2):145-6. PMC: 1175938. DOI: 10.1186/cc3483. View

2.
Patterson E, Wears R . Patient handoffs: standardized and reliable measurement tools remain elusive. Jt Comm J Qual Patient Saf. 2010; 36(2):52-61. DOI: 10.1016/s1553-7250(10)36011-9. View

3.
Aslakson R, Reinke L, Cox C, Kross E, Benzo R, Curtis J . Developing a Research Agenda for Integrating Palliative Care into Critical Care and Pulmonary Practice To Improve Patient and Family Outcomes. J Palliat Med. 2017; 20(4):329-343. PMC: 5385425. DOI: 10.1089/jpm.2016.0567. View

4.
Thoresen S, Tambs K, Hussain A, Heir T, Johansen V, Bisson J . Brief measure of posttraumatic stress reactions: impact of Event Scale-6. Soc Psychiatry Psychiatr Epidemiol. 2009; 45(3):405-12. DOI: 10.1007/s00127-009-0073-x. View

5.
Turnbull A, Sepulveda K, Dinglas V, Chessare C, Bingham 3rd C, Needham D . Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study. Crit Care Med. 2017; 45(6):1001-1010. PMC: 5433919. DOI: 10.1097/CCM.0000000000002435. View