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Supporting Families in the ICU: The Chaplain Family Project Multicenter RCT
The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Our team has developed an approach to high quality spiritual care intervention for ICU surrogates, called the Spiritual Care Assessment and Intervention (SCAI) framework, which is delivered by a chaplain interventionist to ICU surrogates.
To prepare for a fully powered, multi-center study, we propose a 2-arm, attention controlled, randomized pilot trial of high-quality spiritual care for 64 surrogates at 2 additional US medical centers. Specific Aims are: 1. To determine the feasibility and acceptability of all aspects of the study, including enrollment, randomization, delivery of the SCAI framework (e.g., chaplain intervention) and attention control conditions, acceptability, and outcome assessments, in preparation for a larger, Stage III effectiveness trial. 2. To test the effects of spiritual care on the primary outcome of anxiety (GAD-7) and the secondary outcomes of surrogate spiritual well-being and satisfaction with spiritual care (FACIT-Sp-non-illness version, Satisfaction with Care-Chaplain), and decision making for the patient, including the process of decision making and the medical care received by the patient. 3. To study the experience of spiritual care from the perspective of surrogates who are religious and those who are not, those of different faiths, and those who describe themselves as spiritual but not religious. Because chaplains are common in the ICU this intervention is highly scalable. Results will guide hospital leaders, policy makers and the healthcare team regarding how to deploy chaplains to improve surrogates' psychological and spiritual health and the quality of decisions for critically ill patients.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of California- San Francisco
San Francisco, California, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Start Date
February 2, 2026
Primary Completion Date
August 31, 2026
Completion Date
August 31, 2026
Last Updated
January 15, 2026
64
ESTIMATED participants
Spiritual Care Assessment and Intervention (SCAI) Framework
BEHAVIORAL
ICU Guide
BEHAVIORAL
Lead Sponsor
Indiana University
Collaborators
NCT07478393
NCT07456631
Data Source & Attribution
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