Supporting Families in the ICU

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Well-Being; Satisfaction

• Registration Number: NCT07228299
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-10-08
• Status Verified: 2025-11
• Study First Submitted QC: 2025-11-12
• Last Update Submitted: 2025-11-12
• Study First Posted: 2025-11-14
• Last Update Posted: 2025-11-14
• Study Start: 2026-01-05
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of the intervention on surrogate anxiety (GAD-7)	Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital	Generalized Anxiety Disorder- 7 (GAD-7) (7 item inventory of anxiety)- assesses subject's self-reported anxiety for the last two weeks. Scores range from 0-21 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD.

Secondary Outcome Measures

Name	Time	Method
Effect of the intervention on surrogate spiritual well-being (FACIT-Sp)	Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital	Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT- Sp) Scale, a 12-item questionnaire used to measure spiritual well-being in people with chronic illnesses. It assesses aspects like meaning, peace, and faith, and is widely used in research and clinical settings, particularly for patients with cancer and other serious health conditions.
Decision making quality (FS-ICU)	Assessed 6-8 weeks after the patient has discharged from the hospital	Family Satisfaction with the ICU Process of Decision Making Subscale, a 4 item inventory of decision making quality
Satisfaction with Spiritual Care (PSI-C)	Assessed 6-8 weeks after the patient has discharged from the hospital	Patient Satisfaction Instrument- Chaplaincy includes 23 clinical statements which are rated on a 4 (strongly agree) to 1 (strongly disagree) scale.

Trial Locations

Locations (2)

University of California- San Francisco; 🇺🇸 San Francisco, California, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States