Supporting Families in the ICU

NCT ID: NCT07228299

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-02
• Study Completion Date: 2026-08-31

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.

Conditions

Anxiety; Well-Being; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention (SCAI Framework)

Participants in this arm will receive the chaplain led intervention of the Spiritual Care Assessment and Intervention (SCAI) framework.

Group Type: EXPERIMENTAL

Spiritual Care Assessment and Intervention (SCAI) Framework

Intervention Type: BEHAVIORAL

The SCAI intervention includes three visits generally scheduled 48-72 hours apart. After three visits, the chaplain will contact the surrogate at least weekly for the remainder of the hospitalization. If the patient dies, the chaplain will conduct a bereavement visit.

The SCAI framework addresses four dimensions of spirituality. If all four dimensions are not addressed, they may be assessed during follow-up visits. If all four dimensions are addressed during the initial visit, other visits include at least one question from any dimension.

The SCAI framework includes a list of common spiritual care interventions developed based on clinical experience and literature review.. Based on our conceptual framework, interventions are either are emotionally supportive, address spiritual or religious dimensions of care, or address information support such as exploring the meaning of medical events. Consistent with chaplain standards, the chaplain selects and tailors these interventions.

Control (ICU Guide)

Participants in this arm will participate in meetings with a member of the research team to review an ICU guide.

Group Type: ACTIVE_COMPARATOR

ICU Guide

Intervention Type: BEHAVIORAL

The ICU Guide intervention will include three visits with the site RA that are similar in duration to the chaplain visits (based on the single center study, first visit median of 23 minutes, follow-up visit median 12 minutes), with review of a brochure introducing the family member to the ICU including staff, policies and procedures that will be helpful to the family member.

Interventions

Spiritual Care Assessment and Intervention (SCAI) Framework

The SCAI intervention includes three visits generally scheduled 48-72 hours apart. After three visits, the chaplain will contact the surrogate at least weekly for the remainder of the hospitalization. If the patient dies, the chaplain will conduct a bereavement visit.

The SCAI framework addresses four dimensions of spirituality. If all four dimensions are not addressed, they may be assessed during follow-up visits. If all four dimensions are addressed during the initial visit, other visits include at least one question from any dimension.

The SCAI framework includes a list of common spiritual care interventions developed based on clinical experience and literature review.. Based on our conceptual framework, interventions are either are emotionally supportive, address spiritual or religious dimensions of care, or address information support such as exploring the meaning of medical events. Consistent with chaplain standards, the chaplain selects and tailors these interventions.

Intervention Type: BEHAVIORAL

ICU Guide

The ICU Guide intervention will include three visits with the site RA that are similar in duration to the chaplain visits (based on the single center study, first visit median of 23 minutes, follow-up visit median 12 minutes), with review of a brochure introducing the family member to the ICU including staff, policies and procedures that will be helpful to the family member.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• They are age 18 or older at the time of screening.
• They are judged to lack decisional capacity based on either:

a Glasgow Coma Scale (GCS) score of 8 or less; or a GCS of 9-13 with at least one secondary criterion (intubation, sedation, delirium, or noted by clinicians to be unresponsive, comatose or unable to follow commands).

• They have an eligible surrogate willing to participate.

Surrogates will be eligible if:

• They are age 18 or older,
• They are considered the legally authorized representative (LAR) based on prior appointment by the patient or each state's medical consent law.

Patient/surrogate dyads will be ineligible if:

• They are unable to complete enrollment activities within 96 hours of admission to the ICU.

Patients will be ineligible if:

• They are being discharged from the ICU within 24 hours.
• They are intubated for surgery but expected to be extubated soon (typically within 24 hours).
• They are imminently dying or have a planned terminal wean.

Surrogates will be ineligible if:

*They are unable to complete study procedures in English.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Regenstrief Institute, Inc.

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: collaborator

Rush University

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Alexia M. Torke

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California- San Francisco

San Francisco, California, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Central Contacts

Emily S Burke, BA

Role: CONTACT

esburke@regenstrief.org

317-274-9047

Alexia M Torke, MD, MS

Role: CONTACT

atorke@iu.edu

Facility Contacts

Susan Conrad, MDiv, BCC

Role: primary

susan.conrad@ucsf.edu

Jennifer Gabbard, MD

Role: primary

jgabbard@wakehealth.edu

Other Identifiers

R56AG086388

Identifier Type: NIH

Identifier Source: secondary_id

View Link

27922

Identifier Type: -

Identifier Source: org_study_id