Supporting Families in the ICU

NCT07228299 | Not Yet Recruiting

• 2 other identifiers: 27922R56AG086388
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety; Well-Being; Satisfaction

Keywords

spirituality; religion; surrogate decision making; proxy decision making; chaplain

Outcome Measures

Primary Outcomes (1)

• Effect of the intervention on surrogate anxiety (GAD-7)

  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.

  Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital

Secondary Outcomes (3)

• 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

• Decision making quality (FS-ICU)

  Assessed 6-8 weeks after the patient has discharged from the hospital

• Satisfaction with Spiritual Care (PSI-C)

  Assessed 6-8 weeks after the patient has discharged from the hospital

Other Outcomes (13)

• Hospice enrollment

  Assessed 3 months after the patient has discharged from the hospital

• ICU length of stay

  Assessed 3 months after the patient has discharged from the hospital

• DNR declaration

  Assessed 3 months after the patient has discharged from the hospital

Study Arms (2)

Intervention (SCAI Framework)

EXPERIMENTAL

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

Behavioral: Spiritual Care Assessment and Intervention (SCAI) Framework

Control (ICU Guide)

ACTIVE COMPARATOR

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

Behavioral: ICU Guide

Interventions

Spiritual Care Assessment and Intervention (SCAI) Framework 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.

Intervention (SCAI Framework)

ICU Guide 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.

Control (ICU Guide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

We will enroll patient/surrogate dyads. Patients will be eligible if: * 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Wake Forest University: collaborator
• National Institutes of Health (NIH): collaborator
• Regenstrief Institute, Inc.: collaborator
• University of California, San Francisco: collaborator
• Rush University: collaborator
• Indiana University: lead

Study Sites (2)

University of California- San Francisco

San Francisco, California, 94143, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Emily S Burke, BA

CONTACT

317-274-9047; esburke@regenstrief.org

Alexia M Torke, MD, MS

CONTACT

atorke@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: November 14, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)