Supporting Families in the ICU

Part of paid clinical trials in San Francisco, California.

Sponsor
Indiana University
Study ID
NCT07228299
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Satisfaction
  • Well-Being

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention (SCAI Framework)
    Participants in this arm will receive the chaplain led intervention of the Spiritual Care Assessment and Intervention (SCAI) framework.
  • Active Comparator: Control (ICU Guide)
    Participants in this arm will participate in meetings with a member of the research team to review an ICU guide.

Primary Outcome Measure

Effect of the intervention on surrogate anxiety (GAD-7) [ Time Frame: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California- San FranciscoSan FranciscoCalifornia94143
Susan Conrad, MDiv, BCC
[email protected]
Wake Forest UniversityWinston-SalemNorth Carolina27157
Jennifer Gabbard, MD
[email protected]

Find similar trials in San Francisco, CA

By research site
University of California- San Francisco· San Francisco, CAWake Forest University· Winston-Salem, NC

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