Supporting Families in the ICU (SF-ICU)

Indiana University

Status: Not yet enrolling

Conditions: Well-Being; Satisfaction; Anxiety

Treatments: Behavioral: ICU Guide; Behavioral: Spiritual Care Assessment and Intervention (SCAI) Framework

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07228299

R56AG086388 (U.S. NIH Grant/Contract)

27922

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Intervention (SCAI Framework)

Experimental group

Description:

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

Treatment:

Behavioral: Spiritual Care Assessment and Intervention (SCAI) Framework

Control (ICU Guide)

Active Comparator group

Description:

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

Treatment:

Behavioral: ICU Guide