Supporting Families in the ICU

ConditionsAnxiety Well-Being Satisfaction

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

They are age 18 or older at the time of screening.

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.

They are being discharged from the ICU within 24 hours.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

64 Participants

are divided into 2 treatment groups

Group A: Intervention (SCAI Framework)Experimental treatment 1 intervention

Group B: Control (ICU Guide)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Effect of the intervention on surrogate spiritual well-being (FACIT-Sp)

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.

Time frame

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

Decision making quality (FS-ICU)

Family Satisfaction with the ICU Process of Decision Making Subscale, a 4 item inventory of decision making quality

Time frame

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

Satisfaction with Spiritual Care (PSI-C)

Patient Satisfaction Instrument- Chaplaincy includes 23 clinical statements which are rated on a 4 (strongly agree) to 1 (strongly disagree) scale.

Time frame

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

Other outcomes

Hospice enrollment

Total count of patients in both groups who enroll in hospice during the hospitalization

Time frame

Assessed 3 months after the patient has discharged from the hospital

ICU length of stay

Total length of stay for patients in both groups

Time frame

Assessed 3 months after the patient has discharged from the hospital

DNR declaration

Total count of patients in both groups who changed their code status to DNR during the hospitalization

Time frame

Assessed 3 months after the patient has discharged from the hospital

Comfort plan initiation

Total count of patients in both groups who initiated a comfort plan during the hospitalization

Time frame

Assessed 3 months after the patient has discharged from the hospital

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute on Aging (NIA)

Collaborator

Regenstrief Institute, Inc.

Collaborator

University of California, San Francisco

Collaborator

Wake Forest University

Collaborator

Rush University

Collaborator

Oregon Health and Science University

Collaborator

Source ClinicalTrials.gov

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