Spiritual Care for Well-being

(SF-ICU Trial)

Not yet recruiting at 1 trial location

Overseen By Alexia M Torke, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Imminently dying, Terminal wean, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of spiritual care on the well-being of individuals making medical decisions for loved ones in the ICU. It tests a new approach called the Spiritual Care Assessment and Intervention (SCAI) framework, led by a chaplain. One group of participants will receive this spiritual care, while another group will review an ICU guide with the research team. Ideal candidates for this trial are legally authorized decision-makers for ICU patients unable to make their own decisions. As an unphased trial, this study provides a unique opportunity to contribute to understanding how spiritual care can support decision-makers in critical care settings.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on spiritual care for ICU family surrogates, so it's unlikely that medication changes are required.

What prior data suggests that the Spiritual Care Assessment and Intervention (SCAI) framework is safe for ICU family surrogates?

Research has shown that the Spiritual Care Assessment and Intervention (SCAI) framework has been tested with adults who have advanced cancer and their caregivers. Studies indicate that this approach is practical and participants generally respond positively. These studies have reported no specific negative effects or safety issues, suggesting that the intervention is well-tolerated. As a non-drug approach focusing on spiritual care, it is generally considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Spiritual Care Assessment and Intervention (SCAI) Framework because it offers a unique approach to enhancing well-being through spiritual care, something not typically addressed by standard medical treatments. Unlike traditional interventions that focus primarily on physical health, the SCAI Framework, led by chaplains, integrates spiritual assessments and personalized care plans to support emotional and spiritual health. This holistic approach acknowledges the role of spirituality in healing, aiming to improve overall well-being and potentially leading to better health outcomes.

What evidence suggests that the Spiritual Care Assessment and Intervention (SCAI) framework is effective for ICU family surrogates?

Studies have shown that spiritual care can improve mental well-being and quality of life. Research indicates that including spiritual care in mental health support can lower anxiety and enhance overall health. In this trial, participants in the intervention arm will receive the Spiritual Care Assessment and Intervention (SCAI) framework, which aims to enhance both personal and social aspects of spirituality. These benefits are especially helpful for people in challenging medical situations, such as those in intensive care. Early findings suggest that this type of care can significantly impact mental and spiritual health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for family surrogates of ICU patients. Surrogates are typically those responsible for making medical decisions on behalf of the patient. There's no specific inclusion or exclusion criteria provided, so it's open to any surrogate who feels they may benefit from spiritual care and guidance.

Inclusion Criteria

Patients will be eligible if they have an eligible surrogate willing to participate

Surrogates will be eligible if they are considered the legally authorized representative (LAR) based on prior appointment by the patient or each state's medical consent law

I am 18 years old or older.

Exclusion Criteria

I can complete enrollment activities within 4 days of ICU admission.

Patients will be ineligible if they are being discharged from the ICU within 24 hours

Patients will be ineligible if they are imminently dying or have a planned terminal wean

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Spiritual Care Assessment and Intervention (SCAI) framework or participate in meetings to review an ICU guide

Up to 10 weeks

Regular assessments on Days 1, 3, 5, 7, and weekly thereafter until discharge

Follow-up

Participants are monitored for outcomes such as anxiety, spiritual well-being, and decision-making quality

6-8 weeks after discharge

What Are the Treatments Tested in This Trial?

Interventions

• Spiritual Care Assessment and Intervention (SCAI) Framework

Trial Overview The trial is testing the SCAI framework, which provides spiritual care to ICU surrogates by a chaplain interventionist, against an ICU Guide that offers standard information without personalized spiritual support.

How Is the Trial Designed?

Group I: Intervention (SCAI Framework) Experimental Treatment 1 Intervention

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

Group II: Control (ICU Guide) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Regenstrief Institute, Inc.

Collaborator

Trials

27

Recruited

98,500+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11062134/

The impact of spiritual care on the psychological health and ... This systematic review investigated the influence of spiritual care on the psychological well-being and quality of life in adults with HF.

2. journalhumanservices.org journalhumanservices.org/article/142365

Integrating Spiritual Care Within Mental Health Integrating spiritual care within mental health and spiritual public health can improve patient outcomes, decrease anxiety, and increase quality ...

3. bmcpsychology.biomedcentral.com bmcpsychology.biomedcentral.com/articles/10.1186/s40359-025-03275-x

Effectiveness of spiritual health-based interventions in ... Spiritual health interventions have increasingly been recognized for their potential to improve general health outcomes.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07228299?locStr=United+States&country=United+States

NCT07228299 | Supporting Families in the ICU 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0885392421002372

The Content, Teaching Methods and Effectiveness of ... Most reported outcomes comprised changes in intrapersonal spirituality, interpersonal spirituality, and spiritual care assessment. One of the notable ...

6. spiritualaim.org spiritualaim.org/wp-content/uploads/2021/11/Spiritual-Aim-Manual.pdf

SPIRITUAL ASSESSMENT AND INTERVENTION MODEL ( ... Development and pilot testing1 of this manual conducted by the Spiritual AIM team demonstrates that chaplains can make reliable Spiritual AIM assessments,.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8928229/

Spiritual Care Assessment and Intervention (SCAI) for Adult ... The objective of this study was to test the SCAI framework in adults with advanced cancer and their caregivers in outpatient settings. We conducted a single-arm ...

8. tandfonline.com tandfonline.com/doi/abs/10.1080/08854726.2024.2413812

Proof of concept, feasibility, and acceptability of spiritual ... This study's purpose was to verify the feasibility and acceptability of the Spiritual Care Assessment and Intervention framework adapted for home-based ...

9. aafp.org aafp.org/pubs/afp/issues/2022/1000/spiritual-assessment.html

The Spiritual Assessment The spiritual assessment offers the opportunity to enhance the patient-physician relationship and incorporate patient views that may have a significant impact ...

10. link.springer.com link.springer.com/article/10.1007/s40615-024-02258-9

Exploring Spiritual Concerns, Needs, and Resources in ... The Spiritual Care Assessment and Intervention (SCAI) framework key elements and dimension of spirituality. *Examples of questions for each ...