Chaplain Family Project Trial

NCT ID: NCT03702634

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2021-11-04

Brief Summary

Our research team has designed a chaplain delivered intervention focused on surrogate decision makers for hospitalized adults in the ICU. In this study, surrogates will complete an enrollment interview with research staff, including the completion of anxiety screening (GAD-7). Based on their score the surrogate will be put into one of two groups, and then randomized to either the control or intervention group. Control group members will receive usual care, while intervention group members will meet with our study chaplain, who will provide the SCAI (Spiritual Care Assessment and Intervention) framework.

Detailed Description

Unmet spiritual needs may have at least two negative consequences for surrogates. First, they may have high levels of spiritual distress, an important aspect of the surrogate's well-being. Second, surrogates include their religious and spiritual beliefs when making serious medical decisions . Therefore unmet spiritual needs may have a negative effect on the surrogate's ability to make good decisions for the patient, especially when facing extremely distressful decisions such as whether to continue life sustaining treatment or enroll in hospice.

The specific aims of this proposed study are:

1. To determine the effect of the spiritual care intervention on psychological well-being for family surrogates at 3 months post discharge, including anxiety (primary outcome: GAD-7), depression (PHQ-9), Posttraumatic stress (IES-R), and overall distress.

2. To determine the effect of the spiritual care intervention on spiritual well-being for family surrogates, (FACIT-SP- non-illness) and on religious coping (Brief RCOPE positive and negative).

3. To determine the effects of the spiritual care intervention on other aspects of the surrogates' experience, including satisfaction with spiritual care (Patient Satisfaction Instrument--Chaplaincy) communication (FICS), overall satisfaction with the hospital stay (Picker single item) and decision conflict (DCS).

4. To determine the effect of the intervention on treatment at the end of life (life sustaining treatments and hospice utilization) for patients who die in the hospital.

5. To determine differences in outcomes between the intervention group, who will receive our intervention, and the control group, who will receive the usual care provided by the hospital chaplaincy service.

Conditions

Anxiety; PTSD; Depression; Communication; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control (Usual Care)

Surrogate will receive usual care in the hospital, which could include visits from the unit chaplain or other staff from the spiritual care department.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Spiritual Care Assessment and Intervention (SCAI) framework

Group Type: EXPERIMENTAL

Spiritual Care Assessment and Intervention (SCAI) framework

Intervention Type: BEHAVIORAL

The study chaplain will work with the surrogate, using questions in four domains of spiritual care, to assess them and tailor the visit to their specific needs. The study chaplain will then utilize a pre-determined list of spiritual care interventions, and also document observable outcomes that occur at each visit (which are also listed within the SCAI framework).

Interventions

Spiritual Care Assessment and Intervention (SCAI) framework

The study chaplain will work with the surrogate, using questions in four domains of spiritual care, to assess them and tailor the visit to their specific needs. The study chaplain will then utilize a pre-determined list of spiritual care interventions, and also document observable outcomes that occur at each visit (which are also listed within the SCAI framework).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Cognitive Requirements

1. Patient is not decisional due to:

Exclusion Criteria

• Sedation
• Unresponsive
• otherwise unable to communicate (AMS, dementia, delirium, etc.)

Decision Support Requirements

2. Patient has a qualified surrogate decision maker

• Intubated for surgery and expected to be extubated within 24 hours
• Imminently dying as evidenced by patient notes
• Patient and/or family have a care contract or other restriction due to complicated or volatile situation
• Patient is a prisoner
• Patient is being followed by Adult Protective Services (APS)
• Patient meets cognitive criteria but does not have a qualified surrogate decision maker

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regenstrief Institute, Inc.

OTHER

Sponsor Role: collaborator

Indiana University Health

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Alexia M. Torke

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexia M Torke, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University, IU Health, Regenstrief Institute

Locations

IU Health Methodist Hospital

Indianapolis, Indiana, United States

IU Health University Hospital

Indianapolis, Indiana, United States

Countries

United States

References

Torke AM, Varner-Perez SE, Burke ES, Taylor TA, Slaven JE, Kozinski KL, Maiko SM, Pfeffer BJ, Banks SK. Effects of Spiritual Care on Well-Being of Intensive Care Family Surrogates: A Clinical Trial. J Pain Symptom Manage. 2023 Apr;65(4):296-307. doi: 10.1016/j.jpainsymman.2022.12.007. Epub 2022 Dec 14.

Reference Type: DERIVED

PMID: 36526251 (View on PubMed)

Other Identifiers

1806775750

Identifier Type: -

Identifier Source: org_study_id