Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT03702634
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chaplain Family Project Trial
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Chaplain Family Project Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CFP-RCT
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: