Chaplain Family Project Trial

Not Applicable

Completed

• Conditions: Depression; Satisfaction; Anxiety; Communication; PTSD
• Interventions: Behavioral: Spiritual Care Assessment and Intervention (SCAI) framework

• Registration Number: NCT03702634
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-28
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-11
• Primary Completion: 2021-11-04
• Study Completion: 2021-11-04
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Cognitive Requirements

1. Patient is not decisional due to:

   • Intubation (other than surgery- see exclusion criteria below)
   • Sedation
   • Unresponsive
   • otherwise unable to communicate (AMS, dementia, delirium, etc.)

   Decision Support Requirements

2. Patient has a qualified surrogate decision maker

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Spiritual Care Assessment and Intervention (SCAI) framework	Spiritual Care Assessment and Intervention (SCAI) framework

Primary Outcome Measures

Name	Time	Method
Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge	Assessed at enrollment and again 6-8 weeks after hospital discharge	GAD-7 (7 item inventory of anxiety)

Secondary Outcome Measures

Name	Time	Method
Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge	Assessed at enrollment and again 6-8 weeks after hospital discharge	Distress thermometer (a 1-10 scale developed by our team to assess distress)
Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge	Assessed at enrollment and again 6-8 weeks after hospital discharge	PHQ-9 (9 item inventory of depression)
Presence of post traumatic stress at 6-8 weeks post patient discharge	Assessed 6-8 weeks after hospital discharge	IES-R (Impact of Events scale- inventory for PTSD)

Trial Locations

Locations (2)

IU Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States