Chaplain Family Project Trial

Study Overview
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Brief Summary
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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
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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: 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. 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). 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). 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. 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.

Official Title
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Chaplain Family Project Randomized Controlled Trial

Conditions
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Anxiety, PTSD, Depression, Communication, Satisfaction

Intervention / Treatment
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* Behavioral: Spiritual Care Assessment and Intervention (SCAI) framework


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cognitive Requirements 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 Patient has a qualified surrogate decision maker 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1- Control group Arm 2- Intervention group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (Usual Care)<br>Surrogate will receive usual care in the hospital, which could include visits from the unit chaplain or other staff from the spiritual care department. | |
| Experimental: Intervention<br>Spiritual Care Assessment and Intervention (SCAI) framework | Behavioral: Spiritual Care Assessment and Intervention (SCAI) framework<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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