Clinical trial NCT03702634: Chaplain Family Project Trial
Official title: Chaplain Family Project Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
PTSD
Depression
Communication
Satisfaction
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Regenstrief Institute, Inc.
name: Indiana University Health
First posted: 2018-10-11
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1- Control group Arm 2- Intervention group
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge
timeFrame: Assessed at enrollment and again 6-8 weeks after hospital discharge
Secondary outcomes:
measure: Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge
timeFrame: Assessed at enrollment and again 6-8 weeks after hospital discharge
measure: Presence of post traumatic stress at 6-8 weeks post patient discharge
timeFrame: Assessed 6-8 weeks after hospital discharge
measure: Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge
timeFrame: Assessed at enrollment and again 6-8 weeks after hospital discharge
Other outcomes:
measure: Change in spiritual well-being at baseline enrollment interview to 6-8 weeks post patient discharge
timeFrame: Assessed at enrollment and again 6-8 weeks after hospital discharge
measure: Change in religious coping from baseline enrollment interview to 608 weeks post patient discharge
timeFrame: Assessed at enrollment and again 6-8 weeks after hospital discharge
measure: Satisfaction with spiritual care at 6-8 weeks post patient discharge
timeFrame: Assessed 6-8 weeks after hospital discharge
measure: Communication in the hospital at 6-8 weeks post patient discharge
timeFrame: Assessed 6-8 weeks after hospital discharge
measure: Overall satisfaction with the hospital stay at 6-8 weeks post patient discharge
timeFrame: Assessed 6-8 weeks after hospital discharge
measure: Presence of decision conflict at 6-8 weeks post patient discharge
timeFrame: Assessed 6-8 weeks after hospital discharge
measure: Effect of the intervention on end of life care for those who die in the hospital
timeFrame: Chart abstraction to review from the date of admission to the hospital up to one year after admission
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
affiliation: Indiana University, IU Health, Regenstrief Institute
name: Alexia M Torke, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: