Chaplain Family Project Trial (CFP-RCT)
Primary Purpose
Anxiety, PTSD, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spiritual Care Assessment and Intervention (SCAI) framework
Sponsored by

About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
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
Sites / Locations
- IU Health Methodist Hospital
- IU Health University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control (Usual Care)
Intervention
Arm Description
Surrogate will receive usual care in the hospital, which could include visits from the unit chaplain or other staff from the spiritual care department.
Spiritual Care Assessment and Intervention (SCAI) framework
Outcomes
Primary Outcome Measures
Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge
GAD-7 (7 item inventory of anxiety)
Secondary Outcome Measures
Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge
PHQ-9 (9 item inventory of depression)
Presence of post traumatic stress at 6-8 weeks post patient discharge
IES-R (Impact of Events scale- inventory for PTSD)
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)
Full Information
NCT ID
NCT03702634
First Posted
October 4, 2018
Last Updated
March 11, 2022
Sponsor
Indiana University
Collaborators
Regenstrief Institute, Inc., Indiana University Health
1. Study Identification
Unique Protocol Identification Number
NCT03702634
Brief Title
Chaplain Family Project Trial
Acronym
CFP-RCT
Official Title
Chaplain Family Project Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Regenstrief Institute, Inc., Indiana University Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, PTSD, Depression, Communication, Satisfaction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1- Control group Arm 2- Intervention group
Masking
Outcomes Assessor
Masking Description
Research staff conducting interviews with study participants will be masked to study group allocation, until all outcome assessments for that participant have been completed.
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control (Usual Care)
Arm Type
No Intervention
Arm Description
Surrogate will receive usual care in the hospital, which could include visits from the unit chaplain or other staff from the spiritual care department.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Spiritual Care Assessment and Intervention (SCAI) framework
Intervention Type
Behavioral
Intervention Name(s)
Spiritual Care Assessment and Intervention (SCAI) framework
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge
Description
GAD-7 (7 item inventory of anxiety)
Time Frame
Assessed at enrollment and again 6-8 weeks after hospital discharge
Secondary Outcome Measure Information:
Title
Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge
Description
PHQ-9 (9 item inventory of depression)
Time Frame
Assessed at enrollment and again 6-8 weeks after hospital discharge
Title
Presence of post traumatic stress at 6-8 weeks post patient discharge
Description
IES-R (Impact of Events scale- inventory for PTSD)
Time Frame
Assessed 6-8 weeks after hospital discharge
Title
Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge
Description
Distress thermometer (a 1-10 scale developed by our team to assess distress)
Time Frame
Assessed at enrollment and again 6-8 weeks after hospital discharge
Other Pre-specified Outcome Measures:
Title
Change in spiritual well-being at baseline enrollment interview to 6-8 weeks post patient discharge
Description
FACIT-SP- non-illness scale (a validated scale of spiritual well-being)
Time Frame
Assessed at enrollment and again 6-8 weeks after hospital discharge
Title
Change in religious coping from baseline enrollment interview to 608 weeks post patient discharge
Description
Brief RCOPE (a validated scale of religious coping)
Time Frame
Assessed at enrollment and again 6-8 weeks after hospital discharge
Title
Satisfaction with spiritual care at 6-8 weeks post patient discharge
Description
Patient Satisfaction Instrument- Chaplaincy (an adaptation of a scale of patient satisfaction to be used with surrogates)
Time Frame
Assessed 6-8 weeks after hospital discharge
Title
Communication in the hospital at 6-8 weeks post patient discharge
Description
Family Inpatient Communication Survey (FICS) (A validated scale of communication
Time Frame
Assessed 6-8 weeks after hospital discharge
Title
Overall satisfaction with the hospital stay at 6-8 weeks post patient discharge
Description
Picker single item (1-10)
Time Frame
Assessed 6-8 weeks after hospital discharge
Title
Presence of decision conflict at 6-8 weeks post patient discharge
Description
Decision Conflict Scale (DCS) (a validated scale of decision conflict that is used to assess decision conflict when a person has made 1 or more major decisions for a patient in the hospital setting)
Time Frame
Assessed 6-8 weeks after hospital discharge
Title
Effect of the intervention on end of life care for those who die in the hospital
Description
Will use comparative statistics to determine any correlations between intervention and EOL care (life sustaining treatments received and hospice enrollment)
Time Frame
Chart abstraction to review from the date of admission to the hospital up to one year after admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexia M Torke, MD, MS
Organizational Affiliation
Indiana University, IU Health, Regenstrief Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Chaplain Family Project Trial
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