Chaplain Family Project Trial (CFP-RCT)

Chaplain Family Project Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Depression; PTSD; Anxiety; Communication; Satisfaction
• Intervention / Treatment: Behavioral: Spiritual Care Assessment and Intervention (SCAI) 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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist Hospital
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (Usual Care); 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; Spiritual Care Assessment and Intervention (SCAI) framework	Behavioral: Spiritual Care Assessment and Intervention (SCAI) framework; 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).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in spiritual well-being at baseline enrollment interview to 6-8 weeks post patient discharge	FACIT-SP- non-illness scale (a validated scale of spiritual well-being)	Assessed at enrollment and again 6-8 weeks after hospital discharge
Change in religious coping from baseline enrollment interview to 608 weeks post patient discharge	Brief RCOPE (a validated scale of religious coping)	Assessed at enrollment and again 6-8 weeks after hospital discharge
Satisfaction with spiritual care at 6-8 weeks post patient discharge	Patient Satisfaction Instrument- Chaplaincy (an adaptation of a scale of patient satisfaction to be used with surrogates)	Assessed 6-8 weeks after hospital discharge
Communication in the hospital at 6-8 weeks post patient discharge	Family Inpatient Communication Survey (FICS) (A validated scale of communication	Assessed 6-8 weeks after hospital discharge
Overall satisfaction with the hospital stay at 6-8 weeks post patient discharge	Picker single item (1-10)	Assessed 6-8 weeks after hospital discharge
Presence of decision conflict at 6-8 weeks post patient discharge	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)	Assessed 6-8 weeks after hospital discharge
Effect of the intervention on end of life care for those who die in the hospital	Will use comparative statistics to determine any correlations between intervention and EOL care (life sustaining treatments received and hospice enrollment)	Chart abstraction to review from the date of admission to the hospital up to one year after admission

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana University Health; Regenstrief Institute, Inc.
• Investigators: Principal Investigator: Alexia M Torke, MD, MS, Indiana University, IU Health, Regenstrief Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): November 4, 2021
• Study Completion (Actual): November 4, 2021

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 1806775750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No