Chaplain Family Project Trial (CFP-RCT)

• ClinicalTrials.gov Identifier: NCT03702634
• Recruitment Status: Recruiting
• First Posted: October 11, 2018
• Last Update Posted: March 18, 2021
• Sponsor: Indiana University
• Collaborators: Regenstrief Institute, Inc.; Indiana University Health
• Information provided by (Responsible Party): Alexia M. Torke, Indiana University

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.

Condition or disease	Intervention/treatment	Phase
Anxiety; PTSD; Depression; Communication; Satisfaction	Behavioral: Spiritual Care Assessment and Intervention (SCAI) framework	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Arm 1- Control group Arm 2- Intervention group
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Chaplain Family Project Randomized Controlled Trial
• Actual Study Start Date: August 28, 2018
• Estimated Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: June 30, 2021

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge [ Time Frame: Assessed at enrollment and again 6-8 weeks after hospital discharge ]
   GAD-7 (7 item inventory of anxiety)

Secondary Outcome Measures :

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

Other Outcome Measures:

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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Emily Burke, BA; 317-274-9047; esburke@iupui.edu

Locations

United States, Indiana

IU Health Methodist Hospital; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Emily S Burke, BA

Principal Investigator: Alexia M Torke, MD, MS

IU Health University Hospital; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Emily S Burke, BA

Principal Investigator: Alexia M Torke, MD, MS

Sponsors and Collaborators

Indiana University

Regenstrief Institute, Inc.

Indiana University Health

Investigators

• Principal Investigator: Alexia M Torke, MD, MS; Indiana University, IU Health, Regenstrief Institute

More Information

• Responsible Party: Alexia M. Torke, Associate Professor of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT03702634
• Other Study ID Numbers: 1806775750
• First Posted: October 11, 2018
• Last Update Posted: March 18, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Behavioral Symptoms