Chaplain Family Project Trial

NCT03702634 | Completed DMC

• 1 other identifier: 1806775750
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety; PTSD; Depression; Communication; Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge

  Assessed at enrollment and again 6-8 weeks after hospital discharge

• Presence of post traumatic stress at 6-8 weeks post patient discharge

  Assessed 6-8 weeks after hospital discharge

• Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge

  Assessed at enrollment and again 6-8 weeks after hospital discharge

Other Outcomes (7)

• Change in spiritual well-being at baseline enrollment interview to 6-8 weeks post patient discharge

  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

  Assessed at enrollment and again 6-8 weeks after hospital discharge

• Satisfaction with spiritual care at 6-8 weeks post patient discharge

  Assessed 6-8 weeks after hospital discharge

Study Arms (2)

Control (Usual Care)

NO INTERVENTION

Surrogate will receive usual care in the hospital, which could include visits from the unit chaplain or other staff from the spiritual care department.

Intervention

EXPERIMENTAL

Spiritual Care Assessment and Intervention (SCAI) framework

Behavioral: Spiritual Care Assessment and Intervention (SCAI) framework

Interventions

Spiritual Care Assessment and Intervention (SCAI) framework BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cognitive Requirements
• Patient is not decisional due to:

You may not qualify if:

• Sedation
• Unresponsive
• otherwise unable to communicate (AMS, dementia, delirium, etc.)
• Decision Support Requirements
• Patient has a qualified surrogate decision maker
• 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

Sponsors & Collaborators

• Indiana University: lead
• Regenstrief Institute, Inc.: collaborator
• Indiana University Health: collaborator

Study Sites (2)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Torke AM, Varner-Perez SE, Burke ES, Taylor TA, Slaven JE, Kozinski KL, Maiko SM, Pfeffer BJ, Banks SK. Effects of Spiritual Care on Well-Being of Intensive Care Family Surrogates: A Clinical Trial. J Pain Symptom Manage. 2023 Apr;65(4):296-307. doi: 10.1016/j.jpainsymman.2022.12.007. Epub 2022 Dec 14.

  PMID: 36526251 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Depression; Communication; Personal Satisfaction

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alexia M Torke, MD, MS

  Indiana University, IU Health, Regenstrief Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff conducting interviews with study participants will be masked to study group allocation, until all outcome assessments for that participant have been completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Arm 1- Control group Arm 2- Intervention group

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 11, 2018
• Study Start: August 28, 2018
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)