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Feasibility and Acceptability of a Chaplain-Led Post-Code Debrief Intervention (PCD)

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ClinicalTrials.gov Identifier: NCT04874272
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : May 5, 2021
Sponsor:
Collaborators:
Indiana University Health
Daniel F. Evans Center for Spiritual and Religious Values in Healthcare
Information provided by (Responsible Party):
Shelley E. Varner Perez, Indiana University

Study Description
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Brief Summary:
The objective of this study is to increase the frequency and effectiveness of post code debriefs by piloting a novel intervention tool and partnering clinicians with board certified chaplains trained to facilitate group processes. A post code debrief will involve two aspects: a technical debrief (a discussion to process the technical, procedural aspects of a medical code/cardiopulmonary arrest), which will be led by a clinician, and an emotional debrief (a discussion to process the emotional, existential impact of a medical code/cardiopulmonary arrest), which will be led by a chaplain.

Condition or disease Intervention/treatment Phase
Chaplain-led Post-code Debrief Other: Chaplain led post-code debrief Not Applicable

Detailed Description:

Technical debriefs already are a familiar part of practice; the novel portion of this study is the introduction of the chaplain-led portion of emotional debrief. Also novel is the combination of the technical and emotional debriefs. As part of the study debrief, participants are asked to be present for and engaged in the discussion reviewing the code event, though there is no expectation or requirement for providing verbal input. Data about the content of the code debrief and the interventions provided during the debrief will be recorded by the Code Blue Chaplain in REDCap. Data about participants will be self-reported in their REDCap survey responses.

Clinicians who participate in resuscitation attempts during cardio-pulmonary arrests (CPA) experience psychological, emotional, and moral distress, including feelings of anxiety, grief, and regret. These experiences directly impact feelings of burnout, which is a leading cause in staff turnover. While debriefing soon after the experience has been shown to increase positive coping and reduce acute stress, post code debriefs are rarely conducted. Current models rely on physicians to facilitate debriefs and do not provide a standard tool. Physicians often feel untrained and uneasy with this role. To address these findings, we seek to implement a standardized post-code debriefing process that is co-led by a clinician and a chaplain.

Specific Aim 1: Evaluate and describe current stress of clinical staff who participate in CPA events. During the first six months of the grant period, a staff chaplain will respond to all "Code Blues." The chaplain will recruit at least five clinical staff participants from at least two different disciplines to complete surveys one-week and six-weeks after the CPA event.

Specific Aim 2: Pilot intervention to debrief CPA experience. During the second six months of the grant period, the research team will pilot the new debrief tool on the Cardiac Medical Critical Care Unit (CMCC). The designated "Code Blue" Chaplain will respond to all code blues on CMCC. The Code Blue Chaplain will be responsible for establishing the time and location of the Post Code Debrief, providing the technical debrief tool to a qualified clinician, and facilitating the emotional debrief following the semi-structured debrief tool. The Code Blue Chaplain will recruit participants to complete follow up surveys one-week and six-weeks following the CPA event.

Specific Aim 3: Assess feasibility and acceptability. Describe team member experience. During the final year of the grant period, the research team will expand the intervention tool throughout IU Health Methodist Hospital. The Code Blue Chaplain will respond to all overhead code blue pages and proceed with the intervention and recruiting as stated above.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Phased single group study. Phase (arm) 1: Participants complete a survey Phase (arm) 2- Pilot (single hospital unit): Participants attend a chaplain led post-code debrief, complete a survey Phase (arm) 3 (multiple hospital units): Participants attend a chaplain led post-code debrief, complete a survey.

During all phases participants may be approached to complete an additional interview with the research team.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Acceptability of a Chaplain-Led Post-Code Debrief Intervention
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Pre-Intervention
Pre-intervention: participants complete research surveys about codes and are asked to participate in an interview with the research team.
Experimental: Pilot (Single Unit Recruitment)
Pilot intervention: participants participate in a chaplain led post-code debrief, participants complete research surveys about codes.
 Other: Chaplain led post-code debrief
an emotional debrief (a discussion to process the emotional, existential impact of a medical code/cardiopulmonary arrest), which will be led by a chaplain
Experimental: Pilot (Hospital-wide Recruitment)
Pilot intervention: participants participate in a chaplain led post-code debrief, participants complete research surveys about codes.
 Other: Chaplain led post-code debrief
an emotional debrief (a discussion to process the emotional, existential impact of a medical code/cardiopulmonary arrest), which will be led by a chaplain


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate and describe current stress of clinical staff who participate in CPA events [ Time Frame: 6 weeks ]
    Participants complete surveys at 1 and 6 weeks post-CPA event

  2. Pilot the debrief tool on one unit of the hospital [ Time Frame: 6 weeks ]
    Participants participate in the intervention (debrief) and complete surveys at 1 and 6 weeks post-CPA event

  3. Pilot the debrief tool hospital-wide [ Time Frame: 6 weeks ]
    Participants participate in the intervention (debrief) and complete surveys at 1 and 6 weeks post-CPA event


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria for EVENT:

  • Code event occurs on an adult inpatient unit at IU Health Methodist Hospital
  • Cardiopulmonary arrest where cardiopulmonary resuscitation (CPR) was performed for at least one minute
  • Code event occurs when at least two chaplains are available in the hospital.
  • Patient involved is an inpatient
  • Patient involved is over the age of 18
  • Code is called on the overhead paging system

Inclusion Criteria for STAFF:

  • Employee of participating hospital site
  • Actively involved in the CPA in one of the following capacities:
  • Gave compressions
  • Administered medication
  • Provided respiratory support
  • Gave clinical orders or directions to staff
  • Documented interventions during CPA
  • Proficient in written and spoken English
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874272


Contacts
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Contact: Shelley E Varner Perez, MDiv, MPH 317-962-8611 svarnerpe@iuhealth.org
Contact: Emily S Burke, BA 317-274-9047 esburke@iupui.edu

Locations
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United States, Indiana
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Emily S Burke, BA    317-274-9047    esburke@iupui.edu   
Contact: Sarah K Banks    317-274-9173    bankssk@regenstrief.org   
Principal Investigator: Shelley E Varner Perez, MDiv, MPH         
Sponsors and Collaborators
Indiana University
Indiana University Health
Daniel F. Evans Center for Spiritual and Religious Values in Healthcare
Investigators
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Principal Investigator: Shelley E Varner Perez, MDiv, MPH Indiana University
More Information
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Responsible Party: Shelley E. Varner Perez, Senior Program Manager, Research Chaplain, Indiana University
ClinicalTrials.gov Identifier: NCT04874272    
Other Study ID Numbers: 2006053247
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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