- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04874272
Feasibility and Acceptability of a Chaplain-Led Post-Code Debrief Intervention (PCD)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46202
- IU Health Methodist Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
an emotional debrief (a discussion to process the emotional, existential impact of a medical code/cardiopulmonary arrest), which will be led by a chaplain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 weeks
|
|
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
|
6 weeks
|
|
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
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shelley E Varner Perez, MDiv, MPH, Indiana University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2006053247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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