Health Personnel AttitudePCDNCT04874272
Feasibility and Acceptability of a Chaplain-Led Post-Code Debrief Intervention
A study testing Chaplain led post-code debrief in people with Health Personnel Attitude, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Personnel Attitude
- What is being tested?
- Chaplain led post-code debrief
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2020to 12 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
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.
Read the 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.
- Conditions
- Health Personnel Attitude
- Being tested
- Chaplain led post-code debrief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chaplain led post-code debriefOther
an emotional debrief (a discussion to process the emotional, existential impact of a medical code/cardiopulmonary arrest), which will be led by a chaplain
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | No intervention | Pre-intervention: participants complete research surveys about codes and are asked to participate in an interview with the research team. |
| Pilot (Single Unit Recruitment) | Experimental | Pilot intervention: participants participate in a chaplain led post-code debrief, participants complete research surveys about codes. Receives: Other: Chaplain led post-code debrief |
| Pilot (Hospital-wide Recruitment) | Experimental | Pilot intervention: participants participate in a chaplain led post-code debrief, participants complete research surveys about codes. Receives: Other: Chaplain led post-code debrief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate and describe current stress of clinical staff who participate in CPA events
Participants complete surveys at 1 and 6 weeks post-CPA event
Measured: 6 weeks
Pilot the debrief tool on one unit of the hospital
Participants participate in the intervention (debrief) and complete surveys at 1 and 6 weeks post-CPA event
Measured: 6 weeks
Pilot the debrief tool hospital-wide
Participants participate in the intervention (debrief) and complete surveys at 1 and 6 weeks post-CPA event
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start6 Nov 2020
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Personnel AttitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health, Daniel F. Evans Center for Spiritual and Religious Values in Healthcare
- Responsible party
- Principal investigator, Shelley E. Varner Perez, Indiana University
- Investigators
- Shelley E Varner Perez, MDiv, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874272
- Sponsor's protocol ID
- 2006053247
- Acronym
- PCD
- Status last verified
- Feb 2023
- First submitted
- 30 Apr 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Chaplain-Led Post-Code Debrief Intervention
- ClinicalTrials.gov ID
- NCT04874272
- Acronym / sponsor ID
- PCD / 2006053247
- Conditions
- Health Personnel Attitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health, Daniel F. Evans Center for Spiritual and Religious Values in Healthcare
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | No intervention | –Pre-intervention: participants complete research surveys about codes and are asked to participate in an interview with the research team. |
| Pilot (Single Unit Recruitment) | Experimental | Other: Chaplain led post-code debriefPilot intervention: participants participate in a chaplain led post-code debrief, participants complete research surveys about codes. |
| Pilot (Hospital-wide Recruitment) | Experimental | Other: Chaplain led post-code debriefPilot intervention: participants participate in a chaplain led post-code debrief, participants complete research surveys about codes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chaplain led post-code debriefan emotional debrief (a discussion to process the emotional, existential impact of a medical code/cardiopulmonary arrest), which will be led by a chaplain | Other | Pilot (Hospital-wide Recruitment), Pilot (Single Unit Recruitment) |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley E Varner Perez, MDiv, MPH principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chaplain led post-code debrief in people with Health Personnel Attitude, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate and describe current stress of clinical staff who participate in CPA events (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.