NCT04874272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

April 30, 2021

Last Update Submit

February 22, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Evaluate and describe current stress of clinical staff who participate in CPA events

    Participants complete surveys at 1 and 6 weeks post-CPA event

    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

    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

    6 weeks

Study Arms (3)

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.

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.

Other: Chaplain led post-code debrief

Interventions

an emotional debrief (a discussion to process the emotional, existential impact of a medical code/cardiopulmonary arrest), which will be led by a chaplain

Pilot (Hospital-wide Recruitment)Pilot (Single Unit Recruitment)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Officials

  • Shelley E Varner Perez, MDiv, MPH

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Program Manager, Research Chaplain

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 5, 2021

Study Start

November 6, 2020

Primary Completion

August 12, 2022

Study Completion

August 12, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations