Condition category
Circulatory System
Date applied
22/05/2013
Date assigned
22/05/2013
Last edited
16/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cardiac arrest is the sudden stopping of heart function. It affects about 35,000 patients in UK hospitals per year. Less than 20% of cardiac arrest victims survive to leave hospital. Survival requires the delivery of high-quality cardiopulmonary resuscitation (CPR). However, in practice, the delivery of high-quality CPR is not always achieved. Providing feedback (debriefing) to doctors and nurses about their performance at a cardiac arrest may be an effective way to improve the quality of CPR. The aim of this study is to compare the effectiveness of three different debriefing interventions.

Who can participate?
Patients aged 18 and above who have a cardiac arrest at one of the three hospitals which make up the Heart of England NHS Foundation Trust.

What does the study involve?
Following each cardiac arrest, staff are offered debriefing about the quality of CPR provided at the cardiac arrest. The type of debriefing is determined by the hospital site. At hospital one, staff receive written feedback. At hospital two, individuals receive spoken feedback. At hospital three, staff participate in monthly debriefing meetings. At each hospital, staff use defibrillators equipped with technology that measures the quality of CPR provided at the cardiac arrest. This technology consists of a small device that is placed on the patient’s chest during their cardiac arrest. The device also provides immediate feedback about the quality of CPR through audio (e.g. ‘compress faster’) and visual prompts. Patients who have a cardiac arrest receive CPR provided by teams who have received debriefing. The effectiveness of each debriefing intervention is determined by measuring and comparing CPR quality. Information collected during this study is compared with data collected during a previous study.

What are the possible benefits and risks of participating?
Patients taking part may benefit from receiving a higher quality of CPR during their cardiac arrest. This study may help to determine which is the most effective debriefing method. There are no anticipated risks associated with taking part.

Where is the study run from?
Heart of England NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2013 to August 2014

Who is funding the study?
Resuscitation Council (UK)

Who is the main contact?
Keith Couper
keith.couper@heartofengland.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Keith Couper

ORCID ID

Contact details

Academic Department of Anaesthetics
Critical Care & Pain
Birmingham Heartlands Hospital
3 Bordesley Green East
Bordesley Green
Birmingham
B9 5SS
United Kingdom
-
keith.couper@heartofengland.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14495

Study information

Scientific title

A study of the use of debriefing to improve cardiopulmonary resuscitation delivery at in-hospital adult cardiac arrest: a non-randomised interventional process of care and treatment trial

Acronym

Cardiopulmonary Resuscitation Debriefing study (CODE study)

Study hypothesis

Cardiac arrest is the sudden cessation of heart function. It affects approximately 35,000 patients in UK hospitals per year and inevitably leads to death, unless the patient receives prompt defibrillation and high quality cardiopulmonary resuscitation (CPR). However, the quality of the delivery of the delivery of these key interventions is highly variable.

The use of debriefing can be effective way to change clinician behaviour, and thereby improve care delivery. Debriefing offers clinicians the opportunity to engage in a facilitated discussion about their performance, and identify strategies for improvement. The 2010 International resuscitation guidelines recommended the use of debriefing following cardiac arrest. However, despite some promising early results, cardiac arrest debriefing remains in its infancy and the best way to deliver it has not yet been determined. Based on results from our previous work (systematic review, questionnaires, semi-structured interviews), we have developed new debriefing interventions: individual/small group debriefing, and written feedback.

This study will implement these debriefing strategies within Heart of England NHS Foundation Trust hospitals. The effectiveness of these interventions will be evaluated by measuring CPR quality at in-hospital cardiac arrests, using data that is automatically recorded by Trust defibrillators. The study will use data from another study, as the control period for this study. The primary outcome will be chest compression depth. This is a process outcome, that is associated with defibrillation success and cardiac arrest survival.

Ethics approval

Oxford C Research Ethics Committee, 13/08/2013, ref: 13/SC/0363

Study design

Non-randomised interventional process of care and treatment trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care

Intervention

Following each cardiac arrest, staff are offered debriefing about the quality of CPR provided at the cardiac arrest. The type of debriefing is determined by the hospital site. At hospital one, staff receive written feedback. At hospital two, individuals receive spoken feedback. At hospital three, staff participate in monthly debriefing meetings. At each hospital, staff use defibrillators equipped with technology that measures the quality of CPR provided at the cardiac arrest. This technology consists of a small device that is placed on the patient’s chest during their cardiac arrest. The device also provides immediate feedback about the quality of CPR through audio (e.g. ‘compress faster’) and visual prompts. Patients who have a cardiac arrest receive CPR provided by teams who have received debriefing. The effectiveness of each debriefing intervention is determined by measuring and comparing CPR quality. Information collected during this study is compared with data collected during a previous study.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Chest compression depth; timepoint(s): during cardiac arrest

Secondary outcome measures

Added 21/08/2013:
1. Process-based outcomes (all measured by the defibrillator during the cardiac arrest event):
1.1. Chest compression rate
1.2. No-flow time
1.3. Incidence of compression leaning
1.4. Peri-shock pause
1.5. Appropriateness of shocks
1.6. Time to first shock

2. Patient-based outcomes:
2.1. Return of spontaneous circulation, recorded at 20 minutes following the cardiac arrest event
2.2. Survival to hospital discharge, measured at hospital discharge
2.3. Neurological status at discharge, measured at hospital discharge using the cerebral performance category score

Overall trial start date

02/09/2013

Overall trial end date

15/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male & female, lower age limit 18 years
2. Patients sustaining a cardiac arrest at Heart of England NHS Foundation Trust hospitals, which is attended by the hospital emergency team and where resuscitation is attempted

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 520; UK Sample Size: 520

Participant exclusion criteria

Current exclusion criteria as of 21/08/2013:
1. Valid DNAR (Do Not Attempt Resuscitation) order

Previous exclusion criteria:
1. Valid DNAR (Do Not Attempt Resuscitation) order
2. Traumatic cardiac arrest

Recruitment start date

02/09/2013

Recruitment end date

15/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Heartlands Hospital
Birmingham
B9 5SS
United Kingdom

Sponsor information

Organisation

Heart of England NHS Foundation Trust (UK)

Sponsor details

3 Bordesley Green East
Bordesley Green
Birmingham
B9 5SS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.heartofengland.nhs.uk/

Funders

Funder type

Research council

Funder name

Resuscitation Council (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27283061

Publication citations

Additional files

Editorial Notes

16/01/2017: Publication reference added. 21/08/2013: The following changes were made to the trial record: 1. The overall trial start date was changed from 15/06/2013 to 02/09/2013. 2. The target number of participants was changed from "Planned Sample Size: 300; UK Sample Size: 150 " to " Planned Sample Size: 520; UK Sample Size: 520".