Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000434998
Ethics application status
Approved
Date submitted
6/03/2020
Date registered
1/04/2020
Date last updated
1/04/2020
Date data sharing statement initially provided
1/04/2020
Date results information initially provided
1/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
RCT comparing the clinical effectiveness of conventional instructor-facilitated cardiac compression training to automated training using high-fidelity mannequins
Scientific title
RCT comparing the effectiveness of conventional instructor-facilitated cardiac compression training to automated training, using high-fidelity mannequins, on cardiac compression skill levels with clinical and operational staff in a rural hospital
Secondary ID [1] 300399 0
Nil known
Universal Trial Number (UTN)
U1111-1247-4818
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac arrest 316029 0
Condition category
Condition code
Cardiovascular 314307 314307 0 0
Coronary heart disease
Public Health 314923 314923 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Procedures and materials used: The difference in staff competence in performing cardiac compressions will be measured between:
1. A control group who will undergo one off traditional cardiac compression training, using mannequins, incorporating either no feedback or low-fidelity visual feedback mechanisms (Group A);
2. An intervention group who will receive technology-enhanced training, using high-fidelity mannequins, via the Resuscitation Quality Improvement (RQI) training system, and will have continuous access to the training system to practise their skills (Group B) throughout the six months of the trial; and
3. An intervention group who will receive technology-enhanced training, via the RQI training system, but will have no further access to practise their skills (Group C).
The RQI training system incorporates the latest in computer technology into a realistic-looking full body which provides objective, real time, audio-visual feedback to the trainee on compression rate, depth, release and hand position during assessment, to enable trainees to provide high quality continuous chest compressions of appropriate rate and depth. The RQI training system provides objective measurement of cardiac compression skills and records training compliance rates.
The aim of the research is to determine whether technology-enhanced training, using a high-fidelity mannequins, is as effective as standard instructor facilitated training and assessment for cardiac compression skill acquisition and to determine whether regular practise maintains skill levels compared to no practise. The difference in staff competence in performing CPR over time will be measured between the control group and intervention groups.
Intervention administration and mode of delivery: The traditional one-off cardiac compression training will be delivered by nurse educators, within the hospital skills development unit, to individuals and small groups of up to 5 staff, as per current practice and will take approximately 15 minutes. One-off training in the use of the technology-enhanced high-fidelity mannequins will be provided on a 1:1 basis, via the RQI training system, which provides standardised instructions for recommended use, and will take approximately 15 minutes. Once logged onto the system staff will watch a video recording demonstrating the correct cardiac compression technique; carry out compressions on the mannequin whilst receiving visual and auditory feedback on their technique; and, complete scenarios. The same nurse educators, who provide the traditional cardiac compression training, will be available to demonstrate how to access and navigate the RQI system to participants, as required.
Number of times the intervention will be delivered and over what timeframe: The three groups will receive one off training following baseline assessment and randomisation. Groups A and C will then be deactivated on the RQI training system so that they have no further access to it and Group B will be able to access the system to practise their skills throughout the 6 months of the trial.
Location/setting: This three-group randomised controlled trial (RCT) will be carried out in a regional hospital in Queensland, Australia.
Fidelity to the intervention: Fidelity will be assessed at the conclusion of the study by cross checking whether Groups A and C accessed the RQI training system outside of scheduled contacts for baseline and re-assessments. The number of times group B participants practised the skills on the RQI training system over the 6 month period will be calculated from the data stored electronically in the RQI training system to determine whether they practised their skills as requested.
Intervention code [1] 316688 0
Treatment: Devices
Comparator / control treatment
The control group will receive usual instructor-facilitated cardiac compression training.
Control group
Active

Outcomes
Primary outcome [1] 322693 0
Cardiac compression skill level is the primary outcome measure and it will be assessed at baseline, three and six-month time points with all three groups, using the RQI training system. The RQI training system generates a score between 1-100 based on weighted results of a combination of compression rate, depth, release and hand position. The 6 month re-assessment will be the primary time point. Study participants will be blinded to the outcome of the baseline and follow-up assessments. Feedback components on the RQI training system will be deactivated so that participants are unaware of their individual results, which will be stored electronically on the RQI training system under the staff member’s employee number. In addition, outcome assessors and the statistician will be blinded to group allocation, but it will not be possible to blind participants to group allocation.
Timepoint [1] 322693 0
3 and 6 months post baseline assessment. The primary time point for re-assessment will be 6 months post baseline assessment.
Secondary outcome [1] 379322 0
The difference between professions in their level of competence in cardiac compression over time.
Participants will be registered on the RQI training system using their unique staff number which will enable researchers to cross reference this to their professional stream. Re-assessment scores will be stored on the RQI training system under each unique staff number.
Timepoint [1] 379322 0
6 months post baseline assessment.
Secondary outcome [2] 379323 0
The difference in baseline and reassessment cardiac compression scores based on job type.
Participants will be registered on the RQI training system using their unique staff number which will enable researchers to cross reference this to their professional stream. Re-assessment scores will be stored on the RQI training system under each unique staff number.
Timepoint [2] 379323 0
6 months post baseline assessment.
Secondary outcome [3] 379324 0
Predictors of reassessment scores.
Participants will be registered on the RQI training system using their unique staff number which will enable researchers to cross reference this to their professional stream. In addition we will collect some baseline data, such as baseline score, work location, time since last cardiac compression training received. In addition, re-assessment scores will be stored on the RQI training system under each unique staff number.
Timepoint [3] 379324 0
6 months post baseline assessment.
Secondary outcome [4] 379325 0
The the number of times the RQI training system was accessed to practise skills.
Participants will be registered on the RQI training system using their unique staff number which will enable researchers to count how many times participants log on to the RQI training system and identify what they did on the system whether the contact was for baseline or follow-up assessments or for skills practice.
Timepoint [4] 379325 0
6 months post baseline assessment.

Eligibility
Key inclusion criteria
Medical, nursing, allied health and identified operational staff who may be required to provide cardio-pulmonary resuscitation as part of their role
Permanent or temporary employees, with contracts ending after the study end point;
Work in the regional Hospital; and,
Over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Planning extended leave during the study period;
On a modified return to work program which would exclude them from performing cardiac compression; or,
Unable to perform cardiac compression due to pregnancy, injury or ill health

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The holder of the allocation schedule will be based at a central administration site removed from the recruitment of participants. Staff recruiting participants will be notified by telephone of participant group allocation following completion of baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in blocks within each discipline (medical, nursing, allied health, operational) to the three groups to equally distribute participant numbers for each discipline between groups. A computer-generated randomisation code will be created, using simple web-based randomisation, and participants randomised in the order that they attend for baseline assessment within each discipline.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will assume that a 20% difference between group mean competency scores would be clinically significant. To detect a difference of 0.2 between the experimental and control group means with 0.9 power, we calculated that we would need to study 132 subjects in each group (equating to 396 participants) to be able to reject the null hypothesis, that the population means of the experimental and control groups are equal. The Type I error probability associated with this test of the null hypothesis was 0.05. Allowing for 20% attrition, in anticipation of high staff turnover, we aim to recruit 475 participants.

The primary outcome is cardiac compression skill level. We will carry out a multiple-regression analysis, in the form of analysis of co-variance, to adjust for predictive co-variates, including baseline competence scores and the number of times participants practise cardiac compression skills.

Secondary measures include: the difference in baseline and reassessment cardiac compression scores based on job type, which will be analysed in the form of analysis of variance; the difference between professions in their level of competence in cardiac compression over time, which will be analysed using Chi-square; predictors of reassessment scores, which will be analysed via multiple linear regression.
A survival analysis will be carried out to identify the time point post training when cardiac compression skills decline. We will take a decline of =10% in score from baseline to reassessment, as the indicator of a decline in cardiac compression skills, to determine whether “the event” has taken place.

Significance tests will be 2-sided at the 5% level for both primary and secondary outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/01/2017
Date of last participant enrolment
Anticipated
Actual
28/02/2017
Date of last data collection
Anticipated
Actual
6/02/2018
Sample size
Target
475
Accrual to date
Final
502
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16081 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 29593 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 304823 0
Hospital
Name [1] 304823 0
Mackay Hospital and Health Service
Country [1] 304823 0
Australia
Funding source category [2] 305187 0
Charities/Societies/Foundations
Name [2] 305187 0
Mackay Hospital Foundation
Country [2] 305187 0
Australia
Primary sponsor type
Individual
Name
Alison Pighills
Address
Mackay Institute of Research and Innovation
Mackay Hospital and Health Service
P.O.Box 5580
Mackay Mail Centre
Mackay
Qld 4741
Country
Australia
Secondary sponsor category [1] 305541 0
None
Name [1] 305541 0
Address [1] 305541 0
Country [1] 305541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305235 0
Townsville Human Research Ethics Committee
Ethics committee address [1] 305235 0
Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814
Ethics committee country [1] 305235 0
Australia
Date submitted for ethics approval [1] 305235 0
31/03/2016
Approval date [1] 305235 0
18/08/2016
Ethics approval number [1] 305235 0
HREC/16/QTHS/82_4

Summary
Brief summary
Healthcare professionals provide substandard chest compression following cardiac arrest, which is deemed a preventable harm because this skill can be acquired. The recent development of technology-enhanced cardiac compression training devices (high-fidelity mannequins) provides an alternative to traditional instructor-facilitated training. This pilot study aimes to compare the effectiveness of conventional and technology-enhanced training modalities.
A pilot randomised controlled trial design will be used in a regional hospital in Queensland. Following baseline assessment, healthcare staff will be randomised to one of three groups: 1. traditional instructor-facilitated training; 2. high-fidelity mannequin training and continuous access to the training system to practise skills, and 3. high-fidelity mannequin training with no further access to the training system to practise skills. The primary outcome, cardiac compression skill levels, will be analysed using analysis of co-variance, adjusting for predictive co-variates. Secondary measures will be analysed using inferential statistics or presented descriptively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99710 0
A/Prof Alison Pighills
Address 99710 0
Mackay Institute of Research and Innovation
Mackay Base Hospital
P.O.Box 5580
Mackay Mail Centre
Mackay
Qld 4741
Country 99710 0
Australia
Phone 99710 0
+61 07 4885 6793
Fax 99710 0
Email 99710 0
[email protected]
Contact person for public queries
Name 99711 0
A/Prof Alison Pighills
Address 99711 0
Mackay Institute of Research and Innovation
Mackay Base Hospital
P.O.Box 5580
Mackay Mail Centre
Mackay
Qld 4741
Country 99711 0
Australia
Phone 99711 0
+61 07 4885 6793
Fax 99711 0
Email 99711 0
[email protected]
Contact person for scientific queries
Name 99712 0
A/Prof Alison Pighills
Address 99712 0
Mackay Institute of Research and Innovation
Mackay Base Hospital
P.O.Box 5580
Mackay Mail Centre
Mackay
Qld 4741
Country 99712 0
Australia
Phone 99712 0
+61 07 4885 6793
Fax 99712 0
Email 99712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The investigators will share individual deidentified participant data, as requested, for all of the variables collected in this study in either an excel or SPSS file format for a period of up to five years following publication of the results.
When will data be available (start and end dates)?
2020-2025
Available to whom?
Available to researchers who provide a methodologically sound proposal
Available for what types of analyses?
Available to enable researchers to achieve the aims in the approved proposal including for IPD meta-analyses, etc.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
Contact Alison Pighills: [email protected], Tel: (07) 4885 6793


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7271Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.