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Trial registered on ANZCTR


Registration number
ACTRN12616000468426
Ethics application status
Approved
Date submitted
30/03/2016
Date registered
8/04/2016
Date last updated
22/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Impact of face-to-face and web-based simulation training for ward nurses regarding patient deterioration and patient safety.
Scientific title
The Impact of face-to-face and web-based simulation on patient deterioration and patient safety; a multi-site multi-method trial aiming to improve ward nurses' recognition and management of rapidly deteriorating hospital patients, with outcomes identified through audit of patients' medical records.
Secondary ID [1] 288899 0
None known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital patient deterioration 298169 0
Rapid patient deterioration 298170 0
Condition category
Condition code
Public Health 298334 298334 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nurses in medical wards will complete a simulation-based training program on recognition and management of patient deterioration, either via face-to-face simulation (FIRST2ACT) or via a web-based training program (FIRST2ACTWeb). Nurses will be allocated to an intervention program according to the site of their employment.

The training for both groups takes between 1.5 to 2 hours to complete and both include five key components: developing core knowledge; assessment (learning stimulus); simulation; reflective review; and performance feedback. Members of the research team who are senior nurse clinicians will administer and support both forms of training on site at the participating hospitals, assisted by local clinical nurse specialists/educators.

Group 1: Web-based training is completed individually on a personal computer or in a ward training room. The web-hosted ‘e-simulation’ version FIRST2ACTWeb (see http://first2actweb.com/) incorporates three interactive scenarios (myocardial infarction, shock ,and respiratory cases) where patient actors deteriorate (over eight minutes) with participants required to ‘click’ on various potential actions – such as measuring blood pressure or inserting an intravenous line - resulting in further pop-up videos of each action. Detailed performance feedback is then provided to a participant on completion and an explanatory Course Manual is downloadable for reflection and review .

Group 2: The face-to-face version of the program mirrors the web based program. After an introductory briefing, participants work in teams of three with a patient actor and research ‘support’ staff member, in a ward setting to assess and manage the 'patient' who role-plays three clinical deterioration episodes, as described for Group 1.. At the conclusion, a debriefing is conducted by a clinical researcher and nurse participants complete evaluation surveys. An explanatory Course Manual is made available for each participant's reflection and review.
For both groups, prospective program evaluation is conducted through pretest and post-test surveys of nurses' clinical knowledge, performance evaluation using a structured checklist, and post-test satisfaction and feedback.. The web-based version collects evaluation data via a remote server, including which screen-based buttons were clicked and when (to enable scoring of performance), self-completed survey data and analytical data from the website.
Intervention code [1] 294335 0
Treatment: Other
Comparator / control treatment
The web-based training for nurses will act as the comparator
Control group
Active

Outcomes
Primary outcome [1] 297810 0
The primary outcome is quality of nursing assessment, measured via the proportion of patients showing late clinical signs of deterioration, as determined from medical record review. We will use a data extraction tool including early and late signs of clinical deterioration adapted from Harrison, et al, 2005 (The prevalence of recordings of the signs of critical conditions and emergency response in hospital wards – the SOCCER study. Resuscitation 2005;65:149-57).
In addition, appropriate frequency of vital signs documentation and evidence-based responses to deterioration will be collected as proxies for the quality of nursing care. A valid MR audit tool published as McConnell-Henry et al, 2015 (Designing a medical records review tool: An instructional guide. Contemporary Nurse 2015; 50:1-8.) was revised to enable data to be extracted and then recorded electronically (online).
Timepoint [1] 297810 0
Time series analysis - 1, 2, and 3 months before and after the training intervention.
Secondary outcome [1] 322296 0
Secondary outcome: In-hospital mortality; extracted from hospital medical record databases.
Timepoint [1] 322296 0
Time series analysis- a period of 3 months pre- and post training intervention.
Secondary outcome [2] 322297 0
The cost of provision of face-to-face versus eLearning simulation-based clinical training for nurses. The cost analysis will be derived from comparison of the resource costs associated with each intervention (e.g. software development, educator staffing costs, staff release costs, patient actors, etc).
Timepoint [2] 322297 0
A retrospective incremental cost-effectiveness ratio will be derived to compare the two intervention programs, expressed as the incremental costs per proportion of change related to the primary clinical outcomes for that program (e.g. knowledge and skill management and ability to detect and manage deterioration).
Secondary outcome [3] 322299 0
Stakeholders views and attitudes to the forms of program delivery. Qualitative data will be captured in six stakeholder focus groups conducted at the end of the nurse training period.. Participants will include those who attended training and their line managers in order to elicit the impact of the two programs of education.
Timepoint [3] 322299 0
Prospective surveys of stakeholders at point of completion of training.
Secondary outcome [4] 322398 0
Rate of patient admissions to ICU from the prescribed wards, determined from review of medical records and from ICU admissions data.
Timepoint [4] 322398 0
Time series analysis -a period of 3 months pre- and post training intervention.

Eligibility
Key inclusion criteria
Registered Nurses and Enrolled Nurses employed in a medical ward at one of four participating hospitals.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non credentialed nurses- eg., nursing assistants.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
(i) Sample size
Nurse participants: While a population sample of all nurses in prescribed medical wards is desirable, based on pilot hospital-based studies which achieved a participation rate of 82%, we anticipate a similar participation rate for this study (n = >200). This proportion was sufficient to demonstrate significant improvements to nursing practices in an earlier intervention study.
Patient sample size: Pilot data from an earlier rural study indicated that early signs of deterioration were present in 28% of patients while late signs were present in 10%, and that the total sample size required to detect a 5% reduction in late signs of deterioration with a level of significance of 5% and a power of 0.8 is 434 patients (217 before and 217 after the intervention) at each site.
(ii) Analysis: In the simulation training intervention, knowledge and skill performance ratings: participant demographics, questionnaire, and simulation performance will be described with the use of descriptive and inferential statistics. There will be a range of nominal, ordinal and interval data (paired and unpaired) requiring tests such as Chi-square, McNemar, Mann Whitney U, and t-tests. Multivariate analysis (linear and logistic regression) will be used to identify predictors of performance. Stakeholder focus groups will be audio-recorded and transcribed to enable thematic analysis and to help identify the perceived impact of the program.
Patient notes review - A pre-post intervention analysis conducted through time series analyses will identify the primary outcome. The success of the training intervention will be identified by a statistically significant increase in applicable actions; reduction in the proportion of late signs of deterioration, lower in-hospital mortality and decrease in admissions to ICU.
(iii) An economic analysis will assess costs associated with both educational interventions versus benefits. To determine program savings, we will perform a decision analysis, from the hospitals’ perspective with respect to costs such as program development, time, educator commitment and staff release costs relating to both educational interventions. We will measure length of stay, hospital costs (per day, per unit), number of procedures performed, (e.g. x-rays, pathology or lab tests) for each patient.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5509 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [2] 5510 0
Central Gippsland Health Service (Sale) - Sale
Recruitment hospital [3] 5512 0
St John of God Hospital - Bendigo - Bendigo
Recruitment hospital [4] 5513 0
St John of God Hospital - Berwick - Berwick
Recruitment hospital [5] 5514 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [6] 5537 0
Dandenong Hospital - Dandenong

Funding & Sponsors
Funding source category [1] 293229 0
Government body
Name [1] 293229 0
Department of Health and Human Services
Address [1] 293229 0
50 Lonsdale St
Melbourne Vic 3000
Country [1] 293229 0
Australia
Primary sponsor type
Individual
Name
Professor Simon Cooper
Address
Federation University Australia
School of Nursing Midwifery and Healthcare
Northways Rd,
Churchill
Vic, 3842
Country
Australia
Secondary sponsor category [1] 292031 0
None
Name [1] 292031 0
None
Address [1] 292031 0
none
Country [1] 292031 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294708 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 294708 0
Monash Health
246 Clayton Rd,
Clayton Vic. 3168
Ethics committee country [1] 294708 0
Australia
Date submitted for ethics approval [1] 294708 0
18/12/2015
Approval date [1] 294708 0
28/01/2016
Ethics approval number [1] 294708 0
15414L
Ethics committee name [2] 294709 0
Federation University Australia
Ethics committee address [2] 294709 0
Research Services Office
Federation University Australia
Gippsland Campus
Northways Rd
Churchill Vic 3842
Ethics committee country [2] 294709 0
Australia
Date submitted for ethics approval [2] 294709 0
02/11/2015
Approval date [2] 294709 0
09/11/2015
Ethics approval number [2] 294709 0
E15-018 A
Ethics committee name [3] 294731 0
St John of God Health Care Human Ethics Committee
Ethics committee address [3] 294731 0
Level 3, St John of God House,
177-179 Cambridge St,
WEMBLEY WA 6014
Ethics committee country [3] 294731 0
Australia
Date submitted for ethics approval [3] 294731 0
14/10/2015
Approval date [3] 294731 0
22/10/2015
Ethics approval number [3] 294731 0
874

Summary
Brief summary
In this study we aim to address patient safety in relation to first responders’ ‘failure to rescue’ deteriorating patients with a focus on enhancing the assessment and management of clinical deterioration. Over the last 7 years we have developed a face-to-face and web based educational program known as First2Act(Web) http://first2actweb.com/ which has had a demonstrated impact on educational outcomes and in a preliminary study a significant impact on clinical performance. The objectives of this study are to measure and compare the cost- effectiveness and clinical impact of in-situ face-to-face and web-based simulation programs in the management of patient deterioration and related patient outcomes.
Based on these programs our intentions are to train nurse participants in primary responses to emergencies (the first 8 minutes) in medical wards at Monash Health and St John of God Health Care and other hospitals, using either in-situ face-to-face or web based version of First2Act. The impact of these interventions will be determined through quantitative and qualitative approaches; economic analyses and patient notes review (time series analyses) to measure quality of care and patient outcomes. This will enable us to determine the clinical impact of the intervention programs in relation to resource implications.
It is anticipated that this program will reduce the number of in-hospital adverse events, length of stay and hospital costs whilst adding to our understanding of the barriers and enablers to effective decision-making in clinical deterioration and the utility of simulation in the preparation of first responders. Subsequent recommendations and final programs will be made available to the Victorian and International communities
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64758 0
Prof Simon Cooper
Address 64758 0
School of Nursing Midwifery and Healthcare
Federation University Australia
Northways Rd,
Churchill, Vic
Australia 3842
Country 64758 0
Australia
Phone 64758 0
+61351228032
Fax 64758 0
Email 64758 0
s.cooper@federation.edu.au
Contact person for public queries
Name 64759 0
Prof Simon Cooper
Address 64759 0
School of Nursing Midwifery and Healthcare
Federation University Australia
Northways Rd,
Churchill, Vic
Australia 3842
Country 64759 0
Australia
Phone 64759 0
+61351228032
Fax 64759 0
Email 64759 0
s.cooper@federation.edu.au
Contact person for scientific queries
Name 64760 0
Prof Simon Cooper
Address 64760 0
School of Nursing Midwifery and Healthcare
Federation University Australia
Northways Rd,
Churchill, Vic
Australia 3842
Country 64760 0
Australia
Phone 64760 0
+61351228032
Fax 64760 0
Email 64760 0
s.cooper@federation.edu.au

No information has been provided regarding IPD availability
Summary results
No Results