Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001903279
Ethics application status
Approved
Date submitted
21/12/2017
Date registered
22/11/2018
Date last updated
22/11/2018
Date data sharing statement initially provided
22/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Transforming nursing assessment in acute hospitals: A cluster randomised controlled trial of Evidence-based Nursing CORE assessment (the ENCORE trial)
Scientific title
Effectiveness of an evidence-based nursing core assessment protocol in general wards on patient, staff and economic outcomes: A cluster randomised controlled trial
Secondary ID [1] 293655 0
NHMRC Grant ID 1145859
Universal Trial Number (UTN)
U1111-1206-8427
Trial acronym
The ENCORE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deteriorating patients in general wards 305953 0
Condition category
Condition code
Public Health 305146 305146 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ENCORE intervention is a complex systems intervention. Each intervention ward will adopt the following core components of the intervention:

Proactive surveillance: A structured Core Plus nursing surveillance model for recognition of early changes in patient status on general wards.

*Core assessment comprises standardised minimum assessment activities that are common across all clinical areas. The Plus specialty assessment parameters are customised minimum assessment activities relevant to the ward specialty areas.

*The Core Plus model is designed for collection and synthesis of patient data to inform further symptom directed assessment and/or ongoing care decisions. ENCORE informs nursing care planning and multidisciplinary team communication.

Systems re-design: Facilitated ward-level practice change to embed the Core Plus model and optimise early intervention for preventable deterioration.

*Nurses will conduct Core Plus assessment of patients in their allocation at the beginning of each shift.

*The patient’s primary nurse reviews patient status and goals of care during multidisciplinary team ward rounds.

Our partner investigators are committed to support ward-level negotiated and tailored strategies to enable and sustain this practice change and embed the ENCORE intervention in ward routine. In re-focusing nursing assessment practices from minimal vital signs recording to purposeful assessment, the ENCORE intervention will strengthen nurse surveillance to ensure adequate and ongoing monitoring of acute care patients’ health status. This practice model will optimise nurses’ capacity to detect and act on emerging indicators of a change in patient status, enabling early intervention for preventable deterioration and adverse events.

A 6-month implementation period for intervention wards will support staff engagement and participation in developing context-specific solutions for practice change:

*Implementation will adopt an external-internal model of facilitation. Expert external facilitators (research team) will work with internal facilitators (ENCORE leads) on each intervention ward to embed practice change. Each intervention ward will contribute ENCORE leads (clinical nurses) for 6 months as internal facilitators responsible for their ward’s implementation plan, supported by the project coordinator/research team.

*Ward staff (targeting >80% of permanent registered nurses in each ward) will attend face-to-face, group-based introductory (1 x 4 hours) and development (1 x 2 hours) ENCORE workshops over the first month of implementation, facilitated by the project coordinator/research team. Workshops are designed to be collaborative and participatory in customising the Core Plus assessment model and developing local strategies for ward-level practice change.

*Clinical reminders and ENCORE intervention resources will be provided on each intervention ward (i.e. a video demonstrating the core components of the intervention, posters, lanyard-sized cards, Core Plus assessment bedside guidelines, professional stethoscopes for nurses).

Sponsorship for the study was sought from the Executive Directors of Nursing and Chief Executive Officers of each hospital prior to the funding application.

A prospective process evaluation will examine implementation outcomes of the ENCORE intervention including uptake, fidelity, acceptability and sustainability. This will be achieved using surveys, focus group and individual interviews of clinical staff participants conducted by a member of the research team.
Intervention code [1] 299922 0
Early detection / Screening
Intervention code [2] 299923 0
Prevention
Intervention code [3] 299924 0
Behaviour
Comparator / control treatment
Control ward conditions will reflect standard patient assessment and staff practices. Control wards will not receive any element of, or information on, the intervention.
Control group
Active

Outcomes
Primary outcome [1] 304302 0
Medical emergency team (MET) activations collected from patient records. These data will be cross-checked and validated by comparison with MET data by ward.
Timepoint [1] 304302 0
6 months after intervention commencement.
Secondary outcome [1] 341523 0
Serious adverse events defined as a composite of unplanned intensive care unit (ICU) admissions, on-ward resuscitations, and unexpected deaths. Collected from the patient records.
Timepoint [1] 341523 0
6 months after intervention commencement.
Secondary outcome [2] 341525 0
Nursing and medical staff perceptions of safety culture will be measured using the short form Safety Attitudes Questionnaire (SAQ).
Timepoint [2] 341525 0
6 months after intervention commencement.
Secondary outcome [3] 341526 0
Economic evaluation: a benefit-to-cost ratio for the ENCORE intervention related to MET activations, ICU admissions and average patient length of stay. Resource use will be identified through trial records (i.e. for the intervention) and through linkage to admitted patient data in each participating state.
Timepoint [3] 341526 0
6 months after intervention commencement.

Eligibility
Key inclusion criteria
Clusters: Eligible hospital wards (clusters) will be general acute care wards, between 20-30 beds and where >70% of nursing staff are permanent (full or part time).

Patients: Patients will be recruited prospectively from all hospitals using identical tools and methods, six months following commencement of the intervention allowing embedding of the intervention into routine care. All eligible patients admitted to participating wards over a six month period will be recruited using an opt-out approach for access to medical records. Eligible patients will be 18 years and over and screened by ward nursing staff as able to read and understand the plain language study information provided on admission.

Nursing and Medical Staff: All nurses who work as permanent staff in the participating wards and medical officers in those wards will be invited to participate in a survey at baseline, 6 months and 12 months post intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Specialist acute care units (e.g., ICU, Coronary Care Unit, Operating Theatres) will be ineligible to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will be concealed until clusters are recruited and the intervention is ready to be assigned as per the Cluster CONSORT statement. Allocation will adhere strictly to the generated sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted at the ward level because it is more efficient than randomisation at the hospital level: it allows more clusters and hospitals act as their own control. Participating wards will be stratified by (1) hospital and (2) medical or surgical category, and then randomised to either the intervention or control groups in a ratio of 1 intervention ward to 2 control wards. Unequal allocation is the optimal feasible design given the nature of the intervention, which is resource intensive. Randomisation will be conducted by the trial statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
We will conduct a cluster randomised controlled trial to compare a ward based redesign of nursing surveillance (ENCORE intervention) with standard assessment practices (control). This is an organisational level health service intervention where hospital wards (clusters) will be randomised to either intervention or control groups with outcome measures at the patient level.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We plan to recruit 36 wards with 1:2 allocation; 12 wards in the intervention group and 24 wards in the control group. From each ward we expect an average of 1000 patients over a 6 month period, resulting in a total sample size of 36,000. This is a conservative sample size estimate given the size of the wards and assumes that 80% of patients will consent to be in the study. Our sample size will ensure that we have 80% power to deduct a 25% relative risk reduction in MET activations from 7.5% in the control group to 5.6%, assuming a two-sided 5% significance level and an intra-cluster correlation of 0.005. Sample size calculations were conducted in PASS 12 and have assumed a binary outcome, as more than one MET per admission is rare. Our control rate of 7.5% is based on our hospital data, but even if this as low as 5%, we will still have 80% power to detect a reduction to 3.5% (30% difference). ICC is expected to be low due to the large cluster size, findings from previous studies and adjustment for hospital and ward type in the analyses. We will also have sufficient power (greater than 80%) to detect differences for our listed secondary outcomes.

Study endpoints: An intention to treat analysis will be conducted. The primary outcome, number of MET activations, will be analysed using a mixed effects Poisson model. Clustering of patients within wards will be adjusted for in the analysis by the inclusion of a random effect for ward. A mixed effects model can accommodate missing values; the results will be valid provided missing data is random. The model will include study group and any variable used to stratify the randomisation of wards (hospital and ward type). Baseline characteristics will be examined to assess balance between the intervention and control groups. A sensitivity analysis will be conducted by the inclusion of additional factors to the model, for which there is an observed imbalance. Appropriate model checking will also be conducted and the analysis plan will be revised accordingly if model assumptions are violated. Similar analyses will be conducted for the secondary outcomes, with any binary and continuous outcomes being analysed using mixed effects logistic and linear regression models, respectively. Several secondary analyses will be conducted, such as to examine if there is any subgroup for which the intervention is more effective (e.g. type of ward) and a per-protocol analysis. A 5% significance level shall be used for all analyses.

Economic analysis: A within-trial cost-benefit analysis will be undertaken from an Australian health system perspective. Health system resource use and costs will include the cost of the intervention, including staff training and implementation; and downstream costs related to the intervention, such as adverse events. Resource use will be identified through trial records (i.e. for the intervention) and through linkage to admitted patient data in each participating state.

Staff time will be valued using the most recent professional awards (e.g. Queensland and NSW Nurses Award; Medical Practitioners Award). The benefits will include reduction in MERT calls, reduction in ICU admissions and reduction in the average patient length of stay for the ward (cluster), by allocation group. Future costs and benefits will be discounted to obtain present values. All benefits will be quantified in monetary terms, and a benefit-to-cost-ratio will be calculated for the intervention and control group. If the benefit-to-cost ratio for the ENCORE intervention is greater than 1, then the intervention will be considered of value. Sensitivity analyses will be undertaken to assess the impact of changes in key costs and outcomes, including an increased proportion of medical compared to surgical wards; and increased costs for ICU admission. The cost-benefit analysis will be conducted according to best practice methods set out by the Australian government.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
1/07/2020
Actual
Sample size
Target
36000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 9626 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 9627 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 9628 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [4] 9629 0
Caboolture Hospital - Caboolture
Recruitment hospital [5] 9630 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [6] 9631 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [7] 9632 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 18383 0
4032 - Chermside
Recruitment postcode(s) [2] 18384 0
4029 - Herston
Recruitment postcode(s) [3] 18385 0
4020 - Redcliffe
Recruitment postcode(s) [4] 18386 0
4510 - Caboolture
Recruitment postcode(s) [5] 18387 0
2010 - Darlinghurst
Recruitment postcode(s) [6] 18388 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 298272 0
Government body
Name [1] 298272 0
National Health and Medical Research Council (NHMRC)
Country [1] 298272 0
Australia
Funding source category [2] 298279 0
Hospital
Name [2] 298279 0
Metro North Hospital and Health Service
Country [2] 298279 0
Australia
Funding source category [3] 298280 0
Hospital
Name [3] 298280 0
St Vincent's Public Hospital
Country [3] 298280 0
Australia
Funding source category [4] 298281 0
Hospital
Name [4] 298281 0
St Vincent's Private Hospital
Country [4] 298281 0
Australia
Funding source category [5] 298282 0
Hospital
Name [5] 298282 0
Mater Hospital
Country [5] 298282 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
School of Nursing, Victoria Park Road, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 297391 0
None
Name [1] 297391 0
Address [1] 297391 0
Country [1] 297391 0
Other collaborator category [1] 279873 0
University
Name [1] 279873 0
Australian Catholic University
Address [1] 279873 0
Nursing Research Institute, Level 5, deLacy Building, St Vincent's Hospital Sydney, 390 Victoria Street, Darlinghurst NSW 2010
Country [1] 279873 0
Australia
Other collaborator category [2] 279874 0
University
Name [2] 279874 0
The University of Sydney
Address [2] 279874 0
NHMRC Clinical Trials Centre, The University of Sydney, NSW 2006
Country [2] 279874 0
Australia
Other collaborator category [3] 280443 0
University
Name [3] 280443 0
The University of Sydney
Address [3] 280443 0
Sydney School of Public Health, Edward Ford Building (A27), The University of Sydney, NSW 2006
Country [3] 280443 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299274 0
The Prince Charles Hospital Human Research Ethics Committee (EC00168)
Ethics committee address [1] 299274 0
Ethics committee country [1] 299274 0
Australia
Date submitted for ethics approval [1] 299274 0
14/12/2017
Approval date [1] 299274 0
03/04/2018
Ethics approval number [1] 299274 0
HREC/18/QPCH/1
Ethics committee name [2] 302002 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [2] 302002 0
Ethics committee country [2] 302002 0
Australia
Date submitted for ethics approval [2] 302002 0
13/04/2018
Approval date [2] 302002 0
16/04/2018
Ethics approval number [2] 302002 0
1800000183
Ethics committee name [3] 302003 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [3] 302003 0
Ethics committee country [3] 302003 0
Australia
Date submitted for ethics approval [3] 302003 0
18/05/2018
Approval date [3] 302003 0
01/06/2018
Ethics approval number [3] 302003 0
2018-154R

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79874 0
A/Prof Clint Douglas
Address 79874 0
QUT School of Nursing,
Victoria Park Road,
Kelvin Grove QLD 4059
Country 79874 0
Australia
Phone 79874 0
+61 7 3138 3896
Fax 79874 0
Email 79874 0
[email protected]
Contact person for public queries
Name 79875 0
Clint Douglas
Address 79875 0
QUT School of Nursing,
Victoria Park Road,
Kelvin Grove QLD 4059
Country 79875 0
Australia
Phone 79875 0
+61 7 3138 3896
Fax 79875 0
Email 79875 0
[email protected]
Contact person for scientific queries
Name 79876 0
Clint Douglas
Address 79876 0
QUT School of Nursing,
Victoria Park Road,
Kelvin Grove QLD 4059
Country 79876 0
Australia
Phone 79876 0
+61 7 3138 3896
Fax 79876 0
Email 79876 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be shared as per HREC and QLD Public Health Act approval.


What supporting documents are/will be available?

No Supporting Document Provided



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.