Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000265875
Ethics application status
Approved
Date submitted
18/11/2020
Date registered
10/03/2021
Date last updated
23/03/2023
Date data sharing statement initially provided
10/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
ACCELERATE Trial- The effect of improving patient assessment and clinical communication among healthcare staff on patient adverse events in acute general wards.
Scientific title
ACCELERATE Trial - Assessment and CommuniCation ExcelLEnce foR sAfe paTient outcomEs: a stepped-wedge cluster randomised controlled trial to assess the effect of improving patient assessment and clinical communication on patient adverse events
Secondary ID [1] 302269 0
Nil known
Universal Trial Number (UTN)
U1111-1258-1335
Trial acronym
ACCELERATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient deterioration in the acute care setting 319000 0
Inpatient pressure injuries 319078 0
Inpatient falls 319079 0
Condition category
Condition code
Public Health 316965 316965 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ACCELERATE Intervention consists of: 1) Training in comprehensive nursing assessments incorporating risk assessment and mitigation strategies for clinical deterioration, pressure injury and falls; 2) Training in effective clinical handover following observation and analysis of interactions with patients and multidisciplinary team; 3) Ward-specific tailored strategies to enhance assessment and handover practices amongst the multidisciplinary team developed at the workshop (see below) and reviewed fortnightly at dedicated team meetings by hospital leads; 4) Implementation of comprehensive assessment and clinical handover at ward level.

Evidence-based implementation strategies will be conducted at each enrolled hospital and will be run out over a 6 month period and comprises:
i) One 3-hour hospital-based workshop for training in comprehensive assessment and clinical handover for nurses delivered by clinical experts, external facilitator for ACCELERATE for each hospital, researchers and implementation experts using multi-media approach (ie videos, educational, engagement and ownership strategies). Workshops will focus on uplifting and enhancing current assessment and communication practices which currently do not meet evidence-based guidelines. There will be 3 3-hour workshops per ward to enable all nurses to attend. Nurses are only required to attend one workshop.
ii) Collaborative barrier and facilitator identification to improved assessment and handover with clinicians which will inform the ward based action change management plan. This plan will be developed at the workshop and refined over time with involvement of the external facilitator.;
iii) Nurse and medical leadership (at executive, middle management and ward level) and external facilitator (senior nurse not connected to participating wards) to support, drive and monitor change,
iv) Audit and feedback of data on ward level pressure injury, falls and MET call rates every 6 weeks post-workshop presented at progress ward based meetings facilitated by the external facilitator.

The intervention will be delivered in 3 steps at 4-month intervals. The intervention will be sequentially introduced into 9 wards (three clusters with each cluster containing three wards) across three hospitals over 12 months. Wards from each hospital will be randomised into clusters which will determine the commencement date of the intervention, with the condition that each step contains at least one ward from each hospital.
Intervention code [1] 318558 0
Behaviour
Intervention code [2] 319368 0
Prevention
Comparator / control treatment
Standard care is assessment and clinical handover as currently practiced by each participating ward.
Control group
Active

Outcomes
Primary outcome [1] 325076 0
Composite outcome of:
- Number of Medical Emergency Team (MET) calls (Rapid response calls and cardiac arrest calls)
- Number of unplanned intensive care unit (ICU) admissions
- Number of in-hospital falls
- Number of hospital-acquired stage 2-4 pressure injuries

All data will be extracted from patient medical records and hospital databases
Timepoint [1] 325076 0
At discharge/transfer from the study ward.
Secondary outcome [1] 386760 0
Number of Medical Emergency Team (MET) calls as reported in hospital databases as measured by the number of rapid response calls and the number of cardiac arrest calls.
Timepoint [1] 386760 0
At discharge/transfer from the study ward.
Secondary outcome [2] 386761 0
Number of unplanned intensive care unit (ICU) admissions as reported in patient medical records and hospital databases.
Timepoint [2] 386761 0
On transfer from the study ward.
Secondary outcome [3] 386762 0
Number of in-hospital falls as reported in patient medical records and hospital databases
Timepoint [3] 386762 0
At discharge/transfer from the study ward.
Secondary outcome [4] 388433 0
Number of hospital-acquired stage 2-4 pressure injuries as reported in patient medical records and hospital databases.
Timepoint [4] 388433 0
At discharge/transfer from the study ward.
Secondary outcome [5] 388434 0
Patient Measure of Safety PMOS-30 - a validated survey tool self-administered by patients from all participating wards.
Timepoint [5] 388434 0
Pre- and 12 months post-intervention.
Secondary outcome [6] 388435 0
Nurses from all participating wards will complete the following four validated surveys to measure workplace culture

- Perception of nurse-reported safety using the Safety Attitudes Questionnaire.
- Organisational readiness to change using the Organisational Readiness to Change Assessment instrument (ORCA).
- Nurse perception of staff engagement using the Utrecht Work Engagement Scale-17
- Nurse perception of barriers to performing physical assessments using the Barriers to nurses’ use of physical assessment scale
Timepoint [6] 388435 0
Pre- and 12 months post-intervention.
Secondary outcome [7] 391287 0
Patients’ perceptions of their hospital experience using the Friends and Family test which measures how likely patients would be to recommend the hospital to their friends and family.
Timepoint [7] 391287 0
On patient discharge from ward.
Secondary outcome [8] 391288 0
Factors promoting and sustaining uptake of the intervention captured through: face-to-face interviews with nurse unit managers and doctors; and focus group interviews with nurses and ward-based clinical leads.
Timepoint [8] 391288 0
At the conclusion of the trial.

Eligibility
Key inclusion criteria
Three hospital wards from each of three public acute care metropolitan teaching hospitals (2 in NSW and 1 in Victoria) will be recruited. Eligible hospital wards will be general acute care (medical and surgical) and subacute wards, between 20-35 beds who have 70% of all enrolled and registered nurses as permanent staff (including casual and permanent part-time staff who work a minimum of 4 shifts per month but excluding agency staff and assistants in nursing).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Specialist units (CCU, ICU, operating theatres, mental health, emergency) will be ineligible to participate. Agency staff and assistants in nursing 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)
Hospitals and wards will be randomly allocated a unique code by a member of the study team. A separate statistician not involved with the study then will randomly allocate wards using computer software to the stepped-wedge sequence at the beginning of the trial using the unique codes provided. Allocation will be based on clusters and allocation concealment will be at both the cluster level and the individual participant level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation, stratified by hospital.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Stepped-wedge cluster randomised controlled trial with a priori process evaluation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary and secondary outcomes will be analysed using logistic regression, with fixed effects for treatment, time period and hospital. The models will also include a random effect for ward. An interaction between time and treatment will be tested to assess whether there is an effect modification of treatment over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
31/01/2022
Actual
31/01/2022
Date of last data collection
Anticipated
31/05/2022
Actual
31/01/2022
Sample size
Target
3000
Accrual to date
Final
3000
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 17494 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 17495 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 17496 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 31223 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 31224 0
2031 - Randwick
Recruitment postcode(s) [3] 31225 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 306688 0
Other Collaborative groups
Name [1] 306688 0
Nurses Board Victoria Legacy Limited
Country [1] 306688 0
Australia
Funding source category [2] 306699 0
Government body
Name [2] 306699 0
Nursing and Midwifery Strategy Reserve Funding, NSW Department of Health
Country [2] 306699 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst, NSW, 2010
Country
Australia
Secondary sponsor category [1] 307557 0
University
Name [1] 307557 0
Australian Catholic University
Address [1] 307557 0
40 Edward St
North Sydney, NSW, 2060
Country [1] 307557 0
Australia
Secondary sponsor category [2] 307783 0
Hospital
Name [2] 307783 0
Prince of Wales Hospital
Address [2] 307783 0
High St
Randwick, NSW, 2031
Country [2] 307783 0
Australia
Secondary sponsor category [3] 307784 0
Hospital
Name [3] 307784 0
St Vincent's Hospital Melbourne
Address [3] 307784 0
41 Victoria Pde
Fitzroy VIC, 3065
Country [3] 307784 0
Australia
Secondary sponsor category [4] 307862 0
University
Name [4] 307862 0
Australian National University
Address [4] 307862 0
Institute for Communication in Healthcare
Level 3, Baldessin Precinct Bld
Australian National University
Canberra, ACT, 2601
Country [4] 307862 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306865 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 306865 0
Ethics committee country [1] 306865 0
Australia
Date submitted for ethics approval [1] 306865 0
Approval date [1] 306865 0
01/09/2020
Ethics approval number [1] 306865 0
2020/ETH00433

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

Contacts
Principal investigator
Name 105282 0
Prof Sandy Middleton
Address 105282 0
Nursing Research Institute - Australian Catholic University, St Vincent's Health Network Sydney and St Vincent's Hospital Melbourne,
Level 5, deLacy Building
St Vincent’s Hospital Sydney
390 Victoria Street
Darlinghurst NSW 2010
Country 105282 0
Australia
Phone 105282 0
+61 2 8382 3790
Fax 105282 0
Email 105282 0
[email protected]
Contact person for public queries
Name 105283 0
Sandy Middleton
Address 105283 0
Nursing Research Institute - Australian Catholic University, St Vincent's Health Network Sydney and St Vincent's Hospital Melbourne,
Level 5, deLacy Building
St Vincent’s Hospital Sydney
390 Victoria Street
Darlinghurst NSW 2010
Country 105283 0
Australia
Phone 105283 0
+61 2 8382 3790
Fax 105283 0
Email 105283 0
[email protected]
Contact person for scientific queries
Name 105284 0
Sandy Middleton
Address 105284 0
Nursing Research Institute - Australian Catholic University, St Vincent's Health Network Sydney and St Vincent's Hospital Melbourne,
Level 5, deLacy Building
St Vincent’s Hospital Sydney
390 Victoria Street
Darlinghurst NSW 2010
Country 105284 0
Australia
Phone 105284 0
+61 2 8382 3790
Fax 105284 0
Email 105284 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
This contravenes requirements of our ethical 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.