Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000155796
Ethics application status
Approved
Date submitted
23/12/2021
Date registered
31/01/2022
Date last updated
23/02/2024
Date data sharing statement initially provided
31/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Assessment and CommuniCation ExcelLEnce foR sAfe paTient outcomEs (ACCELERATE) PLUS Trial - The effect of improving patient assessment and clinical communication among clinicians on patient adverse events in acute general settings through external remote facilitation.
Scientific title
ACCELERATE Plus Trial: 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] 305881 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
ACCELERATE Plus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient deterioration in the acute care setting 324430 0
Inpatient pressure injuries 324431 0
Inpatient falls 324432 0
Condition category
Condition code
Public Health 321926 321926 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ACCELERATE Plus Intervention consists of three components (refined from the ACCELERATE Trial ACTRN12621000265875).
Intervention
Nurses will be required to:
1) Complete a core physical assessment for all allocated patients at the start of each nursing shift.
2) Perform a structured nurse-to-nurse and multidisciplinary team, patient and family centred bedside nursing handover using: ISBAR (Introduction, Identify, Situation, Background, Assessment / Actions, Recommendations / Readback); and CARE (Connect, Ask, Respond, Empathise).
3) ‘Speak up’ by communicating and escalating assessment finding concerns early to the multidisciplinary team using ISBAR.

Our implementation strategy consists of:
i) Education
A) Train-the-Trainer Education delivered by external facilitators from the research team
The ACCELERATE Plus intervention will be delivered by external experienced facilitators from the researcher team using ‘train-the-trainer’ ‘cascading facilitation’ whereby researchers mentor site leads advising on implementation and behaviour change strategies who in turn then will deliver education at the ward level to nurses to aid embedding of the intervention. The site leads will undertake site lead specific training in a two-day face-to-face session, to: 1) develop their capability and capacity in leading evidence-based change; 2) understand trial milestones; 3) understand data collection timepoints and methods; 4) understand minimum clinical trial elements; and 5) deliver the ward clinician education package.
Site leads will receive a ‘train-the-trainer’ education package consisting of: 1) ward clinician education package, 2) resources consisting of audit tools and action plans and, 3) flowchart with project milestones.

B) Ward Clinician Education delivered by the site leads
Site leads will be responsible for educating ward nurses on the intervention wards. All registered and enrolled nurses on the ward nursing roster will attend one (2-hour duration) on-site face-to-face education sessions consisting of:
1) Training in core physical assessment and clinical handover for nurses using resources provided by the researchers (i.e., short videos, PowerPoint presentations); 2) trial details (i.e., aims, outcome measures and data collection); and 3) Barrier and enabler identification to the conduct of core physical assessments and clinical handover with nurses; 4) development of ward-specific action plans which will be refined over the duration of the Trial with involvement of the site lead and the research team.

The education sessions will be delivered once per day for five consecutive days. To reach all nurses, (i.e., nurses on leave when workshops will be scheduled) the education sessions will be run multiple times with the number of additional education sessions determined by demand from the ward to enable all nurses to attend. Ward nurse education workshop attendance rates will be recorded. Attendance certificates will be provided to ward nurses and will contribute to continuing education hours. The written material used in this intervention will be designed specifically for this study and based on previous work produced by the research team (https://doi.org/10.1111/jan.15110; https://doi.org/10.1111/jocn.13201; https://doi.org/10.7748/ns.2017.e11030).

ii) External facilitation
Site leads also will be provided with ongoing external remote facilitation by the research team for the duration of the Trial. This will consist of a minimum of four one-hour videoconference sessions held at key project milestones, specifically: study commencement, pre-intervention data collection commencement, ward education, and intervention commencement. The number of site leads in a session will depend on their availability to attend a scheduled session. Sessions will be repeated as many times as necessary to ensure all site leads receive the same dose of external remote facilitation. Any additional sessions beyond the four planned sessions and their timing will be determined by demand from the site leads.

Ongoing support for site leads and clinicians will be provided by Nurse leadership (at executive, middle management, and ward level) to support, drive, and monitor change.

iii) Multidisciplinary Ward Clinical Champions
Nursing and medical clinical champions will be identified from each ward to assist the site lead. The site leads, ward Nurse Unit Managers, Nurse Managers and nursing ward clinical champions will liaise with medical colleagues to explain the aim of the trial, and the medical doctors’ role in supporting the intervention.

iv) Reminders
The research team will provide site leads with proactive and responsive email and telephone call remote support as follows:
- Proactive emails from the research team at key milestones (study commencement, pre-intervention data collection commencement, ward education, and ACCELERATE Plus intervention commencement.)
- Responsive emails/ telephone calls from site leads to the research team when required.

The researchers will provide site leads with email reminders to prompt them to progress with implementation and data collection according to the anticipated project timelines as follows:
- Identification of site clinical nursing and medical champions (within two weeks of receiving site specific ethics approval)
- Randomisation of hospitals (within two weeks of receiving site specific ethics approval)
- Pre-intervention surveys completion (for six weeks at the start of each step)
- Nurse education sessions (one week at the start of each step)
- Preparation period (two weeks post ward nurse education sessions)
- Initial action plan (two weeks post education sessions)
- ACCELERATE Plus ‘go-live’ date (three weeks post nurse education sessions)
- ACCELERATE Plus implementation (total duration of four months after the 'go-live' date - two months implementation and two months ‘bedding down’ of the intervention for it to become routine practice)
- post intervention surveys collection (at trial conclusion)
- process evaluation interviews/focus groups (at trial conclusion).

Process evaluation: All data collection will be conducted by researchers who were not involved in the delivery of the intervention. Participants across all organisational levels will be invited to participate, including site leads, nursing executives, medical heads of department, nursing direct line managers, medical officers, nurse unit managers and ward nurses. To maximise variation of contexts, we will purposively sample to ensure participants from sites are included according to the following criteria: large (Principal Referral) and small (Group A/B) AIHW hospital classification; state (NSW and VIC); setting (metropolitan and regional); prior involvement in the ACCELERATE (2021) feasibility study.
Intervention code [1] 322276 0
Behaviour
Intervention code [2] 322277 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] 329687 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/falls with harm
- Number of hospital-acquired pressure injuries (>/= stage 2). All data will be extracted from patient medical records and hospital databases.
Timepoint [1] 329687 0
At discharge/transfer from the study ward.
Secondary outcome [1] 403446 0
Number of Medical Emergency Team (MET) calls as reported in hospital databases and measured by the number of rapid response calls and the number of cardiac arrest calls.
Timepoint [1] 403446 0
At discharge/transfer from the study ward.
Secondary outcome [2] 403447 0
Number of unplanned intensive care unit (ICU) admissions as reported in patient medical records and hospital databases.
Timepoint [2] 403447 0
At discharge/transfer from the study ward.
Secondary outcome [3] 403448 0
Number of in-hospital injurious and non-injurious falls as reported in patient medical records and hospital databases.
Timepoint [3] 403448 0
At discharge /transfer from the study ward.
Secondary outcome [4] 403449 0
Number of hospital-acquired pressure injuries (>/= stage 2) as reported in patient medical records and hospital databases.
Timepoint [4] 403449 0
At discharge /transfer from the study ward.
Secondary outcome [5] 404922 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 [5] 404922 0
Pre- and post-intervention
Secondary outcome [6] 404923 0
Nurses’ perception of organisational readiness to change using the Organisational Readiness to Change Assessment instrument (ORCA).
Timepoint [6] 404923 0
Pre- and post-intervention.
Secondary outcome [7] 404924 0
Nurses’ perception of staff engagement using the Utrecht Work Engagement Scale-17
Timepoint [7] 404924 0
Pre- and post-intervention.
Secondary outcome [8] 404925 0
Nurses’ perception of barriers to performing physical assessments using the Barriers to nurses’ use of physical assessment scale.
Timepoint [8] 404925 0
Pre- and post-intervention.
Secondary outcome [9] 404926 0
Nurses’ perception of safety culture using the Safety Attitudes Questionnaire
Timepoint [9] 404926 0
Pre- and post-intervention.
Secondary outcome [10] 404927 0
Nurses’ perception of interprofessional collaboration using the Interprofessional Collaboration Scale.
Timepoint [10] 404927 0
Pre- and post-intervention.
Secondary outcome [11] 404928 0
Doctors’ perceptions of interprofessional collaboration using the Interprofessional Collaboration Scale.
Timepoint [11] 404928 0
Pre- and post-intervention
Secondary outcome [12] 404929 0
Factors promoting and sustaining uptake of the intervention through a qualitative exploration of organisational, contextual, and structural influences impacting the remote facilitation model. Individual face-to-face/virtual interviews or focus group interviews will be conducted with nurse managers, doctors, site leads, nurses and ward-based clinical champions depending on clinician availability and preference.
Timepoint [12] 404929 0
At the conclusion of the trial.
Secondary outcome [13] 404930 0
Cost effectiveness compared to usual care using a within-trial cost-benefit analysis. We will demonstrate economic value (versus usual care) using a cost-benefit analysis. A within-trial CBA will be undertaken: Intervention costs on clinician training will include total program material costs and staff time for attendance. Hospital costs related to ICU stay, falls and pressure injuries will be valued in monetary terms using Australian Independent Hospital Pricing Authority’s (IHPA) price weights. MET call costs (clinicians’ time, backfilling, equipment, and drug usage) will be calculated from our previous work. If the benefit-to-cost ratio is >1, the intervention will be considered of value To test the robustness of results, one-way and probabilistic sensitivity analyses will be conducted.
Timepoint [13] 404930 0
At the conclusion of the trial.
Secondary outcome [14] 413783 0
Doctors’ perception of safety culture using the Safety Attitudes Questionnaire
Timepoint [14] 413783 0
Pre- and post-intervention
Secondary outcome [15] 413923 0
Patient-reported experience of safety, measured using the Patient Measure of Safety Questionnaire
Timepoint [15] 413923 0
Pre- and post-intervention
Secondary outcome [16] 413924 0
Patient-reported health status, measured using the visual analogue scale from the EuroQol 5 Dimensions
Timepoint [16] 413924 0
Pre- and post-intervention
Secondary outcome [17] 413925 0
Net Promoter Score
Timepoint [17] 413925 0
Pre- and post-intervention

Eligibility
Key inclusion criteria
Three hospital wards from eight public acute care Australian teaching hospitals (7 metropolitan, 1 regional) will be recruited. The hospitals will have at least one staff member to fulfil the role of site lead. Eligible hospital wards will be general acute care wards who have 70% of all enrolled and registered nurses as permanent staff (including casual and permanent part-time staff who work a minimum of four 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. At the beginning of the trial an independent statistician not involved with the study will randomly allocate wards using computer software to one of three steps 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 an a priori process evaluation.

Wards (clusters) from each hospital will be randomised to steps which will determine the commencement date of the intervention, with the condition that each step contains one ward from each hospital.

The intervention will be delivered in three steps at 4-monthly intervals. The intervention will be sequentially introduced into a minimum of 24 wards across eight hospitals over 12 months. Each hospital will contribute three wards.
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.

Process evaluation: Qualitative data from the process evaluation will be thematically analysed and will identify success factors and areas for strengthening the intervention for future use.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/09/2022
Actual
26/09/2022
Date of last participant enrolment
Anticipated
29/12/2023
Actual
29/12/2023
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
60000
Accrual to date
Final
60000
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 21209 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 21210 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 21211 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [4] 21344 0
Lismore Base Hospital - Lismore
Recruitment hospital [5] 23137 0
St George Hospital - Kogarah
Recruitment hospital [6] 23138 0
The Sutherland Hospital - Caringbah
Recruitment hospital [7] 23139 0
Fairfield Hospital - Prairiewood
Recruitment hospital [8] 23140 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 36076 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 36077 0
2031 - Randwick
Recruitment postcode(s) [3] 36078 0
3065 - Fitzroy
Recruitment postcode(s) [4] 36235 0
2480 - Lismore
Recruitment postcode(s) [5] 38496 0
2217 - Kogarah
Recruitment postcode(s) [6] 38497 0
2229 - Caringbah
Recruitment postcode(s) [7] 38498 0
2176 - Prairiewood
Recruitment postcode(s) [8] 38499 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 310228 0
Government body
Name [1] 310228 0
Nursing and Midwifery Strategy Reserve Funding. NSW Department of Health
Country [1] 310228 0
Australia
Funding source category [2] 312218 0
Other Collaborative groups
Name [2] 312218 0
SPHERE Big Ideas Grant
Country [2] 312218 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney Ltd
Address
390 Victoria St
Darlinghurst, NSW, 2010
Country
Australia
Secondary sponsor category [1] 311325 0
University
Name [1] 311325 0
Australian Catholic University
Address [1] 311325 0
40 Edward St
North Sydney, NSW, 2060
Country [1] 311325 0
Australia
Secondary sponsor category [2] 311340 0
Hospital
Name [2] 311340 0
St Vincent's Hospital Melbourne
Address [2] 311340 0
41 Victoria Pde
Fitzroy, Vic. 3065
Country [2] 311340 0
Australia
Secondary sponsor category [3] 311341 0
University
Name [3] 311341 0
Australian National University
Address [3] 311341 0
Level 3, Baldessin Precinct Blvd.
Australian National University
Canberra, ACT 2601
Country [3] 311341 0
Australia
Secondary sponsor category [4] 311607 0
Government body
Name [4] 311607 0
Northern NSW Local Health District
Address [4] 311607 0
60 Uralba St,
Lismore NSW 2480
Country [4] 311607 0
Australia
Secondary sponsor category [5] 311608 0
Government body
Name [5] 311608 0
South Eastern Sydney Local Health District
Address [5] 311608 0
High St
Randwick, NSW, 2031
Country [5] 311608 0
Australia
Secondary sponsor category [6] 313793 0
Government body
Name [6] 313793 0
South Western Sydney Local Health District
Address [6] 313793 0
Gray St, Kogarah NSW 2217
Country [6] 313793 0
Australia
Secondary sponsor category [7] 313794 0
Government body
Name [7] 313794 0
Sydney Local Health District
Address [7] 313794 0
50 Missenden Rd, Camperdown NSW 2050
Country [7] 313794 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309912 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 309912 0
Ethics committee country [1] 309912 0
Australia
Date submitted for ethics approval [1] 309912 0
31/01/2022
Approval date [1] 309912 0
02/03/2022
Ethics approval number [1] 309912 0

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

Contacts
Principal investigator
Name 115806 0
Prof Sandy Middleton
Address 115806 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 115806 0
Australia
Phone 115806 0
+61 2 8382 3790
Fax 115806 0
Email 115806 0
[email protected]
Contact person for public queries
Name 115807 0
Sandy Middleton
Address 115807 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 115807 0
Australia
Phone 115807 0
+61 2 8382 3790
Fax 115807 0
Email 115807 0
[email protected]
Contact person for scientific queries
Name 115808 0
Sandy Middleton
Address 115808 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 115808 0
Australia
Phone 115808 0
+61 2 8382 3790
Fax 115808 0
Email 115808 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
In keeping with the requirements of ethics approval, only summary data not individual data will be presented or published.


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.