Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000237280
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
14/02/2018
Date last updated
14/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Do senior clinical positions rostered after-hours (and known as the UP LATE team) improve outcomes for patients, staff and the hospital?
Scientific title
A mixed method interventional study to measure the effects of senior clinical leads after-hours on patients’ outcomes, staff satisfaction and organisational efficiency
Secondary ID [1] 293918 0
Nil known
Universal Trial Number (UTN)
U1111-1208-7408
Trial acronym
Upholding Patient safety via Leadership Assessment, Teamwork and Education - UP LATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
After-hours hospital care 306403 0
Condition category
Condition code
Public Health 305494 305494 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is evaluating elements of a quality improvement project known as UP LATE. UP LATE is the introduction of a 7 day after-hours (1600-0800) service and includes the following elements:
- Senior Clinical Leads namely Advanced Training Registrars and Nurse Navigators on every evening and night shift. Governance structure and operational workplans have been developed in consultation with key stakeholders to ensure integration with existing after-hours processes and resources. A full day orientation program including simulation scenarios, leadership, team building and technical skills has been developed for the new team. A part-time clinical director has been appointed to oversee and build and integrate the new service.
- Additional meetings and opportunities for improved clinical handover of patients from shift to shift and between transitions of care. These aim to follow best practice clinical handover guidelines and local hospital policies. Roles and responsibilities in relation to clinical handover are documented and audit schedules to monitor compliance have been established.
- Use of an electronic system (Task Manager) to request and manage ward task requests for the after-hours junior medical officers for better management of workloads and workload planning by senior clinicians and administrators. Fact sheets and training sessions have been rolled out to all junior medical officers and ward nursing staff. This is also supported by education videos on-line for easy access. Reporting capabilities are in place and a feedback loop to clinicians and home teams is being trialled.
- Utilisation of a Patient of Concern strategy that enables identification of patient cohorts that are most at risk of clinical deterioration to trigger proactive clinical review by senior clinicians. The Patient of Concern strategy was developed from a literature review and benchmarking against other peer hospitals and then tailored to RBWH using local clinical experts. This strategy has been formally endorsed by the organisation and includes specific criteria to identify patients at most risk of deterioration, an education package to ensure staff are compliant with the identification and management of Patients of Concern, an electronic flagging system, online resources, reporting functions within Patient Flow Manager and a regular audit schedule.
Intervention code [1] 300188 0
Prevention
Comparator / control treatment
Comparisons will be made with historical data coming from a combination HBCIS (overarching hospital administration database), ORMIS (Operating Room database), METAVISION (ICU database), ORACLE (Medical Emergency database), and EDIS (Emergency Department database) - matched by calendar month for pre-post (March to June 2017 compared to March to June 2018) and continually used from March 2015 for the survival analysis.
Control group
Historical

Outcomes
Primary outcome [1] 304624 0
Organisational medical emergency activation rate per occupied bed day, This data will be sourced from the hospital administration database (HBCIS) and the Medical Emergency database (ORACLE) managed and stored in the Safety and Quality Unit, RBWH.
Timepoint [1] 304624 0
12 month trend from March 2018
Primary outcome [2] 304625 0
Time to medical emergency activation for pre-defined patients of concern groups (that is, inter-hospital transfers, after-hours emergency admissions, after hours discharges from operating rooms, discharges from intensive care unit). This data will be sourced from the hospital administration database (HBCIS) and the Medical Emergency database (ORACLE) managed and stored in the Safety and Quality Unit, RBWH.
Timepoint [2] 304625 0
12 month trend from March 2018
Primary outcome [3] 304626 0
Organisational average acute length of stay for overnight emergency admissions and stratified by pre-defined patient of concern groups (that is inter-hospital transfers, after-hours emergency admissions, after hours discharges from operating rooms, discharges from intensive care unit). This data will be sourced from the hospital administration database (HBCIS).
Timepoint [3] 304626 0
12 month trend from March 2018
Secondary outcome [1] 342616 0
Organisational labour costs relevant to after-hours care, including sick leave and overtime costs. It is expected that sick leave and overtime will be reduced and there will be an associated cost saving to the organisation (payroll and Human Resource data will be utilised). Comparison will be made from March to June 2017 to March to June 2018.
Timepoint [1] 342616 0
12 month trend from March 2018.
Secondary outcome [2] 342646 0
Patient and staff satisfaction surveys were completed prior to the implementation and these will be reapplied in May 2018 and November 2018 (convenience sampling). Patient surveys (developed in conjunction with the RBWH Consumer Advisory Group specifically for this initiative) asked about care provision after-hours compared to business hours. Staff satisfaction surveys included staff perception of stress levels, clinical handover, teamwork, senior support, and escalation. The staff satisfaction surveys include a separate survey for nurses and doctors and were developed locally and designed for pre-post survey (not validated).
Timepoint [2] 342646 0
3 and 9 months post March 2018
Secondary outcome [3] 342647 0
Unplanned intensive care unit admissions from the general wards - number and bed days (composite outcome). This data is sourced from a combination hospital administration database (HBCIS) and the RBWH Intensive Care Unit database (METAVISION).
Timepoint [3] 342647 0
12 month trend from March 2018
Secondary outcome [4] 342648 0
Crude mortality ratio stratified by pre-defined patients of concern groups (that is inter-hospital transfers, after-hours emergency admissions, after hours discharges from operating rooms, discharges from intensive care unit)
Timepoint [4] 342648 0
March to June 2017 compared to March to June 2018 (Pre and post comparison)

Eligibility
Key inclusion criteria
All adult inpatients and clinicians working in wards at Royal Brisbane and Women's Hospital (RBWH) - outside of critical care areas and including mental health and obstetrics. RBWH is a large tertiary, quaternary hospital in Brisbane, Queensland, Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients in Intensive Care Unit, Neonatal Intensive Care, Emergency Short Stay Unit, Direct admissions to theatre or Psychiatric Emergency Department.
NB Organisational metrics for length of stay will include all adult inpatients

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Basic descriptive statistics and graphical trends will be generated. Key outcomes will be plotted over time to look for patterns of change pre-post implementation. Potential confounders e.g. seasonal patterns will be adjusted for. Survival analysis will be used for the second primary outcome (i.e. time to first medical emergency response for pre-specified 'patient of concern' groups) with the starting point being the time the subject becomes a 'patient of concern' for example, the time the patient is discharged from Intensive Care Unit or is admitted as an inter-hospital transfer. Model assumptions will be checked to look for patterns and outliers. We will adjust for patients who experience repeat admissions or who meet 'patient of concern' criteria in multiple categories.
For qualitative data, thematic analysis will be used to illustrate changes pre- and post-intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/03/2018
Actual
Date of last participant enrolment
Anticipated
4/03/2019
Actual
Date of last data collection
Anticipated
4/03/2019
Actual
Sample size
Target
70000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9918 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 18727 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 298545 0
Hospital
Name [1] 298545 0
Royal Brisbane and Women's Hospital - Herston
Country [1] 298545 0
Australia
Primary sponsor type
Hospital
Name
Executive Director Medical Services Royal Brisbane and Women's Hospital - Dr Judy Graves
Address
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland 4029
Country
Australia
Secondary sponsor category [1] 297706 0
None
Name [1] 297706 0
Address [1] 297706 0
Country [1] 297706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299516 0
Royal Brisbane and Women's Hospital - Herston
Ethics committee address [1] 299516 0
Ethics committee country [1] 299516 0
Australia
Date submitted for ethics approval [1] 299516 0
27/09/2017
Approval date [1] 299516 0
05/10/2017
Ethics approval number [1] 299516 0
HREC/17/QRBW/560

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2404 2404 0 0
/AnzctrAttachments/374407-Ethics Exemption.pdf (Ethics approval)

Contacts
Principal investigator
Name 80686 0
Dr Julian de Looze
Address 80686 0
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland 4029
Country 80686 0
Australia
Phone 80686 0
+61736468111
Fax 80686 0
Email 80686 0
[email protected]
Contact person for public queries
Name 80687 0
Mary Fenn
Address 80687 0
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland 4029
Country 80687 0
Australia
Phone 80687 0
+61736468111
Fax 80687 0
Email 80687 0
[email protected]
Contact person for scientific queries
Name 80688 0
Julian de Looze
Address 80688 0
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, Queensland 4029
Country 80688 0
Australia
Phone 80688 0
+61736468111
Fax 80688 0
Email 80688 0
[email protected]

No information has been provided regarding IPD availability


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.