Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000404426
Ethics application status
Approved
Date submitted
2/04/2025
Date registered
5/05/2025
Date last updated
5/05/2025
Date data sharing statement initially provided
5/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assess the staggered implementation of a permanent surgical geriatric service embedded within emergency and surgery.
Scientific title
Assess the staggered implementation of a permanent surgical geriatric service embedded within emergency and surgery for the older surgical patients
Secondary ID [1] 313260 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BOOST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
geriatrics 335581 0
Condition category
Condition code
Surgery 332154 332154 0 0
Other surgery
Public Health 333478 333478 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention phase involves implementing a Geriatric Perioperative Care Service (GPS) at John Hunter Hospital to enhance the care of older surgical patients through proactive, integrated geriatric consultation. Unlike the current reactive care model, where general medical or geriatric consultation is ad hoc and based on surgical team referrals, the GPS offers systematic and early involvement of a geriatrician and a Clinical Nurse Consultant (CNC). Patients aged 75 or older (55+ for Aboriginal or Torres Strait Islander individuals) and those with an expected hospital stay of more than 48 hours will be automatically reviewed. Those aged 65-74 (45-54 if Aboriginal or Torres Strait Islander) will either be referred by the surgical team or proactively screened by the geriatrics team. Elective surgical patients at high risk will be identified in the perioperative clinic for preoperative optimization. The GPS team will provide daily rounds and aim to review eligible patients within 24 to 72hours of admission. They will conduct a Comprehensive Geriatric Assessment (CGA) to address comorbidities, medications, frailty, and postoperative risks. The geriatric team will collaborate with the surgical team, which remains in charge of major treatment decisions, but the GPS will assist in managing geriatric syndromes, facilitating shared decision-making, discharge planning, and coordinating with other medical services. Staffing will include geriatricians and CNCs, and research staff will oversee data collection for the study. The staggered implementation trial will start with Emergency general surgery and eventually extend to other departments like elective general surgery, vascular, and urology. After the trial, the GPS will continue as a permanent service, though data collection will cease. The trial aims to assess health service delivery, implementation outcomes, and patient-related outcomes, contributing to the evidence for future geriatric perioperative care models. The frequency pf the intervention, provided by the embedded Geriatrician/ Clinical Nurse Consultant (GPS), will be a proactive co-management service with daily rounds from Monday to Friday and availability for review within 0800 to 1630. Strategies applied for adherence to the intervention are outlined in the design. Proactive screening by the geriatrics team, geriatrician review and screening in perioperative clinic, and dedicated research staff will be used to identify patients. Operating lists, electronic records and admission lists will be utilised. Data will be collected over 3 time-periods: 6-months prior to service implementation (baseline period); during a 6-month period of active service implementation (intervention phase) and the following 6-months of sustained service but without active attention to implementation (sustained phase).
Intervention code [1] 329840 0
Prevention
Comparator / control treatment
Usual care (baseline: 6-months prior to service implementation).
Patients meeting eligibility criteria will be identified from electronic medical records. Patients admitted during the six-month period prior to the intervention commencing for each surgical specialty will be included in the baseline period of usual care. The baseline period represents current standard care at John Hunter Hospital. This means that care is provided with involvement from surgical and allied health teams and referrals are made to other medical specialties as required (ie reactive referral of patients). An ad hoc reactive General Medical or Geriatric Delirium consultation service is available when requested by the surgical team. No comprehensive Geriatric Service is currently available to these patient groups and there is no proactive geriatric service assessments.
Baseline period participant identification
Patients meeting eligibility criteria will be identified from electronic medical records. Patients admitted during the six-month period prior to the intervention commencing for each surgical specialty will be included in the baseline period of usual care.

Control group
Active

Outcomes
Primary outcome [1] 339739 0
Hospital length of stay (days)
Timepoint [1] 339739 0
assessed until hospital discharge
Primary outcome [2] 340923 0
Primary Outcome: Implementation outcomes of- Acceptability- the degree to which staff agree with the intervention,
Timepoint [2] 340923 0
Staff surveys assessed at Baseline period (6 months), Intervention phase (6 months), and sustained phase (6 months) Additionally, they will be assessed in different services and over time. Interviews with staff will occur prior to, during and following implementation of the service.
Primary outcome [3] 340924 0
Primary Outcome: Decision Regret
Timepoint [3] 340924 0
30-days post discharge and 180 days post discharge.
Secondary outcome [1] 446873 0
Primary Outcome: Implementation outcomes of- Acceptability- the degree to which patients agree with the intervention,
Timepoint [1] 446873 0
Baseline and one month post discharge and 6 months post discharge
Secondary outcome [2] 446188 0
Primary Outcome: Mortality
Timepoint [2] 446188 0
In hospital mortality during initial episode of care. Mortality assessed at 30-day post discharge and 180-day post discharge
Secondary outcome [3] 446374 0
Primary Outcome: Hospital satisfaction
Timepoint [3] 446374 0
Measured at 30days post discharge
Secondary outcome [4] 446192 0
Primary Outcome: Cost-effectiveness of the service
Timepoint [4] 446192 0
On completion of the study and data analysis
Secondary outcome [5] 446874 0
Primary Outcome: Health Related Quality of Life
Timepoint [5] 446874 0
Measured prior to surgery (via perioperative service), 30 and 180days post discharge.
Secondary outcome [6] 446371 0
Primary Outcome: Composite Outcomes- Fidelity -degree to which an intervention is delivered as intended. Feasibility-the extent to which the intervention can be carried out within the setting.
Timepoint [6] 446371 0
Assessed during intervention development, implementation and in a sustained phase. Additionally, they will be assessed in different services and over time. Assessed every 6 months until the end of the study.
Secondary outcome [7] 446187 0
Primary Outcome: Hospital re-admission
Timepoint [7] 446187 0
Readmission within 30 days post discharge and 180 days post discharge
Secondary outcome [8] 446189 0
Primary Outcome: Days alive out of hospital
Timepoint [8] 446189 0
Within first 30 days post discharge and 180 days post discharge.
Secondary outcome [9] 446375 0
Primary Outcome: Health Related Quality of Life
Timepoint [9] 446375 0
Measured prior to surgery (via perioperative service), 30 and 180days post discharge. Measured prior to surgical admission for elective patients after admission for emergency surgical patients.
Secondary outcome [10] 446190 0
Primary Outcome: Hospital acquired Complications (HAC) - as per The Australian Commission on Safety and Quality in Health Care Hospital Acquired Complications
Timepoint [10] 446190 0
During admission
Secondary outcome [11] 446191 0
Primary Outcome: Unplanned ICU admissions (number of days)
Timepoint [11] 446191 0
On completion of the study and data analysis

Eligibility
Key inclusion criteria
Eligible patients will be aged 65 years or older, or 45 years and older if Aboriginal and Torres Strait Islander and requiring admission of greater than 48 hours, consistent with the patient inclusion criteria specified in the model of care of the GPS.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the PROMs component of the study if:
-They have insufficient English literacy to complete the surveys.
-They lack the cognitive capacity to complete the PROMs surveys.
Patients in the above exclusion groups will still be able to participate if a surrogate is able to complete surveys on their behalf. The use of a surrogate and the reason for this will be noted as a data point of survey collection. As this is a geriatric population the use of surrogates is justified as the rate of cognitive decline is high and excluding this group is likely to adversely influence the generalisability of the findings.

Study design
Purpose of the study
Treatment
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/04/2025
Date of last participant enrolment
Anticipated
30/08/2027
Actual
Date of last data collection
Anticipated
30/12/2027
Actual
Sample size
Target
2100
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27687 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 43875 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 317710 0
Commercial sector/Industry
Name [1] 317710 0
HCF
Country [1] 317710 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Country
Australia
Secondary sponsor category [1] 320030 0
Commercial sector/Industry
Name [1] 320030 0
HCF Foundation
Address [1] 320030 0
Country [1] 320030 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316404 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316404 0
Ethics committee country [1] 316404 0
Australia
Date submitted for ethics approval [1] 316404 0
14/11/2024
Approval date [1] 316404 0
10/12/2024
Ethics approval number [1] 316404 0

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

Contacts
Principal investigator
Name 137782 0
A/Prof Christine O'Neill
Address 137782 0
Surgical Services John Hunter Hospital Locked Bag 1 Lookout Road New Lambton NSW 2305
Country 137782 0
Australia
Phone 137782 0
+61 249236397
Fax 137782 0
Email 137782 0
[email protected]
Contact person for public queries
Name 137783 0
Michelle Chapman
Address 137783 0
Surgical Services John Hunter Hospital Locked Bag 1 Lookout Road New Lambton NSW 2305
Country 137783 0
Australia
Phone 137783 0
+61407783742
Fax 137783 0
Email 137783 0
[email protected]
Contact person for scientific queries
Name 137784 0
Michelle Chapman
Address 137784 0
Surgical Services John Hunter Hospital Locked Bag 1 Lookout Road New Lambton NSW 2305
Country 137784 0
Australia
Phone 137784 0
+61407783742
Fax 137784 0
Email 137784 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.