Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000237785
Ethics application status
Approved
Date submitted
25/01/2022
Date registered
10/02/2022
Date last updated
7/09/2023
Date data sharing statement initially provided
10/02/2022
Date results information initially provided
10/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a tailored pathway for frail and pre frail older people awaiting elective hip or knee arthroplasty
Scientific title
Evaluation of a tailored pathway on postoperative length of stay in frail and pre frail older people awaiting elective hip or knee arthroplasty
Secondary ID [1] 306271 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective knee replacement
 325022 0
Elective hip replacement 325134 0
Condition category
Condition code
Musculoskeletal 322458 322458 0 0
Other muscular and skeletal disorders
Public Health 322540 322540 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
POPS (Perioperative care of Older People undergoing Surgery) service was established in our local hospital in October 2018. The aim of the service is to identify frail individuals awaiting hip and knee arthroplasty and provide tailored treatment derived from comprehensive geriatric assessment and a 6-weeks centre based exercise program as prehabilitation as standard of care. We aim to evaluate the effect of geriatrician-led comprehensive geriatric assessment and tailored exercise program on post-operative outcomes and length of stay (LOS). The individuals were seen at our POPS @NALHN service between October 2018 to December 2019

Patient's case notes and electronic medical records were retrospectively accessed, with no patient contact involved. Records were accessed from the duration of their first clinic visit to up to 1 month post-hospital discharge.

The primary outcome was post-operative length of stay following POPS service intervention. Secondary outcomes assessed were post-operative medical complications, surgical complications, discharge destination and readmissions within 30 days
Intervention code [1] 322695 0
Diagnosis / Prognosis
Comparator / control treatment
Post-operative length of stay and complications in individuals who underwent elective hip and knee replacement between July 2017 and September 2018- before the implementation of POPS service ,
Patient's case notes and electronic medical records were retrospectively accessed, with no patient contact involved. Records were accessed from the duration of their hospital stay and up to 1 month post-hospital discharge
Control group
Historical

Outcomes
Primary outcome [1] 330243 0
Post-operative length of stay following intervention at POPS clinic
Patient's case notes and electronic medical records were retrospectively accessed, with no patient contact involved.
Timepoint [1] 330243 0
Assessed at the time of hospital discharge
Secondary outcome [1] 405395 0
Post-operative medical complications ( composite)
- Acute renal failure, acute coronary syndrome, anaemia, cardiac arrhythmia, delirium, deep vein thrombosis, electrolytes abnormalities, inadequate pain control, pulmonary embolism, stroke, respiratory failure, pneumonia, urinary tract infection, high dependency unit/intensive care unit admission

Patient's case notes, electronic medical records, blood test investigations and medical imaging results were retrospectively accessed to look at the total incidence of postoperative medical complications as listed above.
Timepoint [1] 405395 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [2] 405396 0
Post-operative surgical complications (composite)
- Bleeding, fracture, dislocation, infection

Incidence of post-operative surgical complications (bleeding, fracture, dislocation, infection) assessed by accessing documentation within patient electronic medical records and case notes review
Timepoint [2] 405396 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [3] 405419 0
Post operative medical complication
- anaemia

Incidence of post-operative anaemia assessed by accessing full blood count results within patient electronic medical records,
Timepoint [3] 405419 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [4] 405420 0
Post operative medical complication
- pulmonary embolism

Incidence of post-operative pulmonary embolism assessed by accessing imaging results and documentation within patient electronic medical records and case notes review
Timepoint [4] 405420 0
Assessed from the time of surgery to hospital discharge,
Secondary outcome [5] 405421 0
Post operative medical complication
-deep vein thrombosis

Incidence of post-operative deep vein thrombosis assessed by accessing imaging results and documentation within patient electronic medical records and case notes review
Timepoint [5] 405421 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [6] 405422 0
Post operative medical complication
- Stroke

Incidence of post-operative stroke assessed by accessing imaging results and documentation within patient electronic medical records and case notes review
Timepoint [6] 405422 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [7] 405423 0
Post operative medical complication
-delirium
Incidence of post-operative delirium assessed by accessing documentation within patient electronic medical records and case notes review
Timepoint [7] 405423 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [8] 405424 0
Post operative medical complication
-pneumonia
Incidence of post-operative pneumonia assessed by accessing imaging results and documentation within patient electronic medical records and case notes review
Timepoint [8] 405424 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [9] 405425 0
Post operative medical complication
-Respiratory failure
Incidence of post-operative respiratory failure assessed by accessing documentation and arterial blood gas results within patient electronic medical records and case notes review
Timepoint [9] 405425 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [10] 405426 0
Need for high dependency unit/intensive care unit admission post operatively (composite)
- This will be assessed by accessing documentation within patient electronic medical records and case notes review
Timepoint [10] 405426 0
Assessed over the duration of hospital admission
Secondary outcome [11] 405427 0
Post operative medical complication
- acute coronary syndrome
Incidence of post-operative acute coronary syndrome assessed by accessing documentation and blood test results within patient electronic medical records and case notes review
Timepoint [11] 405427 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [12] 405428 0
Post operative medical complication
- cardiac arrhythmia
Incidence of post-operative cardiac arrhythmias assessed by accessing electrocardiography results and documentation within patient electronic medical records and case notes review
Timepoint [12] 405428 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [13] 405429 0
Post operative medical complication
-inadequate pain control

Incidence of inadequate pain control post-operatively assessed by accessing numerical rating scale results and documentation within patient electronic medical records and case notes review
Timepoint [13] 405429 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [14] 405430 0
Post operative medical complication
-urinary tract infection

Incidence of post-operative urinary tract infection assessed by accessing urinalysis results within patient electronic medical records and case notes review
Timepoint [14] 405430 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [15] 405431 0
Post operative medical complication
- Electrolyte abnormalities

Incidence of post-operative electrolyte abnormalities assessed by accessing blood test electrolyte results within patient electronic medical records
Timepoint [15] 405431 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [16] 405432 0
Post operative medical complication
- acute renal failure

Incidence of post-operative acute renal failure assessed by accessing blood renal function test results within patient electronic medical records
Timepoint [16] 405432 0
Assessed from the time of surgery to hospital discharge
Secondary outcome [17] 405433 0
Discharge destination
- Discharge destination assessed by accessing documentation within patient electronic medical records and case notes review
Timepoint [17] 405433 0
At the time of hospital discharge
Secondary outcome [18] 405434 0
Readmission within 30 days from discharge from hospital assessed by accessing patient electronic medical records and case notes review
Timepoint [18] 405434 0
Assessed from the time of hospital discharge to 30 days post-discharge

Eligibility
Key inclusion criteria
Inclusion criteria for both groups (intervention and control) included patients who patients who underwent elective total hip replacement (THR) or total knee replacement (TKR), with age 65 years and above and CFS of 4 or greater. Those who underwent upper limb arthroplasty or ankle arthroplasty were excluded.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Baseline characteristics of patients who had surgery were summarised as mean (standard deviation) for continuous variable and as count and percentages (%) for categorical variables. Independent-t test was used to compare continuous variables and Chi-squared test for categorical variables. Fisher’s exact test was used when the expected frequency was less than 5. Baseline characteristics of the POPS clinic patients who did not have surgery were also compared with the ones who had surgery.

Negative binomial regression analysis was performed for the comparison in LOS and the number of complication events, between intervention and control group, with the effect expressed as incidence rate ratios (IRR) and their 95% confidence intervals (CI). The number of medical complication events was calculated by summing the number of medical complications, whereas the number of postoperative complication events was calculated by summing all surgical and medical complications combined. Binary logistic regression analysis was undertaken for comparison between the two groups with regard to other post-operative outcomes, HDU/ICU admissions and 30-day readmissions, with the effect expressed as odds ratios (OR) and their 95% CI. Both unadjusted and adjusted analyses were performed, with adjustment for potential confounders namely age, gender, CFS, and type of surgery (TKR/THR).. A Firth correction was performed on binary logistic models when a usual binary logistic model did not converge. A Fisher’s exact test was used to assess the significance of the association between intervention and discharge destination.

Univariate binary logistic regression analysis of the predictors for prolonged stay (defined as LOS > 4 days) was performed in the control group only, presenting odds ratio, 95% CI and P values . All predictor variables with P value <0.2 on univariate regression were included in an initial multivariable binary logistic model. Backwards elimination was performed, removing the variable with the highest P value one model at a time, until all P values<0.2. P value of less than or equal than 0.05 was considered to be statistically significant.

All analyses were performed using Stata/IC 15.1 (StataCorp LLC, College Station, Texas, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/12/2019
Date of last participant enrolment
Anticipated
Actual
15/07/2020
Date of last data collection
Anticipated
Actual
15/07/2020
Sample size
Target
60
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21562 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 36471 0
5092 - Modbury

Funding & Sponsors
Funding source category [1] 310621 0
Hospital
Name [1] 310621 0
Northern Adelaide Local Health Network (NALHN) Department of Geriatrics Medicine
Country [1] 310621 0
Australia
Primary sponsor type
Hospital
Name
Northern Adelaide Local health Network (NALHN) Department of Geriatrics Medicine
Address
Modbury hospital,
Smart Road, Modbury, SA 5092
Country
Australia
Secondary sponsor category [1] 311827 0
None
Name [1] 311827 0
Address [1] 311827 0
Country [1] 311827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310225 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
Ethics committee address [1] 310225 0
RAH clinical Trial Centre, Wayfinder 3D460.02, Level 3, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000.
Ethics committee country [1] 310225 0
Australia
Date submitted for ethics approval [1] 310225 0
Approval date [1] 310225 0
10/12/2019
Ethics approval number [1] 310225 0
12361
Ethics committee name [2] 310226 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
Ethics committee address [2] 310226 0
RAH clinical Trial Centre, Wayfinder 3D460.02, Level 3, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000.
Ethics committee country [2] 310226 0
Australia
Date submitted for ethics approval [2] 310226 0
Approval date [2] 310226 0
10/12/2019
Ethics approval number [2] 310226 0
12433

Summary
Brief summary
The objective of this study is to evaluate the effect of multi-domain tailored interventions administered through a POPS (Perioperative care of Older People undergoing Surgery) service among patients with varying degrees of frailty awaiting elective hip or knee arthroplasty on post-operative complications and length of stay. We aim to improve our understanding of how individual characteristics, frailty and comorbidities may have an impact on post-operative outcomes.

We hypothesised that a geriatrican-led preoperative comprehensive geriatric assessment (CGA), combined with targeted interventions, along with 6 weeks centre-based exercise program as prehabilitation, would reduce post-operative complications and hence length of stay in older individuals undergoing elective arthroplasty surgery.

This was retrospective observational study comparing a post intervention cohort with historic controls. Patients aged 65 years or older with a Clinical Frailty Scale (CFS) of 4 or greater, who were awaiting elective knee or hip replacement surgery were evaluated in our POPS @NALHN service between October 2018 to December 2019. Post-operative outcomes were compared with individuals who underwent joint replacement surgery between July 2017 to September 2018 without any pre-operative interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116914 0
Dr Bianca Wong
Address 116914 0
Modbury hospital
Smart Rd, Modbury SA 5092
Country 116914 0
Australia
Phone 116914 0
+61 08 73214228
Fax 116914 0
Email 116914 0
bianca.wong@sa.gov.au
Contact person for public queries
Name 116915 0
Dr Ning Ning Choo
Address 116915 0
Hampstead Rehabilitation Centre, Regional Building
207-235 Hampstead Road
Lightsview, SA, 5085
Country 116915 0
Australia
Phone 116915 0
+61 08 82221429
Fax 116915 0
Email 116915 0
ningning.choo@sa.gov.au
Contact person for scientific queries
Name 116916 0
Dr Ning Ning Choo
Address 116916 0
Hampstead Rehabilitation Centre, Regional Building
207-235 Hampstead Road
Lightsview, SA, 5085
Country 116916 0
Australia
Phone 116916 0
+61 08 82221429
Fax 116916 0
Email 116916 0
ningning.choo@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Ning Ning Choo, Alice Bourke, Bianca Kar Man Wong,... [More Details]

Documents added automatically
No additional documents have been identified.