Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment observation
Sponsor South West Sydney Local Health District
Start date August 2013
End date December 2016
Trial size 2200 participants
Trial identifier NCT01899443, ISOAJRS_AU

Summary

Primary total knee or total hip replacement surgeries are costly high volume procedures & outcomes may be affected by surgical & care processes & individual patient characteristics. The primary hypotheses is that non compliance with recommended practice impacts patient outcomes (e.g. the likelihood of complications following surgery). The primary aims of the study are to evaluate the links between processes & outcomes & if possible develop a model that will improve patient outcomes & reduce unnecessary practice variation whilst considering costs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
This study will select up to 20 high volume (>275 cases annually) public and private hospitals across Australia. A random sample of c.2200 patients with diagnosis of osteoarthritis undergoing primary total hip or knee replacement surgery will be recruited.
observation
This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.

Primary Outcomes

Measure
Percentage of participants experiencing the composite outcome up to 35 days post surgery.
time frame: 35 days post total hip or knee replacement surgery

Secondary Outcomes

Measure
Patient-reported quality of life
time frame: 35 days post surgery
Incidence of venous thromboembolism
time frame: 90 days post surgery
Incidence of deep infection.
time frame: 365 days post surgery
Costs of care processes
time frame: 90 days post surgery
Patient reported quality of life (QoL)
time frame: 90 days post surgery
Health-related QoL
time frame: 365 days post surgery
Patient reported joint pain and function
time frame: 90 days post surgery
Patient reported joint pain and function
time frame: 365 days post surgery

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Primary elective unilateral or bilateral total knee arthroplasty (TKA) or total hip arthroplasty (THA) - Primary diagnosis of osteoarthritis - Aged 18 or over, either gender - Able to comprehend the protocol and provide consent (e.g. be able to read English, have no history of dementia) - Available for telephone follow-up within the first 6 weeks, 3 months and then at 12 months post surgery - No further joint replacement surgery planned within the next 3 months of the current surgery Exclusion Criteria: - Cognitive impairment / history of dementia - Hip replacement for fracture - Revision of previous joint replacement - Under 18 years of age

Additional Information

Official title Improving Services and Outcomes for Joint Replacement Patients
Principal investigator Justine M Naylor, PhD,BAppSc (Phty)
Description The primary aim of the study is to identify whether compliance with specific processes is associated with better outcomes. The study is a longitudinal cohort study to examine outcomes after total hip and knee replacement surgeries. We hypothesise the site and patient level compliance is related to the prevalence of a subsequent complication (composite outcome comprising 30 day mortality, readmission, reoperation or surgical complication). METHODS This study will select high volume (>275 cases annually) public and private hospitals across Australia. By involving public and private sites across Australia, the generalisability of the findings is enhanced. Each site will identify a site coordinator to oversee and manage the project at that site. Site coordinators are identified by each site. After hospital discharge, patients are followed up by the investigators. This is a prospective observational study with projected sample of c.2200 consenting patients from up to 20 high volume hospitals. The site coordinator will screen, approach and consent eligible patients during routine preadmission processes. At the time of consent, the patient will be required to: provide socio-demographic details about themselves, past medical history, complete 2 standard patient reported outcome measures. Contact with patients about the study will be made by the site coordinator and routine hospital staff involved in their acute care. Acute data collection will involve prospective audit of medical records to collect peri- and post- operative acute care process data, client characteristics and outcomes by staff at each site. Random and convenience sampling will be used to identify eligible hospital sites which will remain anonymous. Patient follow up regarding longer term outcomes will be completed via telephone by study investigators at three additional time points (approximately 35 and 90 days and 1 year post surgery) to collect repeat data as provided by each patient at the time of consent. Descriptive statistics will be used to profile site level and patient level compliance with key processes of care. Multivariable logistic regression (MLoR) will be used to identify the association between the binary composite outcome measure and patient level compliance. Site and individual patient compliance with evidence based guidelines (where available) or best practice recommendations on key processes and relevant outcomes will be examined (e.g. Venous thromboembolism (VTE) prevention). Sample size calculations have been completed to ensure the analyses have sufficient power. If a useful association between processes and outcomes is identified, cost analyses with specific foci will be undertaken to consider costs for different factors and stages (e.g. acute / post discharge). Secondary analysis will determine the predictors of patient -reported outcomes. Depending on the results of initial data analyses, additional secondary analyses will potentially include analyses at additional time points (beyond initial 35 days) for association between key processes and outcomes, and analysis looking at the association between specific complications and compliance with specific processes. Interim analysis will be undertaken to assess the level of observed compliance with key processes. Re-abstraction of acute care data will be undertaken to ensure accuracy and completeness of submitted date from the sites. Site survey Prior to study commencement at each site, the site coordinators will complete a survey detailing each surgeons protocols for key processes including their VTE and antimicrobial prophylaxes. The extent surgeon protocols align with Australian practice guidelines will be ascertained. Additional secondary analyses will include, but may not be limited to: 1. a comparison of outcomes between patients who go to inpatient rehabilitation and those who go directly home after surgery. Propensity based scoring and matching will be used to determine if outcomes are better in one of the two groups 2. determination of the predictors of the 'unhappy knee' 12 months post surgery. A case controlled matched design will be used. 3. comparison in satisfaction with the acute care experience between private and public patients in a subset 4. a comparison of outcomes between THR patients with an anterior surgical approach and a posterior approach
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by South West Sydney Local Health District.