Improving Services and Outcomes for Joint Replacement Patients

• ClinicalTrials.gov Identifier: NCT01899443
• Recruitment Status: Completed
• First Posted: July 15, 2013
• Last Update Posted: March 24, 2017
• Sponsor: South West Sydney Local Health District
• Information provided by (Responsible Party): Justine Naylor, South West Sydney Local Health District

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Osteoarthritis	Other: Observation

Detailed 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
5. description of ambulation profiles immediately post surgery and variables associated with early ambulation
6. snapshot of rehabilitation received after TKA or THA

Study Design

• Study Type: Observational
• Actual Enrollment: 1900 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Improving Services and Outcomes for Joint Replacement Patients
• Study Start Date: August 2013
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: December 2016

Groups and Cohorts

Group/Cohort	Intervention/treatment
Total hip and knee replacement patients; 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.	Other: Observation; This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.

Outcome Measures

Primary Outcome Measures :

1. Percentage of participants experiencing the composite outcome up to 35 days post surgery. [ Time Frame: 35 days post total hip or knee replacement surgery ]
   The proportion of patients in each group (compliant and non-compliant groups) that experience one or more of the following outcomes - death, readmission, reoperation or surgical complication - up to 35 days post-surgery. Analyses will adjust for patient and service provider confounders.

Secondary Outcome Measures :

1. Patient-reported quality of life [ Time Frame: 35 days post surgery ]
   The EuroQual 5-level (EQ5D) assessment will be used to capture patient-reported quality of life.
2. Incidence of venous thromboembolism [ Time Frame: 90 days post surgery ]
   The number of patients treated with a documented blood clot
3. Incidence of deep infection. [ Time Frame: 365 days post surgery ]
   The number of patients with a documented deep infection. That is, were treated with intravenous antibiotics for their index joint, was readmitted to hospital, and/or had a joint washout.
4. Costs of care processes [ Time Frame: 90 days post surgery ]
   The cost of individual care processes, the cost of healthcare utilisation post discharge from acute care, carer costs and cost of time off work will be calculated for each person. Data will be collected using patient diaries and derived from the acute care study data.
5. Patient reported quality of life (QoL) [ Time Frame: 90 days post surgery ]
   The EQ5D will be used to capture patient-reported QoL
6. Health-related QoL [ Time Frame: 365 days post surgery ]
   The EQ5D will be used to capture QoL
7. Patient reported joint pain and function [ Time Frame: 90 days post surgery ]
   The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function.
8. Patient reported joint pain and function [ Time Frame: 365 days post surgery ]
   The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function

Other Outcome Measures:

1. Day of first ambulation attempt post surgery [ Time Frame: day 0-14 post-surgery ]

   The first post-operative day the patient walked, including any partial or full weight-bearing activities such as walking on the spot, bed-to-chair and bed-to-toilet).

   first post-operative day that patients walked, including any partial or full weight-bearing activities 134

   such as walking on the spot, bed-to-chair and bed-to-toilet).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients undergoing primary total hip or knee replacement in private or public hsopitals in Australia

Criteria

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

Contacts and Locations

Locations

Australia, New South Wales

Concealed site 4 Public

Rural, New South Wales, Australia

Concealed site 6 Private

Rural, New South Wales, Australia

Concealed site 8 Private

Rural, New South Wales, Australia

Concealed site 16 Public

Semi Rural, New South Wales, Australia

Concealed site 1 Public

Sydney, New South Wales, Australia

Concealed site 17 Private

Sydney, New South Wales, Australia

Concealed site 2 Public

Sydney, New South Wales, Australia

Concealed Site 3 Public

Sydney, New South Wales, Australia

Concealed site 5 Private

Sydney, New South Wales, Australia

Concealed site 7 Private

Urban, New South Wales, Australia

Australia, Queensland

Concealed site 15 Public

Rural, Queensland, Australia

Concealed site 13 Private

Urban, Queensland, Australia

Concealed site 14 Public

Urban, Queensland, Australia

Australia, South Australia

Concealed site 12 Private

Urban, South Australia, Australia

Australia, Tasmania

Concealed site 11 Private

Urban, Tasmania, Australia

Australia, Victoria

Concealed site 9 Private

Melbourne, Victoria, Australia

Concealed site 10 Public

Urban, Victoria, Australia

Concealed site 18 - 2 Public sites

Urban, Victoria, Australia

Sponsors and Collaborators

South West Sydney Local Health District

Investigators

• Principal Investigator: Justine M Naylor, PhD,BAppSc (Phty); Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
• Principal Investigator: Ian A Harris, PhD,MBBS; Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
• Principal Investigator: Helen M Badge, MApSc,BAScOT; Ingham Institute for Applied Medical Research, University of NSW
• Principal Investigator: Wei Xuan, PhD; Ingham Institute Applied Medical Research
• Principal Investigator: Christine Lin, PhD, BApScPhty; George Institute, University of Syndey, Australia
• Principal Investigator: Elizabeth Armstrong, BAppScPhty; University of NSW, Sydney, Australia
• Principal Investigator: Kevin Bozic, MD MBA; University of California, San Francisco
• Principal Investigator: John Fletcher, PhD, MBBS; University of Sydney, Australia
• Principal Investigator: Iain Gosbell, PhD, MBBS; University of Western Sydney, Australia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Johns N, Naylor J, McKenzie D, Brady B, Olver J. Is inpatient rehabilitation a predictor of a lower incidence of persistent knee pain 3-months following total knee replacement? A retrospective, observational study. BMC Musculoskelet Disord. 2022 Sep 12;23(1):855. doi: 10.1186/s12891-022-05800-0.

Naylor JM, Hart A, Mittal R, Harris IA, Xuan W. The effectiveness of inpatient rehabilitation after uncomplicated total hip arthroplasty: a propensity score matched cohort. BMC Musculoskelet Disord. 2018 Jul 18;19(1):236. doi: 10.1186/s12891-018-2134-3.

• Responsible Party: Justine Naylor, Senior Principal Research Fellow; Director, South West Sydney Local Health District
• ClinicalTrials.gov Identifier: NCT01899443
• Other Study ID Numbers: ISOAJRS_AU
• First Posted: July 15, 2013
• Last Update Posted: March 24, 2017
• Last Verified: March 2017

Keywords provided by Justine Naylor, South West Sydney Local Health District:

total hip replacement; total knee replacement; patient outcomes; health services research

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases