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Improving Services and Outcomes for Joint Replacement Patients

21 mars 2017 uppdaterad av: Justine Naylor, South West Sydney Local Health District
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Observationell

Inskrivning (Faktisk)

1900

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
    • New South Wales
      • Rural, New South Wales, Australien
        • Concealed site 4 Public
      • Rural, New South Wales, Australien
        • Concealed site 6 Private
      • Rural, New South Wales, Australien
        • Concealed site 8 Private
      • Semi Rural, New South Wales, Australien
        • Concealed site 16 Public
      • Sydney, New South Wales, Australien
        • Concealed site 1 Public
      • Sydney, New South Wales, Australien
        • Concealed site 17 Private
      • Sydney, New South Wales, Australien
        • Concealed site 2 Public
      • Sydney, New South Wales, Australien
        • Concealed Site 3 Public
      • Sydney, New South Wales, Australien
        • Concealed site 5 Private
      • Urban, New South Wales, Australien
        • Concealed site 7 Private
    • Queensland
      • Rural, Queensland, Australien
        • Concealed site 15 Public
      • Urban, Queensland, Australien
        • Concealed site 13 Private
      • Urban, Queensland, Australien
        • Concealed site 14 Public
    • South Australia
      • Urban, South Australia, Australien
        • Concealed site 12 Private
    • Tasmania
      • Urban, Tasmania, Australien
        • Concealed site 11 Private
    • Victoria
      • Melbourne, Victoria, Australien
        • Concealed site 9 Private
      • Urban, Victoria, Australien
        • Concealed site 10 Public
      • Urban, Victoria, Australien
        • Concealed site 18 - 2 Public sites

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Övrig: Observation
This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of participants experiencing the composite outcome up to 35 days post surgery.
Tidsram: 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.
35 days post total hip or knee replacement surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient-reported quality of life
Tidsram: 35 days post surgery
The EuroQual 5-level (EQ5D) assessment will be used to capture patient-reported quality of life.
35 days post surgery
Incidence of venous thromboembolism
Tidsram: 90 days post surgery
The number of patients treated with a documented blood clot
90 days post surgery
Incidence of deep infection.
Tidsram: 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.
365 days post surgery
Costs of care processes
Tidsram: 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.
90 days post surgery
Patient reported quality of life (QoL)
Tidsram: 90 days post surgery
The EQ5D will be used to capture patient-reported QoL
90 days post surgery
Health-related QoL
Tidsram: 365 days post surgery
The EQ5D will be used to capture QoL
365 days post surgery
Patient reported joint pain and function
Tidsram: 90 days post surgery
The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function.
90 days post surgery
Patient reported joint pain and function
Tidsram: 365 days post surgery
The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function
365 days post surgery

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Day of first ambulation attempt post surgery
Tidsram: 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).
day 0-14 post-surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

South West Sydney Local Health District

Utredare

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

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2013

Primärt slutförande (Faktisk)

1 december 2016

Avslutad studie (Faktisk)

1 december 2016

Studieregistreringsdatum

Först inskickad

10 juli 2013

Först inskickad som uppfyllde QC-kriterierna

10 juli 2013

Första postat (Uppskatta)

15 juli 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 mars 2017

Senast verifierad

1 mars 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ISOAJRS_AU

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