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Improving Services and Outcomes for Joint Replacement Patients

21 marzo 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1900

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: Observation
This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of participants experiencing the composite outcome up to 35 days post surgery.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-reported quality of life
Lasso di tempo: 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
Lasso di tempo: 90 days post surgery
The number of patients treated with a documented blood clot
90 days post surgery
Incidence of deep infection.
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 90 days post surgery
The EQ5D will be used to capture patient-reported QoL
90 days post surgery
Health-related QoL
Lasso di tempo: 365 days post surgery
The EQ5D will be used to capture QoL
365 days post surgery
Patient reported joint pain and function
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Day of first ambulation attempt post surgery
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

South West Sydney Local Health District

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2013

Completamento primario (Effettivo)

1 dicembre 2016

Completamento dello studio (Effettivo)

1 dicembre 2016

Date di iscrizione allo studio

Primo inviato

10 luglio 2013

Primo inviato che soddisfa i criteri di controllo qualità

10 luglio 2013

Primo Inserito (Stima)

15 luglio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ISOAJRS_AU

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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