Improving Services and Outcomes for Joint Replacement Patients
Visão geral do estudo
Descrição detalhada
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:
- 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
- determination of the predictors of the 'unhappy knee' 12 months post surgery. A case controlled matched design will be used.
- comparison in satisfaction with the acute care experience between private and public patients in a subset
- a comparison of outcomes between THR patients with an anterior surgical approach and a posterior approach
- description of ambulation profiles immediately post surgery and variables associated with early ambulation
- snapshot of rehabilitation received after TKA or THA
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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New South Wales
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Rural, New South Wales, Austrália
- Concealed site 4 Public
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Rural, New South Wales, Austrália
- Concealed site 6 Private
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Rural, New South Wales, Austrália
- Concealed site 8 Private
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Semi Rural, New South Wales, Austrália
- Concealed site 16 Public
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Sydney, New South Wales, Austrália
- Concealed site 1 Public
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Sydney, New South Wales, Austrália
- Concealed site 17 Private
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Sydney, New South Wales, Austrália
- Concealed site 2 Public
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Sydney, New South Wales, Austrália
- Concealed Site 3 Public
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Sydney, New South Wales, Austrália
- Concealed site 5 Private
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Urban, New South Wales, Austrália
- Concealed site 7 Private
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Queensland
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Rural, Queensland, Austrália
- Concealed site 15 Public
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Urban, Queensland, Austrália
- Concealed site 13 Private
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Urban, Queensland, Austrália
- Concealed site 14 Public
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South Australia
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Urban, South Australia, Austrália
- Concealed site 12 Private
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Tasmania
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Urban, Tasmania, Austrália
- Concealed site 11 Private
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Victoria
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Melbourne, Victoria, Austrália
- Concealed site 9 Private
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Urban, Victoria, Austrália
- Concealed site 10 Public
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Urban, Victoria, Austrália
- Concealed site 18 - 2 Public sites
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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.
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This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of participants experiencing the composite outcome up to 35 days post surgery.
Prazo: 35 days post total hip or knee replacement surgery
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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.
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35 days post total hip or knee replacement surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient-reported quality of life
Prazo: 35 days post surgery
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The EuroQual 5-level (EQ5D) assessment will be used to capture patient-reported quality of life.
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35 days post surgery
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Incidence of venous thromboembolism
Prazo: 90 days post surgery
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The number of patients treated with a documented blood clot
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90 days post surgery
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Incidence of deep infection.
Prazo: 365 days post surgery
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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.
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365 days post surgery
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Costs of care processes
Prazo: 90 days post surgery
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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.
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90 days post surgery
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Patient reported quality of life (QoL)
Prazo: 90 days post surgery
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The EQ5D will be used to capture patient-reported QoL
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90 days post surgery
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Health-related QoL
Prazo: 365 days post surgery
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The EQ5D will be used to capture QoL
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365 days post surgery
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Patient reported joint pain and function
Prazo: 90 days post surgery
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The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function.
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90 days post surgery
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Patient reported joint pain and function
Prazo: 365 days post surgery
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The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function
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365 days post surgery
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Day of first ambulation attempt post surgery
Prazo: day 0-14 post-surgery
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Justine M Naylor, PhD,BAppSc (Phty), Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
- Investigador principal: Ian A Harris, PhD,MBBS, Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
- Investigador principal: Helen M Badge, MApSc,BAScOT, Ingham Institute for Applied Medical Research, University of NSW
- Investigador principal: Wei Xuan, PhD, Ingham Institute Applied Medical Research
- Investigador principal: Christine Lin, PhD, BApScPhty, George Institute, University of Syndey, Australia
- Investigador principal: Elizabeth Armstrong, BAppScPhty, University of NSW, Sydney, Australia
- Investigador principal: Kevin Bozic, MD MBA, University of California, San Francisco
- Investigador principal: John Fletcher, PhD, MBBS, University of Sydney, Australia
- Investigador principal: Iain Gosbell, PhD, MBBS, University of Western Sydney, Australia
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ISOAJRS_AU
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Ensaios clínicos em Observation
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IRCCS Eugenio MedeaMassachusetts Institute of Technology; Politecnico di MilanoConcluído