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Improving Services and Outcomes for Joint Replacement Patients

21 marca 2017 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

1900

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • 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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Inny: Observation
This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of participants experiencing the composite outcome up to 35 days post surgery.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient-reported quality of life
Ramy czasowe: 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
Ramy czasowe: 90 days post surgery
The number of patients treated with a documented blood clot
90 days post surgery
Incidence of deep infection.
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 90 days post surgery
The EQ5D will be used to capture patient-reported QoL
90 days post surgery
Health-related QoL
Ramy czasowe: 365 days post surgery
The EQ5D will be used to capture QoL
365 days post surgery
Patient reported joint pain and function
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Day of first ambulation attempt post surgery
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

South West Sydney Local Health District

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 sierpnia 2013

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2016

Ukończenie studiów (Rzeczywisty)

1 grudnia 2016

Daty rejestracji na studia

Pierwszy przesłany

10 lipca 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 lipca 2013

Pierwszy wysłany (Oszacować)

15 lipca 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 marca 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 marca 2017

Ostatnia weryfikacja

1 marca 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ISOAJRS_AU

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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