- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03426072
Safer Care for Older People in (Residential) Environments (SCOPE)
Przegląd badań
Szczegółowy opis
The aim of this study is to assess the effects of a facilitation-based improvement intervention on three primary performance outcomes: (1) staff reported use of best practices, (2) measures of staff work engagement and job satisfaction, and (3) resident quality of care. Within the context of the Translating Research in Elder Care study (Pro00037937), the influence of staff characteristics related to work performance and unit context scores (leadership, culture, resources) on the three primary outcomes will be assessed Background Translating Research in Elder Care (TREC) is an ongoing applied research program that began in 2007. TREC is focused on practical solutions that will improve quality of care provided to nursing home residents, enrich the work life of their caregivers, and enhance system efficiencies and effectiveness. In TREC 1, teams of researchers worked together with decision makers from the residential long term care (LTC) sector on multiple studies in Manitoba, Saskatchewan, Alberta and to a lesser extent, British Columbia (SCOPE pilot only). Data were collected from approximately 4000 care providers and residents using the Resident Assessment Index Minimum data Set (RAI-MDS) 2.0 in participating TREC nursing homes.
TREC has already established its value to the health system by demonstrating improvements in resident care, clinical outcomes, and staff well-being. Information data collected from over 100,500 resident assessments combined with the staff and facility surveys now forms the TREC Measurement System (TMS Project). This wealth of data has informed the SCOPE pilot project in 2010 and SCOPE was conceived as a result of this data.
The SCOPE intervention is designed as a randomized controlled trial (RCT). For our primary outcome measure (change in Conceptual Research Use (CRU)between pre and post intervention periods) a sample size of 34 units per arm is adequate to detect an effect size of 0.67 or greater (using the standard deviation for the change in CRU between pre and post intervention periods for intervention and non-intervention from the SCOPE pilot data at 80% power, with an alpha 0.05, for a 2-tailed comparison of independent samples. The intervention will take place in as many as 45 of the facilities involved in the TMS project (Pro00037937) to take account of drop -outs. Each facility will have a Senior Sponsor (generally the Director of Care or Exec Director). Participants in the intervention teams will be from a single unit in each intervention facility and will include 3 Health Care Aides who will lead the team, as well as 2 other members of that unit which can include other allied professional staff, nurses, and Occupational Therapist /Rec Aides. One member of the team must be the Team sponsor (generally the unit's care manager) removes obstacles for the team.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Alberta
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Edmonton, Alberta, Kanada, T6G 2P4
- University of Alberta
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
Facilities must be a part of TMS to be eligible for SCOPE. This means that they are:
- A nursing home or residential long term care facility which provides 24-hour on-site housing and health care services care for older adults by professional (nursing) staff and others
- Registered with the provincial government
- 90% of residents aged 65 or over
- RAI-MDS 2.0 implemented since January 2011
- Facility operations conducted in the English language
Urban* facilities located within designated health regions and within 110 km of the TREC-designated hub for the health region:
- Fraser Health Authority (Hub is New Westminster)
- Interior Health Authority (Hubs are Kelowna, Kamloops)
- Alberta (AHS): Edmonton and Calgary Zones (Edmonton & Calgary are hubs)
Exclusion Criteria:
- Facilities that have participated in the SCOPE pilot study (Pro00012517)
Facilities integrated with acute care. Defined as residential long-term care facility (usually one or more resident units) that:
- Are physically located within an acute care facility and
- Share central services (e.g., human resources, laundry), as well as, other functions integral to care delivery such as staffing, supervision, performance management, etc.)
- Co-located services (where the daily operations of the resident units are managed separately and staff independently) are acceptable
- Facilities with more than one sub-acute (e.g., orthopaedic rehab) unit
- Facilities with fewer than 35 long-term care beds
- Facilities which are expected to undergo major change within the next two years
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: modified IHI breakthrough series
The SCOPE intervention is a complex, "high facilitation", multi-component intervention operating at the microsystem (resident care unit) level of the organization and is designed to engage, develop, and equip Health Care Aides to implement improvement initiatives.
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There are five main elements to the intervention:
5. The concluding session is an opportunity for networking, sharing successes and making plans for the continuation of project work following the end of formal support |
Brak interwencji: Control
The control units (propensity matched) have no intervention and form a naturalistic control
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Conceptual Research Use
Ramy czasowe: 1 year
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Conceptual use of best practices: indirect measure of application of research and best practices measured by a 5 item scale.
BMC Health Services Research 2011; 11:107 demonstrating acceptable validity and reliability
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1 year
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Resident Assessment Index -minimal Data Set (RAI-MDS) factors
Ramy czasowe: change between intervention and control groups 1 year post intervention
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Resident outcome data obtained from quarterly RAI-MDS 2.0 reports, examined as the change in the quality indicator worked upon (e.g., pressure ulcers, pain, declining behaviour) between baseline and study end
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change between intervention and control groups 1 year post intervention
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Staff outcomes
Ramy czasowe: change between intervention and control groups 1 year post intervention
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Staff (healthcare aide) outcomes of work engagement, burnout, empowerment, organizational citizenship behaviours and job satisfaction.
We will assess baseline performance using the Rantz Observable Indicators of Quality survey
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change between intervention and control groups 1 year post intervention
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- SCOPE ABBC
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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