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Safer Care for Older People in (Residential) Environments (SCOPE)

15 juli 2022 uppdaterad av: University of Alberta
The overall aim of the program is to advance knowledge translation science in order to improve clinical and staff related outcomes in long term care facilities (nursing homes) in western Canada. SCOPE will assess the effect of Care Aide led Quality Improvement efforts on staff quality of work life as well as resident quality of care. A key element of SCOPE is a leadership development stream which introduces complexity science and education on quality improvement which aims to support front line teams with their improvement initiative

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

32

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studieorter

    • Alberta
      • Edmonton, Alberta, Kanada, T6G 2P4
        • University of Alberta

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

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

There are five main elements to the intervention:

  1. Establishment of the team and set up
  2. Establishing baseline performance and knowledge
  3. Ongoing developmental support
  4. Learning sessions (3)
  5. Action periods (3)
  6. The actual facilitative actions (e.g., coaching, guiding, mentoring, supporting) occur in combination with limited teaching, largely during telephone conferences but also in any visit, which may occur up to quarterly.

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

Inget ingripande: Control
The control units (propensity matched) have no intervention and form a naturalistic control

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Conceptual Research Use
Tidsram: 1 year
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
1 year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Resident Assessment Index -minimal Data Set (RAI-MDS) factors
Tidsram: change between intervention and control groups 1 year post intervention
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
change between intervention and control groups 1 year post intervention
Staff outcomes
Tidsram: change between intervention and control groups 1 year post intervention
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
change between intervention and control groups 1 year post intervention

Samarbetspartners och utredare

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

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 (Faktisk)

4 januari 2018

Primärt slutförande (Faktisk)

30 maj 2020

Avslutad studie (Faktisk)

30 maj 2020

Studieregistreringsdatum

Först inskickad

1 februari 2018

Först inskickad som uppfyllde QC-kriterierna

1 februari 2018

Första postat (Faktisk)

8 februari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 juli 2022

Senast verifierad

1 april 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • SCOPE ABBC

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

the data will be made available on request according to TREC data sharing policies

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Vårdhem

Kliniska prövningar på modified IHI breakthrough series

  • George Washington University
    Stanford University; Gordon and Betty Moore Foundation; West Virginia University... och andra samarbetspartners
    Avslutad
    Njursjukdomar | Kroniska njursjukdomar | Njursjukdom i slutskedet | Slutstadiet av njursjukdom vid dialys | Kronisk njursjukdom som kräver kronisk dialys
    Förenta staterna
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