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CompletedNCT03426072SCOPEUpdated Jul 18, 2022

Safer Care for Older People in (Residential) Environments

An interventional study of modified IHI breakthrough series in Nursing Homes, sponsored by University of Alberta. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2022-07-18.

Sponsored by University of Alberta · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Nursing Homes

Keywords

  • quality improvement
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    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.

    Other: modified IHI breakthrough series

  • No intervention
    Control

    The control units (propensity matched) have no intervention and form a naturalistic control

Interventions

  • Othermodified IHI breakthrough series

    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

05

What researchers measure

Primary outcomes

  1. Conceptual Research Use

    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

    Time frame: 1 year

Secondary outcomes

  1. Resident Assessment Index -minimal Data Set (RAI-MDS) factors

    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

    Time frame: change between intervention and control groups 1 year post intervention

  2. Staff outcomes

    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

    Time frame: change between intervention and control groups 1 year post intervention

06

Study locations

1 site
  • University of Alberta
    Edmonton, Alberta T6G 2P4, Canada
07

References and documents

Individual participant data

Plan to share: No — the data will be made available on request according to TREC data sharing policies

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03426072
Lead sponsor
University of Alberta
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Sponsor
First posted
Feb 8, 2018
Start date
Jan 4, 2018
Primary completion
May 30, 2020
Completion
May 30, 2020
Last update
Jul 18, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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