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Nursing HomesSCOPENCT03426072

Safer Care for Older People in (Residential) Environments

A study testing modified IHI breakthrough series in people with Nursing Homes, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Nursing Homes
What is being tested?
modified IHI breakthrough series
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteCanada
Study dates
4 Jan 2018to 30 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G 2P4

Other trials in Canada

About this study

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.

Conditions
Nursing Homes
Being tested
modified IHI breakthrough series
Keywords
quality improvement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modified IHI breakthrough seriesOther

    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.
    7. 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
Study groups in NCT03426072
Study groupRoleWhat they receive
modified IHI breakthrough seriesExperimentalThe 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.
Receives: Other: modified IHI breakthrough series
ControlNo interventionThe control units (propensity matched) have no intervention and form a naturalistic control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (2)

  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

    Measured: 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

    Measured: change between intervention and control groups 1 year post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start4 Jan 2018
  3. Primary completion30 May 2020
  4. Study completion30 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
cluster randomised controlled trail with nursing home unit as the cluster, care aides and residents as the unit of analysis
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426072
Sponsor's protocol ID
SCOPE ABBC
Acronym
SCOPE
Status last verified
Apr 2021
First submitted
1 Feb 2018
Last updated
18 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: the data will be made available on request according to TREC data sharing policies

Publications

  • Wagg A, Hoben M, Ginsburg L, Doupe M, Berta W, Song Y, Norton P, Knopp-Sihota J, Estabrooks C. Safer Care for Older Persons in (residential) Environments (SCOPE): a pragmatic controlled trial of a care aide-led quality improvement intervention. Implement Sci. 2023 Mar 29;18(1):9. doi: 10.1186/s13012-022-01259-8.

    PubMed 36991434

Questions about this trial

What is this clinical trial studying?

A study testing modified IHI breakthrough series in people with Nursing Homes, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conceptual Research Use (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426072, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.

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