NCT03426072

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 18, 2022

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

February 1, 2018

Last Update Submit

July 15, 2022

Conditions

Keywords

quality improvement

Outcome Measures

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

    1 year

Secondary Outcomes (2)

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

    change between intervention and control groups 1 year post intervention

  • Staff outcomes

    change between intervention and control groups 1 year post intervention

Study Arms (2)

modified IHI breakthrough series

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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

modified IHI breakthrough series

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • % 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2P4, Canada

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
control sites are propensity matched to intervention sites. All sites have comprehensive dataset. Trial status of each home is unknown to assessor and statistician
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: cluster randomised controlled trail with nursing home unit as the cluster, care aides and residents as the unit of analysis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 8, 2018

Study Start

January 4, 2018

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

July 18, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

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

Locations