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

July 15, 2022 updated by: 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Conceptual Research Use
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resident Assessment Index -minimal Data Set (RAI-MDS) factors
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCOPE ABBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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