- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01746459
Sustaining Transfers Through Affordable Research Translation (START) (START)
Sustaining Transfers Through Affordable Research Translation (START): Knowledge Translation Interventions to Support the Uptake of Innovations in Continuing Care Settings
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of this cluster randomized controlled trial is to study the effectiveness of reminders to support the sustainability of an affordable mobility innovation by healthcare aides in supportive living and long-term care facilities. Using a stratified 2x2 factorial design, we will determine which combination of frequency and intensity of reminders is required to sustain a mobility innovation, the sit-to-stand activity. Four research questions guide our study: 1) Do more frequent reminders (every month) improve the sustainability of the innovation by healthcare aides in supportive living and long-term care facilities compared with less frequent reminders (every 3 months)? 2) Do high-intensity reminders (paper-based reminders plus peer reminders) improve the sustainability of the innovation by healthcare aides in supportive living and long-term care facilities compared with low intensity reminders (paper-based reminders only)? 3) Do more frequent reminders plus high-intensity reminders synergistically improve the sustainability of the innovation by healthcare aides in supportive living and long-term care facilities? 4) What are the processes associated with the ongoing uptake of the innovation over a year of follow-up?
We propose to study the effect of varying levels (frequency and intensity) of reminders on the sustainability of a mobility innovation by healthcare aides. Frequency: Our Alberta Health Services collaborators advised that monthly modification of the paper reminders would be frequent yet feasible while aligning with the rhythm of other monthly managerial responsibilities; in contrast, every three months would be infrequent but would align with quarterly managerial responsibilities. Intensity: They agreed that paper-based reminders are low intensity and commonly used in clinical settings. For the high intensity reminder they favored a socially-based "peer reminder". To summarize, the level of reminders will vary in frequency (monthly versus every three months) and intensity (paper reminders versus paper reminders + peer reminders).
Project Plan:
Facility assessment: Eligible facilities will have a minimum of 30 designated supportive living beds or long-term care beds in the Edmonton zone. In the first six months, we will conduct a facility assessment with 24 potential facilities using the Alberta Context Tool, the Work and Well Being Survey, and the Resident Assessment Instrument Minimum Data Set 2.0. Data from this assessment will be used to stratify the facilities into three 'equivalent' groups for randomization. As part of the organizational eligibility, all participating facilities will agree to incorporate the mobility innovation as a best practice policy for their clients.
Education sessions: In collaboration with the facility-based educator, a study educator will complete 20-minute education sessions to train healthcare aides working day and evening shifts to complete the innovation.
Randomization: A stratified blocked randomization procedure will assign facilities to four intervention arms.
Immediately following randomization, we will introduce a simple set of paper-based reminders to all sites. The low intensity paper-based reminders include: a) affixing stickers to doors, walls, or bathrooms; b) posting reminder signs in prominent locations; and c) placing colored flags on the documentation flowsheets. Every month for the high frequency sites, and once every three months for the low frequency sites, we will modify the color or shape of the paper-based reminders. For the high intensity reminders, we will identify healthcare aides to offer peer reminders. These healthcare aides will provide formal and informal peer reminders about the innovation; the formal reminders will take place either monthly or every three months during change of shift meetings, while the informal reminders will be provided as opportunities arise during the work day. Every month for the high frequency sites and every three months for the low frequency sites, the study educator will coach the healthcare aides providing peer reminders.
As the purpose of this study is to examine the effectiveness of reminders to support the sustainability of an innovation by healthcare aides, our primary outcome is healthcare aide uptake as operationalized by the number of completed mobility occasions. We have validated a documentation flowsheet for use by healthcare aides. They will record on this flowsheet the number of mobility repetitions that the client completes on each of two occasions on the day shift and on the evening shift (i.e. four occasions per day).
The secondary outcome measure will be client mobility, as assessed using the 30-second sit-to-stand test. Clients will be timed to see how many repetitions of standing up and sitting down they can complete in 30-seconds. This measure will be gathered once at baseline for all participating clients, and again 1 year later.
Process Evaluation (Research Question 4): The goal of the process evaluation is to understand how facility processes and reminders affect the sustainability of healthcare aide uptake of the innovation. We will examine how the reminders are implemented and perceived by participants, as well as how healthcare aides providing peer reminders are identified, received by their peers and supported by their supervisors. This data will gathered using observations, questionnaires and interviews. Observations: Anytime research staff enter a study facility, they will be alert to observe responses of facility staff or clients to the reminder interventions. Upon exiting the facilities, they will record fieldnotes. Research staff will be instructed to include only general information in their fieldnotes, and not include information that would identify specific site staff or clients. Educators' fieldnotes will be useful for understanding processes of and responses to coaching the healthcare aides that provide reminders. Questionnaire: We will survey a licensed practical nurse and a manager from each facility using a questionnaire to elicit perceptions of the reminders. Interviews-Healthcare Aides: To understand healthcare aides' views of the reminders we will use interviews rather than written questionnaires, as many healthcare aides speak English as a second language. We will interview approximately 6 healthcare aides from purposively sampled facilities until we achieve saturation. Four facilities (2 positive & 2 negative extreme cases; one from each arm) will be sampled based on facility assessments. Interviews-Peer Reminders: To understand the peer reminder experience we will interview approximately 6 healthcare aides providing peer reminders from each high intensity reminder arm until saturation is achieved.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
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Edmonton, Alberta, Canada, T5N 4A3
- Alberta Health Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clients will be eligible to participate if they can transfer independently or with the assistance of one person.
- Healthcare aides will be eligible to participate if they have worked on the unit for a minimum of 3 months, and work at regular intervals (minimum of 6 shifts per month).
- Licensed Practical Nurses and / or other Facility Leaders will be eligible to participate if they have experienced the peer and paper-based reminders within the last 2 months.
Exclusion Criteria:
- Clients who require a mechanical lift, or the assistance of two people to transfer, will be excluded.
- Healthcare aides who have worked for shorter less than 3 months, or fewer than 6 shifts per month, will be excluded.
- Licensed Practical Nurses and / or other Facility Leaders will be excluded if they have not had experience with the peer and paper-based reminders within the last 2 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low Low
Low Intensity, Low Frequency Reminder System
|
Paper-based reminders include: a) affixing stickers to clients' bedroom doors, beside their beds, or in their bathrooms; b) posting signs in prominent locations; and c) placing colored flags on the documentation flowsheets.
|
Active Comparator: Low, High
Low Intensity, High Frequency Reminder System
|
Paper-based reminders include: a) affixing stickers to clients' bedroom doors, beside their beds, or in their bathrooms; b) posting signs in prominent locations; and c) placing colored flags on the documentation flowsheets.
|
Active Comparator: High, Low
High Intensity, Low Frequency Reminder System
|
Paper-based reminders include: a) affixing stickers to clients' bedroom doors, beside their beds, or in their bathrooms; b) posting signs in prominent locations; and c) placing colored flags on the documentation flowsheets.
Healthcare aides will provide formal and informal peer reminders about the mobility activity; the formal reminders will take place either monthly or every three months during change of shift meetings, while the informal reminders will be provided as opportunities arise during the work day.
|
Active Comparator: High, High
High Intensity, High Frequency Reminder System
|
Paper-based reminders include: a) affixing stickers to clients' bedroom doors, beside their beds, or in their bathrooms; b) posting signs in prominent locations; and c) placing colored flags on the documentation flowsheets.
Healthcare aides will provide formal and informal peer reminders about the mobility activity; the formal reminders will take place either monthly or every three months during change of shift meetings, while the informal reminders will be provided as opportunities arise during the work day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare Aide Activity Uptake
Time Frame: 1 Year
|
The purpose of this study is to examine the effectiveness of reminders to support the sustainability of a mobility innovation by healthcare aides.
Our primary outcome is healthcare aide uptake as operationalized by the number of completed mobility activity occasions.
Healthcare aides record on a flowsheet the number of instances that the client completes on each of two occasions on the day shift and on the evening shift (i.e.
four occasions per day).
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Client Mobility
Time Frame: Change from Baseline Mobility at 1 Year
|
We will measure the sustainability of client mobility across the four intervention arms.
At the end of a year of data collection, a sample of clients will be assessed using the 30 second sit-to-stand test.
Using a stopwatch and a standard armchair, we will instruct client participants to stand up and sit down as many times as possible until they are asked to stop after 30 seconds.
|
Change from Baseline Mobility at 1 Year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan Slaughter, PhD, University of Alberta
Publications and helpful links
General Publications
- Slaughter SE, Eliasziw M, Ickert C, Jones CA, Estabrooks CA, Wagg AS. Effectiveness of reminders to sustain practice change among direct care providers in residential care facilities: a cluster randomized controlled trial. Implement Sci. 2020 Jul 1;15(1):51. doi: 10.1186/s13012-020-01012-z.
- Slaughter SE, Jones CA, Eliasziw M, Ickert C, Estabrooks CA, Wagg AS. The Changing Landscape of Continuing Care in Alberta: Staff and Resident Characteristics in Supportive Living and Long-Term Care. Healthc Policy. 2018 Aug;14(1):44-56. doi: 10.12927/hcpol.2018.25549.
- Slaughter SE, Estabrooks CA, Jones CA, Wagg AS, Eliasziw M. Sustaining Transfers through Affordable Research Translation (START): study protocol to assess knowledge translation interventions in continuing care settings. Trials. 2013 Oct 26;14:355. doi: 10.1186/1745-6215-14-355.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00034781
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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