Clinical trial NCT02597569: Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment
Official title: Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment: An Evidence-based, Multi-faceted, Knowledge Translation Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
Cognitive Orientation to daily Occupational Performance
health services accessibility
cognitive impairment
rehabilitation
integrated knowledge translation
interrupted time series
The CO-OP Approach
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: University Health Network, Toronto
name: West Park Healthcare Centre
name: Sinai Health System
name: Providence Healthcare
First posted: 2015-11-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to an inpatient rehabilitation unit with a primary diagnosis of stroke and have a cognitive impairment.

Brief summary: Patients with cognitive impairments following a stroke are often denied access to inpatient rehabilitation, despite evidence of its benefits for them. Patients with cognitive impairment who are admitted to inpatient stroke rehabilitation often receive services based on outdated impairment-reduction models, rather than recommended function-based approaches. These two issues, reduced access to rehabilitation and the knowledge-to-practice gap, both stem from a reported lack of skills and knowledge on the part of some stroke rehabilitation teams to foster recovery in people with cognitive impairments. To address these issues, the investigators will implement and evaluate a multi-faceted, supported, integrated knowledge translation initiative, targeted specifically at the inter-professional application of the Cognitive Orientation to daily Occupational Performance (CO-OP), called CO-OP KT. CO-OP is a contemporary, effective, cognitive strategy-based treatment approach. CO-OP KT is a combination of the CO-OP Approach with multi-faceted knowledge translation support. Clinical staff at participating institutions will receive CO-OP KT training.

The long-term objective of CO-OP KT is to optimize functional outcomes for individuals with stroke and cognitive impairments. Three specific research questions have been posed, one of which is the focus of this registration. That sub study relates to patient outcomes following the CO-OP KT training initiative and it will be addressed using a non-randomized design with historical controls. Patient participants who enroll in the project prior to implementing the CO-OP KT training will belong to the historical control group. Patient participants who enroll in the project after the CO-OP KT training will belong to the CO-OP KT Exposure group.

Detailed description: The investigative team will implement and evaluate a multi-faceted, supported, integrated knowledge translation initiative called CO-OP KT.

The long-term objective of CO-OP KT is to optimize functional outcomes for individuals with stroke and cognitive impairments. Three specific research questions are posed, one of which is the focus of this registration:

1. Is CO-OP KT associated with changes in activity, participation, and self-efficacy to perform daily activities in patients with cognitive impairment following stroke at discharge from inpatient rehabilitation and at 1, 3, and 6-month follow-ups? The research question, which relates to patient outcomes, will be addressed using a non-randomized design with historical controls.

Recruitment:

Five inpatient stroke rehabilitation units or combined stroke/neurology units within the Toronto Stroke Networks have agreed to participate. It is estimated that the 5 units together will have approximately 80 admissions per month. Patients admitted to the inpatient stroke unit who have at least some cognitive impairment will be recruited. Cognitive impairment will be determined using the Montreal Cognitive Assessment (MoCA). Patients with scores lower than 26 will be included. Based on data from a previously published study, a sample size of 13 per group will have 80% power to detect a between-group difference of 9 points on the FIM™, standard deviation of 8. Allowing for 30% attrition from all sources, the investigators will recruit 17 participants per group, 34 in total. Based on past experience, the investigators expect a consent rate of 1 participant per site per month. Thus, recruitment is highly feasible, and will likely be completed in 4 months for each group.

Data Analysis:

Descriptive statistics will be compiled for all quantitative data collected. Between- and within-group differences on the outcome measures will be examined using repeated measures ANOVA for the non-randomized trial of individual patients with historical controls.

Eligibility criteria: Inclusion Criteria:

- Patients who score lower than 26 on the Montreal Cognitive Assessment (MoCA) Test (indicates some level of cognitive impairment)

Exclusion Criteria:

* neurological diagnoses other than stroke
* the presence of major psychiatric illness
* capacity issues requiring the use of a substitute decision maker under Ontario's Substitute Decision Maker Act

Primary outcomes:
measure: Change in Functional Independence Measure [FIM(TM)] score
timeFrame: A) Within 1 week of admission to inpatient rehabilitation, B) At least 72 hours before discharge from inpatient rehabilitation, C) 1 month post discharge, D) 3 months post discharge, and E) 6 months post discharge.
Secondary outcomes:
measure: Change in Canadian Occupational Performance Measure (COPM) score
timeFrame: A) Within 1 week of admission to inpatient rehabilitation, B) At least 72 hours before discharge from inpatient rehabilitation, C) 1 month post discharge, D) 3 months post discharge, and E) 6 months post discharge.
measure: Change in Self-Efficacy Gauge (SEG) score
timeFrame: A) Within 1 week of admission to inpatient rehabilitation, B) At least 72 hours before discharge from inpatient rehabilitation, C) 1 month post discharge, D) 3 months post discharge, and E) 6 months post discharge.
measure: Change in Stroke Impact Scale (SIS) score
timeFrame: A) Within 1 week of admission to inpatient rehabilitation, B) At least 72 hours before discharge from inpatient rehabilitation, C) 1 month post discharge, D) 3 months post discharge, and E) 6 months post discharge.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Providence Healthcare
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre - St. John's Rehab
state: Ontario
city: Toronto
country: Canada
facility: Bridgepoint Active Healthcare
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Sara E McEwen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rios J, Linkewich E, Allen KA, Egan M, Dawson DR, Godleski M, Hunt A, Jutzi K, Quant S, McEwen SE. Lessons learned and functional outcomes following multifaceted team training in a cognitive strategy-based approach to stroke rehabilitation. JBI Evid Implement. 2022 Feb 14;20(1):33-43. doi: 10.1097/XEB.0000000000000308.
citation: Linkewich E, Avery L, Rios J, McEwen SE. Minimal Clinically Important Differences in Functional Independence After a Knowledge Translation Intervention in Stroke Rehabilitation. Arch Phys Med Rehabil. 2020 Apr;101(4):587-591. doi: 10.1016/j.apmr.2019.10.185. Epub 2019 Nov 15.