Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment

NCT02597569 | Completed

• 2 other identifiers: 177-2015PHE-141799
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 5

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Patients with cognitive impairment who are admitted to inpatient stroke rehabilitation often receive services based on outdated impairment-reduction models, rather than recommended function-based approaches.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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Functional Independence Measure [FIM(TM)] score

  A system of disability measurement that rates the level of a patient's disability on a 7 point scale and indicates how much assistance is required for each. Consists of 18 items, 7 points each, 13 of which form the motor sub scale and 5 of which form the cognitive sub scale.

  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 (3)

• Change in Canadian Occupational Performance Measure (COPM) score

  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.

• Change in Self-Efficacy Gauge (SEG) score

  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.

• Change in Stroke Impact Scale (SIS) score

  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.

Study Arms (2)

Historical Control

Patient participants will be recruited from an inpatient rehabilitation stroke unit prior to introducing CO-OP KT training to the stroke team. Patient participants will receive Usual Care from their stroke team.

CO-OP KT Exposure group

Patient participants will be recruited from an inpatient rehabilitation stroke unit after the stroke team has been exposed to CO-OP KT training. Patient participants will receive Usual Care, augmented by CO-OP KT, from their stroke team.

Behavioral: CO-OP KT Exposure

Interventions

CO-OP KT Exposure BEHAVIORAL

Patient participants who receive therapy from clinicians who have received CO-OP KT training will belong to the CO-OP KT Exposure group. Patient participants will not receive treatment that is different from the treatment being offered to patients who do not enroll in the study. The CO-OP KT intervention is directed at the inpatient rehabilitation team. They will be trained in Cognitive Orientation to daily Occupational Performance (CO-OP) and will also receive multi-faceted knowledge translation (KT) support.

CO-OP KT Exposure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• University of Toronto: collaborator
• University Health Network, Toronto: collaborator
• West Park Healthcare Centre: collaborator
• Sinai Health System: collaborator
• Providence Healthcare: collaborator

Study Sites (5)

Providence Healthcare

Toronto, Ontario, M1L 1W1, Canada

Location

Sunnybrook Health Sciences Centre - St. John's Rehab

Toronto, Ontario, M2M 2G1, Canada

Location

Bridgepoint Active Healthcare

Toronto, Ontario, M4M 2B5, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Related Publications (2)

• 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.

  PMID: 35165236 DERIVED

• 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.

  PMID: 31738892 DERIVED

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sara E McEwen, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 5, 2015
• Study Start: January 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

CA (5)