NCT06303765

Brief Summary

After stroke, individuals must be assessed to determine if they can resume driving. Return to driving is very important to people who have experienced a stroke. Unfortunately, health care providers face challenges in addressing driving after stroke. Common issues include being unsure of the best screening practices, difficulty discussing driving with patients, and challenges making informed recommendations about driving that balance the risk of public safety along with supporting patient goals. Occupational Therapists (OTs) are health care providers that provide screening, assessment, and intervention for driving to individuals who have had a stroke. OTs working in stroke care have highlighted the urgency for evidence-based resources to support practice to address driving with patients. The Practice Resource for Driving After Stroke (PReDAS), is an evidenced-based resource to support the clinical practice of OTs in addressing driving in acute stroke settings. A previous pilot study has demonstrated that the PReDAS is considered useful by both health care providers and patients. Further study is needed to evaluate how the PReDAS can support OTs in addressing driving with patients. The current study proposes to provide the PReDAS as an intervention to OTs working in acute stroke settings to see if the intervention increases OT's self efficacy and clinical reasoning for addressing driving. The study will take repeated measures of self-efficacy and clinical reasoning among participating OTs to determine if the PReDAS intervention supports improved self-efficacy and clinical reasoning.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

March 4, 2024

Last Update Submit

April 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • clinical reasoning

    Measured via the Self-Assessment of Clinical Reasoning and Reflection. Min score=26, max score=130, higher scores= better clinical reasoning

    collected at enrollment and end of month 1,2,3,4,5 and 6

  • self-efficacy

    measured via the Personal Efficacy and Beliefs Scale. min score=10, max=60. higher scores= better self efficacy

    collected at enrollment and end of month 1,2,3,4,5 and 6

Study Arms (1)

PReDAS intervention

EXPERIMENTAL

All participants will receive the PReDAS intervention during the study. As per concurrent multiple baseline designs, each participant will be randomized as to WHEN they receive the PReDAS during the 6 month study period. Baseline lengths will vary from 2 to 5 months.

Other: Practice Resource for Driving After Stroke (PReDAS)

Interventions

1. Provision of written copy of PReDAS for occupational therapist to review 2. 1:1 online training session to use the PReDAS (1 hour in length)

PReDAS intervention

Eligibility Criteria

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

You may qualify if:

  • Practicing Occupational therapist
  • current employment on an acute stroke unit

You may not qualify if:

  • there is already a participant enrolled who is located on the same stroke unit
  • the person already has reviewed a copy of the PReDAS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University

London, Ontario, N6G 1H1, Canada

RECRUITING

Related Publications (23)

  • Canadian Council of Motor Transport Administrators. (2020). Determining Driver Fitness in Canada: Part 1 A Model for the Administration of Driver Fitness Programs and Part 2: CCMTA Medical Standards for Drivers. https://ccmta.ca/ images/CCMTAMedicalStandardsDec12015finalcleancopyJune20016 edit.bookmarkspdf.pdf

    BACKGROUND
  • Liddle, J., Turpin, M., McKenna, K., Kubus, T., Lambley, S., & McCaffrey, K. (2009). The experiences and needs of people who cease driving after stroke. Brain Impairment, 10(3), 271-281. https://doi.org/10.1375/brim.10.3.271

    BACKGROUND
  • Patomella AH, Johansson K, Tham K. Lived experience of driving ability following stroke. Disabil Rehabil. 2009;31(9):726-33. doi: 10.1080/09638280802306539.

    PMID: 18946806BACKGROUND
  • Vander Veen A, Laliberte Rudman D. Rethinking Driving Against Medical Advice: The Situated Nature of Driving After Stroke. Can J Occup Ther. 2022 Dec;89(4):406-416. doi: 10.1177/00084174221114670. Epub 2022 Jul 19.

    PMID: 35854415BACKGROUND
  • Korner-Bitensky N, Menon A, von Zweck C, Van Benthem K. Occupational therapists' capacity-building needs related to older driver screening, assessment, and intervention: a Canadawide survey. Am J Occup Ther. 2010 Mar-Apr;64(2):316-24. doi: 10.5014/ajot.64.2.316.

    PMID: 20437919BACKGROUND
  • Sangrar, R., Griffith, L. E., Letts, L., & Vrkljan, B. (2018). Examining Occupational Therapists' Awareness of Medical Fitness-to-Drive Legislation Using a Knowledge-to-Action Approach. Topics in Geriatric Rehabilitation, 34(4), 274-282. https://doi.org/10.1097/TGR.0000000000000205

    BACKGROUND
  • Cammarata, M., Mueller, A. S., Harris, J., & Vrkljan, B. (2017). The Role of the Occupational Therapist in Driver Rehabilitation After Stroke. Physical and Occupational Therapy in Geriatrics, 35(1), 20-33. https://doi.org/10.1080/02703181.2016.1277443

    BACKGROUND
  • Vander Veen A, Cammarata M, Renner S, Alvarez L. The Clinical Usefulness of the Practice Resource for Driving after Stroke (PReDAS). Occup Ther Health Care. 2023 Jan;37(1):119-144. doi: 10.1080/07380577.2021.2018751. Epub 2021 Dec 26.

    PMID: 34955088BACKGROUND
  • Mountain A, Patrice Lindsay M, Teasell R, Salbach NM, de Jong A, Foley N, Bhogal S, Bains N, Bowes R, Cheung D, Corriveau H, Joseph L, Lesko D, Millar A, Parappilly B, Pikula A, Scarfone D, Rochette A, Taylor T, Vallentin T, Dowlatshahi D, Gubitz G, Casaubon LK, Cameron JI. Canadian Stroke Best Practice Recommendations: Rehabilitation, Recovery, and Community Participation following Stroke. Part Two: Transitions and Community Participation Following Stroke. Int J Stroke. 2020 Oct;15(7):789-806. doi: 10.1177/1747493019897847. Epub 2020 Jan 27.

    PMID: 31983292BACKGROUND
  • Bandura, A. (1997). Self efficacy: The exercise of control. Freeman.

    BACKGROUND
  • Simmons B. Clinical reasoning: concept analysis. J Adv Nurs. 2010 May;66(5):1151-8. doi: 10.1111/j.1365-2648.2010.05262.x. Epub 2010 Mar 9.

    PMID: 20337790BACKGROUND
  • Ledford, J. R., & Gast, D. L. (2018). Single Case Research Methodology: Applications in Special Education and Behavioural Sciences. Routledge.

    BACKGROUND
  • Murray A, Di Tommaso A, Molineux M, Young A, Power P. Contemporary occupational therapy philosophy and practice in hospital settings. Scand J Occup Ther. 2021 Apr;28(3):213-224. doi: 10.1080/11038128.2020.1750691. Epub 2020 May 1.

    PMID: 32356478BACKGROUND
  • Vander Veen A, Holmes J, Tucker P, Alvarez L. Addressing Driving in Acute Care: Perceived Relevance and Competence. Can J Occup Ther. 2024 Mar;91(1):88-99. doi: 10.1177/00084174231182898. Epub 2023 Jun 22.

    PMID: 37350112BACKGROUND
  • Riggs, M. L., Warka, J., Babasa, B., Betancourt, R., & Hooker, S. (1994). Development and Validation of Self-Efficacy and Outcome Expectancy Scales for Job-Related Applications. Educational and Psychological Measurement, 54(3), 793-802.

    BACKGROUND
  • O'Brien, K. M., Kearney, M. S., & Sauber, E. (2019). Measuring career and occupational self-efficacy. In M. W. Gallagher & S. J. Lopez (Eds.), Positive psychological assessment: A handbook of models and measures (2nd ed.). (2nd ed., pp. 97-110). American Psychological Association. https://doi.org/10.1037/0000138-007

    BACKGROUND
  • Peterson, J., McGillis Hall, L., O'Brien-Pallas, L., & Cockerill, R. (2011). Job satisfaction and intentions to leave of new nurses. Journal of Research in Nursing, 16(6), 536-548. https://doi.org/10.1177/1744987111422423

    BACKGROUND
  • Royeen, C., Mu, K., Barnett, K., & Luebbeb, A. (2000). Pilot Investigtion: Evaluation of Clinical Refelction and Reasoning. In P. A. H. Crist (Ed.), Innovations in Occupational therapy education (pp. 107-115). American Occupational Therapy Association.

    BACKGROUND
  • Tate. (2018). Multiple-Baseline Designs. In R. Tate & M. Perdices (Eds.), Single-Case Experimental Designs for Clinical Research and Neurorehabilitation Settings (1st ed., pp. 108-130). Routledge. https://doi-org.proxy1.lib.uwo.ca/10.4324/9780429488184

    BACKGROUND
  • Barton, E. E., Lloyd, B. P., Spriggs, A. D., & Gast, D. L. (2018). Visual analysis of graphic data. In J. R. Ledford & D. L. Gast (Eds.), Single Case Research Methodology: Applications in Special Education and Behavioral Sciences (3rd ed., pp. 179-214). https://doi.org/10.4324/9780203521892

    BACKGROUND
  • Fingerhut, J., Xu, X., & Moeyaert, M. (2021). Selecting the proper Tau-U measure for single-case experimental designs: Development and application of a decision flowchart. Evidence-Based Communication Assessment and Intervention, 15(3), 99-114. https://doi.org/10.1080/17489539.2021.1937851

    BACKGROUND
  • Parker RI, Vannest KJ, Davis JL, Sauber SB. Combining nonoverlap and trend for single-case research: Tau-U. Behav Ther. 2011 Jun;42(2):284-99. doi: 10.1016/j.beth.2010.08.006. Epub 2011 Feb 3.

    PMID: 21496513BACKGROUND
  • Vannest, K. J., & Ninci, J. (2015). Evaluating intervention effects in single-case research designs. Journal of Counseling and Development, 93(4), 403-411. https://doi.org/10.1002/jcad.12038

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Liliana Alvarez, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

April Vander Veen, PhD(c)

CONTACT

Liliana Alvarez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: multiple baseline study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

February 1, 2024

Primary Completion

July 1, 2024

Study Completion

August 31, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations