NCT04888416

Brief Summary

The primary objective of this study is to tailor and test implementation strategies to support the adoption of two upper extremity motor outcome measures for stroke: the Fugl-Meyer Assessment and the Action Research Arm Test. The study's interdisciplinary team will address this objective through the following specific aims: (a) Tailor a package of implementation strategies (referred to as I-STROM-Implementation STRategies for Outcome Measurement) to promote outcome measure use across the care continuum, (b) Determine the effectiveness of I-STROM on outcome measure adoption and (c) Evaluate the appropriateness, acceptability, and feasibility of I-STROM in rehabilitation settings across the country. The mixed-methods study design is informed by implementation science methodologies, and the tailoring of I-STROM will be guided by input from stakeholders, including occupational therapy practitioners and administrators. The investigators will collect robust quantitative and qualitative data by means of retrospective chart reviews, electronic surveys, and stakeholder focus groups. This study, "Strategies to Promote the Implementation of Outcome Measures in Stroke Rehabilitation," will address core barriers to outcome measure use through a package of implementation strategies, thus laying the groundwork for I-STROM scale-up in health systems nationwide.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
484

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

May 6, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3.5 years

First QC Date

May 6, 2021

Last Update Submit

August 6, 2025

Conditions

Keywords

Implementation scienceKnowledge translationEvidence-based practiceClinical practice guidelines

Outcome Measures

Primary Outcomes (1)

  • Change in the adoption of outcome measures

    Proportion of patients who are administered the outcome measures

    12-months

Secondary Outcomes (3)

  • Change in acceptability

    12-months

  • Change in appropriateness

    12-months

  • Change in feasibility

    12-months

Study Arms (3)

Acute care

EXPERIMENTAL

Acute care practitioners who will receive the I-STROM intervention

Behavioral: I-STROM

Inpatient

EXPERIMENTAL

Inpatient practitioners who will receive the I-STROM intervention

Behavioral: I-STROM

Outpatient

EXPERIMENTAL

Outpatient practitioners who will receive the I-STROM intervention

Behavioral: I-STROM

Interventions

I-STROMBEHAVIORAL

I-STROM is a combination of the following implementation strategies: (a) initial and ongoing training, (b) learning collaboratives/knowledge sharing meetings, and (c) outcome measure champions

Acute careInpatientOutpatient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Occupational therapist with license in Ohio or administrator who oversees therapists; employed at OSUWMC; completes initial evaluations with stroke patients; oversees evaluations at OSUWMC; for chart audits, patients will have a stroke diagnosis, receive occupational therapy services at OSUWMC, and undergone an evaluation with an occupational therapist

You may not qualify if:

  • Employees not involved in the evaluation/oversight of stroke survivor care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • Juckett LA, Wengerd LR, Faieta J, Griffin CE. Evidence-Based Practice Implementation in Stroke Rehabilitation: A Scoping Review of Barriers and Facilitators. Am J Occup Ther. 2020 Jan/Feb;74(1):7401205050p1-7401205050p14. doi: 10.5014/ajot.2020.035485.

    PMID: 32078516BACKGROUND
  • Juckett LA, Banhos M, Howard ML, Walters T, Horn LM, Kinney AR, Wengerd LR. Bundling implementation strategies supports outcome measure adoption in stroke rehabilitation: preliminary findings. Implement Sci Commun. 2024 Sep 19;5(1):102. doi: 10.1186/s43058-024-00643-3.

MeSH Terms

Conditions

StrokeHemiplegiaParesisBehavior

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa Juckett, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Interrupted time series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 17, 2021

Study Start

October 1, 2021

Primary Completion

March 31, 2025

Study Completion

May 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations