Embedding the Fugl-Meyer Assessment in Occupational Therapists' Routine Practice

A Theory-driven Approach to Embed and Integrate a Post-stroke Upper Extremity Outcome Measure in Routine Clinical Practice

Background: Using outcome measures is emphasized in foundational training and clinical practice guidelines, but less than 50% of rehabilitation professionals consistently use outcome measures in practice. No studies have evaluated the barriers to routine outcome measurement in Singapore's healthcare settings nor identified effective implementation strategies to sustain the use of outcome measures in practice.

Aims: To evaluate the effectiveness of a tailored multi-component implementation intervention effectiveness in improving the consistency of use of the Fugl-Meyer Assessment of Upper Extremity (FMA) among occupational therapists practicing in 4 hospitals in Singapore.

Method: The project will use the Normalisation Process Theory as a framework and data collection sites will include Singapore General Hospital, Sengkang General Hospital, Outram Community Hospital, and Sengkang Community Hospital. The investigators will use a stepped-wedge randomised trial design. The study will begin with an initial period in which no hospitals are exposed to the intervention. Subsequently, at regular intervals, one hospital will cross from the control to the intervention. The investigators will continue this process until the intervention is introduced to all hospitals. The intervention will be fully implemented by the end of the trial, with all 4 hospitals receiving the multi-component intervention.

Project Significance: This trial is part of a larger project that uses a theory-driven approach to systematically explore the embedding and integration of outcome measures in routine clinical care for rehabilitation professionals in Singapore (beyond initial implementation stages). Study findings will contribute to the scientific knowledge base of implementing outcome measures in clinical practice, improve patient care, and support future implementation projects on outcome measurement in different populations and healthcare settings.

Study Overview

• Status: Completed
• Conditions: Stroke; Implementation Science
• Intervention / Treatment: Other: Multi-component implementation intervention

Detailed Description

Study Hypothesis:

The null hypothesis is there is no change in the average rate of adherence to the administration to the FMA 6 months post-intervention. The alternate hypothesis is there is a significant improvement in the average rate of adherence to the administration of the FMA 6 months post-intervention.

Study Design:

The investigators will use a stepped-wedge randomized trial to evaluate the effectiveness of the implementation strategy (i.e. intervention), which involves a sequential crossover of hospitals from the control to the intervention arm (Figure 3). The study will begin with an initial period in which no hospitals are exposed to the intervention. Subsequently, at regular intervals (2 month duration), one hospital will cross from the control to the intervention. The investigators will continue this process until the intervention is introduced to all hospitals. The intervention will be fully implemented by the end of the trial, with all 4 hospitals receiving the intervention. The trial will include the 4 hospitals based on convenience sampling.

Intervention:

This trial will be conducted as part of a larger research project that uses a theory-driven approach to systematically explore the embedding and integration of outcome measures in routine clinical care for rehabilitation professionals in Singapore. The multi-component implementation strategy (i.e. intervention) will be developed in earlier phases of the larger project.

Outcomes:

The primary endpoint will be the average rate of adherence to the administration of the FMA 6 months post-intervention.

Randomisation:

Hospital will be the unit of randomisation. The investigators will employ simple randomisation using concealed envelopes.

Blinding:

Due to the nature of intervention, blinding may not be possible. However, occupational therapists at all 4 hospitals will be blinded to the allocation sequence, with only the next hospital randomised for rollout being revealed at each intervention implementation time point. This will allow for blinding to the intervention partially possible. The investigators will also remind occupational therapists at all 4 hospitals not disclose details about the intervention to other healthcare professionals until the end of the trial.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

A total of 4 acute and hospitals will be part of the study. These hospitals were identified through convenience sampling based on the following criteria:

Inclusion Criteria:

• Affiliated to SingHealth
• Currently using FMA in clinical practice by occupational therapists

Exclusion Criteria:

• Use of FMA in clinical practice by occupational therapists funded by existing research grants
• Not using FMA in clinical practice by occupational therapists

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hospital 1; First hospital in the allocation sequence to cross from control to intervention arm.	Other: Multi-component implementation intervention; The multiple-component implementation intervention will comprise of 3 key components: (1) education, (2) operational process, and (3) audit and feedback
Other: Hospital 2; Second hospital in the allocation sequence to cross from control to intervention arm.	Other: Multi-component implementation intervention; The multiple-component implementation intervention will comprise of 3 key components: (1) education, (2) operational process, and (3) audit and feedback
Other: Hospital 3; Third hospital in the allocation sequence to cross from control to intervention arm.	Other: Multi-component implementation intervention; The multiple-component implementation intervention will comprise of 3 key components: (1) education, (2) operational process, and (3) audit and feedback
Other: Hospital 4; Fourth hospital in the allocation sequence to cross from control to intervention arm.	Other: Multi-component implementation intervention; The multiple-component implementation intervention will comprise of 3 key components: (1) education, (2) operational process, and (3) audit and feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rate	Average rate of adherence to the administration of the FMA by occupational therapists	6 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM)	Brief 4-item pragmatic measure of implementation outcome. Each item is rated on a 5-point ordinal scale.	6 months post-intervention
Intervention Appropriateness Measure (IAM)	Brief 4-item pragmatic measure of implementation outcome. Each item is rated on a 5-point ordinal scale.	6 months post-intervention
Feasibility of Intervention Measure (FIM)	Brief 4-item pragmatic measure of implementation outcome. Each item is rated on a 5-point ordinal scale.	6 months post-intervention

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Sengkang General Hospital; Sengkang Community Hospital; Outram Community Hospital
• Investigators: Principal Investigator: Silvana Choo, PhD, Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Actual): August 2, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 19, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: stroke; outcome measures; implementation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CIRB 2021/2559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No