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

NCT05374239 | Completed

• 1 other identifier: CIRB 2021/2559
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Implementation Science; Stroke

Keywords

implementation; outcome measures; stroke

Outcome Measures

Primary Outcomes (1)

• Adherence rate

  Average rate of adherence to the administration of the FMA by occupational therapists

  6 months post-intervention

Other Outcomes (3)

• Acceptability of Intervention Measure (AIM)

  6 months post-intervention

• Intervention Appropriateness Measure (IAM)

  6 months post-intervention

• Feasibility of Intervention Measure (FIM)

  6 months post-intervention

Study Arms (4)

Hospital 1

OTHER

First hospital in the allocation sequence to cross from control to intervention arm.

Other: Multi-component implementation intervention

Hospital 2

OTHER

Second hospital in the allocation sequence to cross from control to intervention arm.

Other: Multi-component implementation intervention

Hospital 3

OTHER

Third hospital in the allocation sequence to cross from control to intervention arm.

Other: Multi-component implementation intervention

Hospital 4

OTHER

Fourth hospital in the allocation sequence to cross from control to intervention arm.

Other: Multi-component implementation intervention

Interventions

Multi-component implementation intervention OTHER

The multiple-component implementation intervention will comprise of 3 key components: (1) education, (2) operational process, and (3) audit and feedback

Hospital 1; Hospital 2; Hospital 3; Hospital 4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Sengkang General Hospital: collaborator
• Sengkang Community Hospital: collaborator
• Outram Community Hospital: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Silvana Choo, PhD

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hospital will be the unit of randomisation.

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: July 6, 2022
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)