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

Primary Purpose

Implementation Science, Stroke

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Multi-component implementation intervention
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Implementation Science focused on measuring implementation, outcome measures, stroke

Eligibility Criteria

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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

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Hospital 1

Hospital 2

Hospital 3

Hospital 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 10, 2022
Last Updated
October 24, 2022
Sponsor
Singapore General Hospital
Collaborators
Sengkang General Hospital, Sengkang Community Hospital, Outram Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05374239
Brief Title
Embedding the Fugl-Meyer Assessment in Occupational Therapists' Routine Practice
Official Title
A Theory-driven Approach to Embed and Integrate a Post-stroke Upper Extremity Outcome Measure in Routine Clinical Practice
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
June 16, 2023 (Anticipated)
Study Completion Date
June 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Sengkang General Hospital, Sengkang Community Hospital, Outram Community Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implementation Science, Stroke
Keywords
implementation, outcome measures, stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Hospital will be the unit of randomisation.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hospital 1
Arm Type
Other
Arm Description
First hospital in the allocation sequence to cross from control to intervention arm.
Arm Title
Hospital 2
Arm Type
Other
Arm Description
Second hospital in the allocation sequence to cross from control to intervention arm.
Arm Title
Hospital 3
Arm Type
Other
Arm Description
Third hospital in the allocation sequence to cross from control to intervention arm.
Arm Title
Hospital 4
Arm Type
Other
Arm Description
Fourth hospital in the allocation sequence to cross from control to intervention arm.
Intervention Type
Other
Intervention Name(s)
Multi-component implementation intervention
Intervention Description
The multiple-component implementation intervention will comprise of 3 key components: (1) education, (2) operational process, and (3) audit and feedback
Primary Outcome Measure Information:
Title
Adherence rate
Description
Average rate of adherence to the administration of the FMA by occupational therapists
Time Frame
6 months post-intervention
Other Pre-specified Outcome Measures:
Title
Acceptability of Intervention Measure (AIM)
Description
Brief 4-item pragmatic measure of implementation outcome. Each item is rated on a 5-point ordinal scale.
Time Frame
6 months post-intervention
Title
Intervention Appropriateness Measure (IAM)
Description
Brief 4-item pragmatic measure of implementation outcome. Each item is rated on a 5-point ordinal scale.
Time Frame
6 months post-intervention
Title
Feasibility of Intervention Measure (FIM)
Description
Brief 4-item pragmatic measure of implementation outcome. Each item is rated on a 5-point ordinal scale.
Time Frame
6 months post-intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvana Choo, PhD
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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