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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Implementation Science, Stroke

Intervention / Treatment
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* Other: Multi-component implementation intervention


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Hospital will be the unit of randomisation.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implementation, outcome measures, stroke