Clinical trial NCT05374239: 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
Overall status: COMPLETED
Phase: NA
Conditions: Implementation Science
Stroke
Keywords: implementation
outcome measures
stroke
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Sengkang General Hospital
name: Sengkang Community Hospital
name: Outram Community Hospital
First posted: 2022-05-16
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Hospital will be the unit of randomisation.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Adherence rate
timeFrame: 6 months post-intervention
Secondary outcomes:
Other outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 6 months post-intervention
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 6 months post-intervention
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 6 months post-intervention
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Silvana Choo, PhD
role: PRINCIPAL_INVESTIGATOR
References: