A Theory-driven Approach to Embed and Integrate a Post-stroke Upper Extremity Outcome Measure in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Adherence rate
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Use of FMA in clinical practice by occupational therapists funded by existing research grants
- •Not using FMA in clinical practice by occupational therapists
研究组 & 干预措施
Hospital 1
First hospital in the allocation sequence to cross from control to intervention arm.
干预措施: Multi-component implementation intervention (Other)
Hospital 2
Second hospital in the allocation sequence to cross from control to intervention arm.
干预措施: Multi-component implementation intervention (Other)
Hospital 3
Third hospital in the allocation sequence to cross from control to intervention arm.
干预措施: Multi-component implementation intervention (Other)
Hospital 4
Fourth hospital in the allocation sequence to cross from control to intervention arm.
干预措施: Multi-component implementation intervention (Other)
结局指标
主要结局
Adherence rate
时间窗: 6 months post-intervention
Average rate of adherence to the administration of the FMA by occupational therapists
次要结局
未报告次要终点