Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care: a Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,885
- 试验地点
- 10
- 主要终点
- Change in the number of eligible patient screened
研究概览
简要总结
This study proposes to evaluate the process and outcome of an implementation program designed to implement nurse-led symptom distress screening and referral into routine cancer care clinics. Specifically, using a stepped-wedge cluster randomized controlled trial, This study aim to test if a systematic symptom distress screening program increases the proportion of eligible patients screened and referred compared to usual control. For process evaluation, this study will use qualitative methods to assess the experience and response to the implementation program.
详细描述
This study proposes to evaluate the process and outcome of an implementation program designed to implement nurse-led symptom distress screening and referral into routine cancer care clinics. Specifically, using a stepped-wedge cluster randomized controlled trial, this study aim to test if a systematic symptom distress screening program (i.e. using the five implementation strategies including training, audit, feedback, facilitation and adaptable workflow) increases the proportion of eligible patients screened and referred compared to usual control under which no implementation strategies will be used to facilitate the adoption of the systematic symptom distress screening and referral. The investigator hypothesize that (1) the intervention will increase the proportion of eligible patients screened; (2) the intervention will increase the proportion of patients with moderate to severe symptom distress referred for psychosocial support.
For process evaluation, this study will use qualitative methods to assess the experience and response to the implementation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cancer patients within two years post-treatment attending the specialized outpatient clinics for surveillance will be eligible for symptom distress screening, with no exclusions by any demographic and clinical characteristics.
排除标准
- •All cancer patients beyond two years post-treatment
研究组 & 干预措施
Implementation condition
Under implementation condition, a nurse-led symptom distress screening program will be implemented using 5 implementation strategies including training, audit and feedback, facilitation and adaptable workflow.
干预措施: A nurse-led symptom distress screening program (Other)
Control condition
The control condition is the usual clinical outpatient operation without the specific implementation program (i.e. applying the five implementation strategies including training, audit and feedback, facilitation and adaptable workflow) for standardized routine symptom distress screening. Prior to the start of the first 4-month control condition, we will meet each study unit and brief the staff about the purpose of this implementation study, as well as the introduction of the symptom distress screening tool. The symptom distress screening tool and referral forms will be given to the study sites. The staff are encouraged to screened and referred all eligible patients to JCICC, a local cancer care centre. In contrast to the intervention condition, there will be no half-day skill training workshop and no weekly audit and feedback report delivered and discussed with the site facilitator. We will keep the recording of the briefing session for fidelity assessment.
结局指标
主要结局
Change in the number of eligible patient screened
时间窗: Pre- and post-implementation phase, up to 24 months
The primary outcome (the measurement of the reach) is the changes in the number of eligible patients screened. Using a standardized reporting form, each study site will be asked to submit a weekly record of a total number of eligible patients per clinic and the number of patients screened.
Change in the number of eligible patient referred
时间窗: Pre- and post-implementation phase, up to 24 months
The primary outcome (the measurement of the reach) is the changes in the number of eligible patients referred based on the predefined scores. Using a standardized reporting form, each study site will be asked to submit a weekly record of a total number of eligible patients per clinic and the number of patients referred.
次要结局
- Change in referral uptake(Pre- and post-implementation phase, up to 24 months)
- Process evaluation in providers by conducting qualitative interviews(post-implementation phase, up to 24 months)
- Process evaluation in patients by conducting qualitative interviews(post-implementation phase, up to 24 months)
- Number of staff receiving training(pre-implementation phase, up to 24 months)
- Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales(pre- and post-training workshop, and post-implementation phase, up to 24 months)
- Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales(pre- and post-training workshop, and post-implementation phase, up to 24 months)
- Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales(pre- and post-training workshop, and post-implementation phase, up to 24 months)
研究者
Wendy Wing Tak Lam
Associate Professor
The University of Hong Kong