Improving Primary Care After Stroke (IPCAS): A Randomised Controlled Trial to Evaluate a New Model of Care for Stroke Survivors Living in the Community
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,041
- 试验地点
- 2
- 主要终点
- Stroke Impact Scale (SIS v3.0)
研究概览
简要总结
No formal primary care based model of care exists to support stroke survivors living in the community. A large variation in the range, quality and access to health services offered to stroke survivors between and within local clinical commissioning groups suggests that many of the stroke survivors' needs are not being met systematically. Therefore, to address the longer term needs we have developed a multi-factorial primary care model that seeks to enable greater engagement with stroke care and community services, to link effectively to specialist services, and to improve the lives of stroke survivors.
This will be a two-arm cluster randomised controlled trial. Participating general practices will be randomised to deliver either the new model of stroke care or current usual care. The aim of this trial will be to assess the clinical and long-term cost effectiveness of the new model of primary care for stroke survivors living in the community. The primary outcome for the trial will be measured using two sub-scales (emotion and handicap) of the Stroke Impact Scale questionnaire at 12 months.
详细描述
The IPCAS trial is a two-arm cluster randomised controlled trial with general practices as the unit of randomisation. The aim of this trial is to evaluate the clinical and long-term cost effectiveness of a novel model of primary care for stroke survivors living in the community.
People with a history of stroke on the registers of GP practices in the East of England and the East Midlands will be invited to take part. We will aim to recruit approximately 920 people registered with 46 general practices. We will target Practices with a stroke register comprising a minimum of 100 patients, to ensure that we reach our cluster target of 16 - 24 participants.
Potentially eligible participants will be sent an invitation to take part in the study by their GP surgery. Once all invitation letters and reminders have been sent out to patients in a practice, the GP practice will be randomised. GP practices will be randomised in a ratio of 1:1 to intervention or control. Intervention practices will deliver the new model of primary care. The control arm will consist of current usual care.
Data collection will occur at baseline and at 6 and 12 months. This will comprise a combination of postal and telephone administered questionnaires and a review of general practice notes. The primary endpoint for the trial will be two sub-scales (emotion and handicap) of the Stroke Impact Scale (SIS v3.0) as co-primary outcomes at 12 months (adjusted for baseline). Economic evaluation as well as quantitative and qualitative assessments of intervention fidelity will also be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •On practice register with a history of stroke.
- •Able to provide written informed consent (with or without the help of a carer).
- •Age 18 years or older.
排除标准
- •Patients on the palliative care register.
- •Patients living in a nursing home.
结局指标
主要结局
Stroke Impact Scale (SIS v3.0)
时间窗: 12 months after attendance at a review
The primary endpoint for the trial will be two sub-scales (emotion and handicap) of the Stroke Impact Scale as co-primary outcomes. The SIS is a 59-item mail administered stroke-specific health-related quality of life (HRQoL) measure. Each item is rated on a 5 point Likert scale with answers based on the level of difficulty.
次要结局
- Stroke Impact Scale Short Form (SIS-SF)(6 and 12 months after attendance at a review)
- ICEpop CAPability measure for Adults (ICECAP-A)(6 and 12 months after attendance at a review)
- EQ-5D-5L(6 and 12 months after attendance at a review)
- Health Literacy Questionnaire (HLQ)(12 months after attendance at a review)
- Southampton Stroke Self-management Questionnaire (SSSQ)(12 months after attendance at a review)
研究者
Professor Jonathan Mant
Professor of Primary Care Research
University of Cambridge