NCT03353519

Improving Primary Care After Stroke (IPCAS)

Improving Primary Care After Stroke (IPCAS): A Randomised Controlled Trial to Evaluate a New Model of Care for Stroke Survivors Living in the Community

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,041 (actual)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stroke

Interventions

Type	Name	Description
OTHER	Primary care model	Specifically, the intervention will comprise the following components: 1. Structured review of patient needs; 2. A self-management programme (MLAS) for stroke survivors and their carers; 3. A direct point of contact for stroke survivors and carers at the GP surgery; 4. Optimised communication between General Practice staff and specialist services; 5. Service mapping for stroke related needs; 6. Training for General Practice staff.

Timeline

• Start date: 2018-04-30
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2017-11-27
• Last updated: 2021-10-07

Locations

2 sites across 1 country: United Kingdom