Improving Primary Care After Stroke (IPCAS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1041 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The IPCAS Trial is a two-arm cluster randomised controlled trial with general practices as the unit of randomisation.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Primary care model

The new model of care incorporates a multi-factorial package of service aimed at providing a review of patient needs, facilitated self-management of longer-term stroke care needs for survivors and their carers, optimised communication between patients and health and social care services, optimised communication between the different care services, and increased awareness of and access to national and local community and charity provided services.

Group Type EXPERIMENTAL

Primary care model

Intervention Type OTHER

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.

Usual care

The control arm will consist of the usual care currently provided for stroke survivors registered with each general practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.