Clinical trial NCT03353519: Improving Primary Care After Stroke (IPCAS)
Official title: Improving Primary Care After Stroke (IPCAS): A Randomised Controlled Trial to Evaluate a New Model of Care for Stroke Survivors Living in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2017-11-27
Enrollment: 1041
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The IPCAS Trial is a two-arm cluster randomised controlled trial with general practices as the unit of randomisation.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Exclusion Criteria:

* Patients on the palliative care register.
* Patients living in a nursing home.

Primary outcomes:
measure: Stroke Impact Scale (SIS v3.0)
timeFrame: 12 months after attendance at a review
Secondary outcomes:
measure: Stroke Impact Scale Short Form (SIS-SF)
timeFrame: 6 and 12 months after attendance at a review
measure: EQ-5D-5L
timeFrame: 6 and 12 months after attendance at a review
measure: ICEpop CAPability measure for Adults (ICECAP-A)
timeFrame: 6 and 12 months after attendance at a review
measure: Southampton Stroke Self-management Questionnaire (SSSQ)
timeFrame: 12 months after attendance at a review
measure: Health Literacy Questionnaire (HLQ)
timeFrame: 12 months after attendance at a review
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: CRN East Midlands
city: Norwich
country: United Kingdom
facility: CRN Eastern
Study officials:
References:
citation: Blatchford EG, Aquino MRJ, Grant J, Johnson V, Mullis R, Lim L, Mant J. Patients' experience of and participation in a stroke self-management programme, My Life After Stroke (MLAS): a multimethod study. BMJ Open. 2022 Nov 15;12(11):e062700. doi: 10.1136/bmjopen-2022-062700.
citation: Aquino MRJR, Mullis R, Kreit E, Johnson V, Grant J, Lim L, Sutton S, Mant J. Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation. BMJ Open. 2020 Jul 8;10(7):e036879. doi: 10.1136/bmjopen-2020-036879.
citation: Mullis R, Aquino MRJR, Dawson SN, Johnson V, Jowett S, Kreit E, Mant J; IPCAS investigator team. Improving Primary Care After Stroke (IPCAS) trial: protocol of a randomised controlled trial to evaluate a novel model of care for stroke survivors living in the community. BMJ Open. 2019 Aug 18;9(8):e030285. doi: 10.1136/bmjopen-2019-030285.