Improving Primary Care After Stroke (IPCAS)

NCT03353519 | Completed DMC

• 1 other identifier: RG71908
• Study Type: interventional
• Target: 1,041
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Stroke Impact Scale (SIS v3.0)

  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.

  12 months after attendance at a review

Secondary Outcomes (5)

• Stroke Impact Scale Short Form (SIS-SF)

  6 and 12 months after attendance at a review

• EQ-5D-5L

  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

• Southampton Stroke Self-management Questionnaire (SSSQ)

  12 months after attendance at a review

• Health Literacy Questionnaire (HLQ)

  12 months after attendance at a review

Study Arms (2)

Primary care model

EXPERIMENTAL

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.

Other: Primary care model

Usual care

NO INTERVENTION

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

Interventions

Primary care model 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.

Primary care model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Cambridge: lead
• University Hospitals, Leicester: collaborator

Study Sites (2)

CRN East Midlands

Leicester, United Kingdom

Location

CRN Eastern

Norwich, United Kingdom

Location

Related Publications (4)

• Aquino MRJ, Turner G, Kreit E, Blatchford EG, Grant J, Johnson V, Mullis R, Mant J. Implementing a new model of primary care for stroke survivors living in the community: a mixed-methods process evaluation. Trials. 2025 Jul 19;26(1):249. doi: 10.1186/s13063-025-08957-w.

  PMID: 40684242 DERIVED

• 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.

  PMID: 36379661 DERIVED

• 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.

  PMID: 32641334 DERIVED

• 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.

  PMID: 31427339 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Primary Care Research

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

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 27, 2017
• Study Start: April 30, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 7, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)