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Improving Primary Care After Stroke (IPCAS) (IPCAS)

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ClinicalTrials.gov Identifier: NCT03353519
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by (Responsible Party):
Professor Jonathan Mant, University of Cambridge

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.


Condition or disease Intervention/treatment Phase
Stroke Other: Primary care model Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1041 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The IPCAS Trial is a two-arm cluster randomised controlled trial with general practices as the unit of randomisation.
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Usual care
The control arm will consist of the usual care currently provided for stroke survivors registered with each general practice.



Primary Outcome Measures :
  1. Stroke Impact Scale (SIS v3.0) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Stroke Impact Scale Short Form (SIS-SF) [ Time Frame: 6 and 12 months after attendance at a review ]
    The SIS Short Form consists of 8 items comprising one question from each of the SIS domains (strength, hand function, mobility, activities of daily living, memory, communication, emotion and handicap). Each item is rated on a 5 point Likert scale with answers based on the level of difficulty.

  2. EQ-5D-5L [ Time Frame: 6 and 12 months after attendance at a review ]
    The EQ-5D-5L is a standardised measure of health status suitable for health and economic appraisal. The responses to 5 dimensions can be combined to provide a 5 digit profile. The profile can be converted using a link function to a single index value which facilitates the calculation of quality-adjusted life years (QALYs). The questionnaire will be used to allow for economic evaluation.

  3. ICEpop CAPability measure for Adults (ICECAP-A) [ Time Frame: 6 and 12 months after attendance at a review ]
    ICECAP-A is also used in economic evaluation. The ICECAP-A focuses on wellbeing defined in a broader sense rather than health. It comprises of 5 attributes: Attachment, Stability, Achievement, Enjoyment and Autonomy. Each attribute is judged on a 4-point Likert scale ranging from full capability to no capability.

  4. Southampton Stroke Self-management Questionnaire (SSSQ) [ Time Frame: 12 months after attendance at a review ]
    SSSQ is a 28 item scale covering aspects of managing health and communication with health care professionals.

  5. Health Literacy Questionnaire (HLQ) [ Time Frame: 12 months after attendance at a review ]
    The HLQ is a self-report measure of patients' strengths and limitations in their ability to access, understand and effectively use health information and services. It has 44 items covering the following 9 domains: (1) feeling understood and supported by healthcare providers; (2) having sufficient information to manage health; (3) actively managing health; (4) social support for health; (5) appraisal of health information; (6) ability to actively engage with healthcare providers; (7) navigating the healthcare system; (8) ability to find good health information; (9) understand health information.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353519


Locations
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United Kingdom
CRN East Midlands
Leicester, United Kingdom
CRN Eastern
Norwich, United Kingdom
Sponsors and Collaborators
University of Cambridge
University Hospitals, Leicester
  Study Documents (Full-Text)

Documents provided by Professor Jonathan Mant, University of Cambridge:
Study Protocol  [PDF] February 28, 2018
Statistical Analysis Plan  [PDF] April 23, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Jonathan Mant, Professor of Primary Care Research, University of Cambridge
ClinicalTrials.gov Identifier: NCT03353519    
Other Study ID Numbers: RG71908
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases