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Research project: IMPROVE-Stroke: IMproving the PRevention Of Vascular Events after Stroke or TIA: a randomised controlled pilot trial of nurse independent prescriber-led care pathway-based risk factor management

Currently Active: 
Yes

Stroke is the UK’s third biggest killer, and the biggest cause of disability in adults. We do have treatments that reduce the risk of a stroke, particularly after the warning of a mini-stroke or ‘TIA’. The best way is by reducing the person’s blood pressure, but we know that in ‘real life’ it is often difficult to get the blood pressure down and keep it down. This means that if only blood pressure treatment was better than it is, the NHS could prevent more strokes, and save a lot of disability - and money.

Our pilot trial will be trying to improve the treatment of risk factors like blood pressure after a mini-stroke. The trial will compare ‘usual care’ (having your risk factors treated the way they are at the moment, usually by visits to the GP) with an approach that puts treatment in the hands of a new type of nurse, who will prescribe treatment according to a specially-designed plan called a ‘care pathway’. We are hoping this will mean that the person’s risk factors will be better controlled, and their risk of another stroke is reduced. We will check on people’s blood pressure using an automatic arm cuff during normal activities – an ‘ambulatory monitor’, which gives a more reliable result than measurements taken in the clinic. After six months and again after a year we will compare the effects of treatment between ‘usual care’ and the new approach, to see if one is better than the other.

Any treatment is only effective if people can stick with it, and we know that a lot of people on prescribed drugs give up taking them for various reasons. In this trial people will get the chance to tell the researchers the good and bad things about taking part, and whether the new type of nurse-led care pathway worked for them. This is important so that we can understand the things that would help people to stay on treatment. If our pilot is successful, we will go ahead with a larger study aimed at proving the case for using the new ‘care pathway’ throughout the NHS.

Background

There is good evidence of a gap between the findings from randomised controlled trials (RCTs) that risk factor modification after stroke or transient ischaemic attack (TIA) prevents further vascular events, and the implementation of those findings in clinical practice. The resulting failure to fully implement the existing evidence jeopardises the large benefits to patients and the NHS that should otherwise accrue, yet evidence to support effective risk factor management strategies in Primary Care after stroke is lacking. One novel approach may be care led by a Nurse Independent Prescriber, and a recent Cochrane review concluded that this form of intervention warrants further evaluation. However, such a novel and complex intervention requires pilot data prior to a definitive RCT.

Aim

This pilot trial is an essential preliminary to a definitive RCT assessing the effectiveness and cost-effectiveness of a Nurse Independent Prescriber-led care pathway compared to current practice. The purpose of the pilot is to ensure the design and methods of that future trial are sound, practicable and feasible.

The aims of the pilot are:

1. To test the feasibility, practicality, safety and acceptability of the study design and protocol;

2. To resolve practical issues for the conduct of the future RCT such as the reproducibility of the outcome measures, and recruitment and attrition rates;

3. To investigate the acceptability of the care pathway to patients and general practitioners (GPs) and to refine it prior to the full RCT;

4. To inform the sample size calculation for the full trial.

Design and methods

The pilot study will be a scaled down version of the future RCT, and will run for 24 months. 40 patients with minor stroke or TIA and clinic systolic BP (SBP) above 140 mmHg will be recruited within one month of their event. They will be randomised to usual care (risk factor management in primary care according to local guidelines), or to a 6-month programme of follow-up visits with a Nurse Independent Prescriber, who will manage risk factors according to an incremental care pathway. All participants will then be followed up after a further 6 months of usual care. A nested qualitative study will explore patients’ experiences and GP views of this programme of assertive risk factor management, to improve its acceptability prior to the definitive RCT.

Project team

Professor Susan Latter


External:

Dr Martin James (Chief Investigator)
Consultant Stroke Physician / Honorary Clinical Senior Lecturer
Dept of Medicine for the Elderly,Royal Devon & Exeter Hospital

Professor Nicky Britten, Professor of Applied Healthcare Research, Institute of Health Services Research, Penninsula Medical School, University of Exeter

Dr Colin Pritchard, Research Design Consultant and Health Economist
NIHR Research Design Service South West

Dr Phil Evans, Senior Clinical Research Fellow / General Practitioner Principal, Department of Primary Care, Penninsula Medical School

Project funder

NIHR Research for Patient Benefit

Related research groups

Health Work and Systems
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