Stroke. Clinical Trial
Official title:
Evaluation of the Implementation of an Enhanced ESD Service for Stroke Survivors With Moderate to Severe Impairments and the Resulting Clinical and Cost Outcomes When Compared to Similar Patients in an Unchanged Stroke Care Pathway in a Neighbouring Borough.
An Early Supported Discharge (ESD) service for stroke is an evidence based intervention that
aims to enable a particular group of patients who have a mild to moderate stroke to be
discharged from hospital early and receive the same intensity of rehabilitation in their
home. Analysis of almost 1600 patients has demonstrated that ESD can reduce long term
dependency, decrease admission to institutionalized care as well as shorten hospital stay.
This model has also been shown to reduce death and institutionalized care at five years
(Fjaetoft et al, 2011) and has been shown to be cost effective (Saka, 2005.) A study by
National Heath Service (NHS) London showed that patient outcomes has not been affected by
being treated at home and that there have not been an increase in readmissions due to the
setting up of an ESD service.
However, those with moderate to severe strokes are often not eligible for ESD
rehabilitation.
This study aims to offer twenty Camden residents an Enhanced Early Supported Discharge
service in which stroke survivors with moderate to severe impairments are eligible.
Participants will be recruited from the University College London Hospital (UCLH)l Hyper
Acute Stroke Unit and acute stroke units at UCLH and the Royal Free Hospital.
This study will compare health and economic outcomes of early Multidisciplinary stroke
rehabilitation in the community compared to traditional inpatient and community
Multidisciplinary rehabilitation for people with moderate to severe post stroke impairments.
We will also collect the views of the participants and their carers regarding being treated
at home.
The objectives are to discover:
1. What impact does the implementation of an Enhanced ESD service for stroke survivors
with moderate to severe impairments have on clinical and cost outcomes compared to an
unchanged care pathway in a neighbouring borough?
2. What are the staff, participant and carer views and experiences of an Enhanced ESD
service?
Control Group The control group will comprise those who are not eligible as they are
registered with a GP in the London borough of Islington. Islington residents have been
chosen as a control group as currently there is no ESD service for patients to be referred
to. Rehabilitation therefore takes place as an inpatient with community follow up. The
boroughs of Camden and Islington are comparable in terms of ethnic diversity, size, stroke
prevalence and age (SEPHO, 2013.) The control group will not be matched to demographics such
as age and gender due to the fact that we are unable to predict this information. We will
gather information regarding type of stroke, stroke severity and demographics so that this
can be compared as much as possible during the analysis.
Consent will be obtained to collect outcome measure data from the control group and their
carer's. Local agreement is in place to share their anonymised data for the purposes of the
research. The data will be collected by staff on the Acute Stroke Units and by a link
individual within Islington Community Services. The outcome measures collected are the same
as those currently being collected along the stroke pathway in London. The Caregiver Strain
Index and EQ5D are not routinely collected.
A similar number of patients will be identified over the same timescale as the research
group and will be subject to the same battery of outcomes due to standardisation across the
stroke pathway in London hospitals. Local agreement will be met regarding the six month
review outcomes.
Data will be collected within five days post stroke, at approximately nine weeks post stroke
and at six months post stroke.
Cost savings The management of acute stroke and ACS has been revolutionised in Camden over
the last 5 years. Patients, when identified are transferred by London Ambulance service to
UCLH or Royal Free acute trusts. Since the centralisation of Hyper Acute services, the
mortality and morbidity for both conditions has dropped (Hunter et al, 2013.) The study will
include a comprehensive assessment of cost effectiveness which will include direct and
indirect health care costs and social care costs.
Locally the Enhanced ESD service could release acute stroke resources and free monies
associated with these, improve access to specialist stroke rehab in people's homes (thus
improving patient choice) and thus compliance with national guidelines (including the RCP
stroke guidelines, 2012.) Bed days saved from both HASU's and SU will be calculated in terms
of financial saving. Actual therapy and care costs will be calculated for comparison. The
rehabilitation care costs for this project are £15,924 per patient or £318,472 for the
cohort of 20 patients.
The project has been set up using the predicted costs of a complex needs stroke survivor
spending four weeks in an acute stroke unit (tariff £4,646) then transferred for further
inpatient rehabilitation for 56 days at the cost of £280 per day . This equates to £20,326
per patient for direct in-patient care costs.
Although the overall project costs of this study exceed this figure, the service costs which
would be recurrent if the model is deemed clinically and economically viable are less.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02230852 -
Prehospital Stroke Study at the Universitair Ziekenhuis Brussel I (PreSSUB I)
|
N/A |