Enhanced Early Supported Discharge for Stroke in Camden

NCT02053987 | Completed DMC

• 1 other identifier: Enhanced ESD
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.What are the staff, participant and carer views and experiences of an Enhanced ESD service?

Conditions

Stroke.

Outcome Measures

Primary Outcomes (3)

• Modified Barthel Index

  This measure will identify improvements in functional ability.

  This will be collected prior to the start of the intervention (approx 7 days post stroke) and after 8 weeks of therapy (approx 9 weeks post stroke)

• PHQ2

  This measure will monitor psychological status pre and post intervention.

  At the start of the intervention (approx 7 days post stroke) and at the end of the 8 week intervention (approx 9 weeks post stroke)

• The Goal Attainment Scale Lite

  The Goal Attainment Scale Lite will be used to measure changes in patient reported outcome measures.

  At the start of the intervention (approx 7 days post stroke) and at the end of the 8 week intervention (approx 9 weeks post stroke)

Secondary Outcomes (1)

• EQ5D to be used to measure the cost effectiveness of the intervention when compared to standard hospital care.

  Five days post stroke, 9 weeks post stroke and at 6 months.

Other Outcomes (2)

• Staff, patient and carer experience surveys

  After 8 weeks of the intervention (approx 9 weeks post stroke)

• Carer EQ5D and Caregiver Strain Index

  Within approx 7 days of the patient's stroke and 8 weeks later (approx 9 weeks post stroke)

Study Arms (2)

Stroke rehabilitation

EXPERIMENTAL

Other: Intensive rehabilitation in the home.

Control Group

NO INTERVENTION

This group will undergo rehabilitation as per the current stroke rehabilitation pathway.

Interventions

Intensive rehabilitation in the home. OTHER

Stroke rehabilitation

Eligibility Criteria

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

You may qualify if:

• Only those with capacity to consent will be admitted into the study.
• Patient must be registered with a Camden GP to be offered Enhanced ESD. Must be registered with a Camden or Islington GP for the collection and analysis of routine data.
• Patient must be over eighteen years old
• Patient has a confirmed diagnosis of stroke from a Stroke Consultant
• Patient consent provided (assistance given from speech and language therapists where stroke survivor has significant language and communication impairment);
• Patient is medically stable and fit to be managed at home as assessed by Acute Stroke Consultant as part of the MDT. This includes the utilisation of measures such as NHISS score and GCS to determine the medical status of a patient.
• The criteria to make this decision is defined in the Community Care (Delayed Discharges) Act, 2003 as: A clinical decision has been made that the patient is ready for transfer AND a multi-disciplinary team (MDT) decision has been made that the patient is ready for transfer AND the patient is safe to discharge/transfer.
• Patient is intending to return home or to supported accommodation following hospital stay (in line with current ESD guidance;)
• Patient is safe to transfer home with provision of equipment (e.g. Hospital bed, chair, telecare devices etc.) and a care package if required. This means at least the following is conducted prior to discharge where it is appropriate - home visit risk assessment, manual handling risk assessment, cognitive assessment (e.g. mental capacity assessment form (to be provided with referral) and own safety awareness);
• Patient has active nursing / therapy goals and has potential to participate and respond to a rehabilitation / disability management programme;
• Toileting needs can be managed within available care, support and/or equipment (commode, pads and bottle) either at the point of discharge home or within ≤ 2 weeks of returning home;
• Patient is able to transfer with assistance of 2 people and/or equipment;
• Patient's dysphagia, nutrition and hydration can be safely managed in the community, as assessed by stroke consultant and/or medical team responsible for individual's hospital care, ward nursing staff, Enhanced ESD nurses, the referring and receiving SLTs and dietitians. Risk of malnutrition assessed by MDT using standardised nutritional screening tool (eg MUST).

You may not qualify if:

• Patient has failed a Mental Capacity Act Assessment (2005) and is deemed not to have capacity to consent to participation in the study.
• Patient is not able to engage with or respond to a rehabilitation programme, for example, where a significant cognitive impairment / behavioural problem limits their ability to effectively engage in rehabilitation;
• Patient is not safe to be transferred home despite provision of equipment and a care package
• Patient requires help of more than 2 person to transfer, and/or does not have sufficient space within their home to safely accommodate equipment (such as a hoist) required for a safe discharge
• Clients requiring constant supervision over 24 hours which is anticipated not to resolve within seven days. The need for supervision may be secondary to impaired concentration/attention/safety awareness/impulsivity/visual impairment/reduced insight/severe aphasia/need for prompts and hands on assistance to maintain safety when standing, transferring and washing etc.
• Clients whose prognosis for functional improvement is poor and who do not have functional goals that can be achieved within 8 weeks.
• Not able to manage medications with carers dispensing from blister pack and prompting client to take medications.
• Patients whose normal place of residence is a Nursing or Residential home. This cohort of patients are likely to have ongoing long term issues whose needs are best met via the community pathway for long term rehabilitation needs.
• Patients who have a NasoGastric tube in situ and therefore do not have established nutrition. Those who have long term PEGs will not be excluded as their nutritional needs can be met non-orally.

Sponsors & Collaborators

• Camden Clinical Commissioning Group: lead

Study Sites (1)

CNWL NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Charlie Davie, MBBS

  Chief Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: February 4, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 11, 2014

Record last verified: 2014-11

Locations

GB (1)