Condition category
Not Applicable
Date applied
22/06/2012
Date assigned
22/06/2012
Last edited
24/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In England over half a million people die each year and while most people would prefer to die at home, many are not able to do so and more than half die in hospitals. This study will investigate a new rapid response hospice at home service which aims to support patients under hospice care to die in their preferred place. The aim of the study is to provide evidence on the outcomes and costs of rapid response hospice at home teams. The objectives are to assess the impact of the service on:
1. Patients' preference - whether the service enables more patients to die in their preferred place.
2. Carers' quality of life during and after death.
3. The relative costs and consequences of a rapid response hospice at home team compared with usual services.
4. A 'good death'.

Who can participate?
The study will monitor the actual and preferred place of death for 441 newly referred patients to the hospice. We will recruit 504 carers to complete postal questionnaires on quality of life, well-being and caring activities. We will also carry out up to 60 interviews with bereaved carers about the patient’s end of life experience.

What does the study involve?
The intervention to be tested is a rapid response hospice at home service. The main features of the service are that it:
1. Is available to patients in their own home (including care homes).
2. Has a robust ‘hospice standard’ assessment which takes account of: patient preferences, carer/family preferences, patient needs and patient prognosis.
3. Provides hands-on care.
4. Responds rapidly to crises using human and material resources available 24/7 with access to health care assistants, a service coordinator, palliative care nursing, medical advice, and small pieces of equipment which can be carried by car.
5. Works in coordination with other community services.
The hospice operates from three sites covering separate catchment areas. Each site will be randomly allocated to the order in which it will receive the service, with the first site starting with the service and the others offering it after 6 and 12 months, respectively. All patients will be eligible to access the service when it is offered in their area. Sites which do not yet have the service will continue to offer usual services.

What are the possible benefits and risks of participating?
There are no specific benefits or risks to participants as patients and carers will still be able to access the full range of hospice services, including hospice at home if they do not participate.

Where is the study run from?
The study is run from Pilgrims Hospices in East Kent, in collaboration with the Universities of Kent and Surrey and sponsored by East Kent Hospitals University NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
The study started in December 2009 and will run until October 2012. Participants will be recruited for 2 years.

Who is funding the study?
National Institute for Health Research (NIHR)

Who is the main contact?
Dr Claire Butler, Pilgrims Hospices, claire.butler@pilgrimshospices.org
Laura Holdsworth, University of Kent, l.m.holdsworth@kent.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Rose Ward

ORCID ID

Contact details

East Kent Hospitals EKHUFT
c/o Pilgrims Hospice 56 London Road
Canterbury
CT2 8JA
United Kingdom
+44 (0)1227 459700
rose_ward@pilgrimshospice.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9051

Study information

Scientific title

Evaluation of Pilgrims Hospices rapid response community end of life service in East Kent: A Quasi-experimental multi-centre controlled trial

Acronym

Study hypothesis

The quantitative evaluation is a pragmatic quasi-experimental multi-centre controlled trial, with an embedded cost evaluation. The study also includes a qualitative evaluation using in-depth interviews to explore carers' perceptions.

The aim of the study is to contribute to the development of the evidence base on the outcomes and costs of rapid response hospice at home teams.

The main hypothesis to be tested is that the rapid response service will significantly increase the number of patients who die in their initial preferred place of death compared to the control group of patients who receive usual services. Related hypotheses to be tested are that:
1) The rapid response service improves the quality of life of carers of patients in the intervention compared to carers in the control group
2. The overall cost of providing care for patients in the intervention group is not significantly different to the cost of providing care for patients in the control group. In addition the study will contribute to generating a hypothesis on the ways in which carers perceive the quality of care and judge a 'good death.

Ethics approval

NRES Committee South East Coast –Kent, 09-H1101-75; First MREC approval date 22/12/2009

Study design

Quasi-experimental multi-centre controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network, Generic Health Relevance and Cross Cutting Themes; Subtopic: All Cancers/Misc Sites, Generic Health Relevance (all Subtopics); Disease: All, Health Services Research

Intervention

Hospice at home, The main features of the intervention are that it:
1. Is available to patients in their own home
2. Has a robust ‘hospice standard’ assessment
3. Provides hands on care
4. Responds rapidly to crises using human and material resources available 24/7 and
5. Works in coordination with other community services

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient preferred place of death

Secondary outcome measures

1. Carer quality of life and well-being - Carer outcomes will be measured at baseline on patient intake and 8 months later using self completion postal questionnaires. The outcome measures included in the questionnaire are the short-form SF12, measure of anxiety and depression (HADS), a measure of health utility (EQ-5D), and caregiving demand measured at baseline only.
2. Cost evaluation

Overall trial start date

01/01/2010

Overall trial end date

31/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients referred to the Pilgrims Hospices during the study and who die during the data collection period will be entered into the study.
2. All carers and bereaved carers who are able to consent will be eligible to participate.
3. Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1005; UK Sample Size: 1005; Description: 441 patients, 504 carers for questionnaires, 60 bereaved carers for interviews

Participant exclusion criteria

Carers and bereaved carers not capable of giving consent

Recruitment start date

01/01/2010

Recruitment end date

31/01/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

East Kent Hospitals EKHUFT
Canterbury
CT2 8JA
United Kingdom

Sponsor information

Organisation

East Kent Hospitals NHS Trust (UK)

Sponsor details

Ethelbert Road
Canterbury
CT1 3NG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR (UK) - Research for Patient Benefit Programme, Grant: PB-PG-0808-16126

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26701763
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25881623
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25944545

Publication citations

Additional files

Editorial Notes

24/06/2016: Publication references added. 14/01/2016: Publication reference added.