Submission date
23/01/2004
Registration date
23/01/2004
Last edited
14/12/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Prof Geoff Hanks

ORCID ID

Contact details

Department of Palliative Medicine
University of Bristol
Bristol Oncology Centre
Horfield Road
Bristol
BS2 8ED
United Kingdom
+44 (0)117 928 3336
G.W.Hanks@bris.ac.uk

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

NCP/J01

Study information

Scientific title

Acronym

Study hypothesis

This project aims to evaluate the cost and effectiveness of an hospital based palliative care service on subsequent care of advanced cancer patients in the community, in terms of length of index hospital admission, and need for re-admission, quality of symptom control on discharge and at home, quality of life and functional status at home, patient and carer satisfaction, impact on general practitioner/district nurse workload, and eventual place of death. The effects of such a service on the professional satisfaction of the primary care team will also be assessed. The study will be a randomised controlled trial of two levels of intervention by the palliative care team in the United Bristol Healthcare Trust. Assessments will be undertaken both during the hospital admission and after discharge over a 5 month follow-up period or to death.

Ethics approval(s)

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Quality of life

Patient information sheet

Condition

Symptoms and general pathology: Pain

Intervention

1. The visiting service: (the usual service delivered by the Palliative Care Team.) Initial assessment by a specialist doctor/nurse with detailed advice about problems identified in patient's case notes. Follow-up by telephone and in-person consultations with patient, family and medical and nursing staff caring for patient. Liaison also with community-based health professions and palliative care outpatient follow-up if appropriate. Advice and support provided only but over and above the normal service provided to hospital patients.
2. The telephone service: A more limited form of intervention devised as the control. No direct contact between the Palliative Care Team and the patient or family. Telephone consultation took place within one working day of referral between a senior medical PCT member and the referring doctor and also between a clinical nurse specialist and a member of the ward nursing staff involved in the patient's care. A second telephone consultation could be made if necessary but with no further follow-up or advice offered.

Patients randomised to either the visiting service or the telephone service in order to compare: pain, symptom control and global health-related 'quality of life'; satisfaction of patients, carers and health professionals; and use of health service resources.

Intervention type

Other

Primary outcome measure

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall study start date

01/01/2001

Overall study end date

31/12/2001

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients 18 and over newly referred to PCT
2. Able to understand instructions and provide written consent within one day of referral
3. Physically and emotionally well enough to consider participating in a study and to reflect on their illness experience with a researcher
4. Not likely to be discharged with 24 hours of referral. PCT advice requested urgently
5. No strong preference expressed by the patient or patient's clinician for the visiting service of the PCT only
6. Aware of diagnosis
7. Willing to answer questions and be followed up for 4 weeks

Participant type(s)

Patient

Age group

Not Specified

Lower age limit

18 Years

Sex

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Written consent not provided within one day of referral.

Recruitment start date

01/01/2001

Recruitment end date

31/12/2001

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

Department of Palliative Medicine
Bristol
BS2 8ED
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Cancer National Research and Development Programme (UK)

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

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 23/09/2002 Yes No

Additional files

Editorial Notes