Condition category
Not Applicable
Date applied
03/02/2004
Date assigned
25/02/2004
Last edited
24/08/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Fowell

ORCID ID

Contact details

Palliative Care Department
Bodfan
Eryri Hospital
Caernarfon
LL55 2YE
United Kingdom
+44 (0)1286 662775
andrew.fowell@nww-tr.wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PEACE

Study hypothesis

Not provided at time of registration

Ethics approval

Ethical approval for this feasibility study was granted by the North Wales Health Authority Research Committee (West, Central and East sub-committees).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Condition

Palliative care

Intervention

Not prescribing an anti-emetic as standard treatment on commencement of a syringe driver unless patient is symptomatic.

The study utilises a crossover design and is taking place at two sites within the North West Wales NHS Trust.

One site has been independently randomised (by the University of Wales Bangor) to a cluster randomised method for three months. All dying patients in that cluster will not receive an anti-emetic on commencement of a syringe driver. If the patient becomes nauseous or vomits an anti-emetic will be available and administered immediately. Patients falling into this category will form a sub-group. Patients in the cluster site are unaware that the study is taking place, consent to participate is given by the cluster gatekeeper in this case the ward sister, who also has the right if she wishes to withdraw her cluster from the study.

The second site participating in the study have been allocated to use the randomised consent or Zelen method for a period of three months. In this condition patients are approached for consent after randomisation has taken place. Randomisation is being undertaken by the University of Wales Bangor. When a patient is in the last days of life and about to start on a syringe driver and they are asymptomatic a phone call is made to the University and randomisation occurs. Either they are allocated to receive an anti-emetic (Standard Treatment) or not. If they are in the non-standard group then they are approached for their informed consent. Again any patients that are in the non-standard group that become symptomatic will immediately receive medication and their data allocated to the sub-group of the study.

After the three month period the two sites will receive a short de-briefing and then "swap" or cross over the two methods.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2004

Overall trial end date

01/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All patients identified as dying and being cared for on an Integrated Care Pathway at two sites within the Trust who are about to commence syringe driver delivered medication.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2004

Recruitment end date

01/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Palliative Care Department
Caernarfon
LL55 2YE
United Kingdom

Sponsor information

Organisation

North West Wales NHS Trust (UK)

Sponsor details

Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

North West Wales NHS Trust Research and Development Fund (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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15113420

Publication citations

  1. Protocol

    Fowell A, Russell I, Johnstone R, Finlay I, Russell D, Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]., BMC Palliat Care, 2004, 3, 1, 1, doi: 10.1186/1472-684X-3-1.

Additional files

Editorial Notes