Conducting research in palliative care: finding the best way forward - Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study
| ISRCTN | ISRCTN60243484 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60243484 |
| Protocol serial number | N/A |
| Sponsor | North West Wales NHS Trust (UK) |
| Funder | North West Wales NHS Trust Research and Development Fund (UK) |
- Submission date
- 03/02/2004
- Registration date
- 25/02/2004
- Last edited
- 05/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew Fowell
Scientific
Scientific
Palliative Care Department
Bodfan
Eryri Hospital
Caernarfon
LL55 2YE
United Kingdom
| Phone | +44 (0)1286 662775 |
|---|---|
| andrew.fowell@nww-tr.wales.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Conducting research in palliative care: finding the best way forward - Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study |
| Study acronym | PEACE |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Ethical approval for this feasibility study was granted by the North Wales Health Authority Research Committee (West, Central and East sub-committees). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Palliative Care Department
Caernarfon
LL55 2YE
United Kingdom
LL55 2YE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2006 | Yes | No | |
| Protocol article | protocol | 27/04/2004 | Yes | No |
Editorial Notes
05/07/2018: Publication reference added
