Adran Gofal Lliniarol
Palliative Care Department
Bodfan (Eryri Hospital)
Caernarfon LL55 2YE
Tel: No: 01286 662775
FAX 662792
RE: Research in Palliative Care: Finding the Best Way Forward ISRCTN60243484
Cluster Gatekeeper
Dear ******,
Although guidelines in palliative care exist, the evidence base to support these guidelines is poor. There are inherent problems surrounding the design of studies concerning the dying patient. We are intending to conduct a feasibility study exploring two types of randomisation to ascertain, which of the two types will be most appropriate for future studies in palliative care.
To avoid over burdening the dying patient and their relatives or carers at this difficult time, by approaching them for consent to participate, the study has been designed to accommodate this problem by seeking consent at a site or cluster level.
Usually referred to as a " Cluster Representation Mechanism" or CRM, consent is sought from the cluster gatekeeper, usually a ward sister or charge-nurse in the case of a hospital. The cluster gatekeeper has the responsibility for the cluster and assents to the patients in that cluster participating in the study. The cluster gatekeeper can withdraw patients from the study without affecting the level of care the patient receives. The cluster gatekeeper is responsible to the cluster in the first instance and is supervised by the cluster guardian. The cluster gatekeeper and guardian must not be part of the research team. The cluster gatekeeper gives written informed assent and the assent, is witnessed by the cluster guardian. Both the cluster gatekeeper and the guardian are kept up to date as to the progress of the project.
Ethical approval has been sought and granted by the North Wales Research Ethics Committee.
The study will take place at two sites within the North West Wales NHS Trust over a twelve month period. We would like to invite you to act as one of two cluster gatekeepers for the duration of the study.
The study protocol is enclosed for your information together with, the information and paperwork relevant to cluster gatekeepers. If you have any further queries please do not hesitate to contact me.
Looking forward to hearing from you.
Yours sincerely
Dr Andrew Fowell
Macmillan Consultant