What does it cost to establish a practice-nurses-led clinical trial in general practice?
OBJECTIVE
To describe the processes and costs of engaging practice nurses (PNs) to establish a cluster randomised controlled trial (RCT) to study type 2 diabetes in general practice.


METHODS
Descriptive study of the processes and costs of engaging PNs from 59 general practices in Victoria that were participating in the Patient Engagement And Coaching for Health (PEACH) study, prior to practices being randomly assigned in the cluster RCT.


METHODS
Estimated direct research costs and personnel costs for establishing a general practice-based research project involving PNs (eg, costs for approaching Victorian Divisions of General Practice and the Australian Practice Nurses Association; practice and patient recruitment; research project establishment at general practices; and PNs' training, support and engagement during the study establishment period).


RESULTS
The estimated cost to establish our PN-led general practice-based cluster RCT was over $110 000, with an average cost of $2000 per practice. Direct research and personnel costs were considerably higher than anticipated. Lack of research skills among PNs required intensive hands-on support from the research team.


CONCLUSIONS
It is feasible to undertake a PN-led, general practice-based clinical trial in diabetes care. Future research funding needs to account for recruitment costs, including the need to build PN research capacity, and to overcome the inherent difficulties of engaging practices in complex intervention trials in primary care.


BACKGROUND
International Standard Randomised Controlled Trial Number Register ISRCTN50662837.
Blackberry
Irene D
ID
Department of General Practice, University of Melbourne, Melbourne, VIC, Australia.
Furler
John S
JS
Young
Doris
D
Best
James D
JD
D003365:Costs and Cost Analysis; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy; D005194:Family Practice; D006801:Humans; D009722:Nurse Practitioners; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000191:economics*; D012107:Research Design