Cluster randomised controlled trial of computer decision support for management of familial cancer in primary care

ISRCTN	ISRCTN71084565
DOI	https://doi.org/10.1186/ISRCTN71084565
Protocol serial number	N/A
Sponsor	Cancer Research UK (UK)
Funder	Cancer Research UK (CRUK) (UK)

Submission date: 16/10/2002
Registration date: 16/10/2002
Last edited: 08/10/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helen Morris
Scientific

GRAIDS Trial Coordinator
General Practice & Primary Care Research Unit
Department of Public Health & Primary Care
University of Cambridge
Institute of Public Health
Forvie Site
Robinson Way
Cambridge
CB2 2SR
United Kingdom

Phone	+44 (0)1223 330323
Email	hcm29@medschl.cam.ac.uk

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	GRAIDS Trial
Study objectives	This project applies the Medical Research Council (MRC) framework for evaluation of complex interventions and encompasses an optimisation trial of computer decision support for familial cancer in primary care and an audit of current referral patterns for familial cancers to inform power calculations for a subsequent multi-centre trial. This optimisation trial will pilot procedures for the delivery and assessment of the intervention and will, in addition, seek to optimise and identify the most cost-effective intervention that should be evaluated in a full-scale trial by having a fixed and an adaptive intervention arm. The underlying hypotheses are that the provision of computer decision support and a family history questionnaire in primary care will lead to more appropriate and cost-effective referrals for familial cancers (i.e. that are in line with regional referral criteria), and will enable patients to make better informed decisions about their familial risk of cancer.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Familial breast or colorectal cancer
Intervention	Intervention arm subjects: Patients approaching their GP or practice nurse with concerns about their family history of cancer will be given a family history questionnaire to take home to complete, and then return for a second appointment. At the second consultation the trained lead clinician will enter information supplied by the patient and the family history questionnaire into the GRAIDS software. The software will support discussions with the patient about their risk of cancer and subsequent management. Control arm subjects: Subjects in the control practices approaching their GP or practice nurse with concerns about familial cancer will have a normal consultation according to their GPs current practice. All subjects: Subjects who are referred to the Regional Genetics Clinic will be asked to complete the measure of Informed Decision Making (IDM) questionnaire. This request will come from the Clinic with their appointment letter. The subjects will be requested to return the completed questionnaire to the Study Team. Subjects in the intervention practices who are not referred to the Regional Genetics Clinic will be sent a measure of IDM questionnaire by the Study Team. Six months after they have returned the measure of IDM, the subjects will be sent a second measure of IDM to complete and return to the Study Team. Trial Principal Investigator: Professor Jon Emery
Intervention type	Other
Primary outcome measure(s)	1. The number of times that the GRAIDS software is used in the GP practices 2. The total number of referrals to secondary care about familial cancer and the proportion that meet regional referral criteria 3. The cost per use of the software and the cost per appropriate referral
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1300
Key inclusion criteria	Patients approaching their General Prectitioner (GP) or practice nurse with concerns about their family history of cancer.
Key exclusion criteria	1. Children under 18 2. People with learning difficulties 3. Severely ill 4. Other vulnerable groups e.g. mental illness, dementia
Date of first enrolment	01/04/2002
Date of final enrolment	30/09/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

GRAIDS Trial Coordinator

Cambridge
CB2 2SR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/08/2007		Yes	No