A randomised controlled trial of the effect of a practice-based genetic screening facilitator.

ISRCTN	ISRCTN16886710
DOI	https://doi.org/10.1186/ISRCTN16886710
Protocol serial number	PSI03-26
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 04/12/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Modell
Scientific

Primary Care & Population Sciences
Royal Free & University College Medical School
Level 2
Holborn Union Building
London
N19 3UA
United Kingdom

Phone	+44 (0)20 7 288 3247
Email	m.modell@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To investigate the feasibility of improving screening for carriers of the recessively inherited haemoglobin disorders (thalassaemia and sickle cell disorders) in general practice, by using a nurse facilitator to work with primary care teams and the relevant haematology laboratories. To identify problems in communication between all those involved in delivering the service, and to implement solutions.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Genetic screening for haemoglobin disorders
Intervention	The 13 intervention practices were given: posters, and leaflets to explain to the members of the relevant ethnic groups why carrier testing is advisable and how it can be obtained, an aide-memoire card for GPs¿ consulting rooms listing groups to whom screening should be offered, and a practice reference manual containing background information. Intervention practices were offered three formal practice-based 30-60 minute training sessions from the nurse facilitator during the intervention year. Screening requests from study, control and non-participating practices were recorded using computerised hospital haematology laboratory records.
Intervention type	Other
Primary outcome measure(s)	The main outcome measure was the change in the number of requests for screening tests for haemoglobin disorders made by control and intervention practices in the baseline and intervention years. We also recorded the numbers of requests from the non-participating practices. For the 2 year follow-up trial the main outcome measure was the number of requests for screening tests from each intervention practice in 1997 and 1998.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/1997

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Key inclusion criteria	It took place in an area of North London where 29% of residents and 43% of births are in the ethnic groups at risk for haemoglobin disorders (mainly Camden, Islington, Haringey and Enfield). Twenty six of the 93 practices using the services of the Whittington haematology laboratory agreed to take part, and were divided into 13 control and 13 intervention practices.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/1995
Date of final enrolment	01/04/1997

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Primary Care & Population Sciences

London
N19 3UA
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	19/09/1998		Yes	No