Contact information
Type
Scientific
Contact name
Prof Michael Modell
ORCID ID
Contact details
Primary Care & Population Sciences
Royal Free & University College Medical School
Level 2
Holborn Union Building
London
N19 3UA
United Kingdom
+44 (0)20 7 288 3247
m.modell@ucl.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PSI03-26
Study information
Scientific title
Acronym
Study hypothesis
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
GP practice
Study type
Screening
Patient information sheet
Condition
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
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.
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/04/1995
Overall study end date
01/04/1997
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type(s)
Patient
Age group
Other
Sex
Both
Target number of participants
Randomised at practise level, 13 intervention practices, 13 control practices
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/1995
Recruitment end date
01/04/1997
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Primary Care & Population Sciences
London
N19 3UA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/09/1998 | Yes | No |