A randomised controlled trial of the effect of a practice-based genetic screening facilitator.
| ISRCTN | ISRCTN16886710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16886710 |
| Secondary identifying numbers | PSI03-26 |
- 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
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 |
|---|---|
| m.modell@ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| 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 | 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 |
| Completion date | 01/04/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | Randomised at practise level, 13 intervention practices, 13 control practices |
| 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
- England
- United Kingdom
Study participating centre
Primary Care & Population Sciences
London
N19 3UA
United Kingdom
N19 3UA
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
