Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Chris Salisbury
ORCID ID
Contact details
University of Bristol
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
+44 (0)117 954 6658
c.salisbury@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SDO/34/2002
Study information
Scientific title
Acronym
Study hypothesis
To compare the effectiveness, cost-effectiveness, accessibility and acceptability of a Primary Care Dermatology Service. This service is an example of the model, promoted in the NHS Plan, of services provided by GPs with special interests (GPSIs) to other GPs across a PCT area.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
Non-urgent skin problems
Intervention
The Bristol primary care dermatology service is staffed by two GPs with Special Interests (GPSIs) and a specialist nurse, and operates from a suburban health centre. It provides care for patients registered with the 29 general practices in one primary care trust. Both GPSIs have postgraduate training and experience in dermatology. All patients see a GPSI initially but may be followed up by a GPSI or the specialist nurse, or may be referred to hospital outpatient care if necessary. The control arm received care from the hospital outpatient dermatology clinic as usual.
The main study using a revised protocol applied to all patients recruited from 01/09/2002; all patients recruited before this were in the pilot study.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Disease-related quality of life assessed using the dermatology life quality index (DLQI) and a single-item measure of improvement
2. Improved patient-perceived access, assessed using a new scale
Secondary outcome measures
1. Patient satisfaction with consultation (Consultation Satisfaction Questionnaire) and with facilities (new scale)
2. Preference for site of care
3. Proportion of failed appointments
4. Waiting times to first appointment
Overall trial start date
01/02/2002
Overall trial end date
30/04/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients referred to a hospital dermatology clinic assessed on the basis of the referral letter to be potentially suitable for GPSI management. Suitable patients had non-urgent problems with a provisional diagnosis.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
544 (363 primary care arm; 181 hospital arm)
Participant exclusion criteria
1. Children aged less than 16 years
2. Urgent skin problems
3. Patients where the referral letter indicated that the referrer specifically requested hospital management or the patient clearly needed hospital facilities
Recruitment start date
01/02/2002
Recruitment end date
30/04/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Bristol
Bristol
BS6 6JL
United Kingdom
Sponsor information
Organisation
NHS Service Delivery and Organisation Programme (SDO) (UK)
Sponsor details
London School of Hygiene and Tropical Medicine
99 Gower Street
London
WC1E 6AZ
United Kingdom
+44 (0)20 7612 7980
sdo@lshtm.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Service Delivery and Organisation Programme (SDO) (UK) (ref: SDO/34/2002)
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
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/16332728
Publication citations
-
Results
Salisbury C, Noble A, Horrocks S, Crosby Z, Harrison V, Coast J, de Berker D, Peters T, Evaluation of a general practitioner with special interest service for dermatology: randomised controlled trial., BMJ, 2005, 331, 7530, 1441-1446, doi: 10.1136/bmj.38670.494734.7C.