Condition category
Skin and Connective Tissue Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
19/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.bris.ac.uk/Depts/PrimaryHealthCare/research.htm

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 measures

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

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16332728

Publication citations

  1. 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.

Additional files

Editorial Notes