Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PSI B-6
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effect of a risk factor checklist and educational training video on glue ear for general practitioners in reducing practice variation and improving the appropriateness of referral to ENT.
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
Other
Patient information sheet
Condition
Glue ear; otitis media
Intervention
Each practice was randomised to one of the following groups:
1. Control
2. Video only
3. Checklist only
4. Video and checklist.
Intervention type
Other
Primary outcome measure
Overall mean GP and practice referral rates for OME or related conditions remained stable, simplifying the comparisons related to intervention. There was no reduction in variability amongst practices receiving any intervention, compared with practices receiving none. In those receiving both the video and checklist compared with those receiving only one or no intervention, there was a significant improvement in the quality of referrals, as given by more referrals having bilateral HL >20 dB when sent at ENT (ANCOVA for linear trend assuming 0, 1, 2 interventions and adjusting for the period the child waited to be seen at ENT; p = 0.010). No difference was found between the intervention and non-intervention groups in parent satisfaction scores. However, irrespective of intervention group, parents of children who received more information from their GP about glue ear had higher satisfaction scores than those that did not (p = 0.022). Disseminating information on glue ear to GPs in a multi-channel approach can improve the quality of referrals to ENT but appears to make little impact on the parent¿s satisfaction with the information provided by their GP. Much of the variation in GP glue ear referrals and ENT consultants¿ VT insertion rates is still not accounted for, reducing the ability to produce suggestions on how best to compress it. This study provides a worthwhile basis for further large-scale work using such interventions, particularly when used in combination with one another, provided the appropriate outcome measures are used including the patient¿s perspective.
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/02/1997
Overall study end date
01/05/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Fifty general practices from Trent Region and the West of Scotland were recruited into a cluster-randomised controlled trial.
Participant type(s)
Patient
Age group
Other
Sex
Both
Target number of participants
50 practices (177 practitioners)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/02/1997
Recruitment end date
01/05/1999
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Research Fellow in Bio-epidemiology at the CRC Paediatric and Familial Cancer Research Group
Manchester
M27 4HA
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 | 01/07/2001 | Yes | No |