Condition category
Ear, Nose and Throat
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kath Bennett

ORCID ID

Contact details

Research Fellow in Bio-epidemiology at the CRC Paediatric and Familial Cancer Research Group
Royal Manchester Children’s Hospital
Stancliffe
Hospital Road
Manchester
M27 4HA
United Kingdom

Additional identifiers

EudraCT 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

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/1997

Overall trial end date

01/05/1999

Reason abandoned

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

Patient

Age group

Other

Gender

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

United Kingdom

Trial 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

http://www.doh.gov.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11467270

Publication citations

  1. Results

    Bennett K, Haggard M, Churchill R, Wood S, Improving referrals for glue ear from primary care: are multiple interventions better than one alone?, J Health Serv Res Policy, 2001, 6, 3, 139-144.

Additional files

Editorial Notes