Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ISRCTN |
Last refreshed on:
|
13 January 2015 |
Main ID: |
ISRCTN17594119 |
Date of registration:
|
23/01/2004 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Evaluating a risk factor checklist and training video for GPs as a means of reducing practice variation in referral for glue ear.
|
Scientific title:
|
|
Date of first enrolment:
|
01/02/1997 |
Target sample size:
|
50 |
Recruitment status: |
Completed |
URL:
|
http://isrctn.com/ISRCTN17594119 |
Study type:
|
Interventional |
Study design:
|
Randomised controlled trial (Other)
|
Phase:
|
|
|
Countries of recruitment
|
United Kingdom
| | | | | | | |
Contacts
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
Kath
Bennett |
Address:
|
Research Fellow in Bio-epidemiology at the CRC Paediatric and Familial Cancer Research Group
Royal Manchester Children?s Hospital
Stancliffe
Hospital Road
M27 4HA
Manchester
United Kingdom |
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Fifty general practices from Trent Region and the West of Scotland were recruited into a cluster-randomised controlled trial.
Exclusion criteria: Does not match inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Glue ear; otitis media Ear, Nose and Throat Suppurative and unspecified otitis media
|
Intervention(s)
|
Each practice was randomised to one of the following groups: 1. Control 2. Video only 3. Checklist only 4. Video and checklist.
|
Primary Outcome(s)
|
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(s)
|
Not provided at time of registration
|
Source(s) of Monetary Support
|
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|