Close
Objectives
- To determine whether the use of a check list for the 6-week hip check can (i) reduce the number of clinically insignificant referrals from primary to secondary care, and (ii) reduce the number of Developmental dysplasia of the hip (DDH) diagnosed beyond the age of 12 weeks.
- To determine the cost-effectiveness of this intervention considering a life time horizon.
- To conduct an integrated qualitative and quantitative process evaluation in order to: understand the participants' experience with the intervention; identify how the intervention affects general practitioners' capability, opportunity and motivation in relation to the 6-week check; study how the intervention is implemented; and investigate how contextual factors affect uptake of the intervention.
What does the study involve?
| Arm | Intervention |
|---|---|
| Experimental: Diagnostic Aid | The 6 week Hip Checklist Comprehensive 9-item structured guide for correct diagnosis of developmental dysplasia of the hip. Used in paper and electronic format. Seek to improve the ability of doctors in evaluating infants hips |
| No intervention: Standard of Care | Will assess infants according to standard practice during the 6-week hip check. This group will receive a leaflet about the national best practive for this check |
Who can participate?
Inclusion Criteria:
- GP practices registered in England and who carry out the 6-week infant hip check as part of their routine work
- Practice using either EMIS or System One clinical computer systems
- GPs recording all 6 week baby hip examination on their GP computer template
- General practices willing to give informed consent to:
- (a) being randomized
- (b) willing to undergo observations, interviews and questionnaires and
- (c)collaborating secondary care facilities releasing data about all infants undergoing the 6-week hip check GP practices during the duration of the RCT.
- If randomised to the intervention, GP conducting the 6 week check must agree to view the training video on the examination of babies’ hips at 6 weeks at baseline
In the study practice, infants who are eligible for this study will be those presenting to any of the practices if aged <11 weeks when the 6-week check is done in the GP practice. Please note that infants who have completed an ultrasound scan prior to attending their 6-8 week check and who have been deemed as having a normal scan, are still eligible for inclusion in the trial.
Exclusion Criteria:
- Any GP practice that is to close down within 12 months of when the first patient would be recruited in this practice
- Parents/carers aged under 18
Will there be any follow-up?
A researcher will visit the GP practice and collect outcome data about the 6-week hip checks conducted during the study period. We will also be collecting follow-up data from the NHS Digital, Health & Social Care Information Centre data linkage service. By obtaining local patient IDs, this will enable us to track participants for admission/outpatient attendance to any secondary care facilities which GPs refer infants – therefore we will be able to link the data provided by the practice to the data retrieved from the hospitals.
All identifiable data will be transferred directly to an encrypted server, UCL Data Safe Haven.
Confidentiality
The Research Team will use your name and contact details to contact you about the research study, and make sure that relevant information about the study is recorded to oversee the quality of the study. General Data Protection Regulation (GDPR) will apply for all information gathered on you within the study. Individuals from GOSH, KCL and regulatory organisations may look at your research records to check the accuracy of the research study and to audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details. Data will be analysed by the Research Team at KCL and collaborator at University of Bedfordshire in an anonymised form. Participants will not be identifiable in any published report from this study. You can find out more about how we use your information by contacting your.data@gosh.nhs.uk