Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT04101903
Brief Summary:
Developmental dysplasia of the hip (DDH) is one of the most common inborn diseases. Early diagnosis of this condition is very important and it can be harmful both to miss DDH and label normal infants as having DDH. Why DDH can be missed or labelled to normal children is not well understood but can be related to the doctor's knowledge, skill and the way the hip consultation is conducted. This research aims to help overcome these issues and proposes the use of a diagnostic aid (checklist) for DDH in general practices (GP).
The Investigator will divide general practices (GP) in England into two groups. One group will use our checklist for all hip checks they carry out. The other group will work as they usually do, without the aid. The study wishes to compare if GPs who use the checklist will do better in identifying babies with DDH than those who do not use our checklist. The Investigator will also evaluate whether using the checklist reduces costs for families around trips to doctors or hospitals, and costs to the NHS (National Health Service). In addition The Investigators will interview general practitioners, health visitors and carers of infants to elicit their perceptions about the intervention.
The study will include GPs registered in England who carry out the 6-week hip check and agree to being randomised and to hospitals releasing data on infants they had examined during the study period. Practices planning to close within 12 months of the start of the study are not eligible. Eligible infants will be identified by general practice patient registers and infants will be invited to attend a 6-week check at their local practices, the research sites. The study plans to include a total of 152 practices in this study and will collaborate with 15 NIHR (National Institute of Health Research) CRNs (Clinical Research Network) to recruit GP practices with efficient and existing infrastructure.
Detailed Description:
1. 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.
2. Type of trial: Phase III, cluster randomised controlled trial
3. Trial design and methods: This trial incorporates (i) 4-months internal pilot in order to confirm realistic recruitment targets; (ii) process evaluation encompassing qualitative research on changing physician referral behaviour and on normalising the intervention in practice; and (iii) health economic evaluation.
4. Trial duration per participant: 24 months
5. Planned trial sites: 172 GP practices in England. Half will be randomised to the experimental arm (using the diagnostic aid) and half to the control arm (standard of care 6 week hip check)
6. Total number of participants planned: 172 GP practices will be randomised (with an average of 110 infants recruited across the trial period per practice).
7. Main inclusion criteria:
* Inclusion: GP practices registered in England and who carry out the 6-week hip check as part of their routine work - these practices must be using either EMIS or System One clinical computer systems
Study:
NCT04101903
Study Brief:
Protocol Section:
NCT04101903