Clinical trial NCT04101903: Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice
Official title: Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice: Controlled Randomised Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University College, London
name: University of Bedfordshire
name: King's College London
name: Steps Charity Worldwide
name: Longrove Surgery
First posted: 2019-09-24
Enrollment: 172
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

Eligibility criteria: Inclusion Criteria:

* General practices (GP) registered in England and who carry out the 6-week infant hip check as part of their routine work.
* Practice using either EMIS or SystemOne clinical computer systems
* General practitioners recording all 6 week baby hip examination on their computer template
* GPs 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 randomised controlled trial.
* GPs 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.

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

Primary outcomes:
measure: Clinical Importance of referrals
timeFrame: 2 weeks following hip check
Secondary outcomes:
measure: Number of appropriate referrals per GP practice
timeFrame: Within 2 years of hip check
measure: Number of Late diagnoses
timeFrame: Within 2 years of hip check
measure: Consequences of Late diagnoses
timeFrame: Within 2 years of hip check
measure: Volume of referrals
timeFrame: Within 2 years of hip check
measure: Timeliness of referrals
timeFrame: Within 2 years of hip check
measure: Incremental costs of using aid
timeFrame: Within 2 years of hip check
measure: Incidence of developmental dysplasia of the hip
timeFrame: Within 2 years of hip check
measure: Impact of the intervention on general practitioner behaviour
timeFrame: Within 2 years of hip check
measure: Parent/Carer general worry at present
timeFrame: Within 2 weeks of hip check
measure: Parent/Carer worry related to developmental dysplasia of the hip
timeFrame: Within 2 weeks of hip check
measure: Parent/Carer satisfaction with the trial intervention
timeFrame: Within 2 weeks of hip check
measure: Parent/Carer acceptability of trial intervention
timeFrame: Within 2 weeks of hip check
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Rise Group Practice
Study officials:
References:
citation: Roposch A, Warsame K, Chater A, Green J, Hunter R, Wood J, Freemantle N, Nazareth I. Study protocol for evaluation of aid to diagnosis for developmental dysplasia of the hip in general practice: controlled trial randomised by practice. BMJ Open. 2020 Dec 2;10(12):e041837. doi: 10.1136/bmjopen-2020-041837.