Evaluation of Aid to Diagnosis for Congenital Dysplasia of the Hip in General Practice: Controlled Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Clinical Importance of referrals
研究概览
简要总结
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.
详细描述
- 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.
- Type of trial: Phase III, cluster randomised controlled trial
- 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.
- Trial duration per participant: 24 months
- 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)
- Total number of participants planned: 172 GP practices will be randomised (with an average of 110 infants recruited across the trial period per practice).
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 11 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Clinical Importance of referrals
时间窗: 2 weeks following hip check
Number of referred hips that are considered clinically insignificant (referrals resulting in reassurance and discharge from secondary care).
次要结局
- Number of Late diagnoses(Within 2 years of hip check)
- Timeliness of referrals(Within 2 years of hip check)
- Impact of the intervention on general practitioner behaviour(Within 2 years of hip check)
- Parent/Carer general worry at present(Within 2 weeks of hip check)
- Parent/Carer worry related to developmental dysplasia of the hip(Within 2 weeks of hip check)
- Consequences of Late diagnoses(Within 2 years of hip check)
- Volume of referrals(Within 2 years of hip check)
- Number of appropriate referrals per GP practice(Within 2 years of hip check)
- Incremental costs of using aid(Within 2 years of hip check)
- Incidence of developmental dysplasia of the hip(Within 2 years of hip check)
- Parent/Carer satisfaction with the trial intervention(Within 2 weeks of hip check)
- Parent/Carer acceptability of trial intervention(Within 2 weeks of hip check)