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UCL Priment Clinical Trials Unit

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Frequently Asked Questions

Please see below a list of Frequently Asked Questions relating to HipDyS. If your question is not listed, please contact us

What regions within the UK are you recruiting GP practices?

We are recruiting GP practices that are registered in England, who carry out 6-8 week baby check-ups as part of routine care.

What is the purpose of the trial?

The primary aim of the trial is to improve the diagnosis of DDH in primary care by: a) reducing the number of ‘clinically insignificant’ referrals to secondary care.
b) reducing the number of infants with a missed or late diagnosis of DDH

What is the intervention?

The intervention is a decision aid, in the form of a checklist, to be used by GPs for the hip element of their 6-8 week baby checks and a short training video. The video includes demonstrations of the elements in the hip examination and explains the context of the checklist. The video only needs to be watched once, during site initiation but will be made available to watch throughout the trial. As this is a randomised controlled trial only ½ of the GP practices in the trial will be shown the video and use the checklist.

How was the checklist developed?

The elements on the DDH checklist were agreed following an international consensus study and a survey of British specialists and are based on the current evidence.

Are there any specific requirements for the GP practice such as specific electronic patient record system?

Only practices that use EMIS or System One as their clinical computer system are eligible for this trial.
Practices randomised to the intervention arm will have the checklist installed as an electronic template in their patient record system to use during 6-8 week checks. Those that already use a template will have it embedded into their current version.

Will practices need to attend any site initiation visits?

Yes – prior to enrolment in the trial, the lead GP, practice managers and ideally, participating GPs and other relevant members of staff will need to attend.
I) a recruitment visit where you will find out more about the trial, have a chance to ask questions before deciding if your practice wants to take part and consenting to participate if you chose to. This can be done remotely or in person.
II) a site initiation teleconference (occurs after randomisation). This is optional and email confirmation prior to activation can be accepted.

What specifically is being asked of the GP practice who take part in this trial?

Exactly what is expected of practices will depend on whether the GP practice is randomised to the control or intervention arm of the trial. Practice responsibilities will include:
• Conduct all 6-8 week hip checks in-line with the study protocol
• In practices randomised to the intervention GPs conducting baby checks will be expected to watch a training video and to use the DDH-checklist which will be embedded as a template into their electronic patient record system
• Practice staff to post pre-made questionnaire packs to a sample of parent/carers of infants who have had a baby check-up.
• Practice staff to run monthly database searches to identify infants whom have undergone 6-week check
• Practice staff to provide non-identifiable data from these monthly database checks to study team.

What procedure should GPs follow if a patient needs to be referred?

GPs in both the intervention and control arms are to follow their normal referral pathway however, we ask that GPs adhere to the 2-weekly hip pathway national guidelines.

Will GPs/practice staff need to complete any questionnaires?

GPs performing 6-8 week checks to complete up to 3 questionnaires electronically at various time-points throughout the trial

Will GPs need to participate in any other trial related activities, except those mentioned above?

GPs may be observed by a researcher whilst performing a small number of baby checks (subject to consent). This will only take place if/once the government guidelines on social distancing change, in light of the pandemic. GPs who have performed 6-8 week checks may be approached to participate in a qualitative interview by a researcher, to discuss their experience of taking part in the trial and referral practice for suspected DDH. This may be conducted remotely where possible.

Is anything else being asked of the GP practice such as extracting data from patients’ medical records?

We have section 251 approval from the Confidentiality Advisory Group (CAG) to be able to obtain patient NHS numbers and date of birth, without consent. A researcher will visit your practice to collect this data onto an encrypted server at the end of the study.

Will there be any payments to practices?

This can be discussed with the trial team if you are interested to participate.

Who should I contact if I have any more questions?

Please contact the study team on hipdys.admin@ucl.ac.uk with any queries or if you require more information.