A primary care system-level training and support programme for the secondary prevention of domestic violence and abuse: a multicentre cluster randomised trial with economic and process evaluation.
Domestic violence and abuse
The IRIS+ trial will test whether the IRIS+ programme, compared to the IRIS programme, is effective and cost-effective, and whether delivering it on a large scale is possible. This will be done by delivering IRIS+ in many general practices in three areas in England and Wales. In both areas, practices will be assigned by chance to either take part in IRIS+ or standard IRIS. Using the randomised controlled trial design and mixed methods, the trial will then test whether IRIS+, compared to IRIS, is effective and cost-effective for men and children and whether delivering it on a large scale is possible. All eligible and consenting GP practices will be randomised using a 1:1 allocation ratio to the intervention or usual care group based on the randomisation procedure. The randomisation procedure will be: 1. Stratified by centre (Bolton, South Gloucestershire/Bristol, Swansea Bay) 2. Within centre, further stratified by level of prior engagement with IRIS (more recent and no prior engagement with IRIS) 3. Minimised on the number of whole-time equivalent doctors in practice at randomisation (small: < 6500, medium: 6501 to 9999, large: 10,000 or more). Randomisation will be carried out through an online randomisation system designed and administered by a third-party secure internet-based randomisation system (Sealed Envelope Ltd; www.sealedenvelope.com). Randomisation will be carried out by unblinded members of the research team (e.g. Trial Coordinator, Trial Statistician) as it will not be possible to maintain blinding for those team members as they will be involved in arranging the training for the intervention sites. It will also not be possible for the GP practices to be blinded to group allocation for the same reason. Recruited GP practices in the three areas (two in England and one in Wales) will be randomised to either continue with/start the usual care IRIS Programme or receive the IRIS+ intervention. DVA agencies (Fortalice and Next Link in England and Calan i
Inclusion criteria for GP practices: General practices participating (or eligible to participate) in the IRIS programme (commissioned in the local authority/health board area) at the time of recruitment. Inclusion criteria for post-intervention interview participants: 1. DVA advocacy service users: female and male adults referred or self-referred from GP practices participating and supported by the IRIS+ service at the DVA agencies. CYP between the ages of 13-16 referred or self-referred from GP practices participating and supported by the DVA agencies (who have been in direct contact with the IRIS+ CYP worker) and whose non-perpetrating parent or carer agrees for the child to take part and who consent in their own right 2. Key professionals involved with the delivery and facilitation of the IRIS+ intervention
Exclusion criteria for GP practices: General practices not participating (or not eligible to participate) in the IRIS programme at the time of recruitment. Exclusion criteria for post-intervention interview participants: Adults (> 16 years of age): 1. Deemed by the advocate educator or researcher to be put at greater risk if they participate 2. With mental health symptoms that will prevent them from research engagement 3. Adult safeguarding concerns that may compromise the safety of the child/adult participants 4. Incapacitated at the time of seeking consent 5. Unable to understand written information in English to be able to give informed consent and undergo an interview if approached Children: 1. Children under 13 2. Parent or carer or advocate educator/CYP worker or researcher believes that a child’s involvement is likely to cause distress or upset, increase the risk of DVA, or any form of child maltreatment 3. Child or adult safeguarding concerns that may compromise the safety of the child/adult participants 4. Unable to understand written information in English to be able to give informed consent and undergo an interview if approached (v) CYP who do not have capacity to understand or consent to the research process.