Domestic violence and abuse Other
Conditions
Interventions
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 del
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 th
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary outcome measures Referral rate, per general practice, of adult males, children and young people, to DVA agencies, measured using data extracted from the DVA agencies' data systems, for up to 15 months before and following the clinical training session in intervention practices, and a matched date for control practices. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Referral rate, per general practice, of females to DVA agencies, measured using data extracted from the DVA agencies' data systems, for up to 15 months before and following the clinical training session in intervention practices, and a matched date for control practices 2. Cost-effectiveness of IRIS+ measured using individual-level healthcare systems digital data extracted from the DVA agencies, including the EQ-5D, randomisation data, GP practice demographics, service user demographics and referral data. Digital data providers [SAIL Databank, Wales and Graphnet CareCentric, England] will merge data with data held on healthcare use, and physical and mental health (diagnosis, prescribing). Collected for 12 months before and 12 months after referral. Individual-level self-reported DVA advocacy service user data on adult and CYP health and service support outcomes will be extracted from DVA agency data systems’ routine data and collected at baseline, during the advocacy service intervention, and at case closure (circa 3 months after referral). 3. Physical health and mental health (diagnosis, prescribing) measured using individual-level healthcare systems' digital data will be collected on healthcare use, and physical and mental health (diagnosis, prescribing). Held by data providers [SAIL Databank, Wales and Graphnet CareCentric, England]. Collected for 12 months before and 12 months after referral. 4. Adult and CYP self-reported health-outcomes, HRQoL for service-user participants supported by DVA agencies, and adult DVA exposure measured using individual-level self-reported DVA advocacy service user data on adult and CYP health and service support outcomes extracted from DVA agency data systems. Health outcomes collected at baseline and at case closure (circa 3 months after referral). Service support outcomes collected at baseline, during the advocacy service intervention, and at case closure (circa 3 months after referral). Data collected by a researcher in post | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed