Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Primary care Identification and Referral to Improve Safety of women experiencing domestic violence: a randomised controlled trial
Acronym
IRIS
Study hypothesis
Will a training and support programme for general practices increase the identification and referral to domestic violence agencies of women survivors of domestic violence?
Ethics approval
Ethics approval received from the NHS National Research Ethics Service - South East Research Ethics Committee on the 27th July 2007 (ref: 07/MRE01/65).
Study design
Cluster randomised controlled trial; unit of randomisation is practices.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Condition
Domestic violence referrals in General Practices
Intervention
Practices in Hackney and Bristol will be randomly allocated to the intervention and control group.
Intervention:
The intervention is designed to address the barriers to making a general practice domestic violence "competent" and improves the quality of care for survivors of abuse. This will entail two 2-hour multi-disciplinary training sessions with clinicians using case studies and role-play in relation to asking about violence and responding appropriately.
This will be followed by periodic reinforcement sessions feeding back practice data on disclosure and referral and encouraging discussion about improving the quality of care. The clinicians include General Practitioners (GPs) and directly employed practice staff (practice nurses and counsellors) and those employed by trusts (midwives, health visitors, district nurses). We will also engage administrative staff in a session that will highlight their role in data handling and confidentiality.
Feedback of anonymous disclosure and referral data can be done at practice meetings at which the program would be a regular agenda item. In each intervention practice we will identify a "champion" for the project. They can be from any of the clinical disciplines and will have the agreement of the practice to attend additional training about domestic violence and integrating this into the work of the practice. The advocate-educator will, in conjunction with the practice champion, meet with smaller groups of clinicians to address problems that have arisen around identification, support and referral.
Control:
The control group is made up of 12 general practices in Bristol and 12 in London.
The educational and support intervention will be continuous over the year of follow-up from first educational session. Intervention and control practices will be followed up for one year.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Recording in the medical record identification of women who have experienced or are experiencing domestic violence, measured at 3 months, 6 months, 9 months and one year.
Secondary outcome measures
1. Referral of women who have experienced or are experiencing domestic violence to specialist domestic violence agencies and/or practice based counselling
2. Knowledge, beliefs, and practices of health care professionals with regards to domestic violence (Physician REadiness to Manage Intimate partner violence Survey [PREMIS] questionnaire to participating clinicians)
3. Expectations and experiences of clinicians targeted by the intervention (interviews with purposive sample of clinicians in intervention practices
All secondary outcomes will be measured at 3 months, 6 months, 9 months and one year.
Overall trial start date
01/07/2007
Overall trial end date
30/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
General practices within City and Hackney or Bristol Primary Care Trust (PCT) if they record consultations electronically and their systems allow the use of screen prompts.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
48 practices (24 in Hackney and 24 in Bristol)
Participant exclusion criteria
Practices will be excluded if:
1. They do not use electronic medical records
2. Their systems do not allow the use of screen prompts
3. They have already had significant training in identification of women experiencing domestic violence and established a referral pathway to an advocacy service
Recruitment start date
01/07/2007
Recruitment end date
30/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Community Based Medicine
Bristol
BS8 2AA
United Kingdom
Sponsor information
Organisation
The Health Foundation (UK)
Sponsor details
90 Long Acre
London
WC2E 9RA
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Government
Funder name
The Health Foundation (UK) (ref: 6421/4601)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20122266
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22000683
Publication citations
-
Protocol
Gregory A, Ramsay J, Agnew-Davies R, Baird K, Devine A, Dunne D, Eldridge S, Howell A, Johnson M, Rutterford C, Sharp D, Feder G, Primary care identification and referral to improve safety of women experiencing domestic violence (IRIS): protocol for a pragmatic cluster randomised controlled trial., BMC Public Health, 2010, 10, 54, doi: 10.1186/1471-2458-10-54.
-
Results
Feder G, Davies RA, Baird K, Dunne D, Eldridge S, Griffiths C, Gregory A, Howell A, Johnson M, Ramsay J, Rutterford C, Sharp D, Identification and Referral to Improve Safety (IRIS) of women experiencing domestic violence with a primary care training and support programme: a cluster randomised controlled trial., Lancet, 2011, 378, 9805, 1788-1795, doi: 10.1016/S0140-6736(11)61179-3.