Primary care Identification and Referral to Improve Safety of women experiencing domestic violence: a randomised controlled trial

ISRCTN	ISRCTN74012786
DOI	https://doi.org/10.1186/ISRCTN74012786
Secondary identifying numbers	1

Submission date: 21/05/2007
Registration date: 27/09/2007
Last edited: 16/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gene Feder
Scientific

Community Based Medicine
25/27 Belgrave Road
Clifton
Bristol
BS8 2AA
United Kingdom

Study information

Study design	Cluster randomised controlled trial; unit of randomisation is practices.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Screening
Scientific title	Primary care Identification and Referral to Improve Safety of women experiencing domestic violence: a randomised controlled trial
Study acronym	IRIS
Study objectives	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(s)	Ethics approval received from the NHS National Research Ethics Service - South East Research Ethics Committee on the 27th July 2007 (ref: 07/MRE01/65).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/07/2007
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	48 practices (24 in Hackney and 24 in Bristol)
Key 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.
Key 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
Date of first enrolment	01/07/2007
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Community Based Medicine

Bristol
BS8 2AA
United Kingdom

Sponsor information

The Health Foundation (UK)
Charity

90 Long Acre
London
WC2E 9RA
United Kingdom

Website	http://www.health.org.uk
"ROR"	https://ror.org/02bzj4420

Funders

Funder type

Government

The Health Foundation (UK) (ref: 6421/4601)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	02/02/2010		Yes	No
Results article	results	19/11/2011		Yes	No

Editorial Notes

16/01/2018: internal review.