Violence, DomesticNCT03259646
The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women
A study testing Universal Education in people with Violence, Domestic and Violence, Sexual, run by Johns Hopkins University at 9 sites in United States.
Trial summary
Violence against women is a major public health threat that carries significant consequences for women's health. Moreover, women experiencing intimate partner violence (IPV) and sexual assault (SA) are more likely than non-abused women to seek certain forms of health services, such as for sexually transmitted… Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence, Domestic, Violence, Sexual
- What is being tested?
- Universal Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,272 participants
- Where
- 9 sitesUnited States
- Study dates
- 26 May 2017to 25 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Seeking healthcare at one of 14 partner clinics
- Ability to complete a survey on a device (computer/tablet/smartphone in English or Spanish)
- Access to safe device (as defined above) if doing surveys online
- Has a safe email address or safe phone number
- Is not acutely ill
Who cannot join
- Male
- Not seeking healthcare at one of 9 partner clinics
- Younger than 18 years of age
- Older than 59 years of age
- Cannot read/speak English or Spanish
- No access to safe device if doing surveys online
- Does not have a safe email address or safe phone number
- Acutely ill
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Partners Health Care Brigham and Women's Hospital
Boston, Massachusetts, 02115
Women's Health Center
Charleston, West Virginia, 25302
North County HealthCare
Kingman, Arizona, 86401
North Country HealthCare
Lake Havasu City, Arizona, 86403
Valley Health
Mill Creek, West Virginia, 26280
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Greenbrier Co. Health Dept
Ronceverte, West Virginia, 24970
FamilyCare Health Center
Scott Depot, West Virginia, 25560
North Country HealthCare
Williams, Arizona, 86046
About this study
Violence against women is a major public health threat that carries significant consequences for women's health. Moreover, women experiencing intimate partner violence (IPV) and sexual assault (SA) are more likely than non-abused women to seek certain forms of health services, such as for sexually transmitted infections, chronic pain and illnesses, depression and/or pregnancy-related concerns. As a result, the health sector is an ideal setting to identify and support survivors. The U.S. Institute of Medicine has identified the health care system, including the public health infrastructure, as key for identification of and support for survivors of violence, as well as for violence prevention. While some evidence-based models exist, no current national consensus has been reached on scalable best practices in screening and brief counseling for IPV/SA.
This multi-level intervention includes integrating into the clinic setting IPV/SA screening, universal education, trauma informed counseling, warm referrals (e.g. provider/staff contact advocacy program with survivor) to local IPV/SA advocacy agencies, and access to the evidence-based myPlan safety decision aid app. The evaluation, using a cluster randomized trial design, will measure longitudinal outcomes (over 6 months) of patient self-efficacy, health and safety outcomes, as well as participant and provider perceptions of the intervention and clinic level changes in primary and reproductive health clinics in four states (Arizona, Massachusetts, Pennsylvania and West Virginia) to achieve the following aims:
Read more
Aim 1. Evaluate the effectiveness of an evidence-based screening, universal education and trauma-informed counseling with tailored safety action plan and referrals to partner IPV/SA programs compared to standard practice, on survivor health and safety outcomes over a cumulative period of six months.
Aim 2. Examine longitudinal changes in clinic-level screening, universal education, trauma informed counseling, safety action plans and referrals to on-site and/or partner IPV/SA programs and improved standards for documentation through the electronic health record (EHR) and continuous quality measurement and reporting.
- Conditions
- Violence, Domestic, Violence, Sexual
- Being tested
- Universal Education
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal EducationBehavioural
Clinic provider/staff training on implementing universal education into clinical practice to: 1.) provide all women information about IPV/SA, harm reduction, and available safety resources; 2) provide trauma-informed counseling to women who disclose IPV/SA; includes access to the myPlan safety decision aid to develop a tailored safety action plan; 3) provide warm referrals in partnership with local domestic violence and sexual assault (DV/SA) advocacy agencies; 4) integrate documentation and quality improvement templates and measures into clinical settings.
| Study group | Role | What they receive |
|---|---|---|
| Universal Education | Experimental | Train providers to integrate screening, universal education, trauma informed counseling, and mobile health (mHealth) technology through the myPlan app safety decision aid in collaboration with local IPV programs as well as the integration of documentation and quality improvement templates and measures into clinical settings. Receives: Behavioral: Universal Education |
| Standard Practice | No intervention | Standard clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in use of safety behaviors
Measured by percent of safety behaviors the woman has tried and found helpful on the Safety Behaviors Checklist. The checklist was adapted from Sullivan and colleagues and Parker and colleagues. Includes use of community resources and safety steps (e.g. asked for help, hidden emergency money) and use of formal services (e.g., women's shelter, protection order, mental health services).
Measured: 6 months
Change in Self-Efficacy to Use Harm Reduction Strategies
Measure adapted from Tancredi et al and Hibbard et al, assesses confidence to seek help for abuse, if needed, from a health care provider.
Measured: 6 months
Provider Behavior
Clinic level measure. Provider Behavior at Visit Survey items administered after the provider visit to assess the provider's adherence to universal education intervention, i.e. discussing healthy and unhealthy relationships during the visit, and referring to resources.
Measured: Baseline
Secondary outcomes (2)
Change in decisional conflict
We have adapted questions from validated subscales of the Decisional Conflict Scale as a measure of decision process. Measures whether the intervention helps a woman to understand the advantages and disadvantages of safety planning options and to know her values related to them. The Decisional Conflict Scale discriminates between people who make decisions and those who delay making decisions.
Measured: 6 months
Change in Readiness to Take Action
0-10 scale of readiness to make changes to relationship for safety
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start26 May 2017
- Primary completion25 Apr 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence, DomesticStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Research on Women's Health (ORWH), University of Pittsburgh, Futures Without Violence
- Responsible party
- Sponsor
- Investigators
- Nancy Glass, PhD, MPH, RN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259646
- Sponsor's protocol ID
- IRB00090497
- Other IDs
- 6 ASTWH150032-01
- Status last verified
- Jan 2020
- First submitted
- 21 Aug 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IPV Provider Network: Engaging the Health Care Provider Response to Interpersonal Violence Against Women
- ClinicalTrials.gov ID
- NCT03259646
- Acronym / sponsor ID
- IRB00090497
- Conditions
- Violence, Domestic, Violence, Sexual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,272 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Office of Research on Women's Health (ORWH), University of Pittsburgh, Futures Without Violence
- Study start
- 26 May 2017 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Violence against women is a major public health threat that carries significant consequences for women's health. Moreover, women experiencing intimate partner violence (IPV) and sexual assault (SA) are more likely than non-abused women to seek certain forms of health services, such as for sexually transmitted infections, chronic pain and illnesses, depression and/or pregnancy-related concerns. As a result, the health sector is an ideal setting to identify and support survivors. The U.S. Institute of Medicine has identified the health care system, including the public health infrastructure, as key for identification of and support for survivors of violence, as well as for violence prevention. While some evidence-based models exist, no current national consensus has been reached on scalable best practices in screening and brief counseling for IPV/SA.
This multi-level intervention includes integrating into the clinic setting IPV/SA screening, universal education, trauma informed counseling, warm referrals (e.g. provider/staff contact advocacy program with survivor) to local IPV/SA advocacy agencies, and access to the evidence-based myPlan safety decision aid app. The evaluation, using a cluster randomized trial design, will measure longitudinal outcomes (over 6 months) of patient self-efficacy, health and safety outcomes, as well as participant and provider perceptions of the intervention and clinic level changes in primary and reproductive health clinics in four states (Arizona, Massachusetts, Pennsylvania and West Virginia) to achieve the following aims:
Aim 1. Evaluate the effectiveness of an evidence-based screening, universal education and trauma-informed counseling with tailored safety action plan and referrals to partner IPV/SA programs compared to standard practice, on survivor health and safety outcomes over a cumulative period of six months.
Aim 2. Examine longitudinal changes in clinic-level screening, universal education, trauma informed counseling, safety action plans and referrals to on-site and/or partner IPV/SA programs and improved standards for documentation through the electronic health record (EHR) and continuous quality measurement and reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Universal Education | Experimental | Behavioral: Universal EducationTrain providers to integrate screening, universal education, trauma informed counseling, and mobile health (mHealth) technology through the myPlan app safety decision aid in collaboration with local IPV programs as well as the integration of documentation and quality improvement templates and measures into clinical settings. |
| Standard Practice | No intervention | –Standard clinical practice |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Seeking healthcare at one of 14 partner clinics
- Ability to complete a survey on a device (computer/tablet/smartphone in English or Spanish)
- Access to safe device (as defined above) if doing surveys online
- Has a safe email address or safe phone number
- Is not acutely ill
Key exclusion criteria (8 listed)
- Male
- Not seeking healthcare at one of 9 partner clinics
- Younger than 18 years of age
- Older than 59 years of age
- Cannot read/speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Universal EducationClinic provider/staff training on implementing universal education into clinical practice to: 1.) provide all women information about IPV/SA, harm reduction, and available safety resources; 2) provide trauma-informed counseling to women who disclose IPV/SA; includes access to the myPlan safety decision aid to develop a tailored safety action plan; 3) provide warm referrals in partnership with local domestic violence and sexual assault (DV/SA) advocacy agencies; 4) integrate documentation and quality improvement templates and measures into clinical settings. | Behavioural | Universal Education |
Primary outcome
Change in use of safety behaviors
Time frame: 6 months
Measured by percent of safety behaviors the woman has tried and found helpful on the Safety Behaviors Checklist. The checklist was adapted from Sullivan and colleagues and Parker and colleagues. Includes use of community resources and safety steps (e.g. asked for help, hidden emergency money) and use of formal services (e.g., women's shelter, protection order, mental health services).
Change in Self-Efficacy to Use Harm Reduction Strategies
Time frame: 6 months
Measure adapted from Tancredi et al and Hibbard et al, assesses confidence to seek help for abuse, if needed, from a health care provider.
Provider Behavior
Time frame: Baseline
Clinic level measure. Provider Behavior at Visit Survey items administered after the provider visit to assess the provider's adherence to universal education intervention, i.e. discussing healthy and unhealthy relationships during the visit, and referring to resources.
2 secondary outcomes
Change in decisional conflict
Time frame: 6 months
Change in Readiness to Take Action
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Glass, PhD, MPH, RN principal investigator
Johns Hopkins University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal Education in people with Violence, Domestic and Violence, Sexual, run by Johns Hopkins University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in use of safety behaviors (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.