EHR-based Screening and Intervention for Intimate Partner Violence
Phase: NA
Conditions: Violence, Domestic
Sponsor: Medical University of South Carolina

EHR-BASED SCREENING AND INTERVENTION FOR INTIMATE PARTNER 
VIOLENCE: STUDY PROTOCOL FOR A STEPPED WEDGE CLUSTER 
RANDOMIZED CONTROLLED TRIAL 
 
Official project title (Grant title): EHR-based screening and intervention for intimate 
partner violence 
Document date: 12-01-2023  
 
Senior/Key Personnel 
Leslie Lenert  
Medical University of South Carolina  
PD/PI1 
Alyssa Rheingold  Medical University of South Carolina  
MPI2 
Kit Simpson  
Medical University of South Carolina  
Co-Investigator3  
Jenna McCauley  Medical University of South Carolina  
Co-Investigator4 
Vanessa Diaz  
Medical University of South Carolina  
Co-Investigator5 
Brandon Welch  
Medical University of South Carolina  
Co-Investigator1 
1 Biomedical Informatics Center, Department of Public Health Sciences, Medical University of 
South Carolina, Charleston, South Carolina, USA. 
2 Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 
Charleston, South Carolina, USA. 
3 Department of Healthcare Leadership and Management, Medical University of South Carolina, 
Charleston, South Carolina, USA 
4 Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 
Charleston, South Carolina, USA 
5 Department of Family Medicine, Medical University of South Carolina, Charleston, South 
Carolina, USA 
 
Inclusive Dates of Project: 9/13/2018 to 07/31/2023 
Federal Project Officer: Christine Dymek 
Acknowledgment of Agency Support: This grant was funded by the Agency for Healthcare 
Research and Policy. 
Grant Award Number: 1R18HS025654-01A1 
Corresponding author: Leslie Lenert (Lenert@musc.edu) 
Address: 22 WestEdge Street, Suite 200, Room WG213, Charleston, South Carolina, 29403, 
USA 
Telephone: 843-792-4268 

ABSTRACT  
Background: Intimate Partner Violence (IPV) is a frequently occurring condition (25% lifetime 
prevalence) for which screening in primary care is recommended. However existing screening 
tools often lack sensitivity due to high rate of nondisclosure, privacy, and safety concerns. 
Methods/Design: A stepped wedge cluster randomized trial across the 28 clinics in three blocks 
of 8-12 sites will be used to assess the impact of an electronic health record (EHR)-based 
multifactorial intervention screening for Intimate Partner Violence in primary care practice for 
women aged 18 to 49 years. Our EHR intervention will promote IPV screening and risk 
management in primary care and will consist of three components: (1) a non-interruptive EHR 
alert; (2) confidential screening using the 3-item Partner Violence Screening (PVS) instrument 
and (3) confidential assessment and referral of high-risk patients using decision-support 
templates. Efficacy of each of these components will be assessed separately. The trial will be 
conducted in the setting of a control intervention of screening for IPV using nurse interviews and 
an electronic checklist. 
Discussion: This paper describes the use of a stepped wedge cluster randomized trial to evaluate 
a privacy preserving screening approach.  
 
 
 
BACKGROUND 
Intimate Partner Violence (IPV) is a frequently occurring condition (5.9% annual rate of IPV 
reporting in women in US [1]) for which screening in primary care is the United States 
Preventative Service Task Force recommended service [2]. The lifetime prevalence of IPV is 
reported to be 25% of all women [3].  
Screening for IPV is conducted much less frequently in primary care than screening for other 
conditions such as depression [4]. IPV is stigmatizing to its victims and concerns about 
confidentiality are a recognized barrier to disclosure [5]. Self-administered computer 
questionnaires are an effective but underutilized, privacy-preserving approach to screen for IPV 
[6]; alternatively, many healthcare providers often screen for IPV and other issues with oral 
questions.  In IPV, asking questions in an overly routine or uncaring way is a barrier to a 
forthright response [4]. Further complicating matters, IPV screening also generates electronic 
health record (EHR) documentation that can compromise privacy, particularly if the perpetrator 
of the violence has access to a patient’s screening results, EHR summaries, or claims data. An 
EHR diagnosis may also become widely available to personnel within a health system, creating 
concerns that may further inhibit disclosures [4, 7]. Many women, even in emergency 
department settings with evidence of injuries, choose not to disclose abuse because of privacy 
and safety concerns [8]. Therefore, maintaining patients' privacy in screening for IPV in 
healthcare settings is of paramount importance. A lack of expertise of primary care providers in 
the assessment of risk and difficulty linking patients to needed resources may also pose 
significant barriers for providers in screening processes. 
One of the most widely used approaches to change provider behavior is an alert or prompt in an 
EHR for a specific task. These alerts come in two general flavors: interruptive which presents a 
popup alert that blocks a user from further actions on the computer screen until resolved and 
non-interruptive, which has more diverse implementations but often highlights an action on the 
screen. Blocking popup style alerts are the most common type of decision support alert in EHR 
systems; however, this approach has been overutilized, and as a result, providers frequently 

ignore these alerts. A recent review of non-interruptive alerts found these were an effective 
means to alter provider behavior [9]. However, to the best of our knowledge, this method has not 
been previously applied in IPV screening.  
A lack of expertise of primary care providers in the assessment of risk and difficulty linking 
patients to needed resources may also pose significant barriers for providers in screening 
processes. Integrated tools for risk assessment and referral for follow-up of positive IPV 
screening, including reminders of legal conditions that may mandate disclosure (for example, 
children witnessing IPV events), may help providers feel more comfortable with screening tasks 
[5, 10], and thus encourage compliance with screening guidelines. While screening and 
counseling for IPV is a billable activity, the desire to keep discussions private may result in a 
provider not using IPV-related billing codes and losing potential credit for time spent counseling 
in provider productivity calculations. An approach to document time spent in confidential 
activities that a health system might choose not to bill for because of privacy concerns may be 
important positive reinforcement for provider screening behaviors for IPV.  
The objective of this paper is to describe the protocol of a stepped wedge cluster randomized trial 
for evaluating the effectiveness an IPV screening workflow consisting of three major 
components: 
1. a non-interruptive alert for annual IPV screening; 
2. PVS confidential screener; 
3. Provider risk assessment of PVS screening results and patient referrals. 
Stepped wedge study design was chosen for several reasons [11]. Firstly, we had a background 
control condition present (nurse-led screening) in all clinics. Secondly, because each cluster acts 
as its own control we need a limited set of clusters to reach the desired level of statistical power. 
We also needed time to do staff trainings and intervention support, and make sure that they 
follow our intervention protocol, with stepped wedge design we could do trainings in 5 clinics at 
a time. In addition, this design gives us control over temporal trends in the data. 
 
METHODS/DESIGN 
Study design/Participants 
The protocol for this study is based on a stepped wedge cluster randomized controlled trial 
design [12].  
28 clinics (14 Family Medicine, 12 Internal Medicine Primary Care and 2 women’s health 
clinics) are grouped into 3 blocks each holding 8-12 clinics based on number of eligible patients 
seen in 2018-2019 and the number of full-time employees in clinics to assure that each block has 
similar population and employee size. We then use random number generator to randomize the 
starting time for 3 blocks. The target population is all women aged 18-49 who visit the clinics 
during the whole study period. Multiple screenings of the same patient can be made as it is 
described in the Intervention section. The blocks are shown in Figure 1.  
 
 
 
 
 
Control (nurse-led 
screen) 
Intervention Start (nurse-led and confidential screen) 
 
Time Period 0 
Time Period 1 
Time Period 2 
Time Period 3 
 

Q1 2020 – Q2 2020 
Q3 2020 – Q4 2020 
Q1 2021 – Q2 2021 
 
Q3 2021 – Q4 2021 
 
28 clinics 
8-12 clinics 
16-20 clinics 
28 clinics 
 
 
 
 
 
16-20 clinics 
 
 
 
 
 
8-12 clinics 
 
 
 
 
 
Figure 1. Randomized Stepped Wedge design with 28 clinics.  
 
 
The control condition is a nurse-led screen developed by MUSC and deployed in 2019. When 
patients are roomed in all outpatient clinics, nurses complete a checklist where they, based on 
professional judgment (e.g., without asking standardized questions), screen for a variety of 
factors. One of those factors is Abuse/Neglect. Clicking on this item in the Epic EHR user 
interface, opens a second menu for nurses to document either the absence of any evidence of 
abuse/neglect or the presence of different risk factors. Selecting the “caregiver degrades or 
threatens patient”, “abuse/neglect suspected”, “evaluation for abuse”, “excessive fear/withdrawn 
or guarded behavior” or “has unexplained injuries or bruises” was considered a positive screener 
for spousal abuse risk. It is important to note that control screening is always present (though not 
necessarily completed) when patient is eligible for confidential screening intervention, thus two 
screens are working at the same time during intervention period. 
IRB determined that this was a quality improvement effort which did not require consent 
identifying and managing IPV is part of current practice the intervention was the Epic automatic 
fielding and special protection approaches used that decreased patient risk of disclosure. 
 
Intervention 
Working with key stakeholders (i.e., providers, patients, IPV survivors, IPV experts) we will 
adapt an existing program for IPV screening with both paper-based and computer-based 
components used within Northern California Kaiser Permanente Health System [13] to be fully 
implemented within the EHR by Epic Systems in a privacy-preserving way.  
The EHR workflow will use this registry to present an in-menu, non-interruptive alert which 
notifies medical assistants to screen a patient for IPV on an annual basis. Responding to the 
(non-interruptive) alert converts the exam room computer to a kiosk-like mode for use by a 
patient to self-administer an IPV screening questionnaire.  
At a population level, screening will be tracked for the entire eligible clinic population using a 
combination of decision support alerting rules. The non-interruptive reminder for medical 
assistants to screen patients will remain active until a patient is screened. In screener negative 

patients, the non-interruptive reminder for medical assistants is turned off for one-year.  In 
screener positive patients, the reminder for medical assistants to screen remains active for one-
year to encourage repeat screening. In addition, in screener positive patients, providers will 
continue to receive pop-up alerts reminding them of the presence of hidden IPV data on an 
ongoing basis in subsequent primary care visits and to allow providers to trigger re-screening of 
patients. 
The self-reported questionnaire approach is to maximize potential patients' willingness to report 
for IPV [14]. Because of the difficulties in ensuring a tablet computer or other device will be 
available in all primary care settings and in ensuring the privacy of responses after patient use, 
we will develop the kiosk-style approach: the medical assistant assures the patient is alone by 
removing another adult-age family from the room, so that the patient can use exam computer to 
give response to a 3-item PVS initial screening questionnaire [15], which if positive, will cascade 
to an additional questionnaire administered to assess risk levels of future harm [16]. The 
approach provides the maximum feasible level of protection for the privacy of patients’ 
responses. Completion of the questionnaires results in a lock screen for the computer while 
awaiting the provider’s portion of the visit. If the patient has screens positive for IPV, a popup 
alert notifies the provider. Clicking on the “IPV navigator Activity” in the alert takes the 
provider to an electronic form that provides decision support for IPV care.   
The IPV Visit Navigator is a decision support tool that displays patients’ responses to screening 
questions, helps the provider further evaluate a patient’s risk level, offers recommended follow-
up questions with examples of scripted responses, supports documentation of an IPV specific 
physical examination, and of counseling. It also allows the provider to record time spent on this 
issue during the visit to allow potential credit for this time in resource valuation units (RVUs) 
without billing, which might compromise privacy. The results are stored in an electronic flow 
sheet hidden from other visit records. Providers then complete reassessments of risk, physical 
exam findings, and document follow-up recommendations. On return visits, a Blocking BPA 
reminds providers to access the Navigator to review data. All patients screened positive are 
automatically reassessed on their next clinic visit for risk. 
Referral for IPV further care will be managed in two ways. In settings of immediate risk to the 
patient  there will be immediate outreach to hospital security and a nurse specialist providing 
IPV support to the Emergency Department. For lower-risk cases, patients are provided 
psychoeducation and offered a referral to a national hotline for counseling and support for IPV 
victims. In cases where the abuse of the victim is observed by children, the provider is reminded 
in the documentation tool to immediately refer the case to state child protective services, as 
required by law, and contact information was given. 
To prepare clinics for participation, we will work with the Primary Care Service Line Director, 
clinical leaders in clinics and staff to implement the study. We will provide manuals, trainings 
and online education for clinic staff and providers. Online training will be integrated with 
MUSC’s MyQuest staff education system. Educational materials will include tip sheets on 
intimate partner violence and how to implement screening procedures, video demonstration of 
EHR use, as well as videos demonstrating suggested scripting for interactions with patients. 
During the initial week of the roll out, Epic research support personnel will be available in the 
clinics to help providers learn to use software modifications and to answer questions. Provider 
support for in-person individual IPV-related training and case consultations will be provided by 
two experts in IPV training and management through-out the implementation and operation of 
the study. 

 
Data Sources/Collection  
All data will be collected within the Epic EHR system.  
 
Outcome measurement 
The primary outcome measure for the study is the rate at which patients were screened for IPV 
across the clinics. This outcome is calculated as the share of patients who completed PVS 
questions from all eligible patients. The secondary outcome is the rate at which patients at risk 
for IPV are detected by screening procedures. The patient is flagged positive if they are positive 
on one of the three PVS questions (Table 1). Other outcomes are the severity of risk (using 
Danger 5 risk assessment, ranging from 0 to 5) observed in patients, physician compliance with 
IPV management tools (measured as the rate of completion of follow-up decision templates, and 
the rate of referrals for post-visit counseling to a national hotline (a share from screened positive 
patients). 
Table 1. How IPV Positive patients were identified using both screens. 
Screen type 
IPV Positive 
IPV Negative 
Nurse-led  
screening  
One or several of the following 
answers is selected by during 
assessment for Abuse/neglect: 
• Has unexplained injuries, 
bruises, cuts 
• Caregiver degrades or 
threatens patient 
• Abuse/neglect suspected 
• Being evaluated for suspected 
abuse 
One or several of the following 
selected: 
• No suspicion of abuse or 
neglect 
• Poor hygiene, 
dirty/unkept 
inappropriate clothing 
• Excessive fear, 
withdrawn, or guarded 
behavior 
• Non-compliance with 
plan of care 
Confidential 
screening 
In case one of the following answers 
was given: 
• Have you been hit, kicked, 
punched, pushed, shoved, or 
otherwise hurt by someone at 
home in the past year? Yes 
• Do you feel safe in your 
current relationship? No 
• Is there a partner from a 
previous relationship who is 
making you feel unsafe now? 
Yes 
In case when the following 
answers were given: 
• Have you been hit, 
kicked, punched, pushed, 
shoved, or otherwise hurt 
by someone at home in 
the past year? No 
• Do you feel safe in your 
current relationship? 
Yes, or Not applicable. 
• Is there a partner from a 
previous relationship 
who is making you feel 
unsafe now? No 
 
Power Calculations  

This study will involve a total of n=28 clinics which will provide two years of data on 
approximately 68,000 patient visits. Of these, we expect 34,000 to occur during the non-
screening steps and 34,000 visits during the intervention period.  
Based on our current practice visit patterns for unduplicated visits by women between age 18 and 
49 years, we will have approximately 34,000 eligible visits during the non-screening steps and 
34,000 during the screening steps. We have assumed an annual IPV prevalence of 5.5% within 
the preceding year, based on rates reported by the CDC for SC [17], a screening completion rate 
of 95%, a 75% counselling rate for women who screen positive, and a 50% referral rate to the 
Hotline. Studies report the ability of screening to increase patient referral to services from a 2.5 
percentage point to an 8.0 percentage point increase based on current referral rates between 0% 
and 3.6% [18]. Based on an analysis of our archival data, we expect that our current referral rate 
for IPV for women aged 18-49 seen in our clinics is no more than 0.14% and that this rate will 
increase to 3.9% with screening. 
With about 600 relevant patient visits over 6 months per clinic, 8-12 clinics per wedge, and 3 
wedges, we estimate that we will have 97% power to detect an increase in screening (i.e. 0.14% 
vs. 5.5%), and 89% power to detect a difference in the rate of referral for counseling and/or calls 
to the Domestic Violence Hotline (i.e. 0.14% vs. 3.9%). While we may be somewhat 
overpowered for our primary analysis, these numbers of clinics and patients will also allow us to 
make very precise estimates of the treatment effects within relevant patient subgroups (e.g. 
whites vs. blacks, urban vs. rural) and to determine whether there are any differential impacts of 
the intervention on those subgroups. These power calculations are conducted using PASS15 
(NCSS, Kayesville, UT) and verified using the ‘steppedwedge’ function in STATA (StataCorp, 
College Station, TX), assumed an intraclass correlation coefficient of 0.05 (to account for a 
moderate level of clustering of patients within clinics), along with an alpha of 0.05 and two-sided 
testing.  
 
 
 
Statistical analysis 
We will use a generalized linear mixed model with a logit link controlling for block set and a 
fixed effect for each step, as discussed by Hussey and Hughes [19], to compare active screening 
accounting for the cluster design with a random clinic effect. Primary analyses will also adjust 
for patient characteristics (age, race) since these have been associated with risk of IPV. Models 
will be estimated with interaction terms to assess subgroup effects for specific patients, and to 
examine the effect of practices’ characteristics on the heterogeneity of the estimates. 
The intraclass correlation coefficients will also be estimated and reported for screening and 
counselling to assess the assumptions made for the sample size analyses so that this information 
will be available to future investigations using similar designs and outcomes.  
Analysis for the other outcomes will be largely description. Frequency tables with patient 
demographics, including race, insurance, ethnicity, age, and marital status will be reported. 
Responses to individual PVS questions will also be presented in the form of frequency tables. 
Danger 5 risk assessment will be presented using histogram showing counts of patients that 
scored 0 to 5 of the risks [16]. Physician compliance will be measured as percentage of screened 
positive patients for whom decision-support templates have been based. Rates of referrals will be 
reported as percentage from total of patients screened positive.  

In addition, we will perform sensitivity analyses to assess the effects of early vs. late 
randomization, potential “learning” effects that may occur as the screening becomes better 
integrated in practice routines, the effect of the practices’ presence of a IPV champion prior to 
the study, and the effect for practice-specific screening refusal and rate of counselling acceptance 
on the overall estimate. Sensitivity analyses for the primary and secondary outcomes will be 
conducted using several methods, which have different missing data assumptions: 1) Complete 
case analyses which assumes missing data are completely at random; 2) Multiple imputation 
using M=10 imputations, which assumes missing at random; and 3) Assigning contrasting age 
group, race and income category classifications for missing values differentially by intervention 
group, which aligns with non- ignorable missingness (the data missingness is nonrandom and 
related to the actual values.) 
 
Follow-up interview 
A subset of patients, after providing informed consent, will participate in a follow-up telephone 
qualitative interview to gather information on acceptability of this self-report IPV screening 
approach within their primary care visit. 
 
DISCUSSION   
This paper outlines the study design and data analysis process to measure efficiency of our IPV 
screening intervention. Intervention consists of three components, efficiency of each of them will 
be assessed separately. The first component is the use of a non-interruptive alert to remind 
providers to screen for IPV on an annual basis. The second component of the intervention is 
confidential screening by self-report. The third component of the intervention is a physician-
decision support system for assessment of risk and management.  
This kind of dissemination research is needed because, despite strong recommendations for IPV 
screening at a national level, evidence for the overall effectiveness of screening on health 
outcomes is inconsistent and may be a barrier to adoption. Specifically, evidence for the impact 
of EHR-based IPV screening in primary-care settings on rate of initiation of counseling is an 
undeveloped area. Understanding of the link between screening and initiation of counseling has 
been identified as a critical evidence-gap by the USPTF and US Dept. of Health and Human 
Services [20, 21]. In addition, a recent review of IPV referral programs and processes strongly 
recommended the further evaluation of the effectiveness of referral processes for IPV in health 
care settings [22]. 
Our main technical innovations will be addition to Epic support of administration of the PVS 
questionnaires to patients on a recurring basis. This application uses a novel workflow developed 
at MUSC that tracks what questionnaires a patient needs to complete on a given visit and allows 
the exam room computer (i.e., the doctor’s computer) to be safely used by patients to complete 
self-administered questionnaires. This allows screening without purchase and maintenance of 
additional hardware (a tablet may be used optionally if required by clinic layout). This workflow 
operates completely within the Epic system—no additional software or web service interaction is 
required. Questionnaires for IPV screening appear automatically in the workflow on an annual 
basis. The workflow is well-validated at MUSC, having been used in thousands of patients.  
A second technical innovation is the automatic protection of information for patients who screen 
positive for IPV in a confidential department in Epic. This segmentation of information prevents 
inadvertent disclosures of information about IPV to a patients’ partner, which could provoke 
violence to the patient. A novel alerting system helps link the routine care in each clinic with the 

confidential department. In settings where providers are less focused on IPV care, this innovation 
may increase patients’ safety by reducing provider effort to maintain security while making them 
more cognizant of the need for it through EHR alerts.  
 Our approach to screening has some limitations. We think that there might be some barriers for 
older patients to use the kiosk-based screening. Non-interruptive alert, while reducing alert 
fatigue, can lead to physicians ignoring the IPV screening more often. Provider incentives for 
compliance with screening and counseling process may be important in future dissemination 
efforts.  
The study protocol does require significant effort by clinic staff and assessment of its impact on 
clinic productivity may be warranted. However, the elimination of non-scientifically-based 
screening programs that are ineffective may yield sufficient time to allow more effective ones to 
be performed in practice. 
 
 
 
LIST OF PUBLICATIONS AND PRODUCTS 
 
Software 
https://comlib.epic.com/ 
 
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