HHS/CDC/NCIPC
SUPPORTING STATEMENT FOR
OMB INFORMATION COLLECTION REQUEST
Part B
Randomized Controlled Trial of Routine Screening
for Intimate Partner Violence
Supported by:
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention
Government Project Officers:
Joanne Klevens, MD, Ph.D. Science Officer
[email protected]/ 770-488-1386
Jim Martindale, Public Health Advisor
[email protected] / 770-488-1389
National Center for Injury Prevention and Control
Division of Violence Prevention
Prevention Development and Evaluation Branch
4770 Buford Hwy, NE, MS K-60
Atlanta, GA 30341
June 15, 2007
Table of Contents
B. Collections of Information Employing statistical procedures
1. Respondent Universe and Sampling Methods
2. Procedures for the Collection of Information
3. Methods to Maximize Response Rates and Deal with Non-Response
4. Test of Procedures or Methods to be Undertaken
5. Individuals consulted on Statistical Aspects and Individuals collecting and/or analyzing information
B. Collections of Information Employing Statistical Methods.
Sampling frame. All women at least 18 years of age with a scheduled appointment at the Fantus Clinic OB-GYN or family planning clinic are eligible. The following table provides our exclusion criteria and rationale:
Exclusion Criteria |
Rationale |
Non-English speaking |
Audio programming and video clips in multiple languages is cost-prohibitive |
Women >36 weeks pregnant (ONLY Pretest) |
Impending labor will complicate one-week follow-up interview |
Women accompanied by a child >3 years of age who don’t have adequate provision for child care |
Older children may compromise the privacy of the kiosk and for security reasons, they should be with their caretaker |
Visually- or hearing-impaired women |
They will be unable to use either the A-CASI or the touch-screen monitor |
Women who are accompanied by their partner and the two can’t safely be separated |
Patient privacy is essential for the safety of participants |
Women who do not have access to a telephone
|
Unable to complete study task – 1 week CATI follow-up (Pretest) or at one-year (Main Study) |
Severe Mental impairment |
Unable to give Informed Consent and complete study tasks |
Sampling methods: The average number of visits per day to Obstetrics & Gynecology is 90 while Family planning averages 25 visits per day. For the Pretest study, we intend to enroll from the family planning clinics on Tuesdays and Thursdays, and the OB/GYN clinic on Wednesdays during the study period. For the main study, participants will be enrolled every day in both clinics.
Research assistants (RAs) will approach potential patient-participants in a pre-randomized order, by appointment hour block. The day before, the RA pair team scheduled to enroll on the following day will be given a list of patients scheduled for that clinic in 1-hour blocks. Names of patients will be pre-randomized within the hour-long blocks. RAs will begin by approaching 1st pre-selected patients 1 hour before their scheduled appointment. If that patient is not present, they will call out the next name until exhausting all scheduled patients for that block, and then repeat from the top of the list until they successfully enroll an eligible patient.
Sample size: For the Pretest study, 196 women will be recruited and randomized to four arms with 48 women in each arm. With a potential lost to follow-up of 10% at one-week’s time, the final sample size will allow us to estimate continuous baseline measures with a 95% confidence interval with a width of 0.35 of a standard deviation. It would also allow us to detect a standardized effect size of .6 (considered a moderately strong effecti between arms with a significance level of 0.05 and a power of 80%.ii
For the main study, we will be enrolling approximately 3700 women who will be randomly assigned to three arms. Based on an estimated prevalence of about 13% of women in primary or ambulatory care clinics reporting abuse by a partner in the past year.iii,iv,v,vi, this sample size will allow us to detect a standardized effect size of .4 (considered a small to moderate effect sizevii in QOL and mental health score means among women exposed to IPV at a significance level of .05, power of 80%, factoring in a 30% lost-to-follow-up rate.
Sample size estimates and sample selection have been described in Part A.
A standardized questionnaire with a total of 45 and 51 questions have been developed for the baseline assessment in the Pretest and Main study, respectively (Attachments H and J). All questions on the baseline questionnaire have been based on existing scales or surveys as follows:
- Partner Violence Screen (PVS) will be used to assess the presence of current IPV (past year) and women’s perception of being ‘safe’ from IPV among all participants in the Pretest and in Arm 1 of the Main Study. This 3-item screening tool has been used in Emergency Room settings where it was validated using the much longer IPV research instruments Index of Spouse Abuse (ISA) and the Conflict Tactics Scale (CTS) as criterion.viii The sensitivity of PVS was .65 (compared to ISA) and .71 (compared to CTS); specificity for the PVS was .80 (ISA) and .84 (CTS).
- Quality of Life : will be measured with the SF-12ix at both baseline and at follow-up (section A of baseline and follow-up). This measure has shown acceptable reliability and validity and summary scores of the SF-12 can be used to derive a utility value for the health state reported through an established algorithm. This transformation of the SF12 score represents what the general population believes is the quality of life associated with each woman’s health state and allows comparisons with other conditions similarly standardized. This tool has been successfully and extensively used to assess QOL in clinical trials.
- Disability will be assessed at both baseline and follow-up utilizing two items that have been used successfully in the WorldSAFE IPV study.x
- Mental health will be measured using the Self-Report Questionnaire (SRQ-20xi) developed by an international team of mental health experts convened by the World Health Organization. The measure has been translated and validated in over 20 countries around the world showing acceptable criterion validity and internal consistency.
The baseline questionnaire in the Main Study will also have a symptom checklist for conditions that have been associated with IPV developed specifically for this study because to validate the effectiveness of screening evidence is needed that early treatment (during the asymptomatic period) produces better results than waiting for the appearance of symptoms and a diagnosis.xii-xiii
The follow-up survey will ask the same questions as the baseline except for the Partner Violence Screen. In addition we will ask about:
- Lifetime and past year exposure to IPV: will be assessed at follow-up in the Main Study using 10 of the items measuring simple and aggravated assault (threaten and use a gun and threaten and use a knife or other weapon have each been collapsed into 2 items), one of the items measuring sexual assault, and the seven items measuring control utilized in the National Violence Against Women Survey (NVAWS).xiv Factor analysis of the NVAWS data collected with the seven control items suggested that these items measured one construct reliably (Cronbach α=.70).xv These nonviolent control items will allow us to distinguish between situational couple violence (resulting when conflict escalates into mutually violent interactions) and so called “intimate terrorism” (male-to-female aggression motivated by the intent to control).xvi Because these two types of IPV are hypothesized to have a different natural history and outcomes, the impact of any intervention might also differ;
- knowledge of the prevalence and seriousness of IPV and of available services with questions developed for this study as these might be other potential benefits of screening;
- any potential adverse effects as a result of their responding to our questions or receiving information as a participant in the study.
This baseline assessment will be conducted with A-CASI technology. A search of the literature identified the utility of computer assisted surveys in exploring sensitive health issues. The literature suggests that computer assisted surveys achieve higher disclosure rates than self-administered questionnaires or face-to-face encounters for many sensitive health issuesxvii,xviii,xix,xx,xxi, including IPVxxii, are acceptable to patients and health care providers, and may increase solicitation and recall of health advice.xxiii Based on this evidence, we have chosen this technology for use in our RCT of routine screening.
The follow-up questionnaires have 34 and 65 questions (see Attachments I and K) and will be administered with CATI technology. The questionnaires have been tested for comprehension in 8 patients utilizing the A-CASI or CATI system. Revisions were not deemed necessary.
Questionnaires are at the seventh grade reading level. However, a research assistant will be available to assist participants who may have difficulty reading or understanding the questionnaires as well as utilizing the touch screen format at baseline. The follow-up questionnaire will be administered by a trained interviewer who will be able to handle potential questions participants may have over the phone.
Follow-up. One-week (Pretest)/ one-year (Main Study) after completion of the baseline interview, efforts will begin for the follow-up of participants. The same RA that enrolled the participant will be responsible for follow-up of that participant. RAs will schedule calls based on days and times participants’ reported preferring at baseline. All information, except selected demographics and health care utilization, will be collected at the one-year follow-up using a computer-assisted telephone interview (CATI). The RA will open the CATI application and enter the study identifier, log the date and time of contact. For patients who cannot be contacted on the initial attempt, the interviewer will attempt a follow-up call to each of the numbers the participant provided up to 4 times on 3 consecutive days during times specifically negotiated with the women at enrollment, including calls during evening hours. After successful or failed follow-up contact, the patient will be removed from the report and considered as a failed contact. For partially completed or refused follow-up interviews the participant will be asked about the reason for termination of the interview (e.g., safety concerns or time pressures). The CATI program will create an automatic record of all dialings, track the outcome of each contact/interviewing attempt, and document reasons for refusal and the place of termination.
Once contact with participants is established for the follow-up, the interviewer will either proceed with the interview or schedule the interview at a time convenient to the respondent. For patients who are unable to complete the interview, but who request the opportunity to resume the interview at a later date, work will be saved and the interviewer and interviewee will have the option of resuming the interview without repeating questions.
CATI follow up interviews will be conducted in the Collaborative Research Unit at John H. Stroger Hospital -CATI office (Room 1608) following CRU protocol for attempts, response to disconnect, script for call answered by other, etc.). The CATI program will include the text of the question wording, response category wording, and the programming of the skip patterns, and range checks and other on-line consistency checks and procedures during the interview as well as a system to help eliminate the problem of key entry error as a result of accidentally hitting the wrong key. For quality control, these activities will be supervised or reviewed by the study coordinator.
Women called by the RA in the waiting room will be invited to participate in this study, including the follow-up telephone interview. The RA will give women a copy of the consent form and will also read it aloud to her. Those not wishing to participate will receive the standard of care. RAs will keep a log of women who do not wish to participate to determine non-response rates. Participants in the study will be compared to what is known about women attending the Fantus Clinic as to age, race, and insurance coverage to determine potential non-response bias.
Those consenting will be asked to go to a computer kiosk with the RA and respond to the questionnaire. In the Pretest, women will be offered a $20 certificate as an incentive for participation. In the Main Study, participants will be offered a $10 certificate upon completion of the questionnaire and mailed a $15 certificate after the telephone interview in one year.
All interviewers hired by the subcontractor (Dr. Laura Sadowski in the Collaborative Research Unit of John H. Stroger Hospital) will be thoroughly screened and their interviewing abilities tested prior to their being employed by the Collaborative Research Unit. For this study, interviewers will receive approximately 8-12 hours of project‑specific training. The content of training will include: eligibility determination, recruitment, informed consent, enrollment, A-CASI operations, and CATI follow-up. In addition, interviewers will also receive information on IPV and its consequences and will be given a comprehensive set of questions and answers that will provide encouraging responses to questions that respondents may ask.
Telephone interviewing techniques will be modeled utilizing the study questionnaire and practiced by trainees through role-play. Trainees will be observed and given feedback during simulations of the interview until they are able to perform each skill to the PI’s satisfaction. Additional opportunities for practice and feed-back will occur during the Pretest of the study’s procedures.
Research nurses from the Collaborative Research Unit (CRU) will review the questionnaire and A-CASI program. The CRU research nurses have worked on the development and testing of low-literacy interview instruments, patient education materials, and self-management materials for patients with common chronic illnesses (e.g., asthma, and diabetes). The study interview instruments and participant identification procedures and interviewing technologies have been tested for comprehension with 8 patients in both study sites (i.e., family planning and OB/GYN clinic). This test was directly observed by the subcontractor and followed by debriefing with the full research team. No adjustments in questionnaire items appeared to be required.
The feasibility and acceptability of the procedures will then be tested in the Pretest and refinements to the procedures of the Main Study may be required. If changes are required, we will submit these to IRB and OMB for review.
All instruments and procedures have been reviewed extensively by CDC/DVP and the Collaborative Research Unit staff at Cook County Hospital. The following individuals have worked closely in developing the instrument and procedures that will be used, and will be responsible for data analysis:
Joanne Klevens, MD, PhD, CDC PI
NCIPC/DVP/Prevention Development and Evaluation Branch
[email protected] (e-mail)
(770) 488-1386 (phone)
Laura Sadowski, MD, MPH
Co-Director, Collaborative Research Unit, John H. Stroger Hospital
Associate Professor, Department of Internal Medicine, Rush Medical College, Chicago
[email protected] / (312) 864-3646
Romina Kee MD, MPH
Senior Attending Physician, Collaborative Research Unit, John H. Stroger Hospital, Chicago
[email protected] / (312) 864-3630
William Trick, MD
Senior Investigator, Collaborative Research Unit and Department of Obstetrics and Gynecology, John H. Stroger Hospital, Chicago
[email protected] / (312) 864-3631
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| File Type | application/msword |
| Author | T. Taylor |
| Last Modified By | T. Taylor |
| File Modified | 2007-06-19 |
| File Created | 2007-06-14 |