Study of Virtual Patient Advocate for Preconception Care for African American Women
Condition: Preconception Care
Study type: Interventional

Summary: 
      This study is to examine the effectiveness of a health communication system (Gabby) that
      assesses preconception health risks and tailors the intervention to each subject, based on
      her health risks.

      There is a need to develop practical tools that can be used to identify preconception health
      risks and will facilitate the initiation of intervention for these risks; this project
      specifically targets young Black or African American women in order to reduce major
      disparities in birth outcomes. Clinicians do not have time to assess for over 100
      preconception health risks that can impact birth outcomes; this system can streamline that
      assessment and create a personalized list of risks. Patients can then share their list with
      clinicians to make their healthcare visits more effective.

      This study involves a pilot of the system through the Preconception Peer Educator (PPE)
      Program, which is a program created by the Office of Minority Health. The program began in
      historically black colleges in the United States, with the purpose of training students to
      reach out to their community to educate about the increased risk of preterm birth, low birth
      weight and infant mortality among African Americans. The PPEs teach about preconception
      health, or getting healthy before pregnancy, to increase the chances of having a healthy
      baby. Now the PPE program has expanded to colleges in over 20 states across the country.
    

Detailed description: 
      Overview After the development phase, the investigators will first test the Shared Decision
      Making module with a group of 50 women from the Boston community. Then, a group of 20 other
      women from the Boston Community will serve as pre-testers of the full system and will then be
      invited to participate in a focus group to share additional feedback. Then, the investigators
      will conduct a six month randomized control trial (RCT) of PPEs from across the country to
      test whether the Gabby system will result in a lower rate of preconception health risks
      compared to the control group. In the RCT, half of the participants who sign up will use the
      Gabby system (interventions) and the other half will not use the Gabby system (controls).
      Outcomes will be assessed via a 6 month follow-up phone call, which will take approximately
      one hour. Secondary outcomes include: pregnancy rate, Risk Profile for participants who
      become pregnant, participant satisfaction, and number of stories written and heard.

      Pre-Testing Protocol Pre-Testing subjects will be recruited from 3 sources (Family Medicine
      and Ob/Gyn Clinics, ReSPECT Registry, and local stores and restaurants). Each session will
      last up to two hours and will take place in the BMC research offices. Subjects will complete
      the same demographic form that will be used in the RCT, test various components of the system
      - including the risk assessment, risk dialogue ("scripts" from Gabby), My Health To-Do List,
      and story authoring. This will allow the investigators to fully test the completed system
      with members of the target group, debug it, populate the system with additional stories and
      receive feedback on what works and what does not. The objective is to perform a check of the
      system logic, content, and usability of the software. The goal is to ensure that the system
      works as designed. Northeastern investigators will be present for the full system pre-testing
      in order to assist with technical issues and in order to observe the system in use and
      identify problems to fix prior to the RCT.

      After each user tests the system, Dr. Yinusa-Nyahkoon, an experienced African American
      investigator, will conduct a one-on-one interview with each subject that will last
      approximately 30 minutes. Dr. Yinusa-Nyahkoon will use a semi-structured interview guide to
      ask questions about the subjects' perceptions of the system and gather suggestions for
      improvement.

      All focus group and individual interviews will be audio recorded and transcribed verbatim;
      participants will be informed about the audio recording prior to signing the consent form.
      Research team members will review transcripts to change subject names and alter identifying
      information in order to honor subject confidentiality. Audio files of all interviews will be
      password protected, and paper copies of interview transcripts will be assigned subject
      identification numbers. Analysis of interview data will begin after the first focus group
      interview is completed; therefore, data collection and analysis will occur simultaneously,
      and new points of inquiry for subsequent interviews are generated. Grounded theory techniques
      will be used to analyze interview data. Content categories, patterns, and themes will be
      identified across the interview data, and supporting evidence from transcripts will be
      reviewed with research team members to corroborate these findings. This process, referred to
      as researcher triangulation, provides a mechanism to reflect on, confirm, and expand data
      interpretations.

      The following information will be collected from each Pretesting subject: (1) Screening Form
      to determine eligibility(Form A); (2) Signed consent form; (3) Contact Information Sheet
      (Form C); (4) Subject sociodemographics (Form C); (5) Health literacy will be tested with the
      66 word version of the Rapid Estimate of Adult Literacy in Medicine (REALM); (6)
      Multidimensional Scale of Perceived Social Support; (7) Everyday Discrimination Scale; (8)
      Social Networking Immersion Measure; (9) General Self-Efficacy Scale; (10) Contraceptive
      Knowledge Pre-Test; and (11) Nutrition Knowledge Pre-Test.

      Randomized Control Trial Protocol Subject Identification and Recruitment: Subjects will be
      recruited from the Preconception Peer Educator (PPE) program in the Office of Minority Health
      (OMH). The investigators will work with OMH, who will send recruitment emails to their
      contact list of those who have completed the PPE training, to inform them of the study and
      provide the contact information of the Program Manager. If interested, potential subjects can
      email the Program Manager to receive more information about the study and set up a phone call
      to complete the screening and enrollment process and give verbal consent. Potential subjects
      will be emailed the consent form and REALM form prior to the phone call, as well as a flyer
      with basic study information, and instructed to have access to their computer during the
      phone call.

      Inclusion and Enrollment Procedures. The investigators will enroll women age 18 years and
      older, who self-identify as "Black or African American," meet all other eligibility criteria
      and who have participated in the OMH-PPE program. During enrollment the investigators will
      ask them to select their race and ethnicity from a list based on the US standard census
      categories and a list of ethnicities, based on the demographic information used US Census
      Bureau. Participants will be eligible if they choose "Black or African American." Prior to
      obtaining verbal consent, the research staff will then explain: (1) the purpose of the
      project; (2) potential risks and benefits to enrolling in the study; (3) possible
      randomization to a control group; and (4) IRB safeguards. BUMC investigators will obtain
      verbal consent from all participants and fill out enrollment forms.

      Baseline Data Collection. Before randomization, the following information will be collected:
      (1) Eligibility Form A to determine eligibility; (2) Verbal consent; (3) Contact Information
      Sheet (Form C); (4) Demographic Form B; (5) Health literacy will be tested with the 66 word
      version of the Rapid Estimate of Adult Literacy in Medicine (REALM); (6) Multidimensional
      Scale of Perceived Social Support; (7) Everyday Discrimination Scale; (8) Social Networking
      Immersion Measure; (9) General Self-Efficacy Scale; (10) Contraceptive Knowledge Pre-Test;
      and (11) Nutrition Knowledge Pre-Test.

      Randomization. Using a random numbers table, the statistician will prepare a numbered set of
      sealed study allocation envelopes prior to study start that will be used to determine the 75
      subjects who are in the intervention group and the 75 who are in the control group. The
      control group will receive a letter listing the preconception risks identified in the risk
      assessment and they will be encouraged to see their clinician to discuss them.
    

Intervention name(s): Intervention (Virtual Patient Advocate)
Intervention type(s): Behavioral
Intervention description(s): Intervention (Virtual Patient Advocate) participants will have access to the "Gabby" system for 6 months. There is no required "dose" or frequency that they have to log on to the system, but the investigators will suggest that they log on once a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preconception Health; Health Information Technology; Reproductive Life Plan; Healthcare Disparities; Low birth-weight; Preterm Delivery