Randomized Control Trial of a Virtual Patient Advocate for Preconception Care
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 education and intervention to each
      subject, based on her health 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 the over 100 preconception health risks that can impact birth outcomes;
      the investigators 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.

      The investigators will conduct a two-armed randomized controlled trial (RCT) designed to
      enroll 530 African American women ages 18-34. After all subjects complete a comprehensive
      preconception health risk assessment, the intervention group will be trained to use the Gabby
      system and encouraged to use it at least monthly for one year. The control group will receive
      a letter listing the risks identified and they will be encouraged to see their clinician to
      discuss them.

      The investigators primary hypothesis will test whether the Gabby system will result in a
      lower rate of preconception health risks, as defined by CDC, as compared to the control group
      after 12 months. Secondary outcomes include: measurement of usage rates, dose of exposure,
      attrition, subject and healthcare provider satisfaction, and number of women with a
      personalized health plan.
    

Detailed description: 
      The investigators will conduct a two-armed randomized controlled trial designed to enroll 530
      African American women ages 18-34. After all subjects complete enrollment forms a
      comprehensive preconception health risk assessment, the intervention group will be trained to
      use the Gabby system and encouraged to use it at least monthly for one year.The control group
      will receive a letter listing the risks identified and they will be encouraged to see their
      clinician to discuss them.

      System Preparation: Dr. Bickmore and the technical team will be responsible for preparing the
      system for the trial, using the preconception care content and scripts developed by Dr. Jack
      and the research team. Both teams will meet as the working group to discuss final preparation
      and modifications.

      Usability Testing: As software development is complete, the investigators will conduct
      thorough usability testing of the interventions and the RCT protocols, using approximately 20
      subjects who meet the enrollment criteria of the study. The subjects will use the Gabby
      system in the investigators research offices to complete the health risk assessment and to
      begin the interaction about individual risk factors. This session will last no more than one
      hour. Then they will use the Gabby system online in their home for two weeks; their
      interactions with the system will include: learning about their individual preconception
      health risks, managing their "My Health To-Do List," writing stories about their experiences
      with their health risks, and listening to stories left by other users. Usability subjects
      will be given a structured log sheet that lists each part of the intervention with space for
      them to record their reactions and concerns. Research staff (including representatives of
      both the technical and clinical staff) will review the log sheets. Then individual interviews
      examining their perceptions of the Gabby system will be conducted by Dr.Yinusa-Nyahkoon using
      a semi-structured interview guide (see attached Semi-Structured Interview Guide). Dr.
      Yinusa-Nyahkoon will recommend design and content changes based on interviews. These
      usability-testers will be paid for their participation and will not participate in the RCT.
      The investigators anticipate needing to implement a round of system modifications based on
      subject feedback.

      RCT: All RCT participants will be screened for eligibility criteria (see section 21), give
      consent to participate, and complete baseline data collection forms, including the online
      Preconception Health Risk Assessment.

      Randomization. Using a random numbers table, the statistician (Dr. Chetty) will prepare a
      numbered set of sealed study allocation envelopes prior to study start. Block randomization
      will be used to ensure that an equal number of subjects are randomized in each age group.

      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.

      The Intervention Group. Intervention participants from the RCT will be given a username and
      secure password to log on to the Gabby site for the 12 months of the intervention. They will
      be encouraged to log on at least monthly, but using the system is voluntary. They will be
      given the contact information of the Program Manager in the event that they have any issues
      or questions about the system. The research team will call each intervention participant
      after 12 months to conduct a follow-up phone call to collect outcome data. At that point,
      intervention participants will be invited to participate a focus group session, as described
      below.

      Focus Groups. Intervention participants from the RCT will be asked during their follow-up
      phone call if they would like to participate in a focus group. Each focus group session will
      last no more than 2 hours and will have no more than 10 participants; the investigators hope
      to enroll approximately 35 participants in total. Dr. Yinusa-Nyahkoon will conduct the focus
      group discussion to gather feedback about the system and suggestions for future improvement.
      All focus group participants will be invited to participate in an additional one-on-one
      individual interview with Dr. Yinusa-Nyahkoon.

      Individual Interviews. Dr. Yinusa-Nyahkoon will conduct the individual interviews using a
      semi-structured interview guide (see attached Semi-Structured Interview Guide). Each
      interview will last no more than one hour. All focus group participants will be eligible to
      sign up for an individual interviews; participation is voluntary.

      Interviews with Health Care Providers. Dr. Yinusa-Nyahkoon will conduct one-on-one interviews
      with health care providers. Only the providers of individual interview participants will be
      contacted by email for participation. Each health care provider interview will last no more
      than one hour.

      Applying the Intervention. After randomization, the study staff will provide a brief tutorial
      to the participants in the intervention group explaining how to use the Gabby system and
      provide a secure username and password to each participant. After completing the tutorial,
      the participant will be asked to interact with Gabby at least monthly for the next 12 months.
      They will be given the email address of the project staff so they can ask questions about how
      to use the system. The project staff will send an email to participants every two weeks to
      remind them to use the system. Twelve months after enrollment, study staff will call each
      participant to conduct a follow-up phone interview to collect outcome data.
    

Intervention name(s): Virtual Patient Advocate (VPA)
Intervention type(s): Behavioral
Intervention description(s): Intervention participants will have access to the Virtual Patient Advocate (VPA) system for a period of 12 months. They will be encouraged to log on every two weeks or twice a month, but frequency and duration of conversations with the VPA is at the discretion of the participant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preconception Care; Racial Disparities; Health Information Technology