Gabby Implementation: Parent Protocol

Study Overview
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Brief Summary
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The Gabby Preconception Care program is an innovative communication system designed to identify and mitigate or resolve health risks for young Black and African American (AA) women before pregnancy, as a means of reducing racial health disparities in birth outcomes. The system uses embodied conversational agent technology the investigators call Gabby, who empathically interacts with users to assess health risks and delivers interventions to resolve or mitigate these risks. This research team has been working on the Gabby Preconception Care program, which features Virtual Patient Advocate (VPA) technology, for over seven years and the system is now ready for dissemination beyond the research environment and into the clinical and community context. The purpose of this project is to examine the implementation and dissemination process of the evidence-based Gabby Program. Caseworkers at Healthy Start (HS) Programs and healthcare providers at Community Health Centers (CHC's) do not have time to assess for the over 100 preconception health risks that can impact birth outcomes; our system can assist by streamlining that assessment to create a personalized list of risks.Gabby will be introduced/released to sites as part of their standard of care where patients and clients can then share their list with healthcare providers and case workers/managers to make their in-person interactions much more effective. Studies by the research team have shown that Gabby reduces health risks by 25 percent among young Black and AA women. The investigators will evaluate the success of the implementation process through both quantitative and qualitative measures including key informant telephone interviews and guidance from a Gabby Toolkit Advisory Board in order to prepare an implementation toolkit that can be used to facilitate broader dissemination. The Gabby program will not be evaluated as a research intervention, as this has been done previously, instead, how well the Gabby program worked within each site will be assessed.

Detailed Description
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The investigators' implementation approach includes: 1) engaging 6 Healthy Starts and 4 CHCs and assessing the workflow and readiness of these clinical sites; 2) implementing the Gabby program for a period of 3-6 months at each of these clinical sites; 3) assembling a preliminary, revised, and final implementation toolkit; and 4) broadly disseminating the toolkit and results of the implementation. Input from a Gabby Toolkit Advisory Board will guide implementation efforts and toolkit development to be used for wider dissemination into other clinical based sites. Data sources will include qualitative and quantitative methods, such as surveys/ assessments, key informant interviews, system-generated data, learning communities, and implementation logs. Evaluation will focus on site recruitment, training, and engagement; client engagement; clinical risk reduction; toolkit, technical assistance, and support resources; and dissemination efforts.

Official Title
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Implementation of a Health Information Technology System for Young African American Women Into Community-Based Clinical Sites

Conditions
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Preconception Care

Intervention / Treatment
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* Other: Gabby implementation
* Other: Evaluate the Gabby implementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For staff at Healthy Start sites and Community Health Centers Staff (community health workers, social workers, clinicians, administrators) who work at a participating site Trained about the Gabby system by the investigators Speak and read English For Gabby system users Women who identify as black or African American who are clients of a participating Healthy Start site or receive care at a participating Community Health Center Currently not pregnant Speaks and read English Has access to a smartphone or laptop/tablet Has internet access Plans to use the Gabby system for 6 months Exclusion Criteria: For Staff at Healthy Start sites and Community Health Centers None For Gabby system users None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Start Program 1<br>Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|
| Community Health Center 1<br>Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|
| Healthy Start Program 2<br>Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|
| Community Health Center 2<br>Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|
| Healthy Start Program 3<br>Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|
| Community Health Center 3<br>Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|
| Healthy Start Program 4<br>Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|
| Community Health Center 4<br>Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|
| Healthy Start Program 5<br>Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|
| Healthy Start Program 6<br>Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black | Other: Gabby implementation<br>* Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings<br>Other: Evaluate the Gabby implementation<br>* Assess implementation outcomes using the Proctor Implementation Outcomes Framework<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Gabby system by staff | Information about the acceptability of the Gabby system will be gleaned form qualitative and quantitative data. Virtual interviewers of key staff will be done informed by an interview guide to collect the qualitative data. The quantitative data will be assessed using an investigator developed 33-question Likert scale-based survey. Responses along the 5-point Likert scale will consist of Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), Strongly Agree (5). Higher score from acceptability related questions indicate greater acceptability. | 6 months | 
| Feasibility of Gabby system by staff | Information about the feasibility of the Gabby system will be gleaned form qualitative and quantitative data. Virtual interviewers of key staff will be done informed by an interview guide to collect the qualitative data. The quantitative data will be assessed using an investigator developed 33-question Likert scale-based survey. Responses along the 5-point Likert scale will consist of Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), Strongly Agree (5). Higher score from feasibility related questions indicate greater feasibility. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of preconception health risks for Gabby users | The total number of preconception risks is collected during the client/patient's interaction with the Gabby system and will be obtained from Gabby system reports produced by the Gabby System server | 6 months | 
| Change in number of preconception risks at 3 months | The number of preconception risks is collected during the client/patient's interaction with the Gabby system and will be obtained from Gabby system reports produced by the Gabby System server | baseline, 3 months | 
| Change in number of preconception risks at 6 months | The number of preconception risks is collected during the client/patient's interaction with the Gabby system and will be obtained from Gabby system reports produced by the Gabby System server | baseline, 6 months | 
| Stage of change for each preconception risk identified | The client's stage of change for each preconception risk is collected during the client/patient's interaction with the Gabby system and will be obtained from Gabby system reports produced by the Gabby System server | 6 months | 
| Number of Gabby sessions by user | The Gabby system records the number of log-ons/sessions for each user which will be obtained from Gabby system reports produced by the Gabby System server. | 6 months | 
| Total number of minutes used Gabby | The Gabby system records the number of minutes of each session for every user which will be obtained from Gabby system reports produced by the Gabby System server. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Start program, Community Health Centers, Implementation Science Research, Uptake, Organizational Readiness, Health Information Technology, Embodied Conversational Agent, Preconception Health, Black and African American women