Gabby Implementation: Parent Protocol

• ClinicalTrials.gov Identifier: NCT04514224
• Recruitment Status: Active, not recruiting
• First Posted: August 14, 2020
• Last Update Posted: December 28, 2021
• Sponsor: Boston Medical Center
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Boston Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Preconception Care	Other: Gabby implementation; Other: Evaluate the Gabby implementation

Detailed Description:

The investigators' implementation approach includes: 1) engaging 6 Healthy Starts and 6 CHCs and assessing the workflow and readiness of these clinical sites; 2) implementing the Gabby program for a period of 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Implementation of a Health Information Technology System for Young African American Women Into Community-Based Clinical Sites
• Actual Study Start Date: October 15, 2017
• Estimated Primary Completion Date: June 2022
• Estimated Study Completion Date: June 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Healthy Start Program 1; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Community Health Center 1; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Healthy Start Program 2; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Community Health Center 2; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Healthy Start Program 3; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Community Health Center 3; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Healthy Start Program 4; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Community Health Center 4; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Healthy Start Program 5; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Community Health Center 5; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Healthy Start Program 6; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework
Community Health Center 6; 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; Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings; Other: Evaluate the Gabby implementation; Assess implementation outcomes using the Proctor Implementation Outcomes Framework

Outcome Measures

Primary Outcome Measures :

1. Acceptability of Gabby system by staff [ Time Frame: 6 months ]
   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.
2. Feasibility of Gabby system by staff [ Time Frame: 6 months ]
   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.

Secondary Outcome Measures :

1. Total number of preconception health risks for Gabby users [ Time Frame: 6 months ]
   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
2. Change in number of preconception risks at 3 months [ Time Frame: baseline, 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
3. Change in number of preconception risks at 6 months [ Time Frame: baseline, 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
4. Stage of change for each preconception risk identified [ Time Frame: 6 months ]
   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
5. Number of Gabby sessions by user [ Time Frame: 6 months ]
   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. Total number of minutes used Gabby [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 39 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of staff members at participating sites and clients who use the Gabby system. The staff will be from the 6 selected Healthy Start sites and the 6 selected Community Health Centers who volunteer to participate by responding to a survey, being interviewed, or participating in a focus group about implementation of the Gabby program. The clients will be adult eligible women who receive services from one of the participating sites who meet the eligibility criteria.

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston Medical Center

Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Brian Jack, MD; Boston Medical Center, Family Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Walter AW, Julce C, Sidduri N, Yinusa-Nyahkoon L, Howard J, Reichert M, Bickmore T, Jack BW. Study protocol for the implementation of the Gabby Preconception Care System - an evidence-based, health information technology intervention for Black and African American women. BMC Health Serv Res. 2020 Sep 21;20(1):889. doi: 10.1186/s12913-020-05726-0.

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT04514224
• Other Study ID Numbers: H-36816; 1R18HS025131-01 ( U.S. AHRQ Grant/Contract )
• First Posted: August 14, 2020
• Last Update Posted: December 28, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Medical Center:

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