Gabby Implementation: Parent Protocol

NCT04514224 | Completed

• 2 other identifiers: H-368161R18HS025131-01
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Preconception Care

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Total number of preconception health risks for Gabby users

  6 months

• Change in number of preconception risks at 3 months

  baseline, 3 months

• Change in number of preconception risks at 6 months

  baseline, 6 months

• Stage of change for each preconception risk identified

  6 months

• Number of Gabby sessions by user

  6 months

Study Arms (10)

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; Other: Evaluate the Gabby implementation

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; Other: Evaluate the Gabby implementation

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; Other: Evaluate the Gabby implementation

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; Other: Evaluate the Gabby implementation

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; Other: Evaluate the Gabby implementation

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; Other: Evaluate the Gabby implementation

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; Other: Evaluate the Gabby implementation

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; Other: Evaluate the Gabby implementation

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; Other: Evaluate the Gabby implementation

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; Other: Evaluate the Gabby implementation

Interventions

Gabby implementation OTHER

Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings

Community Health Center 1; Community Health Center 2; Community Health Center 3; Community Health Center 4; Healthy Start Program 1; Healthy Start Program 2; Healthy Start Program 3; Healthy Start Program 4; Healthy Start Program 5; Healthy Start Program 6

Evaluate the Gabby implementation OTHER

Assess implementation outcomes using the Proctor Implementation Outcomes Framework

Community Health Center 1; Community Health Center 2; Community Health Center 3; Community Health Center 4; Healthy Start Program 1; Healthy Start Program 2; Healthy Start Program 3; Healthy Start Program 4; Healthy Start Program 5; Healthy Start Program 6

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• For Staff at Healthy Start sites and Community Health Centers
• None
• For Gabby system users
• None

Sponsors & Collaborators

• Boston Medical Center: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 32958031 DERIVED

Study Officials

• Brian Jack, MD

  Boston Medical Center, Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 14, 2020
• Study Start: October 15, 2017
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)