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Gabby Implementation: Parent Protocol

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04514224
Enrollment
125
Registered
2020-08-14
Start date
2017-10-15
Completion date
2022-03-15
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed description

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.

Interventions

OTHERGabby implementation

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

OTHEREvaluate the Gabby implementation

Assess implementation outcomes using the Proctor Implementation Outcomes Framework

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Boston Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of Gabby system by staff6 monthsInformation 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.
Feasibility of Gabby system by staff6 monthsInformation 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

MeasureTime frameDescription
Change in number of preconception risks at 6 monthsbaseline, 6 monthsThe 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
Stage of change for each preconception risk identified6 monthsThe 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
Total number of preconception health risks for Gabby users6 monthsThe 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
Total number of minutes used Gabby6 monthsThe 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.
Number of Gabby sessions by user6 monthsThe 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.
Change in number of preconception risks at 3 monthsbaseline, 3 monthsThe 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026