Gabby Implementation: Parent Protocol

August 4, 2022 updated by: Boston Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 months
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
baseline, 3 months
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
baseline, 6 months
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
6 months
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 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agency for Healthcare Research and Quality (AHRQ)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian Jack, MD, Boston Medical Center, Family Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-36816
  • 1R18HS025131-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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