Preconception CareNCT04514224
Gabby Implementation: Parent Protocol
An observational study of Preconception Care, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Preconception Care
- What is being tested?
- Gabby implementation and Evaluate the Gabby implementation
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- For Staff at Healthy Start sites and Community Health Centers
- None
- For Gabby system users
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preconception Care
- Being tested
- Gabby implementation, Evaluate the Gabby implementation
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabby implementationOther
Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings
Evaluate the Gabby implementationOther
Assess implementation outcomes using the Proctor Implementation Outcomes Framework
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Gabby implementation; Other: Evaluate the Gabby implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start15 Oct 2017
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preconception CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Brian Jack, MD, Principal investigator, Boston Medical Center, Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514224
- Sponsor's protocol ID
- H-36816
- Other IDs
- 1R18HS025131-01
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2020
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32958031
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Health Information Technology System for Young African American Women Into Community-Based Clinical Sites
- ClinicalTrials.gov ID
- NCT04514224
- Acronym / sponsor ID
- H-36816
- Conditions
- Preconception Care
- Keywords
- Healthy Start program, Community Health Centers, Implementation Science Research, Uptake, Organizational Readiness, Health Information Technology, Embodied Conversational Agent, Preconception Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Healthy Start Program 1 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black |
| Community Health Center 1 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity 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 |
| Healthy Start Program 2 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black |
| Community Health Center 2 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity 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 |
| Healthy Start Program 3 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black |
| Community Health Center 3 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity 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 |
| Healthy Start Program 4 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black |
| Community Health Center 4 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity 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 |
| Healthy Start Program 5 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black |
| Healthy Start Program 6 | – | Other: Gabby implementation, Other: Evaluate the Gabby implementationCommunity Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- For Staff at Healthy Start sites and Community Health Centers
- None
- For Gabby system users
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabby implementationIimplement an evidence-based preconception care intervention, Gabby, into community-based health settings | Other | 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 implementationAssess implementation outcomes using the Proctor Implementation Outcomes Framework | Other | 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 |
Primary outcome
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.
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 secondary outcomes
Total number of preconception health risks for Gabby users
Time frame: 6 months
Change in number of preconception risks at 3 months
Time frame: baseline, 3 months
Change in number of preconception risks at 6 months
Time frame: baseline, 6 months
Stage of change for each preconception risk identified
Time frame: 6 months
Number of Gabby sessions by user
Time frame: 6 months
Total number of minutes used Gabby
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Derived from this study: PubMed 32958031Walter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Jack, MD principal investigator
Boston Medical Center, Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preconception Care, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Gabby system by staff (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04514224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.