Clinical trial NCT04514224: Gabby Implementation: Parent Protocol
Official title: Implementation of a Health Information Technology System for Young African American Women Into Community-Based Clinical Sites
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-08-14
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Acceptability of Gabby system by staff
timeFrame: 6 months
measure: Feasibility of Gabby system by staff
timeFrame: 6 months
Secondary outcomes:
measure: Total number of preconception health risks for Gabby users
timeFrame: 6 months
measure: Change in number of preconception risks at 3 months
timeFrame: baseline, 3 months
measure: Change in number of preconception risks at 6 months
timeFrame: baseline, 6 months
measure: Stage of change for each preconception risk identified
timeFrame: 6 months
measure: Number of Gabby sessions by user
timeFrame: 6 months
measure: Total number of minutes used Gabby
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Family Medicine
name: Brian Jack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.