Testing Preliminary Effectiveness of a Training to Support CHWs Outreach on Dental to African American Caregivers (GRIN)

November 6, 2024 updated by: KDH Research & Communication
Two arm study, experimental and control, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of African American youth via their caregivers.

Study Overview

Detailed Description

The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the GRIN prototype and explore the following research question: To what extent does exposure to the GRIN prototype relate to positive changes in CHWs' knowledge, attitudes and beliefs, perceived self-efficacy, and intent to conduct oral health care outreach to low-income Black guardians? The community-driven nature of the project will ground the evaluation in the principles of an equitable evaluation that incorporates a racial equity lens. An equitable evaluation is "an approach that addresses the dynamics and practices that have historically undervalued the voices, knowledge, expertise, capacity, and experiences of all evaluation participants and stakeholders, particularly people of color and other marginalized groups." This approach "requires that evaluators engage in a process of ongoing self-reflection and adjustment, including a willingness to question and adapt traditional evaluation methods in response to stakeholder input." Working with communities to reflect the specific needs of their constituents, investigators will develop and enhance collaborations that leverage stakeholder expertise; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to conduct outreach with low-income Black guardians. The PI, with input from the SC, will develop necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials, which then be reviewed against an equitable evaluation checklist, obtaining input on revisions from community members where needed. The PI will also outline the appropriate statistical analysis methods. All procedure documents will be reviewed by the KDHRC Institutional Review Board before the evaluation launch.

The investigators will recruit participants through evaluation partners who will disseminate the study information to CHWs via electronic notifications and flyers. Evaluation partners include National Association of Community Health Workers (NACHW) and the University of Southern Mississippi College of Nursing and Health Professionals (see Letters of Support for more details). The notification will provide information about the goal of the study, participant eligibility, and a link to an interest and eligibility form. Once a potential participant completes the interest and eligibility form and s/he is eligible for the project, they will receive a link to a consent form located on a secure online platform.

CHWs will be randomly assigned to the intervention or control group after consent and enrollment in the study. All participants will complete an online pretest survey. The intervention group will be exposed to GRIN and will complete an online posttest survey two weeks after completing the GRIN modules. The control group participants will not be exposed to the GRIN program and will complete a posttest two weeks after completing the pretest. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.

The investigators will download and export the data from SurveyGizmo into an encrypted Excel file and import the raw data into STATA. The investigators will match the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of GRIN exposure on changes in CHWs' knowledge, attitudes and beliefs, self-efficacy, and intentions to conduct pediatric oral health care outreach to low-income Black guardians. The a priori feasibility criterion is: Statistically significant differences between pretest and posttest knowledge and self-efficacy measures among the intervention group participants.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

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

    • Georgia
      • Atlanta, Georgia, United States, 30309
        • KDH Research & Communication

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

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Must be at least 18 years old.
  • Must self-identify as a community health worker.
  • Must conduct outreach to Black parents of children and adolescents.
  • Must have six months of field experience. KDHRC defines "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events
  • Must be an active CHW. KDHRC defines "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
  • Must have Internet access either at home or at work to access the the GRIN virtual education session and/or online surveys.

Exclusion criteria:

-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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exposed to GRIN training
participates in the intervention
multi module online training
No Intervention: control/unexposed
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge Pretest Score
Time Frame: Baseline
We asked participants 12 multiple choice knowledge questions related to oral health which we averaged to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We averaged these composite scores across all participants for both groups to create mean scores ranging from 0 to 100, the higher the score the more questions participants answered correctly.
Baseline
Attitudes Pretest Score
Time Frame: Baseline
We asked all participants seven Likert-type scale questions about attitudes towards conducting oral health outreach. Each answer choice rating ranged from 1 to 10, with higher ratings representing higher perceptions of oral health outreach importance. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest score and 10 being the highest. Higher score means better outcome. Then, we averaged these composite scores for each group.
Baseline
Self-efficacy Pretest Score
Time Frame: Baseline
We asked all participants 10 Likert-type scale questions related to perceived self-efficacy with conducting oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceptions of confidence in providing oral health outreach. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for both groups.
Baseline
Intentions Pretest Score
Time Frame: Baseline
We asked all participants five Likert-type scale questions related to their intentions to conduct oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceived likelihood of providing oral health outreach in the future. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for each group.
Baseline
Knowledge Posttest Score
Time Frame: Posttest (2 weeks after baseline)
We asked participants 12 multiple choice knowledge questions related to oral health which we averaged to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We averaged these composite scores across all participants for both groups to create mean scores ranging from 0 to 100. Higher scores mean better outcome.
Posttest (2 weeks after baseline)
Attitudes Posttest Score
Time Frame: Posttest (2 weeks after baseline)
We asked all participants seven Likert-type scale questions about attitudes towards conducting oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceptions of oral health outreach importance. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for each group.
Posttest (2 weeks after baseline)
Self-efficacy Posttest Score
Time Frame: Posttest (2 weeks after baseline)
We asked all participants 10 Likert-type scale questions related to perceived self-efficacy with conducting oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceptions of confidence in providing oral health outreach. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for each group.
Posttest (2 weeks after baseline)
Intentions Posttest Score
Time Frame: Posttest (2 weeks after baseline)
We asked all participants five Likert-type scale questions related to their intentions to conduct oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceived likelihood of providing oral health outreach in the future. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for each group.
Posttest (2 weeks after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction at Posttest Score
Time Frame: Baseline (2 weeks after baseline)
We asked only the intervention group participants five Likert-type scale questions related to their satisfaction with the GRIN intervention. Each rating ranged from 1 to 5, with higher scores representing higher satisfaction with the GRIN intervention. We averaged ratings from each question to create an average composite rating for each intervention participant, then averaged these scores across the intervention group. Scores ranged from 1 to 5, with higher scores meaning better satisfaction/outcome.
Baseline (2 weeks after baseline)

Collaborators and Investigators

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

Investigators

  • Study Chair: Eric C Twombly, PhD, KDH Research & Communication

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)

January 1, 2022

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-02-04
  • 1R43MD016352 (U.S. NIH 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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