Prepared
Title:
Promoting Preconception Care and Diabetes Self-Management among Reproductive-Aged Women with Diabetes: The PREPARED Trial
Dates:
August 2021 – June 2026
Funding Source:
National Institute of Diabetes and Digestive Kidney Diseases (NIDDK)
Grant Number:
R01DK127184
Background:
Women of reproductive age with type 2 diabetes are at greater risk for a number of negative health and reproductive outcomes. We developed the Promoting REproductive Planning And REadiness in Diabetes (PREPARED) strategy to [1] promote medication safety, [2] prompt provider preconception counseling, and [3] deliver patient-friendly educational tools and post-visit text messages to support diabetes self-care. We will test the effectiveness of PREPARED, against usual care, to improve patient knowledge of reproductive risks and recommended self-care activities, engagement in diabetes self-management behaviors, and glycemic control.
Abstract:
More than 90% of women with Type 2 Diabetes, especially those who are disadvantaged, receive care in primary care. Yet studies have repeatedly shown that primary care providers are less likely to advise on reproductive health concerns than specialists. PREPARED addresses this by promoting comprehensive preconception care and diabetes self-management in primary care through:
medication reconciliation and reproductive planning via an EHR-generated, patient tool
provider counseling at the point of care prompted via EHR ‘best practice’ alerts (BPAs)
dissemination of understandable, actionable information on reproductive risks and T2DM self-care generated automatically via the EHR and printed with after-visit summaries (AVS) or via the patient portal
routine, community-based support for diabetes self-care delivered directly to patients via short message service (SMS) text messages.
Our study aims are to: 1) test the effectiveness of PREPARED, compared to usual care, to improve patient knowledge of reproductive risks, engagement in diabetes self-care behaviors, and glycemic control; 2) assess whether PREPARED reduces disparities in these outcomes versus usual care; and 3) evaluate the fidelity of PREPARED to prompt medication reconciliation and preconception counseling and to deliver patient education and post-visit support of diabetes self-care. We will build upon extensive prior work by our team to implement and evaluate PREPARED. For Aim 1, we will test PREPARED against usual care in a randomized trial at several primary care practices in academic and community health centers in Chicago, IL. English and Spanish-speaking women, ages 18-44, with Type 2 Diabetes will be enrolled (N=840; n=420 per arm) and interviewed post index clinic visit and at 1, and 3 months to measure knowledge and behavioral outcomes. For Aim 2, we will move beyond effectiveness to assess whether PREPARED can reduce well-documented health literacy and racial/ethnic disparities in diabetes outcomes. For Aim 3, we will use mixed methods to assess intervention implementation and to explore patient, provider, and health system barriers and facilitators to the strategy.
ClinicalTrials.gov identifier:
NCT04976881
Contact
Principal Investigator: Stacy Bailey, PhD MPH
Project Manager: Guisselle Wismer, MPH