Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes

Stacy C. Bailey*, Allison P. Pack, Guisselle Wismer, Norma Calderon, Evelyn Velazquez, Stephanie Batio, Abbey Ekong, Alice Eggleston, Amisha Wallia, Michael S. Wolf, Jacob M. Schauer, Sandi Tenfelde, David M. Liebovitz, William A. Grobman

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care. Methods and analysis We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to 'hardwire' preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18-44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic's assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects. Ethics and dissemination This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request. Trial registration number ClinicalTrials.gov Registry (NCT04976881).

Original languageEnglish (US)
Article numbere078282
JournalBMJ open
Volume13
Issue number11
DOIs
StatePublished - Nov 8 2023

Keywords

  • diabetes in pregnancy
  • health informatics
  • health literacy
  • randomized controlled trial

ASJC Scopus subject areas

  • General Medicine

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