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other·obstetrics and gynecology, endocrinology, clinical trial, internal medicine, public health·PMC10173964

Multicomponent provider–patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes: clinical trial protocol for the ACHIEVE study

BMJ Open · 14 authors, 8 centres

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TL;DR

This protocol describes a two-arm randomised controlled trial (ACHIEVE) comparing a multicomponent intervention (mHealth app, provider dashboard, CGM, community health worker, and team-based care) versus standard care for improving glycaemic control in 124 Medicaid-insured pregnant individuals with type 2 diabetes and poor glycaemic control. No completed results are reported; the paper details planned methods, outcomes, and trial design.

Full summary

758 CHARS

The intervention integrates an mHealth app, provider dashboard, continuous glucose monitoring, community health worker referral for social needs, and team-based care, compared against standard diabetes and prenatal care. The planned sample is 124 participants recruited from an integrated diabetes and prenatal care programme at a tertiary care academic health system in the Midwestern USA. The study is non-blinded to providers and patients but blinded for outcome assessment. Limitations include single-site design, restricted generalizability, lack of power for adverse pregnancy outcomes, and focus on glycaemic control during pregnancy without addressing periconception or postpartum periods. This is a protocol paper with no completed results reported.

STUDY TYPE

other

SPECIALTY

obstetrics and gynecology

SUMMARISED BY

AI pipeline

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100% · A

ORIGINAL PAPER

PMC10173964

Multicomponent provider–patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes: clinical trial protocol for the ACHIEVE study

BMJ Open

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ABSTRACT

Abstract Introduction Type 2 diabetes (T2D) is one of the most frequent comorbid medical conditions in pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the pregnant individual and infant. Achieving glycaemic control can be challenging for Medicaid-insured pregnant individuals who experience a high burden of unmet social needs. Multifaceted provider–patient-based approaches are needed to improve glycaemic control in this high-risk pregnant population. Mobile health (mHealth) applications (app), provider dashboards, continuous glucose monitoring (CGM) and addressing social needs have been independently associated with improved glycaemic control in non-pregnant individuals living with diabetes. The combined effect of these interventions on glycaemic control among pregnant individuals with T2D remains to be evaluated. Methods and analysis In a two-arm randomised controlled trial, we will examine the combined effects of a multicomponent provider–patient intervention, including a patient mHealth app, provider dashboard, CGM, a community health worker to address non-medical health-related social needs and team-based care versus the current standard of diabetes and prenatal care. We will recruit 124 Medicaid-insured pregnant individuals living with T2D, who are ≤20 weeks of gestation with poor glycaemic control measured as a haemoglobin A1c ≥ 6.5% assessed within 12 weeks of trial randomisation or within 12 weeks of enrolling in prenatal care from an integrated diabetes and prenatal care programme at a tertiary care academic health system located in the Midwestern USA. We will measure how many individuals achieve the primary outcome of glycaemic control measured as an A1c<6.5% by the time of delivery, and secondarily, adverse pregnancy outcomes; patient-reported outcomes (eg, health and technology engagement, literacy and comprehension; provider–patient communication; diabetes self-efficacy; distress, knowledge and beliefs; social needs referrals and utilisation; medication adherence) and CGM measures of glycaemic control (in the intervention group). Ethics and dissemination The Institutional Review Board at The Ohio State University approved this study (IRB: 2022H0399; date: 3 June 2023). We plan to submit manuscripts describing the user-designed methods and will submit the results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings. Trial registration number NCT05662462 Keywords: Diabetes in pregnancy, OBSTETRICS, General diabetes, Clinical Trial, Health Equity

CITATION EXPORT

Kartik K Venkatesh, Joshua J Joseph, Christine Swoboda et al.. Multicomponent provider–patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes: clinical trial protocol for the ACHIEVE study. BMJ Open. (2023). https://doi.org/10.1136/bmjopen-2023-074657

AUTHORS

14 · 8 CENTRES

Kartik K Venkatesh, Joshua J Joseph, Christine Swoboda, Robert Strouse, Jenelle Hoseus, Carrie Baker, Taryn Summerfield, Anna Bartholomew, Lisa Buccilla, X Pan, Cynthia Sieck, Ann Scheck McAlearney, Timothy R Huerta, Naleef Fareed

1Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, The Ohio State University, Columbus, Ohio, USA
2Deparment of Medicine, Division of Endocrinology, Diabetes, and Metabolism, The Ohio State University, Columbus, Ohio, USA
3CATALYST – The Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, The Ohio State University, Columbus, Ohio, USA
4Department of Research Information Technology, The Ohio State University, Columbus, Ohio, USA
5Health Impact Ohio, Columbus, Ohio, USA
6Department of Biomedical Informatics, The Ohio State University, Columbus, Ohio, USA
7Department of Pediatrics, Wright State University, Dayton, Ohio, USA
8Department of Family and Community Medicine, The Ohio State University, Columbus, Ohio, USA