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

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.

Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy.

OBJECTIVE: To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy. METHODS: This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined. RESULTS: From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24-1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48-0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31-2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51-0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44-4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27-4.95) and women without private insurance (aOR 1.68, 95% CI 1.10-2.59). CONCLUSION: Frequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation. CLINICAL TRIAL REGISTRATION: ClinialTrials.gov, NCT01990612.