About this trial
DIP : To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM.
Follow up PP CARE: To engage with individuals with a history of GDM through a patient-centered mixed-methods survey and qualitative assessment to evaluate the barriers to and facilitators of Cardiovascular health (CVH) counseling and risk-reduction postpartum at the patient and healthcare system levels inclusive of Social determinants of health (SDOH) and structural factors, as well as patient preferences and perspectives on CVH and wellness interventions
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Immediately postpartum individuals during their delivery hospital admission
≥ 18 years old with the ability to give informed consent.
Elevated one-hour 50-gram glucose challenge test any time during pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis OR
Two elevated values on a 3-hour 100-gram glucose tolerance test any time in pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis
Disqualifiers
Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)
Not English or Spanish speaking
Trial design
Parallel
Treatments tested in this trial
Immediate inpatient postpartum OGTT
Diagnostic testThe intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge
Standard of care 4-12 week postpartum OGTT
Diagnostic testStandard of care is 4-12 week outpatient postpartum OGTT
Treatment groups
Trial outcomes
Primary outcomes
Rate of postpartum diabetes mellitus screening
For patients randomized to inpatient immediate postpartum OGTT, completion of the inpatient test will be confirmed and documented by study staff prior to patient discharge. For patients randomized to the inpatient immediate postpartum OGTT who do not undergo inpatient testing and for patients randomized to the outpatient 4-12 week OGTT, individuals will receive an electronic survey via email at 12 weeks inquiring as to whether they underwent postpartum outpatient OGTT and about the results of testing, if performed.
Patient reported outcome of postpartum Cardiovascular health (CVH) counseling received within the first 12 months after delivery
Patient reported outcome of postpartum CVH counseling received within the first 12 months after delivery measured with modified questions from the Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 9 Core Mail Questionnaire and the clinical outcome of postpartum dysglycemia defined as a diagnosis of prediabetes or type 2 diabetes within the first 12 months after delivery.
Patient perspectives, preferences and barriers to engagement with respective to postpartum interventions to improve CVH.
Semi-structured virtual interviews will be performed including questions that encompass patient perspectives, preferences and barriers to engagement with respective to postpartum interventions to improve CVH.
Secondary outcomes
Risk perception and lifestyle modification
"What do you think your risk or chance is for getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance.") "If you don't change your lifestyle behaviors, such as diet or exercise, what is your risk or chance of getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance.") "Have you recently made changes in any lifestyle behaviors that you believe will lower your chance of getting diabetes?" (Responses: yes, no) "Are you planning to make changes in any lifestyle behaviors in the near future that you believe will lower your chances of getting diabetes?" (Responses: yes, no)
Rates of primary care provider (PCP) visits within 1 year of delivery
All individuals will be sent an electronic survey via email inquiring as to whether they have attended a visit with a primary care provider (internal medicine, family medicine or primary care nurse practitioner) and for what reason since the time of their delivery.
Risk Perception Survey for Developing Diabetes
The survey comprises 53 items and has four subscales and other individual items to address various dimensions of risk perception. Risk perception will be assessed as both continuous scales and as a dichotomous outcome ("no chance" and "slight chance" will be categorized as "low" risk perception, and "moderate chance" and "high chance" will be categorized as "high" risk perception.
Diabetes Treatment Satisfaction Questionnaire
8 question survey will be scored as a continuous scale.
Sponsors and contacts
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