Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women: The STEP-UP Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,306
- 试验地点
- 4
- 主要终点
- Primary care visit (PCV) completion
研究概览
简要总结
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).
详细描述
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP) by promoting:
- counseling and referral to primary care, during OB visits, via electronic health record (EHR)-based clinical decision support (CDS)
- dysglycemia testing for women with prior GDM, prompted via CDS during both OB and primary care visits
- dissemination of understandable information on future risk and the need for ongoing evaluation generated automatically via the EHR and printed for patients with after-visit summaries (AVS)
- motivational messaging and reminders supporting transitions of care delivered directly to patients via short message service (SMS) text messages
- individualized outreach and support for those who need additional help arranging a primary care visit
We will utilize a stepped wedge design to achieve the study's specific aims, which are to:
Aim 1 Test the effectiveness of STEP-UP, compared with usual care, to improve patient: 1) knowledge of reproductive risks associated with T2DM and recommended self-care activities; 2) engage in self-care behaviors, including diet, physical activity, adherence to diabetes medications, and use of folic acid and most or moderately effective contraception, when indicated; and 3) clinical measures, including hemoglobin A1c, blood pressure, and LDL cholesterol.
Aim 2 Investigate the heterogeneity of STEP-UP intervention effects by patients' race, ethnicity, and language.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Delivered during an accrual period,
- •Had a chart diagnosis during their index pregnancy of GDM and/or HDP,
- •Attended at least 1 prenatal care visit at a study site in the 6 months prior to delivery,
- •Speak English or Spanish,
- •Age 18 or older
排除标准
- 未提供
研究组 & 干预措施
STEP-UP
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP
干预措施: Primary Care Provider Clinical Decision Support (CDS) (Behavioral)
STEP-UP
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP
干预措施: OB Provider Clinical Decision Support (CDS) (Behavioral)
STEP-UP
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP
干预措施: Patient Education (OB Visit) (Behavioral)
STEP-UP
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP
干预措施: Text messaging (Behavioral)
Usual Care
Patients will receive the usual standard of care
STEP-UP
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP
干预措施: Patient Outreach (Behavioral)
STEP-UP
STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior GDM and/or HDP
干预措施: Patient Education (Primary Care Visit) (Behavioral)
结局指标
主要结局
Primary care visit (PCV) completion
时间窗: 6 months
Assess completion of a primary care visit (yes/no) within 6 months of delivery. Using procedures from a pilot study, the investigator will consider an encounter a PCV if it occurred by 6 months after the delivery date; had an assigned provider type of "nurse practitioner," "physician," "internal medicine," "family medicine," and/or "physician assistant;" and did not have an assigned provider type of "OB/GYN" and/or "certified nurse midwife." The PCV rate across STEP-UP vs. UC will be calculated by dividing eligible patients with greater than or equal to 1 PCV (numerator) by the denominator of all eligible patients.
次要结局
- Orders for dysglycemia testing(6 months)
- Completion of dysglycemia testing(6 months)
- Dysglycemia and hypertension cases detected(6 months)
研究者
Stacy C Bailey
Associate Professor
Northwestern University