Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,320
- 试验地点
- 1
- 主要终点
- Completion of a primary care visit
研究概览
简要总结
The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the >30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.
详细描述
Over 30% of pregnant people have at least one chronic medical condition, and 20% have certain prenatal conditions (e.g., pregnancy-related hypertension, gestational diabetes) that increase the risk of chronic disease later in life. While patients with these conditions are typically highly engaged in prenatal care, they encounter a "postpartum cliff" in health system support after delivery; many receive no postpartum primary care at all despite having ongoing medical needs. At a time of increased stress, sleep deprivation, and competing demands, they must navigate administrative burdens in accessing primary care, often without scheduling assistance or any formal handoff between their obstetric and primary care clinician (PCP). These burdens may lead to avoided or delayed postpartum primary care, exacerbating health inequities that existed prenatally even for those fortunate enough to have a PCP. Given the many benefits of primary care, this lack of obstetric-to-primary care coordination represents a missed opportunity to increase primary care engagement and manage chronic conditions earlier in life. The primary objective is to increase postpartum primary care engagement, quality, and experience by strengthening obstetric-to-primary care coordination using a behavioral economics-informed intervention. The intervention, integrated into routine inpatient postpartum care, includes default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient. Using a robust randomized controlled trial of 1,320 participants that is built off of the team's pilot study, the proposed study will: (Aim 1) measure the intervention's impact on postpartum primary care visit completion, sustained engagement, and disparities in these outcomes; (Aim 2) measure the intervention's impact on high-value primary care service use; and (Aim 3) measure the intervention's impact on patient experience. The study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice and will provide insight into postpartum patients' health care experiences. By targeting a vulnerable population at a time of great need and opportunity, postpartum-to-primary care coordination has the potential to catalyze sustained primary care engagement throughout life and improve long-term health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, 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
- •Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)
- •Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age
- •If postpartum, has a neonate that is currently living at the time of enrollment
- •Has one or more of the following conditions listed in the "Problem List," "Medical History," or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):
- •Chronic or essential hypertension
- •Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)
- •Type 1 or 2 diabetes (i.e., pre-existing diabetes)
- •Gestational diabetes
- •Class II Obesity (pre-pregnancy body mass index ≥35 kg/m2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg/m2)
- •Depression or anxiety disorder
- •Has a primary care clinician listed in the patient's medical record
- •Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities
- •Able to read/speak English or Spanish language
- •Is age ≥18 years old
排除标准
- •Any individual not meeting all inclusion criteria
研究组 & 干预措施
Facilitated Transition Group
The intervention is integrated into routine inpatient postpartum care and includes the following components: default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient.
干预措施: Facilitated Transition to Primary Care (Other)
Routine Care
Routine postpartum care
结局指标
主要结局
Completion of a primary care visit
时间窗: 155 days after date of delivery
Observation of a visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology).
Receipt of condition-specific recommended health screening and counseling by a primary care practitioner
时间窗: 155 days after date of delivery
For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as documented in the electronic health record. For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) in the electronic health record. For individuals with chronic conditions, appropriate management is defined as receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling, discussion of a management, and/or referral for or acknowledgment of subspecialist management for that condition by a primary care practitioner as documented in the electronic health record. "
Self-report of having a known, reliable primary care practitioner
时间窗: 155 days after date of delivery
The outcome is the Self-report of having a known, reliable primary care practitioner (doctor, nurse practitioner, or physician's assistant).
Self-report of mental health
时间窗: 155 days after date of delivery
Edinburgh Perinatal Depression Scale will be administered and the total EPDS score compared.
次要结局
- Self-report of contraception(365 days)
- Interpregnancy interval(584 days after date of delivery)
- Contraception use(584 days)
- Self-report of mental health(365 days after date of delivery)
- Completion of an annual exam with a primary care practitioner(548 days after date of delivery)
- Self-report of completion of a primary care visit(365 days after date of delivery)
- Self-report of an annual exam with a primary care practitioner(365 days after date of delivery)
- Completion of a primary care visit(548 days after date of delivery)
- Repeated primary care practitioner engagement(548 days after date of delivery)
- Self-report of repeated primary care practitioner engagement(365 days after date of delivery)
- Extent of primary care practitioner engagement(548 days after date of delivery)
- Self-report of extent of primary care practitioner engagement(365 days after date of delivery)
- Self-report of receipt of condition-specific recommended health screening and counseling by a primary care practitioner(155 days after date of delivery)
- Receipt of recommended screening and counseling for chronic condition by primary care practitioner(548 days after date of delivery)
- Receipt of recommended screening for gestational condition by primary care practitioner(548 days after date of delivery)
- Self-report of receipt of recommended screening and counseling for chronic condition by primary care practitioner(365 days after date of delivery)
- Self-report of receipt of recommended screening for gestational condition by primary care practitioner(365 days after date of delivery)
- Self-report of having a known, reliable primary care practitioner(365 days after date of delivery)
- Urgent or emergent care use(584 days after date of delivery)
- Self-report of urgent or emergent care use(365 days after date of delivery)
- Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder(584 days)
- Urgent or emergent care use(155 days after date of delivery)
- Self-report of urgent or emergent care use(155 days after date of delivery)
- Urgent or emergent care use(365 days after date of delivery)
- Interpregnancy interval(365 days after date of delivery)
- Completion of an annual exam with a primary care practitioner(155 days after date of delivery)
- Self-report of completion of a primary care visit(155 days after date of delivery)
- Self-report of an annual exam with a primary care practitioner(155 days after date of delivery)
- Completion of a primary care visit(365 days after date of delivery)
- Completion of an annual exam with a primary care practitioner(365 days after date of delivery)
- Repeated primary care practitioner engagement(365 days after date of delivery)
- Extent of primary care practitioner engagement(365 days after date of delivery)
- Receipt of recommended screening and counseling for chronic condition by primary care practitioner(155 days after date of delivery)
- Receipt of recommended screening for gestational condition by primary care practitioner(155 days after date of delivery)
- Receipt of recommended screening and counseling for chronic condition by primary care practitioner(365 days after date of delivery)
- Receipt of recommended screening for gestational condition by primary care practitioner(365 days after date of delivery)
- Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder(155 days)
- Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder(365 days)
- Contraception use(155 days)
- Contraception use(365 days)
- Self-report of contraception(155 days)
研究者
Mark Clapp, MD MPH
Physician Investigator
Massachusetts General Hospital