Effect of a Technology-based Collaborative Model on Persistent Hypertension and Preventive Care Attendance Among Postpartum People With Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,536
- 试验地点
- 10
- 主要终点
- Persistent hypertension
研究概览
简要总结
This is a hybrid type 1 non-inferiority implementation effectiveness trial among postpartum patients with hypertension (N=1536) that will test the hypothesis that RI-SPHERES (a technologically enabled collaborative care model) is non-inferior to a standard self-measured blood pressure program in terms of persistent hypertension at six weeks postpartum and preventive care receipt within one year of delivery.
详细描述
Uncontrolled hypertensive disorders of pregnancy (HDP) are a major source of maternal mortality. National guidelines recommend blood pressure (BP) measurement 3-10 days after discharge and ≥1 preventive care visit within one year of delivery. Yet, barriers such as childcare or transportation issues reduce adherence to in-person BP checks, particularly among racial or ethnic minority patients. Programs in which patients self-measure BP (SMBP) at home show promising results regardless of patient race. However, a recent meta-analysis concluded current SMBP programs do not reduce maternal mortality or racial disparities in clinical outcomes, potentially due to their specific limitations: they end within six weeks of birth (though HDP can persist for months) and have decreased engagement with non-White people or those living in disadvantaged areas, though these populations are at the highest risk of persistent HTN and its adverse long-term effects. Thus, there is an urgent need to optimize SMBP programs to target short- and long-term HDP-related morbidity and to broadly implement these programs to eliminate disparities in HDP-related outcomes. One such program is Rhode Island (RI)-Statewide Postpartum HypErtension REmote Surveillance (RI-SPHERES), a technology-based SMBP program that aims to reduce short- and long-term HDP-associated morbidity in RI using the collaborative care model, a health services intervention that improves health outcomes and reduces racial disparities on a population level for people with chronic conditions. The proposed research aims to determine the effectiveness of RI-SPHERES in reducing short- and long-term morbidity associated with HDP throughout RI. This builds upon our pilot RCT (NCT05595629), in which a standard SMBP program was compared to a SMBP program that used a Bluetooth-enabled BP cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. RI-SPHERES will expand this SMBP program to provide app-based patient-informed educational content on HDP-specific preventive care and bidirectional communication with RI-SPHERES staff for one year postpartum. Incorporating adaptive and automatic messaging increases RI-SPHERES' scalability by reducing clinical staff burden. However, formal analysis of factors that may hinder widespread implementation of RI-SPHERES is needed. Thus, we will conduct a Hybrid Type I Non-Inferiority Implementation-Effectiveness Trial among 1536 patients with HDP that compares a standard SMBP program to RI-SPHERES in terms of persistent HTN at six weeks postpartum and receipt of preventive care within one year of delivery (Specific Aim 1). We will examine the effect of both programs on increasing equity in terms of race, ethnicity, language, and geography for postpartum patients with HDP in Rhode Island (Specific Aim 2). We will also develop an implementation toolkit to facilitate the dissemination of RI-SPHERES (Specific Aim 3). The proposed project is expected to deliver a mechanism that will fill multiple research gaps for HDP identified by the US Preventive Services Task Force: 1) addressing health inequities through multilevel interventions, 2) evaluating SMBP programs; and 3) mitigating HDP's short- and long-term health consequences of HDP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both remote hypertension monitoring programs are managed by a different nurse practitioner who, by necessity, will not be masked. However, all care providers who provide perinatal care for enrolled participants will be masked to their patient's study group.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum patient aged 18 years or more at any birthing hospital in Rhode Island
- •Diagnosed during pregnancy or after delivery with hypertensive disorder of pregnant
- •English-, Spanish-, Portuguese-, or Haitian-Creole-speaking
- •Smartphone ownership
排除标准
- •Prior enrollment in this trial
- •Prisoners or incarcerated people
- •Inability or unwillingness to provide informed consent
- •Inability to communicate with study team, despite an interpreter
结局指标
主要结局
Persistent hypertension
时间窗: Six weeks postpartum
Persistent stage II hypertension will be defined as systolic blood pressure of 140 mmHg or higher and/or diastolic blood pressure of 90 mmHg or higher
次要结局
- Attendance of preventive care visit(From six weeks postpartum until one year postpartum)
- Blood pressure ascertainment(1-10 days after hospital discharge)
- Total number of self-measured blood pressure assessments provided to program in immediate postpartum period(Hospital discharge to six weeks postpartum)
- Total number of self-measured blood pressure assessments provided to program after six weeks postpartum(Six weeks postpartum until one year postpartum)
- Severe maternal morbidity after hospital discharge(Hospital discharge until 6 weeks postpartum)
- Persistent stage I hypertension(Six weeks, six months, and 12 months postpartum)
- Persistent stage II hypertension(Six and 12 months postpartum)
- Severe hypertension after hospital discharge(Hospital discharge to 6 weeks postpartum)
- Emergency room visit for hypertension-related etiology(Hospital discharge to 6 weeks postpartum)
- Readmission to inpatient hospital for hypertension-related etiology(Hospital discharge until 6 weeks postpartum)
- Initiation or titration of antihypertension medication(Hospital discharge to 6 weeks postpartum)
- Postpartum visit attendance(Four to six weeks postpartum)
- System usability scale(Six weeks, six months, and 12 months postpartum)
- Client satisfaction questionnaire(Six weeks, six months, and 12 months postpartum)
