Clinical trial NCT06842875: Rhode Island - Statewide Postpartum Hypertension Remote Surveillance
Official title: Effect of a Technology-based Collaborative Model on Persistent Hypertension and Preventive Care Attendance Among Postpartum People With Hypertensive Disorders of Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension in Pregnancy
Postpartum Preeclampsia
Postpartum Complication
Keywords: postpartum hypertensive disorders of pregnancy
postpartum preeclampsia
digital health
collaborative care model
population health
self-measured blood pressure
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Brown University
name: Kent Hospital, Rhode Island
First posted: 2025-02-24
Enrollment: 1536
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Persistent hypertension
timeFrame: Six weeks postpartum
Secondary outcomes:
measure: Attendance of preventive care visit
timeFrame: From six weeks postpartum until one year postpartum
measure: Blood pressure ascertainment
timeFrame: 1-10 days after hospital discharge
measure: Total number of self-measured blood pressure assessments provided to program in immediate postpartum period
timeFrame: Hospital discharge to six weeks postpartum
measure: Total number of self-measured blood pressure assessments provided to program after six weeks postpartum
timeFrame: Six weeks postpartum until one year postpartum
measure: Severe maternal morbidity after hospital discharge
timeFrame: Hospital discharge until 6 weeks postpartum
measure: Persistent stage I hypertension
timeFrame: Six weeks, six months, and 12 months postpartum
measure: Persistent stage II hypertension
timeFrame: Six and 12 months postpartum
measure: Severe hypertension after hospital discharge
timeFrame: Hospital discharge to 6 weeks postpartum
measure: Emergency room visit for hypertension-related etiology
timeFrame: Hospital discharge to 6 weeks postpartum
measure: Readmission to inpatient hospital for hypertension-related etiology
timeFrame: Hospital discharge until 6 weeks postpartum
measure: Initiation or titration of antihypertension medication
timeFrame: Hospital discharge to 6 weeks postpartum
measure: Postpartum visit attendance
timeFrame: Four to six weeks postpartum
measure: System usability scale
timeFrame: Six weeks, six months, and 12 months postpartum
measure: Client satisfaction questionnaire
timeFrame: Six weeks, six months, and 12 months postpartum
Other outcomes:
Locations:
city: Newport
country: United States
facility: Newport Hospital
state: Rhode Island
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Wakefield
country: United States
facility: South County Hospital
state: Rhode Island
city: Warwick
country: United States
facility: Kent Hospital
state: Rhode Island
city: Woonsocket
country: United States
facility: Landmark Hospital
state: Rhode Island
Study officials:
References: