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Recruiting NCT06842875

Rhode Island - Statewide Postpartum Hypertension Remote Surveillance

No phase Interventional Hypertension in Pregnancy Postpartum Preeclampsia Postpartum Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RI-SPHERES, Standard self-measured blood pressure program.
Who it may be relevant to
Registry conditions: Hypertension in Pregnancy, Postpartum Preeclampsia, Postpartum Complication. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of a Technology-based Collaborative Model on Persistent Hypertension and Preventive Care Attendance Among Postpartum People With Hypertensive Disorders of Pregnancy

Overview

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.

Interventions

  • Behavioral RI-SPHERES
    Participants assigned to the RI-SPHERES group will be introduced virtually or in-person to the care manager (CM), who demonstrate how to communicate directly with patients through the app for medical or non-medical needs. Each participant will learn how to obtain SMBP, sync the LTE-enabled BP cuff to the RI-SPHERES app, and respond to adaptive messaging pertaining to BP measurements, which include the ability to receive on-demand education on postpartum topics (e.g., HDP, breastfeeding, mood dis
  • Behavioral Standard self-measured blood pressure program
    Participants assigned to the routine care group meet virtually or in-person with a member of WIH's existing SMBP program and enroll in WIH's EPIC MyChart Portal to allow the SMBP program to receive patient-entered BP measurements and respond to messages. Participants will be provided with BP cuffs and taught how to obtain SMBP and report their BP through MyChart. At six weeks postpartum, WIH SMBP staff send a MyChart message to recommend BP ascertainment once per month and to describe the import

Primary outcome measures

  • Persistent hypertension [Time frame: Six weeks postpartum]
Secondary outcome measures (12)
  • Attendance of preventive care visit [Time frame: From six weeks postpartum until one year postpartum]
  • Blood pressure ascertainment [Time frame: 1-10 days after hospital discharge]
  • Total number of self-measured blood pressure assessments provided to program in immediate postpartum period [Time frame: Hospital discharge to six weeks postpartum]
  • Total number of self-measured blood pressure assessments provided to program after six weeks postpartum [Time frame: Six weeks postpartum until one year postpartum]
  • Severe maternal morbidity after hospital discharge [Time frame: Hospital discharge until 6 weeks postpartum]
  • Persistent stage I hypertension [Time frame: Six weeks, six months, and 12 months postpartum]
  • Persistent stage II hypertension [Time frame: Six and 12 months postpartum]
  • Severe hypertension after hospital discharge [Time frame: Hospital discharge to 6 weeks postpartum]
  • Emergency room visit for hypertension-related etiology [Time frame: Hospital discharge to 6 weeks postpartum]
  • Readmission to inpatient hospital for hypertension-related etiology [Time frame: Hospital discharge until 6 weeks postpartum]
  • Initiation or titration of antihypertension medication [Time frame: Hospital discharge to 6 weeks postpartum]
  • Postpartum visit attendance [Time frame: Four to six weeks postpartum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Health services research

Study locations

United States · 5 centers
  • Newport Hospital — Newport
  • Women & Infants Hospital of Rhode Island — Providence
  • South County Hospital — Wakefield
  • Kent Hospital — Warwick
  • Landmark Hospital — Woonsocket

Publications

  • Nunez SD, Spratt LM, Ware CF, Machado S, Rousseau J, Jackson TL, Buckley J, Magee S, Wohler D, Blosser E, Sales S, Simmons D, Ramos VN, Castillo MM, Murray C, Bailey K, Gutman R, Richardson CR, Grobman WA, Hauspurg A, Miller ES, Tuuli MG, Lewkowitz AK. Protocol for a type 1 hybrid effectiveness implementation trial to evaluate whether a technology-based collaborative care model is non-inferior to PMID 41139061

Identifiers

NCT: NCT06842875 · 2184383

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗