Rhode Island - Statewide Postpartum Hypertension Remote Surveillance

Conditions

• Hypertension in Pregnancy
• Postpartum Complication
• Postpartum Preeclampsia

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• RI-SPHERES — BEHAVIORAL
  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 disorders) per participant preference. During the study period, the CM will respond to needs elicited from the SDoH screening by facilitating referrals to community resources. After six weeks, the focus of RI-SPHERES will transition to preventive care in addition to SMBP. The CM will engage monthly with each study participant to ensure they have a primary care provider and to facilitate preventive care visits or specialist appointments, if needed.
• Standard self-measured blood pressure program — BEHAVIORAL
  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 importance of attending a clinical visit with a primary care provider within a year of birth.

Study Details

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.

Key Dates

Start date

Apr 15, 2025

Status verified

Feb 2025

Primary completion

Mar 1, 2029

Completion

Mar 1, 2029

Study Design

Enrollment

1,536 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: RI-SPHERES
  A technology enabled collaborative care model. Participants will receive a LTE-enabled blood pressure (BP) cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. The first six weeks of the program will focus on BP control, and the remaining time will help transition people to receive recommended preventive care. As part of the collaborative care model, the nurse practitioner will lead weekly meetings with a multidisciplinary clinical team about all enrolled people.
• Active Comparator: Standard self-measured blood pressure program
  Our hospital has a remote hypertension monitoring program that recommends daily blood pressure ascertainment for 6 weeks, at which time they are discharged and provided printed resources to encourage preventive care in the next few months. In this program, patients manually enter their self-measured BPs into the electronic medical record for the clinical team to manually review and respond.

Primary Outcome Measure

Persistent hypertension [ Time Frame: Six weeks postpartum ]

Central Contacts

• Stephanie Nunez, Research Coordinator
  401-274-1122
  [email protected]

Locations (5)

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