Rhode Island - Statewide Postpartum Hypertension Remote Surveillance

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.

Conditions

• Hypertension in Pregnancy
• Postpartum Preeclampsia
• Postpartum Complication

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 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.

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 importance of attending a clinical visit with a primary care provider within a year of birth.

Sponsors & Collaborators

• Brown University

  collaborator OTHER

• Kent Hospital, Rhode Island

  collaborator OTHER

• Women and Infants Hospital of Rhode Island

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-15

Primary Completion

2029-03-01

Completion

2029-03-01

Countries

• United States

Study Locations