Rhode Island - Statewide Postpartum Hypertension Remote Surveillance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorWomen and Infants Hospital of Rhode Island
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
RI-SPHERES
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
1,536 Participants
are divided into 2 treatment groupsGroup A: RI-SPHERESExperimental treatment 1 intervention
Group B: Standard self-measured blood pressure programActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Persistent hypertension
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
Time frame
Six weeks postpartumSecondary outcomes
1
Attendance of preventive care visit
Participant attends a non-urgent appointment during which an internal medicine physician, family medicine physician, or primary care advanced practice provider (APP, including nurse practitioners or physician assistants) ascertains BP and provides patient counseling pertaining to HTN. While obstetrician-gynecologists (OBGYNs) or certified nurse midwives (CNMs) can provide preventive care, for this aim, visits provided by an OBGYN or CNM will only qualify if the visit occurs ≥6 weeks postpartum and the medical record states that HTN was discussed in the visit.
Time frame
From six weeks postpartum until one year postpartum2
Blood pressure ascertainment
Participant measured any BP (either in-person or via self-measured blood pressure)
Time frame
1-10 days after hospital discharge3
Total number of self-measured blood pressure assessments provided to program in immediate postpartum period
Number of blood pressures sent in to the participant's self-measured blood pressure program (RI-SPHERES or standard program)
Time frame
Hospital discharge to six weeks postpartum4
Total number of self-measured blood pressure assessments provided to program after six weeks postpartum
Number of blood pressures sent in to the participant's self-measured blood pressure program (RI-SPHERES or standard program)
Time frame
Six weeks postpartum until one year postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Women and Infants Hospital of Rhode Island
Lead sponsor
Brown University
Collaborator
Kent Hospital, Rhode Island
Collaborator
Source ClinicalTrials.gov