Hypertension in Pregnancy, Postpartum Complication, Postpartum Preeclampsia
Conditions
Keywords
postpartum hypertensive disorders of pregnancy, postpartum preeclampsia, digital health, collaborative care model, population health, self-measured blood pressure
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.
Interventions
BEHAVIORALRI-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.
BEHAVIORALStandard 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
Brown University
Kent Hospital, Rhode Island
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Both remote hypertension monitoring programs are managed by a different nurse practitioner who, by necessity, will not be masked. However, all care providers who provide perinatal care for enrolled participants will be masked to their patient's study group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent hypertension | Six weeks postpartum | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum visit attendance | Four to six weeks postpartum | Attendance to the recommended in-person postpartum visit |
| Attendance of preventive care visit | From six weeks postpartum until one year postpartum | 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. |
| Blood pressure ascertainment | 1-10 days after hospital discharge | Participant measured any BP (either in-person or via self-measured blood pressure) |
| Total number of self-measured blood pressure assessments provided to program in immediate postpartum period | Hospital discharge to six weeks postpartum | Number of blood pressures sent in to the participant's self-measured blood pressure program (RI-SPHERES or standard program) |
| Total number of self-measured blood pressure assessments provided to program after six weeks postpartum | Six weeks postpartum until one year postpartum | Number of blood pressures sent in to the participant's self-measured blood pressure program (RI-SPHERES or standard program) |
| Severe maternal morbidity after hospital discharge | Hospital discharge until 6 weeks postpartum | Severe maternal morbidity, as defined by the Centers for Disease Control's composite. |
| Initiation or titration of antihypertension medication | Hospital discharge to 6 weeks postpartum | Initiation or increase in dose titration of antihypertensive medication(s) |
| Persistent stage II hypertension | Six and 12 months postpartum | Systolic blood pressure at or above 140 mmHg and/or diastolic blood pressure at or above 90 mmHg |
| Severe hypertension after hospital discharge | Hospital discharge to 6 weeks postpartum | Systolic blood pressure at or above 160 mmHg or diastolic blood pressure at or above 110 mmHg on two or more occasions |
| Emergency room visit for hypertension-related etiology | Hospital discharge to 6 weeks postpartum | Presentation to emergency room for hypertension-related chief complaint |
| Readmission to inpatient hospital for hypertension-related etiology | Hospital discharge until 6 weeks postpartum | Readmission to inpatient hospital for hypertension-related chief complaint |
| System usability scale | Six weeks, six months, and 12 months postpartum | A 10-question survey designed to provide a global view of subjective assessments of usability for a technology-based program or intervention |
| Client satisfaction questionnaire | Six weeks, six months, and 12 months postpartum | A survey designed to provide an overview of individual satisfaction with a program or intervention |
| Persistent stage I hypertension | Six weeks, six months, and 12 months postpartum | Systolic blood pressure between 130-139 mmHg and/or diastolic blood pressure between 80-89 mmHg |
Countries
United States
Contacts
Primary ContactStephanie Nunez, Research Coordinator
Outcome results
None listed