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| Name | Class |
|---|---|
| Brown University | OTHER |
| Kent Hospital, Rhode Island | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RI-SPHERES | Experimental | 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. |
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| Standard self-measured blood pressure program | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Six weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Nunez, Research Coordinator | Contact | 401-274-1122 | snunez@wihri.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Hospital | Not yet recruiting | Newport | Rhode Island | 02840 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41139061 | Derived | 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 remote blood pressure monitoring on persistent hypertension and preventive care attendance among postpartum people with hypertension. Contemp Clin Trials. 2025 Dec;159:108114. doi: 10.1016/j.cct.2025.108114. Epub 2025 Oct 23. |
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Data will be collected from human subjects and will be shared according to NIH guidelines. The investigators are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. The investigators will make a complete study dataset available for sharing. The investigators will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. The investigators will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.
5 years after completion of study
The investigators will make the data and associated documentation available to users under a data-sharing agreement that provides for commitment to: a) using the data only for research purposes and not to identify any individual participant; b) securing the data using appropriate computer technology; and c) destroying or returning the data after analyses are completed. Timelines for distribution of data will vary depending on any required restrictions as mentioned above. Data may be distributed by a number of electronic methods, including web-based databases, datasets, and spreadsheets, or via electronic media such as compact discs.
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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.
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| 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. |
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| From six weeks postpartum until one year postpartum |
| Blood pressure ascertainment | Participant measured any BP (either in-person or via self-measured blood pressure) | 1-10 days after hospital discharge |
| 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) | Hospital discharge to six weeks postpartum |
| 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) | Six weeks postpartum until one year postpartum |
| Severe maternal morbidity after hospital discharge | Severe maternal morbidity, as defined by the Centers for Disease Control's composite. | Hospital discharge until 6 weeks postpartum |
| Persistent stage I hypertension | Systolic blood pressure between 130-139 mmHg and/or diastolic blood pressure between 80-89 mmHg | Six weeks, six months, and 12 months postpartum |
| Persistent stage II hypertension | Systolic blood pressure at or above 140 mmHg and/or diastolic blood pressure at or above 90 mmHg | Six and 12 months postpartum |
| Severe hypertension after hospital discharge | Systolic blood pressure at or above 160 mmHg or diastolic blood pressure at or above 110 mmHg on two or more occasions | Hospital discharge to 6 weeks postpartum |
| Emergency room visit for hypertension-related etiology | Presentation to emergency room for hypertension-related chief complaint | Hospital discharge to 6 weeks postpartum |
| Readmission to inpatient hospital for hypertension-related etiology | Readmission to inpatient hospital for hypertension-related chief complaint | Hospital discharge until 6 weeks postpartum |
| Initiation or titration of antihypertension medication | Initiation or increase in dose titration of antihypertensive medication(s) | Hospital discharge to 6 weeks postpartum |
| Postpartum visit attendance | Attendance to the recommended in-person postpartum visit | Four to six weeks postpartum |
| System usability scale | A 10-question survey designed to provide a global view of subjective assessments of usability for a technology-based program or intervention | Six weeks, six months, and 12 months postpartum |
| Client satisfaction questionnaire | A survey designed to provide an overview of individual satisfaction with a program or intervention | Six weeks, six months, and 12 months postpartum |
| Women & Infants Hospital of Rhode Island | Recruiting | Providence | Rhode Island | 02903 | United States |
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| South County Hospital | Not yet recruiting | Wakefield | Rhode Island | 02879 | United States |
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| Kent Hospital | Recruiting | Warwick | Rhode Island | 02886 | United States |
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| Landmark Hospital | Recruiting | Woonsocket | Rhode Island | 02895 | United States |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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