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The goal of this randomized clinical trial is to evaluate the effectiveness of a collaborative care intervention, consisting of remote blood pressure monitoring and support from community health workers, in improving blood pressure control and reducing postpartum complications among Black women with hypertensive disorders of pregnancy (HDP). The primary objectives are to determine whether the intervention leads to improved blood pressure control at 12 months postpartum compared to standard care, and whether it reduces the incidence of serious maternal morbidity, including hospitalizations and cardiovascular events. Secondary objectives include examining whether patient activation and trust in the healthcare system mediate the relationship between the intervention and clinical outcomes. Participants will be enrolled at approximately 6 weeks postpartum and randomized to either the collaborative care intervention or standard postpartum care. All participants will self-monitor blood pressure using a provided device, receive guidance on hypertension management, and complete study assessments at multiple time points. Participants assigned to the intervention arm will additionally receive ongoing support from community health workers, including health education, care coordination, and assistance with healthcare navigation. Clinical outcomes and patient-reported measures will be assessed over a 12-month follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collaborative Care Intervention | Experimental | Participants assigned to this arm will receive a collaborative care intervention that includes home blood pressure monitoring using a provided device and support from community health workers. The intervention includes education on hypertension management, assistance with care coordination, and support with healthcare navigation. Participants will regularly measure blood pressure and receive ongoing guidance throughout the 12-month postpartum follow-up period. |
|
| Standard Postpartum Care | Active Comparator | Participants assigned to this arm will receive standard postpartum care. In addition, participants will be provided with a home blood pressure monitoring device and instructed to measure their blood pressure regularly. No additional community health worker support will be provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collaborative care | Other | Bluetooth-enabled Remote Patient Monitoring (RPM) with algorithm-driven Community Health Worker (CHW) support. CHWs provide support (averaging 2.3 contacts/week) to facilitate medication titration and address social determinants of health. Treatment follows a standardized protocol using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Control (BP <130/80 mmHg) | Primary endpoint - The proportion of patients achieving a target blood pressure of less than 130/80 mmHg. Blood pressure will be analyzed both as a dichotomous variable (normal <130/80 mmHg vs. elevated) and as a continuous variable (mean systolic and diastolic readings). | Baseline (6 weeks) postpartum to 12 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Measure (PAM-13) | Evaluation of survey-based mechanisms of action to determine if they mediate the impact of the Collaborative Care intervention on blood pressure outcome. It assesses patient engagement and activation. A 13-item survey instrument with scores ranging from a minimum of 0 to a maximum of 100. Higher scores indicate a better outcome (greater patient engagement and activation). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sajid Shahul, MD, PhD | Contact | 773-398-2956 | sshahul@unmc.edu | |
| Mridula Ghotane, MPH | Contact | 445-260-9532 | mghotane@unmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sajid Shahul, MD, PhD | Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2084735 | Background | Anderson LA, Dedrick RF. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep. 1990 Dec;67(3 Pt 2):1091-100. doi: 10.2466/pr0.1990.67.3f.1091. | |
| Background | Health IDoP. llinois Maternal Morbidity and Mortality Report: October 2023; 2023 [01082024]. Available from: https://dph.illinois.gov /content/dam/soi/en/web/idph/publications/idph/topics-and-services/life-stages-populations/ maternal-child-family-health-services/maternal-health/mmmr/maternal-morbidity-mortalityreport2023.pdf. | ||
| Background | AHA. Postpartum Systems of Care Recommendations. https://wwwheartorg/-/media/files /professional/quality-improvement/maternal-health/recommendationsformatted. 2024. | ||
| Background | Assistant Secretary for Public Affairs (ASPA) DoHaHSH. Strengthening Maternal Health. Available from: https://www.hhs.gov/healthcare/maternal-health/index.html. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2026 |
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Participants will be randomized in a parallel assignment design to either the collaborative care intervention or standard postpartum care at approximately 6 weeks postpartum. The collaborative care intervention includes remote blood pressure monitoring using a home device and support from community health workers who provide education, care coordination, and assistance with healthcare navigation. The standard care group will receive usual postpartum care along with home blood pressure monitoring. Participants will be followed for 12 months postpartum to assess blood pressure control, clinical outcomes, and patient-reported measures
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| Standard of Care (SOC) | Other | Traditional clinical management consisting of manual blood pressure monitoring and clinic-based medication titration. Treatment follows the same standardized protocol as the intervention arm, using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg. |
|
| At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum |
| Morisky Medication Adherence Scale (MMAS-8) | A survey-based mechanism of action evaluated via an 8-item self-report survey scale to determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome. It measures medication adherence behavior. Scores range from a minimum of 0 to a maximum of 8, where higher scores indicate a better outcome (higher medication adherence). Scores are categorized into low (<6), medium (6 to <8), and high (8) adherence. | At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum. |
| Trust in Physician Scale | An 11-item exploratory survey instrument used to evaluate trust in the health care system and determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome. Scores range from a minimum of 11 to a maximum of 55, where higher scores indicate a better outcome (greater trust in the healthcare provider). | At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum. |
| Severe Maternal Morbidity (SMM) Composite Rate | Composite Endpoint - Incidence rates of severe maternal morbidity events to assess the efficacy of the Collaborative Care model in reducing overall maternal risk. This composite variable tracks the occurrence of any unplanned emergency department (ED) visit, unplanned hospitalization, or the presence of a severe morbidity event. Severe morbidity events are strictly defined as the clinical occurrence of severe hypertension, acute heart failure, pulmonary edema, eclampsia, acute renal failure, shock, sepsis, cardiac arrest, arrhythmias, myocardial infarction, pulmonary embolism, stroke, or death. | Baseline (6weeks) postpartum to 12 months (1 year) postpartum |
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| May 13, 2026 |
| Prot_SAP_000.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided