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| ID | Type | Description | Link |
|---|---|---|---|
| HMC-2023C2-33345 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Boston Healthcare for the Homeless Program (BHCHP) | UNKNOWN |
| Boston Medical Center General Internal Medicine primary care (BMC GIM) | UNKNOWN |
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High blood pressure (BP) or hypertension (HTN) affects over 100 million individuals in the US, increasing the risk of adverse outcomes, including stroke, myocardial infarction (MI), and chronic kidney disease (CKD). Effective therapies include non-pharmacologic approaches and multiple medication classes. Successful HTN management requires ongoing patient engagement for BP monitoring and treatment intensification. Reaching this goal is challenging, and many patients with HTN do not have controlled BP.
Using a collaborative partnership between patients, clinicians, health system and public health stakeholders, and the research team the investigators plan to overcome barriers to widespread implementation of evidence-based health system strategies to improve BP control in a large, urban, primary care-based safety-net setting for diverse populations experiencing disparities in HTN-related outcomes.
A hybrid type 1 effectiveness-implementation study will be implemented to evaluate the comparative impact of each intervention on clinical outcomes while also assessing implementation at each site. The multi-site cluster randomized stepped-wedge design allows for feasible resource allocation and sequential roll out of the interventions for comparison, ensuring each site has the opportunity to benefit from both approaches. Data will be collected for multiple patient reported outcomes (PROs) to understand the range of impacts of the interventions from the patient perspective.
The specific aims are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Blood Pressure Monitoring (RBPM) | Experimental | Individual level interventions fo monitor blood pressure. |
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| Multilevel Intensification interventions (MII) | Experimental | Team-based interventions to mitigate clinical inertia which is the lack of intensification of treatment despite inadequate disease control such as for HTN. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBPM | Behavioral | Standardized blood pressure measurement and treatment protocols in clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure (SBP) improvement | Change in BP abstracted from the electronic health record (EHR). | Baseline, every 3 months up to 54 months |
| Interventions received | The number and proportion of individuals who receive each intervention. | Baseline, 54 months |
| Patient activation | Patient activation will be assessed with the Consumer Health Activation index (CHAI), a 10 item validated instrument that generates a score of 0-100, with ≥80 indicating moderate/high activation. | Baseline, 18 months, 30 months, 36 months, 42 months, 54 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure control | Assessed as Yes/No from EHR records for Systolic BP<140 mmHg and Systolic BP<130 mmHg. | Baseline, 18 months, 30 months, 36 months, 42 months, 54 months |
| Medication intensification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Fischer, MD MS | Contact | (617) 414-7288 | Michael.Fischer@bmc.org | |
| Justine Scott, MPH | Contact | (617) 414-7288 | Justine.Scott@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Fischer, MD MS | Boston Medical Center, Internal Medicine | Principal Investigator |
| Cheryl Clark, MD ScD | Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Healthcare for the Homeless (BHCHP) | Recruiting | Boston | Massachusetts | 02118 | United States | |
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| Boston Medical Center Family Medicine Primary Care (BMC FM) | UNKNOWN |
| NeighborHealth Center Family Medicine at Maverick Street (NH FM) | UNKNOWN |
| NeighborHealth Center Internal Medicine at Gove Street (NH IM) | UNKNOWN |
| NeighborHealth South End (NH South End) | UNKNOWN |
| Manet Community Health Center (Maner CHC) | UNKNOWN |
| Mattapan Community Health Center (Mattapan) | UNKNOWN |
| Greater Roslindale Medical and Dental Center (GRMDC) | UNKNOWN |
| Boston University School of Public Health (BUSPH) | UNKNOWN |
| BUSPH Biostatistics and Epidemiology Data Analytics Center (BEDAC) | UNKNOWN |
A hybrid type 1 effectiveness-implementation study with a cluster randomized stepped wedge study design will be used. This will be a longitudinal repeated measures design. RBPM will begin for all clusters in September, 2025. At the end of month 12, MII implementation will begin for the group in the first wedge, with the second and third groups implementing at 6-month intervals thereafter. All sites will continue interventions as part of ongoing operations, with final long-term follow-up assessment at the end of month 54.
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| MII | Other | Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications. |
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Assessed from EHR and claims data.
| Baseline, 18 months, 30 months, 36 months, 42 months, 54 months |
| BP monitoring | Assessed by EHR data on the frequency of BP monitoring. | Baseline, 18 months, 30 months, 36 months, 42 months, 54 months |
| Fidelity of interventions | The number and proportion of individuals who receive all key elements of the interventions based on EHR data. | Baseline, 18 months, 30 months, 36 months, 42 months, 54 months |
| Medication adherence | the 3-item self-report scale by Wilson will be used to assess this outcome. It queries patients about how many days they missed medications and overall consistency over the last 30 days. This measure has been standardized to a 0-100 scale, with good adherence defined as ≥80. | Baseline, 18 months, 30 months, 36 months, 42 months, 54 months |
| Trust in primary care | Assessed with the 10 item Wake Forest Physician Trust Scale. The scale uses a 5-point Likert scale [1=strongly disagree to 5=strongly agree]. Total scores can range from 10 to 50, and higher scores represent greater trust. | Baseline, 18 months, 30 months, 36 months, 42 months, 54 months |
| Boston Medical Center Family Medicine |
| Recruiting |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| Boston Medical Center, General Internal Medicine primary care | Recruiting | Boston | Massachusetts | 02118 | United States |
| Neighborhood Health | Recruiting | Boston | Massachusetts | 02118 | United States |
| Mattapan Community Health Center | Recruiting | Boston | Massachusetts | 02126 | United States |
| Manet Community Health Center | Recruiting | Quincy | Massachusetts | 02169 | United States |
| Greater Roslindale Medical and Dental Center (GRMDC) | Recruiting | Roslindale | Massachusetts | 02131 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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