Improving Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult (age>18) patients receiving primary care at one of the 9 participating sites, with primary care provider (PCP) visit in the preceding year

Presence of HTN defined by one or more of: 1) diagnosis included on active problem list, 2) active HTN medications in prior year, 3) 3 separate elevated BP measurements

Uncontrolled HTN defined as systolic blood pressure (SBP)>140

Disqualifiers

Not meeting the inclusion criteria

Trial design

Design model

Sequential

Treatments tested in this trial

  • RBPM

    Behavioral

    Standardized blood pressure measurement and treatment protocols in clinical practice.

  • MII

    Other intervention

    Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications.

Treatment groups

16,895 Participants
are divided into 2 treatment groups
Group A: Remote Blood Pressure Monitoring (RBPM)Experimental treatment 1 intervention
Group B: Multilevel Intensification interventions (MII)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Systolic blood pressure (SBP) improvement

Change in BP abstracted from the electronic health record (EHR).

Time frame
Baseline, every 3 months up to 54 months
2

Interventions received

The number and proportion of individuals who receive each intervention.

Time frame
Baseline, 54 months
3

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.

Time frame
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

Secondary outcomes

1

Blood pressure control

Assessed as Yes/No from EHR records for Systolic BP\<140 mmHg and Systolic BP\<130 mmHg.

Time frame
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
2

Medication intensification

Assessed from EHR and claims data.

Time frame
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
3

BP monitoring

Assessed by EHR data on the frequency of BP monitoring.

Time frame
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
4

Fidelity of interventions

The number and proportion of individuals who receive all key elements of the interventions based on EHR data.

Time frame
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Medical Center

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Boston Healthcare for the Homeless Program (BHCHP)

Collaborator

Boston Medical Center General Internal Medicine primary care (BMC GIM)

Collaborator

Boston Medical Center Family Medicine Primary Care (BMC FM)

Collaborator

NeighborHealth Center Family Medicine at Maverick Street (NH FM)

Collaborator

NeighborHealth Center Internal Medicine at Gove Street (NH IM)

Collaborator

NeighborHealth South End (NH South End)

Collaborator

Manet Community Health Center (Maner CHC)

Collaborator

Mattapan Community Health Center (Mattapan)

Collaborator

Greater Roslindale Medical and Dental Center (GRMDC)

Collaborator

Boston University School of Public Health (BUSPH)

Collaborator

BUSPH Biostatistics and Epidemiology Data Analytics Center (BEDAC)

Collaborator