Hypertension
Conditions
Brief summary
This study seeks to evaluate the impact of a remote patient monitoring (RPM)-specific tech-enabled community health worker workforce on the use of RPM for the management of hypertension among Latinx patients. This study is a step-wedge randomized controlled trial that aims to assess the effectiveness and implementation of RPM-enabled community health workers (CHWs) compared to standard of care RPM hypertension management on blood pressure reduction and evaluate the implementation of the RPM-enabled CHWs for hypertension (HTN) management. The study aims to examine adoption, acceptability, fidelity, cost, sustainability, and equity as outcomes of implementation effectiveness.
Interventions
BEHAVIORALRemote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support
CHWs will implement RPM by being provided with training modules and implementing electronic health record (EHR) support tools for HTN management.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
With the stepped-wedge design, each clinic will function as a control or usual care group prior to the implementation of the intervention. During this period, the clinic will prescribe and treat patients enrolled in the RPM hypertension program using usual protocols.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Self-identify as Latinx 2. Be fluent in English or Spanish 3. Be age 18 years or older 4. Receiving care at one of the 10 safety-net primary care clinics 5. Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg) 6. Have been prescribed at least one anti-hypertensive medication and be non-adherent to their medications, defined as adherence \<80% in the preceding 12 months, as determined by prescription orders obtained from the clinic EHR.
Exclusion criteria
1. Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks) 2. Participation in other hypertension-related clinical trials 3. Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR) 4. Plan to discontinue care at the clinic within the next 15 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic blood pressure | Baseline, Month 18 |
| Change in diastolic blood pressure | Baseline, Month 18 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hypertension control | Month 18 | Outcome measure will be assessed using the National Quality Forum-defined thresholds for controlled/uncontrolled hypertension (BP\<140/90 mmHg). |
Countries
United States
Contacts
Primary ContactDevin Mann, MD
Backup ContactTiffany Martinez
Outcome results
None listed