Hypertension
Conditions
Brief summary
The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN).
Interventions
BEHAVIORALStandard and One-time Training
Patient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring. Clinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach.
BEHAVIORALStandard and Practice Facilitation
Patient-level intervention: Patients in the standard group will receive automated reminder SMS text messages and remote BP monitoring. Clinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach.
BEHAVIORALHigh-intensity and One-time Training
Patient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring. Clinic-level intervention: Clinics in the one-time training group will receive one-time training on standard work and algorithms, audit and feedback, and panel-based outreach.
BEHAVIORALHigh-intensity and Practice Facilitation
Patient-level intervention: Patients in the high-intensity group will receive personalized feedback SMS text messages and remote BP monitoring. Clinic-level intervention: Clinics in the practice facilitation group will receive regular/ongoing training on standard work and algorithms, audit and feedback, and panel-based outreach.
Sponsors
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * Any sex/gender * Any race or ethnicity * Have hypertension or high blood pressure (BP) (BP \>=140/90 mmHg at least twice in the previous 18 months) * Can read and write English or Spanish * Be able to provide consent
Exclusion criteria
• We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported: * Pregnancy * Lactating/nursing * Dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic BP (clinic) | Baseline, 6 months | Clinic-based BP readings in EHR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic BP (home) | Baseline, 6 months | Home-based BP readings |
| Patient activation and satisfaction | Baseline, 6 months | Patients will complete the Patient Assessment of Chronic Illness Care (PACIC) survey of 20 questions regarding elements of the care of their chronic condition(s) over the last six months. Patients answer using a Likert scale of answers ranging from 1-5, with 1 signifying "Almost Never" and 5 signifying "Almost Always". |
| Number of participants with BP control | Baseline, 6 months | \<140/90mmHg, at the patient level within the EHR |
| Medication intensification when BP is uncontrolled | Baseline, 6 months | Number of classes of anti-hypertensive medications prescribed per patient |
| Patient-reported medication adherence | Baseline, 6 months | Patients will complete the 4-item Krousel-Wood Medication Adherence Scale (M-Wood-MAS-4). The scale score is calculated by summing the points for the 4 questions (scale score ranges from 0 to 4, with higher score indicating worse adherence); low adherence on the K-Wood-MAS-4 is defined as a score ≥1. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORUrmimala Sarkar
University of California, San Francisco
Outcome results
None listed