Comparing Hypertension Remote Monitoring Evaluation Redesign

Study Overview
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Brief Summary
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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).

Official Title
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Comparing Hypertension Remote Monitoring Evaluation Redesign

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Standard and One-time Training
* Behavioral: Standard and Practice Facilitation
* Behavioral: High-intensity and One-time Training
* Behavioral: High-intensity and Practice Facilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard and One-time Training<br>Patient level: Standard, automatic reminders Clinic level: One-time training | Behavioral: Standard and One-time Training<br>* 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.<br>|
| Experimental: Standard and Practice Facilitation<br>Patient level: Standard, automatic reminders Clinic level: Regular, ongoing coaching | Behavioral: Standard and Practice Facilitation<br>* 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.<br>|
| Experimental: High-intensity and One-time Training<br>Patient level: Personalized feedback Clinic level: One-time training | Behavioral: High-intensity and One-time Training<br>* 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.<br>|
| Experimental: High-intensity and Practice Facilitation<br>Patient level: Personalized feedback Clinic level: Regular, ongoing coaching | Behavioral: High-intensity and Practice Facilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic BP (clinic) | Clinic-based BP readings in EHR | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic BP (home) | Home-based BP readings | Baseline, 6 months | 
| Patient activation and satisfaction | 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. | Baseline, 6 months | 
| Number of participants with BP control | <140/90mmHg, at the patient level within the EHR | Baseline, 6 months | 
| Medication intensification when BP is uncontrolled | Number of classes of anti-hypertensive medications prescribed per patient | Baseline, 6 months | 
| Patient-reported medication adherence | 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. | Baseline, 6 months |