Hypertension
Conditions
Keywords
physician inertia, hypertension, telemedicine, mobile technology
Brief summary
High blood pressure leads to heart attacks and strokes which can be prevented by blood pressure-lowering medication. However, the current office-based prescription of one pill and one dose at a time is ineffective. the investigators want to pilot-test a more effective patient-centered treatment approach, where patients will receive a prescription with gradual but automatic weekly increases of dose and number of pills. Patients will measure their blood pressure with an iPhone compatible cuff, which transmits readings to the doctor or pharmacist, who will stop escalation when the desired blood pressure level is reached. The investigators hypothesize that the intervention will decrease the time to control blood pressure and increase the overall rate of blood pressure control. Therefore, this new treatment model could prevent heart attacks and strokes, and reduce healthcare costs.
Detailed description
This is a pilot 2A trial of an innovative behavioral economics theory-based antidote for physician inertia in the medical treatment of hypertension (HTN). In the current reactive physician-centered model, blood pressure (BP) is measured and medical decisions are made in the physician office; when deciding whether or not to prescribe new medication for a high office BP reading, the physician's default behavior is inaction. The investigators propose default medication intensification as a new patient-centered/pharmacist-assisted proactive treatment model to eliminate physician inertia. For enrolled patients with office BP\>155/95, the physician will prescribe a one-month protocol that automatically escalates drug dose and drug number each week. The pharmacist will fill the prescription in a blister pack to simplify adherence. The patient will measure daily home BP with an iPhone cuff that transmits the data electronically to the pharmacist, who will halt the protocol if goal home BP\<135/85 is achieved ahead of schedule. the investigators will pilot test the feasibility and safety of self-monitoring plus the new automatic intensification protocol packaged in blisters. Default medication intensification could revolutionize HTN treatment and reduce healthcare costs.
Interventions
OTHERdefault intensification
The investigators will determine which blood pressure medications to use. No specific drug will be tested but rather the automatic intensification of medications is the intervention. Examples of drugs used in this study are calcium channel blockers (e.g., amlodipine 2.5 mg to 10 mg) or ACE-inhibitors (e.g., lisinopril 5 mg to 40 mg) or diuretics (HCTZ 25 mg).
Sponsors
University of California, Los Angeles
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
default drug escalation
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 55 years old * office BP of ≥160 mmHg systolic and ≥100 mmHg diastolic (treated or untreated) AND \<180 mmHg systolic.
Exclusion criteria
* chronic kidney disease * symptomatic coronary artery disease * congestive heart failure * more than mild valvular heart disease * Diabetes mellitus * obstructive left ventricular hypertrophy * severe electrolyte abnormalities * multiple medication intolerances * orthostatic hypotension * cognitive impairment and mental disorders affecting ability to self-monitor BP * patients who are unwilling to measure and transmit BP readings throughout the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic hypotension | from enrollment to 12 weeks | Primary safety outcome is symptomatic hypotension during study participation (12 weeks). Safety monitoring will be achieved with patient-directed iPhone-based BP measuring and transmitting to study staff. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hypertension control rate | at 12 weeks | The investigators will assess blood pressure throughout the study period (12 weeks) with iPhone based technology. Hypertension control is defined as home blood pressure \<135/85 mmHg |
Countries
United States
Outcome results
None listed