Default BP Medication Intensification

Cedars-Sinai Medical Center

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Hypertension

Treatments: Other: default intensification

Study type: Interventional

Funder types: Other

Identifiers

NCT01994408

Pro00030558

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

default intensification arm (all)

Experimental group

Description:

all subjects will receive blister packs with weekly increasing blood pressure medications. There is no control arm for this study

Treatment:

Other: default intensification