Clinical trial NCT01994408: Default BP Medication Intensification
Official title: Automatic Medication Increase Protocol in the Treatment of Elevated Blood Pressure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hypertension
Keywords: physician inertia
hypertension
telemedicine
mobile technology
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2013-11-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: default drug escalation
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic hypotension
timeFrame: from enrollment to 12 weeks
Secondary outcomes:
measure: hypertension control rate
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Florian Rader, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phillips LS, Branch WT, Cook CB, Doyle JP, El-Kebbi IM, Gallina DL, Miller CD, Ziemer DC, Barnes CS. Clinical inertia. Ann Intern Med. 2001 Nov 6;135(9):825-34. doi: 10.7326/0003-4819-135-9-200111060-00012.
citation: O'Connor PJ. Overcome clinical inertia to control systolic blood pressure. Arch Intern Med. 2003 Dec 8-22;163(22):2677-8. doi: 10.1001/archinte.163.22.2677. No abstract available.
citation: Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857.
citation: Bray EP, Holder R, Mant J, McManus RJ. Does self-monitoring reduce blood pressure? Meta-analysis with meta-regression of randomized controlled trials. Ann Med. 2010 Jul;42(5):371-86. doi: 10.3109/07853890.2010.489567.