Default BP Medication Intensification

NCT ID: NCT01994408

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

default intensification arm (all)

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

Group Type: EXPERIMENTAL

default intensification

Intervention Type: OTHER

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).

Interventions

default 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).

Intervention Type: OTHER

Other Intervention Names

weekly increasing blood pressure medications.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Florian Rader, MD, MSc

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Florian Rader, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11694107 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14662620 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18577730 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20504241 (View on PubMed)

Other Identifiers

Pro00030558

Identifier Type: -

Identifier Source: org_study_id