Pharmacist Use of ECG to Inform Drug Therapy Decisions for Patients Receiving QT Prolonging Medications

Torsade de pointes (TdP) is a cardiac arrhythmia associated with QT interval prolongation which may lead to cardiac arrest. Prescription medications which cause QT interval prolongation are commonly used in daily practice. To lessen risk of TdP, pharmacists work to minimize combinations of QT interval prolonging drugs. If community pharmacists had real-time information about a patient's QT interval duration, this would have the direct ability to inform their decision making about which patients may be at highest risk of TdP and who may need heightened avoidance of QT prolonging drugs. This project will provide 3 community pharmacies with mobile ECG devices to easily determine QT intervals among patients who have a prescription profile alert for QT interval prolongation. Study outcomes will include: frequency of QT interval prolongation, changes in drug therapy related to QT interval determination, and patient and pharmacist satisfaction with having pharmacist assessment of QT interval.

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Key information

Conditions

Torsades de Pointe Caused by Drug (Disorder) Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Qt Interval, Variation in Tachycardia Tachycardia, Ventricular Torsades de Pointes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeast Iowa Family Practice

Waterloo, Iowa, 50702, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female at least 18 years of age.
Subject is receiving a prescription medication for which there is a "QT/QTc interval prolongation" alert observed on the dispensing pharmacy prescription software.
English speaking

Exclusion criteria

Patients with implantable pacemakers or automatic implantable cardioverter defibrillators
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Patient has known atrial or ventricular arrhythmia

Treatment and study plan

Pharmacist Intervention

Other

The pharmacist will record a 30 second rhythm strip from patients using the KardiaMobile device and calculate the QTc interval using the Bazett calculation formula. The pharmacist will discuss the result with the patient and if necessary, will contact the prescriber to effect a medication change. If the QTc interval is greater than the 99th percentile, (470 ms for males, 480 ms for females) the pharmacist must contact the prescriber. The pharmacist will record any prescription changes which resulted from the intervention and the prescriber response. The pharmacist will email the rhythm strip (with study participation number) to a secure email at the Northeast Iowa Family Practice Center (NEIFPC). Rhythm strips will be archived for future potential research evaluation in a secure, electronic file.

Primary outcomes

Frequency of medication order changes due to QTc interval prolongation

Time frame: through study completion (anticipated to last 8 months)

Physician/provider will be contacted if elevated QTc interval is present (>470 ms for males, >480 ms for females). Frequency of medication changes due to QTc interval prolongation will be assessed.

Sponsors and collaborators

Lead sponsor

Northeast Iowa Medical Education Foundation

Other

Registry information

Official study title

Community Pharmacist Use of Mobile ECG to Inform Drug Therapy Decision Making for Patients Receiving QT Prolonging Medications

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jun 27, 2019
Registry last updated: Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed