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

Community Pharmacist Use of Mobile ECG to Inform Drug Therapy Decision Making 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.

Study Overview

• Status: Completed
• Conditions: Torsades de Pointes; Qt Interval, Variation in; Torsades de Pointe Caused by Drug (Disorder)
• Intervention / Treatment: Other: Pharmacist Intervention

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Waterloo, Iowa, United States, 50702
      • Northeast Iowa Family Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Eligible Participants; Eligible Participants that consent will receive the pharmacist intervention.

Other: Pharmacist Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of medication order changes due to QTc interval prolongation	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.	through study completion (anticipated to last 8 months)

Collaborators and Investigators

• Sponsor: Northeast Iowa Medical Education Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2019
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (ACTUAL): June 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia, Ventricular; Tachycardia; Torsades de Pointes
• Other Study ID Numbers: 19-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No