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

NCT04000542 | Completed

• 1 other identifier: 19-0005
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Torsades de Pointe Caused by Drug (Disorder); Torsades de Pointes; Qt Interval, Variation in

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Eligible Participants

EXPERIMENTAL

Eligible Participants that consent will receive the pharmacist intervention.

Other: Pharmacist Intervention

Interventions

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.

Eligible Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northeast Iowa Medical Education Foundation: lead

Study Sites (1)

Northeast Iowa Family Practice

Waterloo, Iowa, 50702, United States

Location

MeSH Terms

Conditions

Torsades de Pointes

Condition Hierarchy (Ancestors)

Tachycardia, Ventricular; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: July 11, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)