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

Qt Interval, Variation in Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000542
• Other study ID #: 19-0005
• Status: Completed
• Phase: N/A
• Start date: July 11, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: Northeast Iowa Medical Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
United States	Northeast Iowa Family Practice	Waterloo	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Northeast Iowa Medical Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)