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

Not Applicable

Completed

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

• Registration Number: NCT04000542
• Lead Sponsor: Northeast Iowa Medical Education Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Study Start: 2019-07-11
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eligible Participants	Pharmacist Intervention	Eligible Participants that consent will receive the pharmacist intervention.

Primary Outcome Measures

Name	Time	Method
Frequency of medication order changes due to QTc interval prolongation	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.

Trial Locations

Locations (1)

Northeast Iowa Family Practice; 🇺🇸 Waterloo, Iowa, United States