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
NCT number | NCT04000542 |
Other study ID # | 19-0005 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 11, 2019 |
Est. completion date | March 31, 2020 |
Verified date | April 2020 |
Source | Northeast Iowa Medical Education Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northeast Iowa Family Practice | Waterloo | Iowa |
Lead Sponsor | Collaborator |
---|---|
Northeast Iowa Medical Education Foundation |
United States,
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) |
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