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出境医 / 临床实验 / Pharmacist Use of ECG to Inform Drug Therapy Decisions for Patients Receiving QT Prolonging Medications

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Torsades de Pointe Caused by Drug (Disorder) Torsades de Pointes Qt Interval, Variation in Other: Pharmacist Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Community Pharmacist Use of Mobile ECG to Inform Drug Therapy Decision Making for Patients Receiving QT Prolonging Medications
Actual Study Start Date : July 11, 2019
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. Frequency of medication order changes due to QTc interval prolongation [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
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United States, Iowa
Northeast Iowa Family Practice
Waterloo, Iowa, United States, 50702
Sponsors and Collaborators
Northeast Iowa Medical Education Foundation
Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date April 9, 2020
Actual Study Start Date  ICMJE July 11, 2019
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019) 		Frequency of medication order changes due to QTc interval prolongation [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacist Use of ECG to Inform Drug Therapy Decisions for Patients Receiving QT Prolonging Medications
Official Title  ICMJE Community Pharmacist Use of Mobile ECG to Inform Drug Therapy Decision Making for Patients Receiving QT Prolonging Medications
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Torsades de Pointe Caused by Drug (Disorder)
  • Torsades de Pointes
  • Qt Interval, Variation in
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Eligible Participants
Eligible Participants that consent will receive the pharmacist intervention.
Intervention: Other: Pharmacist Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2020) 		54
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2019) 		150
Actual Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000542
Other Study ID Numbers  ICMJE 19-0005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jim Hoehns, Northeast Iowa Medical Education Foundation
Study Sponsor  ICMJE Northeast Iowa Medical Education Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Northeast Iowa Medical Education Foundation
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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