Pharmacist-assisted implementation of guideline recommendations for QTc monitoring during psychopharmacotherapy - a prospective, randomised feasibility study

Not Applicable

• Conditions: R94.3; F00-F99; Abnormal results of cardiovascular function studies; Mental and behavioural disorders

• Registration Number: DRKS00033127
• Lead Sponsor: Zentrum für Integrative Psychiatrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-28
• Study Completion: 2024-07-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Admission to wards B3.01, B3.11, B6.01 and to the day clinic B22
- Expected length of stay at least 30 days
- Use of at least one QT-prolonging drug during the stay (known, possible or conditional risk according to CredibleMeds)
- Signed declaration of consent

Exclusion Criteria

- Patients who are not taking a QT-prolonging drug during the study period
- Patients who sleep on the psychiatric wards but who are hospitalized for somatic treatment

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in QTc time in the observation period between T0 (QTc time in ECG on admission) and T1 (QTc time in ECG 30 days after admission) <br>The QT time for heart rates < 71/min is corrected using the Bazett formula and for heart rates > 70/min using the Fridericia formula.

Secondary Outcome Measures

Name	Time	Method
- Number of patients with QTc prolongation <br>oQTc times > 450 ms (m) or > 460 ms (f)<br>oor > 500 ms <br>oor increase of > 60 ms <br>- Implementation rate of guideline recommendations<br>- Occurrence of cardiac events<br>- Satisfaction of psychiatric physicians with the pharmaceutical support <br>- Physicians' desire for continuation of pharmaceutical support