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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033127
Enrollment
160
Registered
2023-11-28
Start date
2024-01-08
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R94.3 F00-F99

Interventions

Group 1: Intervention group: Guideline-based monitoring of QTc time supported by a clinical pharmacist who may order ECG and laboratory checks Group 2: Control group: Guideline-based monitoring of QTc

Sponsors

Zentrum für Integrative Psychiatrie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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) The QT time for heart rates 70/min using the Fridericia formula.

Secondary

MeasureTime frame
- Number of patients with QTc prolongation o QTc times > 450 ms (m) or > 460 ms (f) o or > 500 ms o or increase of > 60 ms - Implementation rate of guideline recommendations - Occurrence of cardiac events - Satisfaction of psychiatric physicians with the pharmaceutical support - Physicians' desire for continuation of pharmaceutical support

Countries

Germany

Contacts

Public ContactKatharina Wien

Universitätsklinikum Schleswig-Holstein, Apotheke

k.wien@alumni.uni-luebeck.de+49 451 500 11872

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026