Medication Incidents Clinical Trial
Official title:
Medication Incidents in Primary Care Medicine: A Study by the Swiss Federal Sentinel Reporting System
Prospective reporting of safety incidents concerning drug treatment by approximately 120 primary care physicians or pediatricians during 2015.
Objectives: Patient safety is a major concern in healthcare systems worldwide. Although most
safety research has been conducted in the inpatient setting, evidence indicates that medical
errors and adverse events pose a serious threat for patients in the primary care setting as
well, since most patients receive ambulatory care. Information about frequency and outcomes
of safety incidents in primary care is required to identify risks or "hot spots," to
prioritize them and to take the action as needed.
Methods:
Participants: Patients undergoing drug treatment by approximately 120 primary care
physicians or pediatricians reporting to the Sentinel system.
Collection of data: Questionnaires for cases, for clinical denominator data, and for
physician practice specification.
Study intervention: none.
Primary outcome:
● To describe the type, frequency, seasonal and regional distribution of medication
incidents
Secondary outcomes:
● To elucidate risk factors like age, gender, poly-medication, morbidity, foreign care,
hospitalization.
Statistics: Descriptive statistics, logistic regression. Estimated sample size: 500.
Flow chart: January 2015: Baseline physicians questionnaire. May 2015: Denominator data
collection during 14 d. December 2015: Final physicians questionnaire. January to December
2015: Collection of case questionnaires / Counting of daily patient-to-physician contacts.
After December 2015: Statistical Evaluation of data, publication.
;
Observational Model: Case-Only, Time Perspective: Prospective