Clinical trial NCT02295371: Medication Incidents in Primary Care Medicine
Official title: Medication Incidents in Primary Care Medicine: A Study by the Swiss Federal Sentinel Reporting System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Incidents
Keywords: Drug therapy
Patient safety
Polydrug therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Lausanne
First posted: 2014-11-20
Enrollment: 213
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients consulting primary care practices

Brief summary: Prospective reporting of safety incidents concerning drug treatment by approximately 120 primary care physicians or pediatricians during 2015.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Any erroneous event (as defined by the physician) related to the medication process interfering with normal treatment course

Exclusion Criteria:

* Lacking treatment effect, adverse drug reactions or drug-drug or drug-disease interactions, without detectable treatment error.
* Refusal of patients to refer data to the Sentinel system.

Primary outcomes:
measure: type, frequency, seasonal and regional distribution of medication incidents
timeFrame: 12 monthes
Secondary outcomes:
measure: possible risk factors for medication incidents like age, gender, poly-medication, morbidity, previous hospitalization
timeFrame: 12 monthes
Other outcomes:
Locations:
city: Steinach
country: Switzerland
facility: Praxis Dr. med. Markus Gnaedinger
state: SG
Study officials:
affiliation: Institute for General Medicine, Zurich University Hospital
name: Markus P. Gnädinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gnadinger M, Herzig L, Ceschi A, Conen D, Staehelin A, Zoller M, Puhan MA. Chronic conditions and multimorbidity in a primary care population: a study in the Swiss Sentinel Surveillance Network (Sentinella). Int J Public Health. 2018 Dec;63(9):1017-1026. doi: 10.1007/s00038-018-1114-6. Epub 2018 May 21.
citation: Gnadinger M, Ceschi A, Conen D, Herzig L, Puhan M, Staehelin A, Zoller M. Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System. BMJ Open. 2015 Apr 23;5(4):e007773. doi: 10.1136/bmjopen-2015-007773.