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Clinical Trials/NCT02295371
NCT02295371CompletedNot Applicable

Medication Incidents in Primary Care Medicine: A Study by the Swiss Federal Sentinel Reporting System

University of Zurich1 site in 1 country213 target enrollmentStarted: January 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
213
Locations
1
Primary Endpoint
type, frequency, seasonal and regional distribution of medication incidents

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

type, frequency, seasonal and regional distribution of medication incidents

Time Frame: 12 monthes

Descriptives

Secondary Outcomes

  • possible risk factors for medication incidents like age, gender, poly-medication, morbidity, previous hospitalization(12 monthes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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