Medication Incidents in Primary Care Medicine

Completed

• Conditions: Medication Incidents

• Registration Number: NCT02295371
• Lead Sponsor: University of Zurich

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-20
• Study Start: 2015-01
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
type, frequency, seasonal and regional distribution of medication incidents	12 monthes	Descriptives

Secondary Outcome Measures

Name	Time	Method
possible risk factors for medication incidents like age, gender, poly-medication, morbidity, previous hospitalization	12 monthes	Logistic regression

Trial Locations

Locations (1)

Praxis Dr. med. Markus Gnaedinger; 🇨🇭 Steinach, SG, Switzerland