Medication Incidents in Primary Care Medicine

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

Detailed Description
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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.

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

Conditions
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Medication Incidents

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with an incident<br>Patients undergoing a safety incident while being treated with drugs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type, frequency, seasonal and regional distribution of medication incidents | Descriptives | 12 monthes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| possible risk factors for medication incidents like age, gender, poly-medication, morbidity, previous hospitalization | Logistic regression | 12 monthes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy, Patient safety, Polydrug therapy