Medication Incidents in Primary Care Medicine

Medication Incidents Clinical Trial

— MIPC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295371
• Other study ID #: MIPC
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: January 11, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Medication Incidents

Locations

Country	Name	City	State
Switzerland	Praxis Dr. med. Markus Gnaedinger	Steinach	SG

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	type, frequency, seasonal and regional distribution of medication incidents	Descriptives	12 monthes	Yes
Secondary	possible risk factors for medication incidents like age, gender, poly-medication, morbidity, previous hospitalization	Logistic regression	12 monthes	Yes

External Links

•   Study home page