Medication Incidents in Primary Care Medicine (MIPC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02295371|
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : January 12, 2016
|Condition or disease|
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.
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.
● To describe the type, frequency, seasonal and regional distribution of medication incidents
● 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.
|Study Type :||Observational|
|Actual Enrollment :||213 participants|
|Official Title:||Medication Incidents in Primary Care Medicine: A Study by the Swiss Federal Sentinel Reporting System|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
Patients with an incident
Patients undergoing a safety incident while being treated with drugs
- type, frequency, seasonal and regional distribution of medication incidents [ Time Frame: 12 monthes ]Descriptives
- possible risk factors for medication incidents like age, gender, poly-medication, morbidity, previous hospitalization [ Time Frame: 12 monthes ]Logistic regression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295371
|Praxis Dr. med. Markus Gnaedinger|
|Steinach, SG, Switzerland, 9323|
|Principal Investigator:||Markus P. Gnädinger, MD||Institute for General Medicine, Zurich University Hospital|