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Medication Incidents in Primary Care Medicine (MIPC)

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ClinicalTrials.gov Identifier: NCT02295371
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : January 12, 2016
Sponsor:
Collaborator:
University of Lausanne
Information provided by (Responsible Party):
University of Zurich

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

Condition or disease
Medication Incidents

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.

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Study Type : Observational
Actual Enrollment : 213 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Group/Cohort
Patients with an incident
Patients undergoing a safety incident while being treated with drugs



Primary Outcome Measures :
  1. type, frequency, seasonal and regional distribution of medication incidents [ Time Frame: 12 monthes ]
    Descriptives


Secondary Outcome Measures :
  1. possible risk factors for medication incidents like age, gender, poly-medication, morbidity, previous hospitalization [ Time Frame: 12 monthes ]
    Logistic regression



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients consulting primary care practices
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Switzerland
Praxis Dr. med. Markus Gnaedinger
Steinach, SG, Switzerland, 9323
Sponsors and Collaborators
University of Zurich
University of Lausanne
Investigators
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Principal Investigator: Markus P. Gnädinger, MD Institute for General Medicine, Zurich University Hospital
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02295371    
Other Study ID Numbers: MIPC
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Keywords provided by University of Zurich:
Drug therapy
Patient safety
Polydrug therapy