Medication Incidents in Primary Care Medicine (MIPC)

January 11, 2016 updated by: University of Zurich

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

213

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • SG
      • Steinach, SG, Switzerland, 9323
        • Praxis Dr. med. Markus Gnaedinger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients consulting primary care practices

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
type, frequency, seasonal and regional distribution of medication incidents
Time Frame: 12 monthes
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
Time Frame: 12 monthes
Logistic regression
12 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University of Lausanne

Investigators

  • Principal Investigator: Markus P. Gnädinger, MD, Institute for General Medicine, Zurich University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MIPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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