Medication IncidentsMIPCNCT02295371
Medication Incidents in Primary Care Medicine
An observational study of Medication Incidents, run by University of Zurich at 1 site in Switzerland.
Trial summary
Prospective reporting of safety incidents concerning drug treatment by approximately 120 primary care physicians or pediatricians during 2015. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication Incidents
- How many people
- 213 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients consulting primary care practices
Who may be able to join
- Any erroneous event (as defined by the physician) related to the medication process interfering with normal treatment course
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Praxis Dr. med. Markus Gnaedinger
Steinach, Canton of St. Gallen, 9323
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication Incidents
- Keywords
- Drug therapy, Patient safety, Polydrug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with an incident | Patients undergoing a safety incident while being treated with drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
type, frequency, seasonal and regional distribution of medication incidents
Descriptives
Measured: 12 monthes
Secondary outcomes (1)
possible risk factors for medication incidents like age, gender, poly-medication, morbidity, previous hospitalization
Logistic regression
Measured: 12 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication IncidentsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Sponsor
- Investigators
- Markus P. Gnädinger, MD, Principal investigator, Institute for General Medicine, Zurich University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295371
- Sponsor's protocol ID
- MIPC
- Acronym
- MIPC
- Status last verified
- Jan 2016
- First submitted
- 10 Nov 2014
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gnadinger M, Herzig L, Ceschi A, Conen D, Staehelin A, Zoller M, Puhan MA. Chronic conditions and multimorbidity in a primary care population: a study in the Swiss Sentinel Surveillance Network (Sentinella). Int J Public Health. 2018 Dec;63(9):1017-1026. doi: 10.1007/s00038-018-1114-6. Epub 2018 May 21.
PubMed 29786762Gnadinger M, Ceschi A, Conen D, Herzig L, Puhan M, Staehelin A, Zoller M. Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System. BMJ Open. 2015 Apr 23;5(4):e007773. doi: 10.1136/bmjopen-2015-007773.
PubMed 25908679
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Incidents in Primary Care Medicine: A Study by the Swiss Federal Sentinel Reporting System
- ClinicalTrials.gov ID
- NCT02295371
- Acronym / sponsor ID
- MIPC / MIPC
- Conditions
- Medication Incidents
- Keywords
- Drug therapy, Patient safety, Polydrug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Lausanne
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective reporting of safety incidents concerning drug treatment by approximately 120 primary care physicians or pediatricians during 2015.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an incident | – | –Patients undergoing a safety incident while being treated with drugs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients consulting primary care practices
Key inclusion criteria (1 listed)
- Any erroneous event (as defined by the physician) related to the medication process interfering with normal treatment course
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
type, frequency, seasonal and regional distribution of medication incidents
Time frame: 12 monthes
Descriptives
1 secondary outcome
possible risk factors for medication incidents like age, gender, poly-medication, morbidity, previous hospitalization
Time frame: 12 monthes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Derived from this study: PubMed 29786762Gnadinger M, Herzig L, Ceschi A, Conen D, Staehelin A, Zoller M, Puhan MA. Chronic conditions and multimorbidity in a primary care population: a study in the Swiss Sentinel Surveillance Network (Sentinella). Int J Public Health. 2018 Dec;63(9):1017-1026. doi: 10.1007/s00038-018-1114-6. Epub 2018 May 21.
- Derived from this study: PubMed 25908679Gnadinger M, Ceschi A, Conen D, Herzig L, Puhan M, Staehelin A, Zoller M. Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System. BMJ Open. 2015 Apr 23;5(4):e007773. doi: 10.1136/bmjopen-2015-007773.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus P. Gnädinger, MD principal investigator
Institute for General Medicine, Zurich University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Incidents, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type, frequency, seasonal and regional distribution of medication incidents (time frame: 12 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295371, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.