- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670433
Medication Reconciliation for Patients Over 65 Years Old : Cost Analysis of the Process Implemented in the Polyvalent Internal Medical Unit of Rennes University Hospital (CONTEMPS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All medication errors are not serious. Nevertheless 4 studies show that respectively 5.6%, 5.7%, 6.3% and 11.7% of the medication errors intercepted by medication reconciliation (MR) could have had major, critical or catastrophic consequences for patients. If the consequences of a medication error have a clinical or institutional translation for the patient, they can also directly impact the hospital or caregivers, for example by extending the average length of stay or by increasing the number of consultations or readmissions.
The efficiency of the medication reconciliation approach has never been evaluated in France in comparison with standard care. Before initiating cost-effectiveness studies, we propose to conduct a micro-costing study to evaluate the production costs of this conciliation approach.
The costs are almost exclusively related to human resources and the present study will assess the time spent by the different actors involved in the process.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rennes, France, 35000
- Rennes University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients over 65 years old
- Patient non-institutionalized at entry
For MR :
- Entry : patients admitted at UMIP between 09/04/2017 and 10/31/2017
- Discharge : patients returning home or going to a rehabilitation service between 04/09/2017 and 31/10/2017 and having received MR evaluation
Exclusion Criteria:
- Patients not returning home
- Refusal of participation
- Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients admitted in the Polyvalent Internal Medical Unit
Patients over 65 years old admitted in the Polyvalent Internal Medical Unit (UMIP) of Rennes University Hospital between 09/04/2017 and 10/31/2017 or going back home or to a rehabilitation service during the same period. Cost analysis of medication reconciliation. |
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time spent by professionals
Time Frame: At the inclusion day
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Evaluation of the time spent by each professionals involved in the completion of each step of the MR process.
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At the inclusion day
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Average cost of MR process
Time Frame: At the inclusion day
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Evaluation of average cost of MR process at UMIP.
Only costs related to human resources are considered.
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At the inclusion day
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Number of unintentional discrepancies detected
Time Frame: At the inclusion day
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Number of unintentional discrepancies detected during MR at admission of patients at UMIP.
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At the inclusion day
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Severity of unintentional discrepancies detected
Time Frame: At the inclusion day
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Severity of unintentional discrepancies detected during MR at admission of patients at UMIP.
Evaluation based on the algorithm provided by the HAS.
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At the inclusion day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Berengere CADOR, MD, Rennes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 35RC17_3081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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