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)

September 12, 2018 updated by: Rennes University Hospital
Among the strategies to secure the patient's care path, medication reconciliation is a powerful approach for the prevention and interception of medication errors.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

100

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

      • Rennes, France, 35000
        • Rennes University Hospital

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 65 years admitted at the UMIP of Rennes University Hospital between 09/04/2017 and 10/31/2017.

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

  1. The MR at entry is performed by the pharmaceutical team as soon as possible after admission. The sequences of the medical conciliation are attributed to the health professionals according to the recommendations of the French National Authority for Health (HAS).
  2. The MR at the discharge is carried out in collaboration between the pharmaceutical and medical teams. It associates the patient through pharmaceutical interview and relies on the sharing of informations related to the patient's medical treatments. These informations are synthesized in an output conciliation sheet transmitted in real time by secure messaging to the attending physician and the dispensing pharmacist. In parallel, the liaison letter and the patient discharge order are generated in order to guarantee a perfect homogeneity between all the documents transmitted at the patient's exit. MR sequences are attributed to health professionals according to the recommendations of the HAS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent by professionals
Time Frame: At the inclusion day
Evaluation of the time spent by each professionals involved in the completion of each step of the MR process.
At the inclusion day
Average cost of MR process
Time Frame: At the inclusion day
Evaluation of average cost of MR process at UMIP. Only costs related to human resources are considered.
At the inclusion day
Number of unintentional discrepancies detected
Time Frame: At the inclusion day
Number of unintentional discrepancies detected during MR at admission of patients at UMIP.
At the inclusion day
Severity of unintentional discrepancies detected
Time Frame: At the inclusion day
Severity of unintentional discrepancies detected during MR at admission of patients at UMIP. Evaluation based on the algorithm provided by the HAS.
At the inclusion day

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Berengere CADOR, MD, Rennes University Hospital

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 (Actual)

September 5, 2017

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC17_3081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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