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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03670433
Other study ID # 35RC17_3081
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 5, 2017
Est. completion date October 31, 2017

Study information

Verified date September 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Among the strategies to secure the patient's care path, medication reconciliation is a powerful approach for the prevention and interception of medication errors.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 31, 2017
Est. primary completion date October 31, 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Cost analysis of medication reconciliation
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). 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.

Locations

Country Name City State
France Rennes University Hospital Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time spent by professionals Evaluation of the time spent by each professionals involved in the completion of each step of the MR process. At the inclusion day
Primary Average cost of MR process Evaluation of average cost of MR process at UMIP. Only costs related to human resources are considered. At the inclusion day
Primary Number of unintentional discrepancies detected Number of unintentional discrepancies detected during MR at admission of patients at UMIP. At the inclusion day
Primary Severity of unintentional discrepancies detected 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
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