NCT03670433

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

September 12, 2018

Last Update Submit

September 12, 2018

Conditions

Keywords

Medication reconciliationCare pathPrevention

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Number of unintentional discrepancies detected

    Number of unintentional discrepancies detected during MR at admission of patients at UMIP.

    At the inclusion day

  • 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

Study Arms (1)

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.

Other: Cost analysis of medication reconciliation

Interventions

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.

Patients admitted in the Polyvalent Internal Medical Unit

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients not returning home
  • Refusal of participation
  • Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

Study Officials

  • Berengere CADOR, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 13, 2018

Study Start

September 5, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

September 13, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations