Medication Reconciliation at Discharge: Impact on Patient's Care (CONCIVILLE)

A Comparative Pilot Study in an Infectious Disease Department Assessing the Impact of Medication Reconciliation at Discharge Associated With a Patient's Counseling Session, Both Provided by a Pharmacist, on Patient's Care After Discharge

Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP). The investigators aim to assess in this study the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of medication reconciliation at discharge we expect a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge.

Study Overview

• Status: Completed
• Conditions: Medication Reconciliation
• Intervention / Treatment: Behavioral: Reconciliation

Detailed Description

Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients and may lead to further hospitalization. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP) and from discrepancies between patient's current medications and drugs prescribed at discharge.

Preventing adverse drug events (ADEs) remains a patient safety priority not only in hospitals but also across the continuum of care for patients. Implementing medication reconciliation at all transitions in care is an effective strategy for preventing discrepancies and ADEs. Medication reconciliation prevents and corrects medication errors by promoting transmissions of complete and accurate information about medicines.

Furthermore, ADEs may be the result of a failure to understand and manage post-discharge care needs and can lead to hospital readmission.

We assume that medication reconciliation at discharge, secondarily transmitted to the PCP with a discharge counseling session between the patient and a clinical pharmacist could have a positive impact on the maintenance of therapeutic optimization decided by in-hospital practitioners.

In order to evaluate this assumption, we will conduct a randomized controlled study on 120 patients (as a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge is expected).

The follow-up will last 1 month after discharge from hospital. The first prescription from the PCP will be collected and analyzed. In addition, patients and PCPs will be contacted by the pharmacist to answer specific questionnaires.

The primary objective of the study is to assess the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Garches, France, 92150
    • Hopital Raymond Poincare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age ≥ 18 years old
• hospitalized in infectious disease department
• with a chronic disease and a current medical prescription including at least three drugs
• discharged home or nursing home
• not opposed to the study

Exclusion Criteria:

• foreigners, patients under legal guardianship
• advanced dementia (MMS<20) or phone tracking impossible
• primary care physician opposed to answer questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Medical and pharmaceutical management (at admission, during hospitalization and at discharge) will follow standard healthcare procedures of the department.
Experimental: Reconciliation group; Standard healthcare procedures and pharmacist's involvement	Behavioral: Reconciliation; In addition to standard healthcare procedures, the pharmacist will analyze discharge prescriptions and proceed to medication reconciliation. A patient's counseling session will also be provided by the pharmacist. A reconciliation mail will be addressed to the PCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of in-hospital prescription changes not maintained by the Primary Care Physician (PCP) one month after discharge.	The number of in-hospital prescription changes will be evaluated only on discharge prescription transmitted to the patient (after prescription analysis by a clinical pharmacist in the "reconciliation" group) Compared to the list of all current medications at admission, in-hospital prescription changes include the following: Adding a new drug; Discontinuing a drug; Drug switch; Modifying a dose Among these hospital prescription changes, some will not be maintained by the PCP one month after discharge. In-hospital prescription changes not maintained by the PCP will be evaluated on the first prescription of the PCP following discharge.	1 month

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Investigators: Principal Investigator: Frederique BOUCHAND, PharmD, APHP; Study Director: Benjamin DAVIDO, MD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Actual): July 2, 2019
• Study Completion (Actual): July 2, 2019

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016-A01628-43

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