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

Sponsor
Centre d'Investigation Clinique et Technologique 805 (Other)
Overall Status
Completed
CT.gov ID
NCT03029052
Collaborator
(none)
120
1
2
28.7
4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Reconciliation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Monocenter, randomized, controlled, pilot study.Monocenter, randomized, controlled, pilot study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 8, 2017
Actual Primary Completion Date :
Jul 2, 2019
Actual Study Completion Date :
Jul 2, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of in-hospital prescription changes not maintained by the Primary Care Physician (PCP) one month after discharge. [1 month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Raymond poincaré Garches France 92150

Sponsors and Collaborators

  • Centre d'Investigation Clinique et Technologique 805

Investigators

  • Principal Investigator: Frederique BOUCHAND, PharmD, APHP
  • Study Director: Benjamin DAVIDO, MD, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frederique Bouchand, PharmD, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT03029052
Other Study ID Numbers:
  • 2016-A01628-43
First Posted:
Jan 24, 2017
Last Update Posted:
Jul 14, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 14, 2020