NCT02734017

Brief Summary

The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups:

  1. 1.group receiving a pharmacist-led standardized medication review (experimental group); and
  2. 2.group not receiving the medication review (control group).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
470

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 23, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2019

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

March 23, 2016

Last Update Submit

July 25, 2023

Conditions

Re-hospitalization

Outcome Measures

Primary Outcomes (1)

  • Rate of readmission

    30 days

Secondary Outcomes (3)

  • Satisfaction with Medicines Questionnaire (SatMed-Q®)

    30 days

  • Medication errors on medical admission prescription

    24 hours

  • Number of consultations post discharge

    30 days

Study Arms (2)

standard course

OTHER

group not receiving medication review

Other: pharmacist-led standardized medication review

pharmacist-led standardized medication review

OTHER

pharmacist-led standardized medication review including : * Medical and pharmaceutical admission medication reconciliation and treatment review * Medical and pharmaceutical medication reconciliation at discharge and treatment review * Medication Liaison Service

Other: pharmacist-led standardized medication review

Interventions

pharmacist-led standardized medication reviewOTHER

the goal of this study is to assess the impact of the standardized medication review on the rate of readmissions and/or death at 30 days following initial hospitalization discharge.

pharmacist-led standardized medication reviewstandard course

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged under 18 or over 65 years
  • Subject hospitalized in the multidisciplinary pediatric service or internal medicine ward, after emergency department visit at Timone hospital (Marseille, France) regardless of the reason for admission
  • Subject with or without any comorbidity
  • Living in France
  • With national publicly-founded health insurance
  • Major subject and/or holder of parental authority of a hospitalized child, who fulfills the eligibility criteria mentioned above, in the multidisciplinary pediatric ward;
  • Whatever the reason for hospitalization of the patient;
  • Major subject, designated by the patient or designating himself as the person most involved in the daily life of the patient;
  • Whatever the reason for hospitalization of the patient;
  • Whatever relationship or proximity to the study patient (family member, friend, neighbor);

You may not qualify if:

  • Patients whose care requires regular re-hospitalization / programmed less than 30 days after discharge of initial hospitalization
  • Vulnerable persons according to French law (pregnant women, adults under guardianship, persons deprived of liberty)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • Renaudin P, Baumstarck K, Daumas A, Esteve MA, Gayet S, Auquier P, Tsimaratos M, Villani P, Honore S. Impact of a pharmacist-led medication review on hospital readmission in a pediatric and elderly population: study protocol for a randomized open-label controlled trial. Trials. 2017 Feb 9;18(1):65. doi: 10.1186/s13063-017-1798-6.

    PMID: 28183322DERIVED

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 12, 2016

Study Start

July 1, 2016

Primary Completion

January 2, 2019

Study Completion

March 23, 2019

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

FR(1)