NCT02598115

Brief Summary

The primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older. This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention every fifteen days after the start of inclusions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
622

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

September 19, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2016

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

November 4, 2015

Last Update Submit

February 27, 2020

Conditions

AgedPatient AdmissionHospitalization

Keywords

collaborative pharmaceutical care

Outcome Measures

Primary Outcomes (2)

  • Number of patients with at least one preventable medication error

    Day 1 (medical prescription at hospital admission)

  • Number of patients with at least one preventable medication error

    Number of patients with at least one preventable medication error not accepted by the prescribing doctor during the interventional phase

    Phase 2 (maximum 105 days)

Secondary Outcomes (10)

  • Preventable medication error rate

    Day 1 (medical prescription at hospital admission)

  • Number of patients at high risk for adverse drug events

    Day 1 (medical prescription at hospital admission)

  • Readmission rate for in-patient hospitalization

    30 days after hospital discharge (expected maximum of 21 days of hospitalization)

  • Readmission rate for in-patient hospitalization

    90 days after hospital discharge (expected maximum of 21 days of hospitalization)

  • Mortality rate

    30 days after hospital discharge (expected maximum of 21 days of hospitalization)

  • +5 more secondary outcomes

Study Arms (2)

Before collarborative pharmaceutical care

NO INTERVENTION

All clusters start in this arm for 15 days. Following the start of the study, 1 randomly chosen cluster will switch to the experimental arm every 15 days. Days 1 to 15: all clusters in the "before arm" Days 16 to 30: 1 cluster in the "Collaborative Pharmaceutical Care" arm Days 31 to 45: 2 clusters in the "Collaborative Pharmaceutical Care" arm Days 46 to 60: 3 clusters in the "Collaborative Pharmaceutical Care" arm Days 61 to 75: 4 clusters in the "Collaborative Pharmaceutical Care" arm Days 76 to 90: 5 clusters in the "Collaborative Pharmaceutical Care" arm Days 91 to 105: all 6 clusters in the "Collaborative Pharmaceutical Care" arm

After collarborative pharmaceutical care

EXPERIMENTAL

All clusters start in the "No Intervention" arm for 15 days. Following the start of the study, 1 randomly chosen cluster will switch to the experimental arm every 15 days. Days 1 to 15: all clusters in the "before arm" Days 16 to 30: 1 cluster in the "Collaborative Pharmaceutical Care" arm Days 31 to 45: 2 clusters in the "Collaborative Pharmaceutical Care" arm Days 46 to 60: 3 clusters in the "Collaborative Pharmaceutical Care" arm Days 61 to 75: 4 clusters in the "Collaborative Pharmaceutical Care" arm Days 76 to 90: 5 clusters in the "Collaborative Pharmaceutical Care" arm Days 91 to 105: all 6 clusters in the "Collaborative Pharmaceutical Care" arm

Other: Collaborative Pharmaceutical Care

Interventions

Collaborative Pharmaceutical CareOTHER

The pharmacist performs collaborative pharmaceutical care in the ward: reconciliation of drug treatments and revision of drug prescriptions indicated on the admission drug prescription. He/she emits pharmaceutical interventions recorded on the standardized support provided by the French Society of Clinical Pharmacy. The pharmaceutical interventions are discussed during a collaborative interview.

After collarborative pharmaceutical care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • The patient or his/her legal representative was informed about the study
  • The patient is admitted as an in-patient to one of the participating hospitals
  • The patient is available for 3 months of follow-up

You may not qualify if:

  • The subject is participating in another drug study
  • The subject is under judicial protection
  • It is impossible to correctly inform the patient or his/her legal representative
  • The patient or his/her legal representative refuses to participate in the study
  • The expected life span of the patient is less than the required 3 months of follow-up
  • It is impossible to contact the patient after hospitalisation
  • Hospitalizatin for longer than 21 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU de Grenoble - Hôpital Albert Michallon

Grenoble, 38043, France

Location

CHU de Nice - Hôpitaux L'Archet 1 et 2

Nice, 06202, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHRU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67098, France

Location

CHRU de Toulouse - Hôpital Paule de Viguier

Toulouse, 31059, France

Location

Related Publications (2)

  • Leguelinel-Blache G, Bouvet S, Bedouch P, Bachelet B, Chenailler C, Dantin T, Geneletti L, Janes A, Scher F, Cireasa B, Kinowski JM, Castelli C, Roux-Marson C; Working Group "Valorisation of Pharmacist Interventions" of the French Society of Clinical Pharmacy; MEDREV working group. Impact of collaborative pharmaceutical care on older inpatients' medication safety: multicentre stepped-wedge cluster randomised trial (MEDREV Study). BMC Geriatr. 2025 Jul 11;25(1):516. doi: 10.1186/s12877-025-06122-1.

    PMID: 40646458DERIVED

  • Leguelinel-Blache G, Castelli C, Roux-Marson C, Bouvet S, Andrieu S, Cestac P, Collomp R, Landais P, Louliere B, Mouchoux C, Varin R, Allenet B; MEDREV Working Group; Bedouch P, Kinowski JM. Impact of collaborative pharmaceutical care on in-patients' medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study). Trials. 2018 Jan 8;19(1):19. doi: 10.1186/s13063-017-2412-7.

    PMID: 29310711DERIVED

Study Officials

  • Jean-Marie Kinowski, PharmD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 5, 2015

Study Start

September 19, 2016

Primary Completion

December 25, 2016

Study Completion

December 25, 2016

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

FR(6)