Impact of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older (MEDREV)

February 27, 2020 updated by: Centre Hospitalier Universitaire de Nīmes

Impact of the Implementation of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The secondary objectives are to evaluate:

A. The potential and observed clinical impact of the implementation of collaborative pharmaceutical care.

B. The acceptance rate of pharmaceutical interventions during collaborative pharmaceutical care.

C. Avoidable costs related to the consumption of care generated by the occurrence of serious adverse drug reactions.

D. The satisfaction of health professionals concerning the transfer of information on the patient's drug therapy carried out as part of collaborative pharmaceutical care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
622

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble Cedex 9, France, 38043
        • CHU de Grenoble - Hopital Albert Michallon
      • Nice, France, 06202
        • CHU de Nice - Hôpitaux L'Archet 1 et 2
      • Nîmes Cedex 09, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau
      • Rouen, France, 76031
        • CHU de Rouen - Hôpital Charles Nicolle
      • Strasbourg, France, 67098
        • CHRU de Strasbourg - Hopital de Hautepierre
      • Toulouse Cedex 9, France, 31059
        • CHRU de Toulouse - Hôpital Paule de Viguier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Before collarborative pharmaceutical care

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
Experimental: After collarborative pharmaceutical care

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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with at least one preventable medication error
Time Frame: Day 1 (medical prescription at hospital admission)
Day 1 (medical prescription at hospital admission)
Number of patients with at least one preventable medication error
Time Frame: Phase 2 (maximum 105 days)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preventable medication error rate
Time Frame: Day 1 (medical prescription at hospital admission)
Potential clinical impact: preventable medication error rate detected in the medical prescription at admission (MPA) according to the level of criticality 1, 2 or 3. This error rate is defined by the ratio of the number of avoidable errors to the number of unrevised lines in the MPA.
Day 1 (medical prescription at hospital admission)
Number of patients at high risk for adverse drug events
Time Frame: Day 1 (medical prescription at hospital admission)
Potential clinical impact: number of patients at high risk for adverse drug events (Trivalle score calculated on the medical prescription at hospital admission)
Day 1 (medical prescription at hospital admission)
Readmission rate for in-patient hospitalization
Time Frame: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)
Clinical impact observed: readmission rate for in-patient hospitalization
30 days after hospital discharge (expected maximum of 21 days of hospitalization)
Readmission rate for in-patient hospitalization
Time Frame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Clinical impact observed: readmission rate for in-patient hospitalization
90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Mortality rate
Time Frame: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)
30 days after hospital discharge (expected maximum of 21 days of hospitalization)
Mortality rate
Time Frame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Length of hospital stay
Time Frame: hospital discharge (expected maximum of 21 days of hospitalization)
hospital discharge (expected maximum of 21 days of hospitalization)
Acceptance rate of pharmaceutical interventions during collaborative interview.
Time Frame: Day 1, hospital admission
Day 1, hospital admission
Avoided costs related to the occurrence of medication errors (criticality 3)
Time Frame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Satisfaction questionnaire (for health care professionals) on the implementation of collaborative pharmaceutical care
Time Frame: End of study (expected at 195 days)
End of study (expected at 195 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Marie Kinowski, PharmD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PREPS/2014/JMK-01
  • 2015-A00421-48 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aged

Clinical Trials on Collaborative Pharmaceutical Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings