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

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: Completed
• Conditions: Aged; Hospitalization; Patient Admission
• Intervention / Treatment: Other: Collaborative Pharmaceutical Care

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: Interventional
• Enrollment (Actual): 622
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble Cedex 9, France, 38043
    • CHU de Grenoble - Hôpital 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preventable medication error rate	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	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	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	Clinical impact observed: 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)
Mortality rate		90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Length of hospital stay		hospital discharge (expected maximum of 21 days of hospitalization)
Acceptance rate of pharmaceutical interventions during collaborative interview.		Day 1, hospital admission
Avoided costs related to the occurrence of medication errors (criticality 3)		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		End of study (expected at 195 days)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean-Marie Kinowski, PharmD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): December 25, 2016
• Study Completion (Actual): December 25, 2016

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: collaborative pharmaceutical care
• Other Study ID Numbers: PREPS/2014/JMK-01; 2015-A00421-48 (Other Identifier: RCB number)