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

Not Applicable

Completed

• Conditions: Hospitalization; Patient Admission; Aged
• Interventions: Other: Collaborative Pharmaceutical Care

• Registration Number: NCT02598115
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

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 Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Study Start: 2016-09-19
• Primary Completion: 2016-12-25
• Study Completion: 2016-12-25
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 622

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
After collarborative pharmaceutical care	Collaborative 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

Primary Outcome Measures

Name	Time	Method
Number of patients with at least one preventable medication error	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

Secondary Outcome Measures

Name	Time	Method
Readmission rate for in-patient hospitalization	90 days after hospital discharge (expected maximum of 21 days of hospitalization)	Clinical impact observed: readmission rate for in-patient hospitalization
Number of patients at high risk for adverse drug events	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)
Acceptance rate of pharmaceutical interventions during collaborative interview.	Day 1, hospital admission
Preventable medication error rate	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.
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)
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)

Trial Locations

Locations (6)

CHU de Grenoble - Hôpital Albert Michallon; 🇫🇷 Grenoble Cedex 9, France

CHU de Nice - Hôpitaux L'Archet 1 et 2; 🇫🇷 Nice, France

CHU de Rouen - Hôpital Charles Nicolle; 🇫🇷 Rouen, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

CHRU de Strasbourg - Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

CHRU de Toulouse - Hôpital Paule de Viguier; 🇫🇷 Toulouse Cedex 9, France