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

Aged Clinical Trial

— MEDREV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598115
• Other study ID #: PREPS/2014/JMK-01
• Secondary ID: 2015-A00421-48
• Status: Completed
• Phase: N/A
• Start date: September 19, 2016
• Est. completion date: December 25, 2016

Study information

• Verified date: February 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: December 25, 2016
• Est. primary completion date: December 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Hospitalization
• Patient Admission

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Grenoble - Hôpital Albert Michallon	Grenoble Cedex 9
France	CHU de Nice - Hôpitaux L'Archet 1 et 2	Nice
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen
France	CHRU de Strasbourg - Hôpital de Hautepierre	Strasbourg
France	CHRU de Toulouse - Hôpital Paule de Viguier	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with at least one preventable medication error		Day 1 (medical prescription at hospital admission)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Mortality rate		30 days after hospital discharge (expected maximum of 21 days of hospitalization)
Secondary	Mortality rate		90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Secondary	Length of hospital stay		hospital discharge (expected maximum of 21 days of hospitalization)
Secondary	Acceptance rate of pharmaceutical interventions during collaborative interview.		Day 1, hospital admission
Secondary	Avoided costs related to the occurrence of medication errors (criticality 3)		90 days after hospital discharge (expected maximum of 21 days of hospitalization)
Secondary	Satisfaction questionnaire (for health care professionals) on the implementation of collaborative pharmaceutical care		End of study (expected at 195 days)