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

NCT ID: NCT02598115

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

622 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2016-12-25

Brief Summary

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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

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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.

Conditions

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Aged Patient Admission Hospitalization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Collaborative Pharmaceutical Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Marie Kinowski, PharmD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Grenoble - Hôpital Albert Michallon

Grenoble, , France

Site Status

CHU de Nice - Hôpitaux L'Archet 1 et 2

Nice, , France

Site Status

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

CHU de Rouen - Hôpital Charles Nicolle

Rouen, , France

Site Status

CHRU de Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

Site Status

CHRU de Toulouse - Hôpital Paule de Viguier

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 40646458 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29310711 (View on PubMed)

Other Identifiers

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2015-A00421-48

Identifier Type: OTHER

Identifier Source: secondary_id

PREPS/2014/JMK-01

Identifier Type: -

Identifier Source: org_study_id

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