Clinical trial NCT02598115: Impact of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older
Official title: Impact of the Implementation of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Patient Admission
Hospitalization
Keywords: collaborative pharmaceutical care
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 622
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with at least one preventable medication error
timeFrame: Day 1 (medical prescription at hospital admission)
measure: Number of patients with at least one preventable medication error
timeFrame: Phase 2 (maximum 105 days)
Secondary outcomes:
measure: Preventable medication error rate
timeFrame: Day 1 (medical prescription at hospital admission)
measure: Number of patients at high risk for adverse drug events
timeFrame: Day 1 (medical prescription at hospital admission)
measure: Readmission rate for in-patient hospitalization
timeFrame: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)
measure: Readmission rate for in-patient hospitalization
timeFrame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
measure: Mortality rate
timeFrame: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)
measure: Mortality rate
timeFrame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
measure: Length of hospital stay
timeFrame: hospital discharge (expected maximum of 21 days of hospitalization)
measure: Acceptance rate of pharmaceutical interventions during collaborative interview.
timeFrame: Day 1, hospital admission
measure: Avoided costs related to the occurrence of medication errors (criticality 3)
timeFrame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)
measure: Satisfaction questionnaire (for health care professionals) on the implementation of collaborative pharmaceutical care
timeFrame: End of study (expected at 195 days)
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: CHU de Grenoble - Hôpital Albert Michallon
city: Nice
country: France
facility: CHU de Nice - Hôpitaux L'Archet 1 et 2
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: CHRU de Strasbourg - Hôpital de Hautepierre
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital Paule de Viguier
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-Marie Kinowski, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.