Aged Clinical Trial
— MEDREVOfficial title:
Impact of the Implementation of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older
Verified date | February 2020 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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) |
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