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Clinical Trials/NCT02598115
NCT02598115
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes6 sites in 1 country622 target enrollmentSeptember 19, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aged
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
622
Locations
6
Primary Endpoint
Number of patients with at least one preventable medication error
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 19, 2016
End Date
December 25, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of patients with at least one preventable medication error

Time Frame: 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 Outcomes

  • Readmission rate for in-patient hospitalization(90 days after hospital discharge (expected maximum of 21 days of hospitalization))
  • Number of patients at high risk for adverse drug events(Day 1 (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))
  • 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))

Study Sites (6)

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