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NCT Number: NCT02598115

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

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.

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Key information

Conditions

Aged Hospitalization Patient Admission

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Grenoble - Hôpital Albert Michallon, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collaborative Pharmaceutical Care

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.

Primary outcomes

  1. Number of patients with at least one preventable medication error

    Time frame: Day 1 (medical prescription at hospital admission)

  2. 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

  1. Preventable medication error rate

    Time frame: Day 1 (medical prescription at hospital admission)

    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.

  2. Number of patients at high risk for adverse drug events

    Time frame: Day 1 (medical prescription at hospital admission)

    Potential clinical impact: number of patients at high risk for adverse drug events (Trivalle score calculated on the medical prescription at hospital admission)

  3. Readmission rate for in-patient hospitalization

    Time frame: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)

    Clinical impact observed: readmission rate for in-patient hospitalization

  4. Readmission rate for in-patient hospitalization

    Time frame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)

    Clinical impact observed: readmission rate for in-patient hospitalization

  5. Mortality rate

    Time frame: 30 days after hospital discharge (expected maximum of 21 days of hospitalization)

  6. Mortality rate

    Time frame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)

  7. Length of hospital stay

    Time frame: hospital discharge (expected maximum of 21 days of hospitalization)

  8. Acceptance rate of pharmaceutical interventions during collaborative interview.

    Time frame: Day 1, hospital admission

  9. Avoided costs related to the occurrence of medication errors (criticality 3)

    Time frame: 90 days after hospital discharge (expected maximum of 21 days of hospitalization)

  10. Satisfaction questionnaire (for health care professionals) on the implementation of collaborative pharmaceutical care

    Time frame: End of study (expected at 195 days)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: MEDREV

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2015
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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