Guaranteeing the Continuity of the Care Pathway for the Elderly Patient: Evaluation of a Territorial Approach of Clinical Pharmacy

NCT04018781 | Completed

• 2 other identifiers: 35RC19_300222019-A00455-52
• Study Type: observational
• Target: 443
• Locations: 1 country
• Sites: 6

Brief Summary

In the context of the ageing of the French population, drug iatrogeny in the elderly is a major public health issue, responsible for approximately 7,500 deaths per year and 3.4% of hospitalizations among patients aged 65 and over. The interest of the Medication Reconciliation (MR) in reducing medication errors and unintentional discrepancies in prescriptions at transition points in patients' medication care pathways no longer seems to be in doubt both in France and abroad. On the other hand, the literature on the clinical impact of these drug errors (i. e. occurrence of an adverse drug event (ADE) or readmission rates) is currently limited in France and presents variable results abroad.

Conditions

Medication Reconciliation at Discharge

Keywords

Medication reconciliation; clinical pharmacy

Outcome Measures

Primary Outcomes (1)

• Adverse drug event-related hospital revisits

  Rate of adverse drug event-related hospital revisits within 30 days after discharge

  30 days after discharge

Secondary Outcomes (9)

• General Practitioner consultation

  30 days after discharge

• All-causes readmissions and/or Emergency Department visits

  30 days after discharge

• All-causes readmissions and/or Emergency Department visits

  90 days after discharge

• Incremental Cost-Effectiveness Ratio (ICER) at Day 30

  30 days after discharge

• Incremental Cost-Effectiveness Ratio (ICER) at Day 90

  90 days after discharge

Study Arms (2)

MR group

Patients who benefit from a full process of medication reconciliation (entrance and discharge) before being discharged to home.

Other: medication reconciliation

Control group

Patients who benefitted from a medication reconciliation at entrance only before being discharged to home.

Other: medication reconciliation

Interventions

medication reconciliation OTHER

During hospitalization, the hospital pharmacist will carry out a pharmaceutical analysis for all patients included in the study, each time the prescription is changed and within a maximum of 24 hours (working days). If necessary, in consultation with the doctor in charge of the patient, the pharmacist may also propose a pharmaceutical interview to the patient at any time during his hospitalisation (e.g. proposal for the de-prescription of benzodiazepines, Proton Pump Inhibitors, etc., according to the recommendations in force).

Control group; MR group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 65 years admitted inside one of the thirteen wards from 6 hospitals located around Rennes and Fougères, between 13/06/2019 and 13/09/2019

You may qualify if:

• Patient \> 65 years old
• Patient hospitalized inside one of the thirteen wards in the 6 hospitals participating in the study
• Informed consent given

You may not qualify if:

• Patients in palliative care
• Persons deprived of their liberty

Sponsors & Collaborators

• Rennes University Hospital: lead
• Ecole des Hautes Etudes en Santé Publique: collaborator

Study Sites (6)

Hopital des Marches de Bretagne

Antrain, 35560, France

Location

General Hospital

Fougères, 35306, France

Location

General Hospital

Janzé, 35150, France

Location

General Hospital

Montfort-sur-Meu, 35160, France

Location

University Hospital

Rennes, 35000, France

Location

General Hospital

Saint-Méen-le-Grand, 35290, France

Location

Related Publications (1)

• Bajeux E, Alix L, Cornee L, Barbazan C, Mercerolle M, Howlett J, Cruveilhier V, Line-Iehl C, Cador B, Jego P, Gicquel V, Schweyer FX, Marie V, Hamonic S, Josselin JM, Somme D, Hue B. Pharmacist-led medication reconciliation at patient discharge: a tool to reduce healthcare utilization? an observational study in patients 65 years or older. BMC Geriatr. 2022 Jul 13;22(1):576. doi: 10.1186/s12877-022-03192-3.

  PMID: 35831783 DERIVED

MeSH Terms

Interventions

Medication Reconciliation

Intervention Hierarchy (Ancestors)

Medication Errors; Drug Therapy; Therapeutics; Medical Errors; Health Services; Health Care Facilities Workforce and Services; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Benoit HUE, MD, PhD

  University Hospital of Rennes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 15, 2019
• Study Start: June 13, 2019
• Primary Completion: November 13, 2019
• Study Completion: February 13, 2020
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)