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

Eval CONPARMED Haute-Bretagne : Guaranteeing the Continuity of the Care Pathway for the Elderly Patient: Evaluation of a Territorial Approach of Clinical Pharmacy

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.

Study Overview

• Status: Completed
• Conditions: Medication Reconciliation at Discharge
• Intervention / Treatment: Other: medication reconciliation

Detailed Description

The medication reconciliation implementation mobilizes human resources (pharmacists, pharmacy technician, nurses...) and constitutes an investment for healthcare institutions. However, the resulting improvement in patients' health status (and the potential reduction in ADEs) could reduce their care consumption and thus reduce costs from a healthcare system perspective. We therefore propose to assess the cost-effectiveness of this care strategy.

Finally, we will study the impact of the MR deployment on existing professional organizations, both in hospital and between community healthcare professionals and hospital as well as its conditions of implementation.

• Study Type: Observational
• Enrollment (Actual): 443

Contacts and Locations

Study Locations

• France
  • Antrain, France, 35560
    • Hopital des Marches de Bretagne
  • Fougères, France, 35306
    • General Hospital
  • Janzé, France, 35150
    • General Hospital
  • Montfort-sur-Meu, France, 35160
    • General Hospital
  • Rennes, France, 35000
    • University Hospital
  • Saint-Méen le Grand, France, 35290
    • General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion criteria :

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

Non inclusion and Exclusion Criteria :

• Patients in palliative care
• Persons deprived of their liberty

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MR group; Patients who benefit from a full process of medication reconciliation (entrance and discharge) before being discharged to home.	Other: medication reconciliation; 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; Patients who benefitted from a medication reconciliation at entrance only before being discharged to home.	Other: medication reconciliation; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug event-related hospital revisits	Rate of adverse drug event-related hospital revisits within 30 days after discharge	30 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Practitioner consultation	Rate of General Practitioner consultation within 30 days after discharge	30 days after discharge
All-causes readmissions and/or Emergency Department visits	Composite rate of readmissions and/or Emergency Department visits within 30 days after discharge	30 days after discharge
All-causes readmissions and/or Emergency Department visits	Composite rate of readmissions and/or Emergency Department visits within 90 days after discharge	90 days after discharge
Incremental Cost-Effectiveness Ratio (ICER) at Day 30	Medico-economic analysis : Incremental Cost-Effectiveness Ratio (ICER) : cost per hospitalization for Drug Adverse Event avoided and cost per all-causes hospitalization, according to a collective perspective at Day 0.	30 days after discharge
Incremental Cost-Effectiveness Ratio (ICER) at Day 90	Medico-economic analysis : Incremental Cost-Effectiveness Ratio (ICER) : cost per hospitalization for Drug Adverse Event avoided and cost per all-causes hospitalization, according to a collective perspective at Day 90.	90 days after discharge
Patient reported experience measures	Patient reported experience measures are realized by a short phone call interview, 7 days after the patients' homecoming	7 days after discharge
Severity of Unintended Medication Discrepancies	Severity of Unintended Medication Discrepancies intercepted during medication reconciliation at admission	At admission
Number of Unintended Medication Discrepancies	Number of Unintended Medication Discrepancies intercepted during medication reconciliation at admission	At admission
Impact of the implementation of the intervention on professional organizations	Qualitative analysis based on : First, an inventory of organizations prior to the implementation of the intervention in participating health facilities; Then, an assessment of the impacts of the implementation of the intervention on different aspects of professional organizations: collaborative exchanges, multi-professional information sharing, division of labour, exchanges with city practitioners, learning effects, evolution of professional practices.	Before and after the implementation of the intervention in the participating wards

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Ecole des Hautes Etudes en Santé Publique
• Investigators: Study Director: Benoit HUE, MD, PhD, University Hospital of Rennes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 13, 2019
• Primary Completion (ACTUAL): November 13, 2019
• Study Completion (ACTUAL): February 13, 2020

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (ACTUAL): July 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: clinical pharmacy; Medication reconciliation
• Other Study ID Numbers: 35RC19_30022; 2019-A00455-52 (OTHER: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No