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

Medication Reconciliation at Discharge Clinical Trial

— CONPARMED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018781
• Other study ID #: 35RC19_30022
• Secondary ID: 2019-A00455-52
• Status: Completed
• Start date: June 13, 2019
• Est. completion date: February 13, 2020

Study information

• Verified date: August 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: February 13, 2020
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Reconciliation at Discharge

Intervention

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).

Locations

Country	Name	City	State
France	Hopital des Marches de Bretagne	Antrain
France	General Hospital	Fougères
France	General Hospital	Janzé
France	General Hospital	Montfort-sur-Meu
France	University Hospital	Rennes
France	General Hospital	Saint-Méen le Grand

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ecole des Hautes Etudes en Santé Publique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse drug event-related hospital revisits	Rate of adverse drug event-related hospital revisits within 30 days after discharge	30 days after discharge
Secondary	General Practitioner consultation	Rate of General Practitioner consultation within 30 days after discharge	30 days after discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Severity of Unintended Medication Discrepancies	Severity of Unintended Medication Discrepancies intercepted during medication reconciliation at admission	At admission
Secondary	Number of Unintended Medication Discrepancies	Number of Unintended Medication Discrepancies intercepted during medication reconciliation at admission	At admission
Secondary	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