Clinical trial NCT04018781: Guaranteeing the Continuity of the Care Pathway for the Elderly Patient: Evaluation of a Territorial Approach of Clinical Pharmacy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Reconciliation at Discharge
Keywords: Medication reconciliation
clinical pharmacy
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ecole des Hautes Etudes en Santé Publique
First posted: 2019-07-15
Enrollment: 443
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse drug event-related hospital revisits
timeFrame: 30 days after discharge
Secondary outcomes:
measure: General Practitioner consultation
timeFrame: 30 days after discharge
measure: All-causes readmissions and/or Emergency Department visits
timeFrame: 30 days after discharge
measure: All-causes readmissions and/or Emergency Department visits
timeFrame: 90 days after discharge
measure: Incremental Cost-Effectiveness Ratio (ICER) at Day 30
timeFrame: 30 days after discharge
measure: Incremental Cost-Effectiveness Ratio (ICER) at Day 90
timeFrame: 90 days after discharge
measure: Patient reported experience measures
timeFrame: 7 days after discharge
measure: Severity of Unintended Medication Discrepancies
timeFrame: At admission
measure: Number of Unintended Medication Discrepancies
timeFrame: At admission
measure: Impact of the implementation of the intervention on professional organizations
timeFrame: Before and after the implementation of the intervention in the participating wards
Other outcomes:
Locations:
city: Antrain
country: France
facility: Hopital des Marches de Bretagne
city: Fougères
country: France
facility: General Hospital
city: Janzé
country: France
facility: General Hospital
city: Montfort-sur-Meu
country: France
facility: General Hospital
city: Rennes
country: France
facility: University Hospital
city: Saint-Méen le Grand
country: France
facility: General Hospital
Study officials:
affiliation: University Hospital of Rennes
name: Benoit HUE, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.