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

Sponsor
Rennes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04018781
Collaborator
Ecole des Hautes Etudes en Santé Publique (Other)
443
6
8
73.8
9.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
443 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jun 13, 2019
Actual Primary Completion Date :
Nov 13, 2019
Actual Study Completion Date :
Feb 13, 2020

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Adverse drug event-related hospital revisits [30 days after discharge]

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

Secondary Outcome Measures

  1. General Practitioner consultation [30 days after discharge]

    Rate of General Practitioner consultation within 30 days after discharge

  2. All-causes readmissions and/or Emergency Department visits [30 days after discharge]

    Composite rate of readmissions and/or Emergency Department visits within 30 days after discharge

  3. All-causes readmissions and/or Emergency Department visits [90 days after discharge]

    Composite rate of readmissions and/or Emergency Department visits within 90 days after discharge

  4. Incremental Cost-Effectiveness Ratio (ICER) at Day 30 [30 days after discharge]

    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.

  5. Incremental Cost-Effectiveness Ratio (ICER) at Day 90 [90 days after discharge]

    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.

  6. Patient reported experience measures [7 days after discharge]

    Patient reported experience measures are realized by a short phone call interview, 7 days after the patients' homecoming

  7. Severity of Unintended Medication Discrepancies [At admission]

    Severity of Unintended Medication Discrepancies intercepted during medication reconciliation at admission

  8. Number of Unintended Medication Discrepancies [At admission]

    Number of Unintended Medication Discrepancies intercepted during medication reconciliation at admission

  9. Impact of the implementation of the intervention on professional organizations [Before and after the implementation of the intervention in the participating wards]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital des Marches de Bretagne Antrain France 35560
2 General Hospital Fougères France 35306
3 General Hospital Janzé France 35150
4 General Hospital Montfort-sur-Meu France 35160
5 University Hospital Rennes France 35000
6 General Hospital Saint-Méen le Grand France 35290

Sponsors and Collaborators

  • Rennes University Hospital
  • Ecole des Hautes Etudes en Santé Publique

Investigators

  • Study Director: Benoit HUE, MD, PhD, University Hospital of Rennes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT04018781
Other Study ID Numbers:
  • 35RC19_30022
  • 2019-A00455-52
First Posted:
Jul 15, 2019
Last Update Posted:
Aug 5, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rennes University Hospital

Study Results

No Results Posted as of Aug 5, 2021