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NCT Number: NCT04018781

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.

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Key information

Conditions

Medication Reconciliation At Discharge

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital des Marches de Bretagne, Antrain, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Adverse drug event-related hospital revisits

    Time frame: 30 days after discharge

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

Secondary outcomes

  1. General Practitioner consultation

    Time frame: 30 days after discharge

    Rate of General Practitioner consultation within 30 days after discharge

  2. All-causes readmissions and/or Emergency Department visits

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: At admission

    Severity of Unintended Medication Discrepancies intercepted during medication reconciliation at admission

  8. Number of Unintended Medication Discrepancies

    Time frame: At admission

    Number of Unintended Medication Discrepancies intercepted during medication reconciliation at admission

  9. Impact of the implementation of the intervention on professional organizations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ecole des Hautes Etudes en Santé Publique

Registry information

Official study title

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

Acronym: CONPARMED

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 15, 2019
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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