Impact of Pharmaceutical Interviews on the Medication Adherence of Epileptic Patients (EPIPHARM)

Study of the Impact of Pharmaceutical Interventions on the Medication Adherence of Epileptic Patients and Their Medication Knowledge

Many studies have reported a disparity in medication adherence among epileptic patients. In this population, Medication Possession Ratio (MPR) is an index of medication adherence. MPR is defined as the ratio of the number of days of treatment delivered to the number of days in the period of interest.

No-adherents patients are defined by a MPR of less than 80% , in whom an increase in seizures and the rate of hospitalization can be observed. A pharmacist-led intervention and medication information to epileptic patients could improve patient medication adherence to antiepileptic drugs, and possibly decrease the frequency of seizures, hospitalizations and the health costs generated by these hospitalizations. This intervention could also improve patient knowledge about their medications.

The aim of this study is to evaluate the effectiveness of a pharmacist-led intervention on medication adherence of epileptic patients with the MPR. Secondary objectives include the comparison of medication adherence with health insurance score, the evaluation of patients knowledges about their medications, community pharmacists' satisfaction about community hospital network, the comparison of the seizure free patient rate and the comparison of the rate of patient in whom seizure have decreased by 50%

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Other: Pharmacist intervention; Other: Standard of care

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe DERAMBURE, MD,PhD; Phone Number: +33 0320445962; Email: philippe.derambure@chru-lille.fr
• Study Contact Backup: Name: Fanny MOREAU, PhD; Phone Number: +33 0320445962; Email: fanny.moreau@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hôpital Roger Salengro, CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Epileptic patients seeing a neurologist in the neurophysiology clinic with a regular follow-up by the Lille University Hospital reference center
• Adult over 18 years old
• Living at home
• Socially insured patient
• In the case of cognitive problems, the presence of a reliable caregiver managing the medications

Exclusion Criteria:

• Inpatients
• Patient under curatorship, guardianship and/or institutionalized
• Dementia
• Patient who has participated in a therapeutic education program (TEP) about his epilepsy within the previous two years
• Administrative reasons: impossibility to receive informed information, impossibility to participate in the entire study, lack of coverage by the social security system, refusal to sign the consent form.
• Switching to home care by a registered nurse for treatment management

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist-led intervention	Other: Pharmacist intervention; In the intervention arm, the patient meets with the pharmacist. Pharmaceutical intervention (H1) about anti-epileptic drugs prescribed will be done: information on when to take the medication, what to do if you forget to take it or vomit, and an explanation of adverse events. The aim is to improve medication adherence and patient knowledge. A report will be sent to the community pharmacist. An assessment of medication adherence to antiepileptic drug by MPR at H1 3 months and 6 months (phone call to community pharmacist) will be done. The health insurance score will also be done. An assessment of patient knowledge by a self-made knowledge questionnaire (10 items) at H1 in pre- post interview -, 3 and 6 months (phone call to patient) will be done. An assessment of pharmacists' satisfaction about community hospital network by a satisfaction questionnaire will be done.
Sham Comparator: Standard of care	Other: Standard of care; An assessment of medication adherence to antiepileptic drug by MPR at the inclusion then 3 months and 6 months later will be done by a phone call to the community pharmacist. An assessment of patient knowledge by a self-made knowledge questionnaire (10 items) at the inclusion then 3 and 6 months later will be done by a phone call to the patient. The health insurance score will be also done during this call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Possession Ratio (MPR)	Compare adherence to antiepileptic drugs between patients who received pharmacist led intervention and those who did not by Medication Possession Ratio (MPR) 3 months after inclusion	at 3 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Possession Ratio (MPR)	Compare adherence to antiepileptic drugs between patients who received pharmacist led intervention and those who did not by Medication Possession Ratio (MPR) 6 months after inclusion	at 6 months after inclusion
Rate of MPR >80 percent	Compare the rate of adherent patients rate (MPR > 80 percent) between the two arms at 3 and 6 months	at 3 months and 6 months
Pharmaceutical interview measured by responses to the knowledge Questionnaire (10-point score)	Evaluate the development (before vs after led pharmacist intervention) and maintenance of patient knowledge of patients received pharmacist intervention and compare them to the patient knowledge who received conventional management.	at 1 hour, 3 months and 6 months
Satisfaction score on a Likert scale (score 1 to 5)	Evaluate the satisfaction of community pharmacist about community hospital network by a satisfaction questionnaire in the intervention group	at 3 months and 6 months
Assessment of health insurance score (Score 0 to 6)	Compare drug adherence via the health insurance score between the 2 arms	at 3 months and 6 months
Rate of patients with no seizures	Compare the rate of seizure free patients between the two arms	at 6 months
Rate of patient in whom seizure have decreased by 50 percent	Compare the rate of patient in whom seizure have decreased by 50 percent between the two arms	at 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Philippe DERAMBURE, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: epilepsy; Treatment adherence; hospital pharmacy; clinical pharmacy; pharmacist intervention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 2020_84; 2021-A00578-33 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

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