Comprehensive Information Imparted to Patients With Epilepsy and Comorbidity and Decreased Prevalence of Adverse Treatment Effects. The EDU-COM Study.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 187
- Locations
- 2
- Primary Endpoint
- The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study.
Study Overview
Brief Summary
Epilepsy requires long-term drug treatment and is frequently associated with other clinical conditions. Combinations of antiepileptic drugs and other compounds are fairly common and increase with age. Adverse drug reactions and drug interactions are expected and may affect compliance, particularly in patients not receiving adequate information. Primary objective of the study is to verify if a comprehensive and standardized educational plan is followed by a significant reduction of the number of adult patients with epilepsy and comorbidity presenting clinically relevant adverse treatment effects. Secondary objectives include effects on number of adverse treatment events, health-related quality of life (HRQOL), direct medical costs, and patient's compliance. The study is a randomized, controlled, open-label, pragmatic trial. Included are consecutive adult outpatients with 1+ concurrent clinical conditions on chronic treatment and at least one clinically relevant treatment-related adverse event and/or clinically relevant drug interaction. Eligible patients will be randomized to receive a comprehensive and standardized educational plan (experimental arm) or to usual care, ie management of adverse event/drug interaction as done in clinical practice (control arm). The experimental plan consists in discussing with patient and caregiver the cause and nature of adverse event/drug interaction, the tolerability profile of each drug, the clinical manifestations associated with current drug interaction(s), contraindications of potentially interfering over-the-counter drugs, indications and benefits of suggested treatment changes, and withdrawal of potentially interfering, contraindicated or ineffective drugs. All patients will be seen at one, three and six months after admission.
Expected results: The number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study is expected to be higher in patients assigned to comprehensive and standardized educational plan compared to usual care (primary outcome). Patients on the experimental plan are also expected to be more commonly free from relevant adverse events and/or drug interactions at each intermediate visit, to present a lower number of adverse treatment events, to imply lower costs for medical contacts, hospital admissions, and drugs, to present better HRQOL scores, and to present less weekly treatment omissions.
Detailed Description
OBJECTIVES OF THE STUDY The primary objective of the study is to verify whether or not a comprehensive and standardized educational plan is followed by a significant reduction of the number of adult patients with epilepsy and comorbidity presenting clinically relevant adverse treatment effects.
Secondary objectives include the effects of the following comprehensive and standardized educational plan:
- Reduction of the total number of adverse treatment events
- Reduction of the number of medical contacts
- Improvement of the health-related quality of the patient's life (HRQOL)
- Reduction of the direct costs of the health care assistance
- Improvement of the patient's compliance
The hypothesis to be tested is that a comprehensive and standardized educational plan is superior to the present modalities adopted to manage treatment safety in clinical practice for the following reasons:
- It raises the level of attention towards the putative adverse effects of the drugs currently taken and the possible drug interactions
- It helps identifying any clinically relevant event at onset to prevent the occurrence of symptoms or signs leading to medical contact and hospital admission
- It educates the patient to live with the treatment schedule representing the best compromise in terms of safety
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Presence of one or more concurrent clinical conditions requiring chronic treatment (ie, daily treatment lasting one month or longer)
- •At least one clinically relevant adverse event attributable to the present treatment(s) and/or a clinically relevant drug interaction; for the purposes of this study, a clinically relevant adverse event is any symptom and/or clinical and/or laboratory sign requiring treatment change; a clinically relevant drug interaction is an interaction requiring active monitoring and/or treatment change
- •The treatment schedule can be modified to eliminate adverse event(s) and/or risky drug interactions; the decision to modify the treatment is left to the caring physician's judgment
Exclusion Criteria
- •Age younger than 18 years
- •Absence of concurrent chronic treatments
- •Presence of polytherapy with AEDs unassociated to treatments for concurrent (non-epileptic) disorders
- •The treatment schedule cannot be changed even at the presence of clinically relevant adverse events
- •Patient is unable to understand or comply with an educational plan; the application of this exclusion criterion is left to the caring physician's judgment
- •Patient or caregiver is unwilling to release a written informed consent
Outcomes
Primary Outcomes
The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study.
Time Frame: 6 months
Secondary Outcomes
- The mean and median number of adverse treatment events in each treatment arm, at each intermediate visit and at end of study(6 months)
- Total HRQOL summary score changes (comparing last follow-up to admission visit(6 months)
- The mean and median number of drug interactions in each treatment arm, at each intermediate visit and at end of study(6 months)
Investigators
Dr. Simone Beretta
MD, PhD, Research Neurologist (Study Coordinator)
San Gerardo Hospital