Standardized Educational Plan for Epilepsy Patients With Comorbidities
Information source: San Gerardo Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Standardized educational plan (Other); usual care (Other)
Phase: Phase 4
Status: Completed
Sponsored by: San Gerardo Hospital Official(s) and/or principal investigator(s): Simone Beretta, MD, PhD, Study Director, Affiliation: Azienda Ospedaliera San Gerardo Monza
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.
Clinical Details
Official title: Comprehensive Information Imparted to Patients With Epilepsy and Comorbidity and Decreased Prevalence of Adverse Treatment Effects. The EDU-COM Study.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: The mean and median number of adverse treatment events in each treatment arm, at each intermediate visit and at end of studyTotal HRQOL summary score changes (comparing last follow-up to admission visit The mean and median number of drug interactions in each treatment arm, at each intermediate visit and at end of study
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
METHODS Study design. This is a randomized, controlled, open-label, pragmatic trial. Study
population. Patients eligible for inclusion are identified among those consecutively seen in
the outpatient services of the participating units.
Intervention. Patients fulfilling the inclusion/exclusion criteria will be randomized to
receive a comprehensive and standardized educational plan (experimental arm) or to usual
care, ie the management of the adverse event/drug interaction as usually done in clinical
practice and in keeping with each unit's modalities (control arm).
The comprehensive and standardized educational plan consists in the discussion with the
patient and, if available, the caregiver of each of the following points (of which a written
summary will be made available:
- The cause and nature of the adverse event and/or drug interaction
- The tolerability profile of each drug present in the schedule, illustrated as a simple
list including the commonest adverse events presented in decreasing order of frequency
- The clinical manifestations (if any) associated with the current drug interaction(s)
- Any contraindication to the use of over-the-counter drugs potentially interfering with
the current treatment schedule
- The reasons for and the potential benefits of the suggested treatment change
- An encouragement to withdraw any potentially interfering or contraindicated drug or
compounds not unequivocally found to be efficacious for that specific case
Study conduction. After signing the informed consent form, eligible patients will be
immediately randomized to receive the comprehensive and standardized educational plan or to
usual care. Patients assigned to the experimental arm will be given an appointment for a
one-hour private meeting to discuss all the items included in the comprehensive educational
plan. The patients assigned to the control arm will be managed as done in the context of
usual care in that same ambulatory visit. All patients will be seen at one, three and six
months after admission and whenever indicated for the management of the individual case.
Outcomes. These include one primary and a number of secondary outcomes. The primary outcome
is defined by the number of patients free from clinically relevant adverse treatment events
and/or the number of drug interactions in each treatment arm at end of study.
Secondary outcomes include the following:
- The number of patients free from clinically relevant adverse treatment events and/or
drug interactions in each treatment arm at each intermediate visit
- The mean and median number of adverse treatment events in each treatment arm, at each
intermediate visit and at end of study
- The monetary costs of medical contacts, hospital admissions, and drugs; the one-hour
meetings with patients assigned to the experimental arm will be included in the costs.
Costs will be calculated by the healthcare economy service of Mario Negri Institute
according to current national values.
- Total HRQOL summary score changes (comparing last follow-up to admission visit)
- Number of patients with at least weekly omissions of the assigned treatment schedules
Randomization. A centralized randomization procedure will be adopted. Randomization will be
performed by accessing to a user-friendly, protected centralized database, which will
proceed to the assignment to the experimental or control arm after verification of the
appropriateness of the inclusion/exclusion criteria. To control for center-related
confounding, a separate randomization list will be made available for each center.
Blinding (masking). For the purposes of the study, treating and evaluating physicians will
be represented by different persons. Given the diversity between the two management
policies, neither the patients nor the caring physicians involved in administering
interventions will be blind to the assigned arm. An attempt will be made to blind physicians
assessing outcomes.
Statistical analysis. The data will be analyzed using the SPSS-13 package for PC. The
statistical analysis plan will include descriptive statistics to compare the baseline
characteristics of the two populations and the distribution of the treatment schedules, the
number and type of adverse events (present at baseline or occurring during follow-up), and
the proposed changes, along with the cost items (medical contacts, hospitalizations, drug
costs) and the HRQOL scores. For descriptive statistics, the chi-square test, the Student's
t test, the analysis of variance (ANOVA) or equivalent non parametric tests will be used as
appropriate. The chi-square test will be also used to test the number of patients free from
relevant adverse events at end of study (primary end-point) and at each intermediate visit.
The analysis of the primary end-point is based on the intention-to-treat analysis and
includes all randomized patients. Repeated measures ANOVA will be used to compare the
difference between the two treatment arms in the mean change in the number of adverse
events, the number of omitted drug doses, the total monetary costs, and the total HRQOL
scores at each follow-up visit (where applicable) and at study end.
Timing. The duration of the entire study is 24 months with the following distribution:
- Months 1-3: Protocol approval by the local units' ethics committees and preparation of
the electronic database
- Months 4-15: Patients' enrolment
- Months 16-21: Completion of follow-up
- Months 22-24: Data analysis and scientific report An interim assessment of the
recruitment rate will be performed at the end of month 12 to decide whether or not the
enrolment can be completed as expected. If needed, a request will be made to postpone
patients' enrolment to the end of month 21 and the study completion of the end of month
30.
Ethical aspects. Each eligible patient will be properly informed about the study aims, the
use of the diaries, and the requirements to be met at each visit. A summary sheet outlining
the study objectives and conduct will be given to the patient and will be part of the
written informed consent form. The patient will be also instructed about the possibility to
withdraw from the study for any plausible reason without any interference with the
management of his/her disease as done in clinical practice. The confidentiality of the data
collected for the study purposes will be granted by giving access (through nominal username
and password) only to persons officially involved in the study conduction. The data will be
managed without disclosing the patients' identity.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Azienda Ospedaliera San Gerardo, Central Contact (9 recruting centers), Monza, MB 20900, Italy
Additional Information
Starting date: February 2009
Last updated: March 5, 2013
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