Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comprehensive Information Imparted to Patients With Epilepsy and Comorbidity and Decreased Prevalence of Adverse Treatment Effects. The EDU-COM Study.
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.


Options:
A: Inclusion Criteria:

* Aged 65 years and older
* Medicare Part A and B traditional, fee for service insurance coverage
* One or more of the following chronic conditions:
* Heart failure
* Coronary Disease
* Diabetes mellitus
* Asthma
* Hypertension
* Hypercholesterolemia
* A Geriatric Risk Stratification Level of 2 or more based on a pre-enrollment screening tool
* Geriatric Risk Stratification Level changed in Sep 2006 to a Level of 3 or more
* Willingness of the participant's primary care provider to collaborate

Exclusion Criteria:

* Amyotrophic lateral sclerosis
* Alzheimer's disease
* Dementia
* Diagnosis or history of cancer (other than skin) in the past 5 years
* End-stage renal disease
* Life expectancy on enrollment less than 6 months
* HIV or AIDS
* Huntington's disease
* Organ transplant candidate
* Psychosis or schizophrenia
* Resident of or imminent plan for long-term nursing home placement
* Seasonal relocation outside of the area for more than 4 weeks per year
* Anyone receiving service from Health Quality Partners in the past
B: 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
C: Inclusion Criteria:

* Seeking treatment at the primary or specialty care site, and be planning to continue living in the area of that clinic for the duration of the study
* Meets clinical criteria for nonpsychotic MDD, recurrent (with the current episode being at least 2 months in duration), or chronic (current episode greater than 2 years) as defined by a clinical interview and confirmed by the MINI International Neuropsychiatric Interview (MINI)
* Screening 17 item HRSD score of 16 or greater
* Treatment with antidepressant medication combinations is clinically acceptable
* Patient with and without current suicidal ideation may be included in the study as long as outpatient treatment is clinically appropriate

Exclusion Criteria:

* Pregnant or breastfeeding
* Plans to become pregnant over the ensuing 8 months following study entry or are sexually active and not using adequate birth control
* History (lifetime) of psychotic depression, schizophrenia, bipolar (I, II, or NOS), schizoaffective, or other Axis I psychotic disorders
* Current psychotic symptom(s)
* History (within the last 2 years before study entry) of anorexia or bulimia
* Current primary diagnosis of obsessive compulsive disorder
* Current substance dependence that requires inpatient detoxification or inpatient treatment
* Requiring immediate hospitalization for a psychiatric disorder
* Definite history of intolerance or allergy (lifetime) to any protocol medication
* History of clear nonresponse to an adequate trial of an FDA-approved monotherapy in the current MDE if recurrent, or during the last 2 years before study entry if chronic
* History of clear nonresponse to an adequate trial of any study medication used as a monotherapy, or to one or more of the protocol combinations in the current or any prior MDE
* Currently taking any of the study medications at any dose
* Having taken Prozac (fluoxetine) or an MAOI in the 4 weeks before study entry
* Presence of an unstable general medical condition (GMC) that will likely require hospitalization or to be deemed terminal (life expectancy less than 6 months after study entry)
* Currently taking medications or have GMCs that contraindicate any study medications (e.g., seizure disorder)
* Requiring medications for GMCs that contraindicate any study medication
* Epilepsy or other conditions requiring an anticonvulsant
* Lifetime history of having a seizure including febrile or withdrawal seizures
* Receiving or have received vagus nerve stimulation (VNS), electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or other somatic antidepressant treatments
* Currently taking or having taken within the 7 days before study entry any of the following exclusionary medications: antipsychotic medications, anticonvulsant medications, mood stabilizers, or central nervous system stimulants (antidepressant medication used for the treatment of depression or other purposes such as smoking cessation or pain are excluded since these agents may interfere with the testing of the major hypotheses under study)
* Uncontrolled narrow angle glaucoma
* Taking thyroid medication for hypothyroidism may be included only if stable on the medication for 3 months
* Using agents within the 7 days before study entry that are potential augmenting agents (e.g., T3 in the absence of thyroid disease, SAMe, St. John's Wort, lithium, buspirone)
* Therapy that is depression-specific
D: Inclusion Criteria:

* Workers with at least one chronic physical condition (\> 6 months).
* Working full time (at least 20 hours per week).
* Able to read and speak in English language.

Exclusion Criteria:

* Impending retirement or major career change (next 12 months).
* Not available to attend group workshops after working hours.

Answer: B