Please select the eligibility criteria that correspond to the clinical trial below.
Title: Tobacco Treatment Outreach to Reduce Disparities for Primary Care Populations
Brief Summary: The objectives of this project are to develop and evaluate a multi-level approach to tobacco treatment for low-SES and minority patients. The components of this intervention would include Integrated Voice Response(IVR)-facilitated systematic outreach, linkage to a tobacco treatment specialist, free Nicotine Replacement Therapy (NRT) directed at the patient, and integration of this program with both an individual's primary care physician through an electronic health record (EHR), as well as referral to community resources to address the socio-contextual barriers to tobacco cessation. To achieve these objectives, this intervention will test an innovative model of systematic outreach to low-SES and minority smokers using systematic phone outreach (including cell phones which are particularly prevalent among minority and low-SES groups), coordinated with the PCP, using both a cost-effective technology and a dedicated tobacco treatment specialist to increase smoking cessation in these populations. The proposed intervention will have multiple levels of influence (patient, PCP) and provide linkages to community resources. If successful, this model could be generalized to other health systems with an EHR, which are increasingly being promoted to improve the safety and quality of health care.

Hypothesis 1 (Reach and Effectiveness): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can reach these patients to increase quit rates and use of tobacco treatment effectively.

Hypothesis 2 (Adoption and Implementation): An EHR-linked, IVR-mediated personalized treatment program for low-SES and minority smokers can be adopted across a variety of practice settings and be consistently implemented across diverse patient populations.


Options:
A: Inclusion Criteria:

* Aged 18 to 80 years old, inclusive, on Day 1.
* Diagnosis of sporadic or familial ALS.
* Onset of first ALS symptoms within 24 months prior to Day 1.
* World Federation of Neurology El Escorial criteria are met for a possible, laboratory-supported probable, probable, or definite ALS diagnosis.
* Upright slow vital capacity (SVC) of 65% or more at screening.
* Patients taking or not taking Riluzole are eligible for this study: if a patient has never taken Riluzole, he or she is eligible; if a patient is currently taking Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient has discontinued Riluzole, he or she must have stopped taking it for at least 30 days.
* Must be able to swallow tablets at the time of study entry.

Exclusion Criteria:

* Other medically significant illness.
* Clinically significant abnormal laboratory values.
* Pregnant women or women breastfeeding.
* Prior exposure to dexpramipexole.
* Currently taking pramipexole or other dopamine agonists.

Other protocol-defined inclusion/exclusion criteria may apply.
B: Inclusion Criteria:: 1) men and women aged \>40 years participating in supervised Phase II CR. The CR population tends to be older (mean age: 64.5+11.9, range 38-83 years, Preliminary Studies C.6.) and by including adults as young as 40 years, we expect to offer the program to the majority of Phase II CR patients. (2) scheduled to complete Phase II CR in the next 4 weeks, 3) able to read and speak English, 4) provide consent for medical chart review to extract disease and treatment variables, 5) able to walk unassisted. 6) We plan to include patients who participated in Phase II CR due to a diagnosis of coronary heart disease (e.g., post- MI, CABG, chronic angina pectoris) or chronic heart failure.

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Exclusion Criteria:1) Prior neurological brain disorder (e.g., Seizure Disorder, Traumatic Brain Injury. Patients with prior neurological disease, including large vessel stroke and Alzheimer's Disease will be excluded. 2) An arbitrary Mini-Mental Status Examination (MMSE) cutoff score of \>10 will be set to exclude patients whose scores suggest dementia or cognitive impairments that will interfere with ability to provide informed consent and complete research demands.

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C: Inclusion Criteria:

* Hypertension, hypercholesterolemia, and/or diabetes mellitus, all of which are treated with medication, measured in the clinic, or confirmed by primary care provider (systolic blood pressure greater than or equal to 140 mm Hg, diastolic blood pressure greater than or equal to 90 mm Hg, low density lipoprotein cholesterol \[LDL-C\] greater than or equal to 130 mg/dL, or fasting blood sugar greater than 125 mg/dL)
* BMI of at least 30 to 50 kg/m2 and weight less than or equal to 400 lbs
* Willing to change diet, physical activity, and weight
* Willing to be randomly assigned to any of the study groups
* Patient of a participating doctor
* Patient self-reports two doctor visits in the 12 months before study entry
* Demonstrated use of Web and e-mail
* Access to Internet at least 4 days per week
* People with the following conditions are eligible to enroll in the study with primary care provider approval:

  1. Diabetes mellitus
  2. Prior cardiovascular disease event more than 6 months before study entry
  3. Known stable cardiovascular disease or peripheral vascular disease
  4. Screen positive on Rose Questionnaire

Exclusion Criteria:

* Heart attack, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in the 6 months before study entry
* Serious medical condition that is likely to hinder accurate measurement of weight, for which weight loss is not advisable, or that would cause weight loss \[e.g., end-stage renal disease (ESRD) on dialysis, cancer diagnosis or treatment in the 2 years before study entry\]
* Prior or planned bariatric surgery
* Use of prescription weight loss medication, including off-label drugs (e.g., topiramate, bupropion, byetta) or over-the-counter orlistat in the 6 months before study entry
* Long-term use (in the 6 months before study entry) of medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine)
* Unintentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
* Intentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
* Pregnant or breastfeeding in the 6 months before study entry
* Planning to become pregnant in the 2 years after study entry
* Planning to relocate from area in the 2 years after study entry
* Another member of the household is a study participant or study staff member
* Self-reported average consumption of more than 14 alcoholic drinks each week
* Psychiatric hospitalization in the 1 year before study entry
* Unstable angina
* Blood pressure greater than 160/100 mm Hg
D: Inclusion Criteria:

* Must be 18 years of age or older.
* Must be a current smoker.
* Must receive primary care at one of the participating clinics.
* Must have had a PCP visit within the last month at a participating clinic.
* Must have a working phone number listed in Partner's database.
* Must report race /ethnicity as African American or Hispanic or live in a low-SES block group (a census block group with a median income of \< $65,000).
* Must speak English or Spanish.

Exclusion Criteria:

* Hearing impaired patients who cannot use the telephone.

Answer: D