Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
Brief Summary: Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized each year, and hospital admission offers a "teachable moment" for intervention. Hospital-initiated smoking cessation intervention is effective, but only if contact continues for more than 1 month after discharge. The challenge is to translate this research into clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals can adopt. The major barrier is sustaining contact after discharge. This project tests an innovative strategy to streamline the delivery and maximize the uptake of post-discharge smoking interventions.

Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of evidence-based tobacco treatment (counseling and medication) after hospital discharge, thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco abstinence.

Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All subjects will receive a brief in-hospital smoking intervention and be randomly assigned at discharge to either Standard Care (passive referral to their state quitline) or Extended Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.

Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month follow-up \[primary outcome\] and other tobacco abstinence measures); (2) treatment utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine the intervention's effect on hospital readmissions and mortality in the 6 months after discharge.


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:

* Cigarette smoker (smoked at least 1 cigarette in the month before hospital admission and at least 1 cigarette per day when smoking at baseline rate in the month before hospital admission)
* Counseled by hospital smoking counselor during hospital stay
* Plans to stop smoking tobacco products after hospital discharge
* Agrees to take home a supply of smoking cessation medication after discharge
* Agrees to and able to accept telephone calls after hospital discharge

Exclusion Criteria:

* No access to a telephone or unable to communicate by telephone
* Severe psychiatric or neurologic disease precluding ability to provide informed consent and to be counseled
* Pregnant, nursing, or planning to become pregnant in next 3 months
* Unable to speak English
* Medical instability precluding study participation
C: Inclusion Criteria:

1. \>1 ICD9 Diagnosis 401.0, 401.1, 401.9
2. Designated Primary Care Provider
3. \>1 Primary Care visit between 1/01/01-12/31/01
4. Restricted to NC and VA addresses
5. \>1 Medication CV100, CV150, CV200, CV490, CV701, CV702, CV704, CV800, CV805

Exclusion Criteria:

1. Dialysis patient
2. Hospitalization for stroke in prior 3 months
3. Myocardial infarction in prior 3 months
4. Coronary artery revascularization in prior 3 months
5. Metastatic cancer diagnosis in prior 3 months
6. Transplant of: kidney; liver; lung; pancreas; peripheral stem cells; bone; bone marrow; heart; intestine; stem cells; tissue V42.9; complications of transplants
7. Nursing home resident
8. Documented diagnosis of dementia
9. Difficulty hearing
D: Inclusion Criteria:

* DSM-IV criteria for alcohol abuse or dependence
* Age 18 or older
* English speaking
* Smoking 1 or more cigarettes/day
* Male or female veterans eligible for VA healthcare
* Female nonveterans also eligible

Exclusion Criteria:

* Allergy or hypersensitivity to nicotine or adhesives used in nicotine patch
* Weigh less than 100 lbs
* Lack of interest in stopping smoking
* Pregnant or lactating females or females not practicing acceptable form of contraception

Answer: B