Please select the arm or intervention descriptions that belong 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: Arm Label: Dexpramipexole; Type: EXPERIMENTAL; Interventions: Drug: Dexpramipexole | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Dexpramipexole; Assigned to Arm(s): Dexpramipexole | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Standard care; Type: OTHER; Interventions: Behavioral: Standard Care | Arm Label: Sustained Care; Type: EXPERIMENTAL; Interventions: Behavioral: Sustained Care | Intervention Type: BEHAVIORAL; Name: Sustained Care; Assigned to Arm(s): Sustained Care | Intervention Type: BEHAVIORAL; Name: Standard Care; Assigned to Arm(s): Standard care
C: Arm Label: Arm 1; Type: OTHER; Interventions: Behavioral: Telephone behavioral education, Behavioral: Computer behavioral education | Intervention Type: BEHAVIORAL; Name: Telephone behavioral education; Assigned to Arm(s): Arm 1 | Intervention Type: BEHAVIORAL; Name: Computer behavioral education; Assigned to Arm(s): Arm 1
D: Arm Label: 1 concurrent smoking cessation; Type: EXPERIMENTAL; Interventions: Behavioral: behavioral counseling plus contingency management | Arm Label: 2 deferred smoking cessation; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: behavioral counseling plus contingency management | Intervention Type: BEHAVIORAL; Name: behavioral counseling plus contingency management; Assigned to Arm(s): 1 concurrent smoking cessation, 2 deferred smoking cessation

Answer: B