Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial
Brief Summary: Cigarette smoking is the leading preventable cause of death in the U.S. Nearly 4 million U.S. smokers are hospitalized each year, many of them at high risk for tobacco-related disease or death. A hospital admission provides an opportunity for a smoker to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for \>1 month after discharge. Smoking cessation medications add benefit to counseling but are not often used. The challenge is to translate this efficacy research into routine clinical practice. The major barrier is to make the transition from inpatient to outpatient care. An evidence-based, cost-effective intervention model that can be adopted by U.S. hospitals is needed to realize the potential impact of hospital smoking interventions.

The Specific Aim of this project is to conduct a randomized controlled comparative effectiveness trial of two strategies to promote smoking cessation in hospitalized patients: (1) a hospital-only intervention that meets the current standard of the National Hospital Quality Measures("Standard Care"), and (2) an "Extended Care Management" model with 2 components that aims to encourage and facilitate the sustained use of smoking cessation treatment (counseling and medication use) after discharge in order to achieve long-term abstinence. It adds to Standard Care 3 months of telephone-based contact after discharge and feature 2 innovations: (1) to increase medication use, smokers willing to make a quit attempt receive a free, refillable 30-day sample of their choice of FDA-approved smoking cessation medication at hospital discharge; (2) to increase counseling cost-effectiveness, interactive voice recognition (IVR) technology is used to make automated telephone calls to identify the smokers interested in or most likely to benefit from continued counseling after discharge. The trial will enroll 330 adult smokers admitted to Massachusetts General Hospital, a 900-bed teaching hospital. Outcomes will be measured 1,3 and 6 months after hospital discharge. Study hypotheses are that the enhanced care arm, compared to usual care, is feasible and will increase (1) the use of smoking cessation treatment after discharge, (2) the duration of post-discharge tobacco abstinence, and (3) validated tobacco abstinence 6 months after hospital discharge (primary outcome). The principal secondary outcome measure is self-reported 7-day point prevalence tobacco abstinence after hospital discharge. Other secondary endpoints include self-reported point prevalence abstinence at 1 and 3 months, prolonged abstinence (self-reported tobacco abstinence at 1, 3, and 6 months). The cost-effectiveness (cost per quit) of the interventions will be also be compared.


Options:
A: Arm Label: Standard support; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Reactive (standard) telephone support | Arm Label: Proactive telephone support; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Proactive telephone support | Arm Label: Standard support & offer NRT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Reactive (standard) telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement Therapy | Arm Label: Proactive support & offer NRT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Proactive telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement Therapy | Intervention Type: BEHAVIORAL; Name: Proactive telephone support; Assigned to Arm(s): Proactive support & offer NRT, Proactive telephone support | Intervention Type: BEHAVIORAL; Name: Reactive (standard) telephone support; Assigned to Arm(s): Standard support, Standard support & offer NRT | Intervention Type: DRUG; Name: Offer of voucher for cost-free Nicotine Replacement Therapy; Assigned to Arm(s): Proactive support & offer NRT, Standard support & offer NRT
B: Arm Label: Standard Care; Type: OTHER; Interventions: Other: Standard Care | Arm Label: Extended Care Management; Type: EXPERIMENTAL; Interventions: Other: Extended Care Management | Intervention Type: OTHER; Name: Extended Care Management; Assigned to Arm(s): Extended Care Management | Intervention Type: OTHER; Name: Standard Care; Assigned to Arm(s): Standard Care
C: Arm Label: PRO+NRT+TC; Type: EXPERIMENTAL; Interventions: Other: proactive outreach (PRO), Other: telephone counseling (TC), Other: Nicotine replacement therapy (NRT) | Arm Label: Usual Care (UC); Type: ACTIVE_COMPARATOR; Interventions: Other: Usual care (UC) | Intervention Type: OTHER; Name: proactive outreach (PRO); Assigned to Arm(s): PRO+NRT+TC | Intervention Type: OTHER; Name: telephone counseling (TC); Assigned to Arm(s): PRO+NRT+TC | Intervention Type: OTHER; Name: Nicotine replacement therapy (NRT); Assigned to Arm(s): PRO+NRT+TC | Intervention Type: OTHER; Name: Usual care (UC); Assigned to Arm(s): Usual Care (UC)
D: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Smoking cessation program; Type: EXPERIMENTAL; Interventions: Other: Smoking cessation program | Intervention Type: OTHER; Name: Smoking cessation program; Assigned to Arm(s): Smoking cessation program

Answer: B