Smoking Interventions for Hospital Patients

Study Overview
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Brief Summary
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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.

Official Title
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Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Other: Extended Care Management
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cigarette smoker (daily smoker when smoking in usual way during the month before hospital admission) Counseled by hospital smoking counselor during hospital stay Plans to stop smoking tobacco products after hospital discharge Appropriate for use of smoking cessation medication after discharge Exclusion Criteria: Expected hospital length of stay <24 hours Not expected to be discharged to home No access to a telephone Unable to communicate by telephone Severe psychiatric or neurologic disease precluding ability to be counseled Pregnant, nursing, or planning to become pregnant in next 3 months Active substance abuse other than tobacco Unable to speak English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Care<br>Standard tobacco counseling provided to hospital inpatients as part of routine, clinical-guideline compliant care in the study hospital. No post-discharge treatment is offered in this arm. | Other: Standard Care<br>* Usual care provided to hospitalized smokers during their inpatient stay, with no post-discharge care management plan<br>|
| Experimental: Extended Care Management<br>In addition to Standard Care, subjects in this arm receive Extended Care Management intervention to facilitate the continued use of smoking cessation treatment (counseling and medication use) after hospital discharge. This consists of 3 months of telephone-based contact after discharge. | Other: Extended Care Management<br>* Telephone-based care management of tobacco cessation for 3 months after hospital discharge that features 2 innovations: (1) to increase medication use, smokers receive a free refillable 30-day sample of their choice of FDA-approved smoking cessation medication (nicotine replacement, bupropion, or varenicline) 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 seeking or most likely to benefit from continued counseling after hospital discharge.<br>* Other names: telephone counseling for smoking cessation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated 7-day point prevalence tobacco abstinence | 7-day point prevalence tobacco abstinence, validated by saliva cotinine <= 10 ng/ml or if using NRT, expired air CO <=9ppm, or confirmation by proxy | 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of tobacco treatment after hospital discharge | patient-reported receipt of either smoking cessation counseling (defined as contact in person or by telephone) or smoking cessation pharmacotherapy (use of nicotine replacement therapy, bupropion, or varenicline)in the 3 months after hospital discharge | during 3 months and 6 months after hospital discharge | 
| Duration of tobacco abstinence after hospital discharge | Number of days that patient reports not smoking any tobacco product after hospital discharge | Up to 6 months after hospital discharge | 
| Self-reported 7-day point prevalence tobacco abstinence |  | 6 month follow-up | 
| Self-reported 7-day point prevalence tobacco abstinence |  | 3 months after hospital dicharge | 
| Self-reported 7-day point prevalence tobacco abstinence |  | 1 month after hospital discharge | 
| Prolonged tobacco abstinence | Self-reported 7-day point prevalence abstinence at each of 3 time points: 1 month, 3 months, and 6 months after hospital discharge | at 1, 3, and 6 months after hospital discharge | 
| Continuous tobacco abstinence | Self-reported continuous tobacco abstinence at (1) 1 month, (2) 3 months and (3) 6 months after hospital discharge | Up to 6 months after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cigarette smoking, Tobacco smoking