Smoking Interventions for Hospital Patients (Helping HAND)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cigarette Smoking |
Other: Extended Care Management Other: Standard Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial |
- Validated 7-day point prevalence tobacco abstinence [ Time Frame: 6 months after discharge ] [ Designated as safety issue: No ]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
- Use of tobacco treatment after hospital discharge [ Time Frame: during 3 months and 6 months after hospital discharge ] [ Designated as safety issue: No ]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
- Duration of tobacco abstinence after hospital discharge [ Time Frame: Up to 6 months after hospital discharge ] [ Designated as safety issue: No ]Number of days that patient reports not smoking any tobacco product after hospital discharge
- Self-reported 7-day point prevalence tobacco abstinence [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
- Self-reported 7-day point prevalence tobacco abstinence [ Time Frame: 3 months after hospital dicharge ] [ Designated as safety issue: No ]
- Self-reported 7-day point prevalence tobacco abstinence [ Time Frame: 1 month after hospital discharge ] [ Designated as safety issue: No ]
- Prolonged tobacco abstinence [ Time Frame: at 1, 3, and 6 months after hospital discharge ] [ Designated as safety issue: No ]Self-reported 7-day point prevalence abstinence at each of 3 time points: 1 month, 3 months, and 6 months after hospital discharge
- Continuous tobacco abstinence [ Time Frame: Up to 6 months after hospital discharge ] [ Designated as safety issue: No ]Self-reported continuous tobacco abstinence at (1) 1 month, (2) 3 months and (3) 6 months after hospital discharge
| Estimated Enrollment: | 330 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Standard Care
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
Usual care provided to hospitalized smokers during their inpatient stay, with no post-discharge care management plan
|
|
Experimental: Extended Care Management
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
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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Nancy A Rigotti, MD | 617-724-4709 | nrigotti@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Nancy A Rigotti, MD 617-724-4709 nrigotti@partners.org | |
| Principal Investigator: | Nancy A Rigotti, MD | Massachusetts General Hospital |
More Information
No publications provided by Massachusetts General Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nancy A. Rigotti, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01177176 History of Changes |
| Other Study ID Numbers: | 1RC1HL099668, 1RC1HL099668 |
| Study First Received: | August 3, 2010 |
| Last Updated: | April 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Cigarette smoking Tobacco smoking |
Additional relevant MeSH terms:
|
Smoking Habits Bupropion Varenicline Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013