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Smoking Interventions for Hospital Patients (Helping HAND)

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ClinicalTrials.gov Identifier: NCT01177176
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : September 18, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nancy A. Rigotti, Massachusetts General Hospital

August 3, 2010
August 6, 2010
September 18, 2014
July 2010
November 2012   (Final data collection date for primary outcome measure)
Validated 7-day point prevalence tobacco abstinence [ Time Frame: 6 months after discharge ]
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
Validated 7-day point prevalence tobacco abstinence [ Time Frame: 3 months after discharge ]
7-day point prevalence tobacco abstinence, validated by saliva cotinine <= 10 ng/ml
Complete list of historical versions of study NCT01177176 on ClinicalTrials.gov Archive Site
  • Use of tobacco treatment after hospital discharge [ Time Frame: during 3 months and 6 months 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
  • Duration of tobacco abstinence after hospital discharge [ Time Frame: Up to 6 months after hospital discharge ]
    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 ]
  • Self-reported 7-day point prevalence tobacco abstinence [ Time Frame: 3 months after hospital dicharge ]
  • Self-reported 7-day point prevalence tobacco abstinence [ Time Frame: 1 month after hospital discharge ]
  • Prolonged tobacco abstinence [ Time Frame: at 1, 3, and 6 months after hospital discharge ]
    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 ]
    Self-reported continuous tobacco abstinence at (1) 1 month, (2) 3 months and (3) 6 months after hospital discharge
  • Use of tobacco treatment after hospital discharge [ Time Frame: during 3 months 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
  • Duration of tobacco abstinence after hospital discharge [ Time Frame: Up to 3 months after hospital discharge ]
    Number of days that patient reports not smoking any tobacco product after hospital discharge
Not Provided
Not Provided
 
Smoking Interventions for Hospital Patients
Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cigarette Smoking
  • 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:
    • nicotine replacement therapy
    • bupropion
    • varenicline
    • interactive voice response
    • telephone counseling for smoking cessation
  • Other: Standard Care
    Usual care provided to hospitalized smokers during their inpatient stay, with no post-discharge care management plan
  • 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.
    Intervention: Other: Standard Care
  • 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.
    Intervention: Other: Extended Care Management

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
397
330
December 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01177176
1RC1HL099668( U.S. NIH Grant/Contract )
1RC1HL099668 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Nancy A. Rigotti, Massachusetts General Hospital
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
Massachusetts General Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP