Smoking Interventions for Hospital Patients (Helping HAND)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nancy A. Rigotti, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01177176
First received: August 3, 2010
Last updated: June 17, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • nicotine replacement therapy
  • bupropion
  • varenicline
  • interactive voice response
  • telephone counseling for smoking cessation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177176

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01177176     History of Changes
Other Study ID Numbers: 1RC1HL099668, 1RC1HL099668
Study First Received: August 3, 2010
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Cigarette smoking
Tobacco smoking

Additional relevant MeSH terms:
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 August 20, 2014