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Completed

NCT Number: NCT01177176

Smoking Interventions for Hospital Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended Care Management

Other

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

Standard care

Other

Usual care provided to hospitalized smokers during their inpatient stay, with no post-discharge care management plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Self-reported 7-day point prevalence tobacco abstinence

    Time frame: 6 month follow-up

  4. Self-reported 7-day point prevalence tobacco abstinence

    Time frame: 3 months after hospital dicharge

  5. Self-reported 7-day point prevalence tobacco abstinence

    Time frame: 1 month after hospital discharge

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial

Acronym: Helping HAND

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2010
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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