Smoking Interventions for Hospital Patients

Cigarette Smoking Clinical Trial

— Helping HAND  

Official title:

Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177176
• Other study ID #: 1RC1HL099668
• Secondary ID: 1RC1HL099668
• Status: Completed
• Phase: N/A
• First received: August 3, 2010
• Last updated: September 16, 2014
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: September 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rigotti NA, Regan S, Levy DE, Japuntich S, Chang Y, Park ER, Viana JC, Kelley JH, Reyen M, Singer DE. Sustained care intervention and postdischarge smoking cessation among hospitalized adults: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):719-28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Self-reported 7-day point prevalence tobacco abstinence		6 month follow-up	No
Secondary	Self-reported 7-day point prevalence tobacco abstinence		3 months after hospital dicharge	No
Secondary	Self-reported 7-day point prevalence tobacco abstinence		1 month after hospital discharge	No
Secondary	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	No
Secondary	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	No