Smoking Interventions for Hospital Patients (Helping HAND)

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Other: Standard Care; Other: Extended Care Management

• Study Type: Interventional
• Enrollment (Actual): 397
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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: varenicline; bupropion; nicotine replacement therapy; interactive voice response; telephone counseling for smoking cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Self-reported 7-day point prevalence tobacco abstinence		6 month follow-up
Self-reported 7-day point prevalence tobacco abstinence		3 months after hospital dicharge
Self-reported 7-day point prevalence tobacco abstinence		1 month after hospital discharge
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

General Publications

• Duffy SA, Cummins SE, Fellows JL, Harrington KF, Kirby C, Rogers E, Scheuermann TS, Tindle HA, Waltje AH; Consortium of Hospitals Advancing Research on Tobacco (CHART). Fidelity monitoring across the seven studies in the Consortium of Hospitals Advancing Research on Tobacco (CHART). Tob Induc Dis. 2015 Sep 3;13(1):29. doi: 10.1186/s12971-015-0056-5. eCollection 2015.
• Rigotti NA, Chang Y, Rosenfeld LC, Japuntich SJ, Park ER, Tindle HA, Levy DE, Reid ZZ, Streck J, Gomperts T, Kelley JHK, Singer DE. Interactive Voice Response Calls to Promote Smoking Cessation after Hospital Discharge: Pooled Analysis of Two Randomized Clinical Trials. J Gen Intern Med. 2017 Sep;32(9):1005-1013. doi: 10.1007/s11606-017-4085-z. Epub 2017 Jun 14.
• 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. doi: 10.1001/jama.2014.9237.
• Japuntich SJ, Regan S, Viana J, Tymoszczuk J, Reyen M, Levy DE, Singer DE, Park ER, Chang Y, Rigotti NA. Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:124. doi: 10.1186/1745-6215-13-124.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 3, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 6, 2010

Study Record Updates

• Last Update Posted (Estimate): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Cigarette smoking; Tobacco smoking
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion; Varenicline
• Other Study ID Numbers: 1RC1HL099668 (U.S. NIH Grant/Contract)