Clinical trial NCT01177176: Smoking Interventions for Hospital Patients
Official title: Smoking Interventions for Hospital Patients: A Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Cigarette smoking
Tobacco smoking
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-08-06
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Validated 7-day point prevalence tobacco abstinence
timeFrame: 6 months after discharge
Secondary outcomes:
measure: Use of tobacco treatment after hospital discharge
timeFrame: during 3 months and 6 months after hospital discharge
measure: Duration of tobacco abstinence after hospital discharge
timeFrame: Up to 6 months after hospital discharge
measure: Self-reported 7-day point prevalence tobacco abstinence
timeFrame: 6 month follow-up
measure: Self-reported 7-day point prevalence tobacco abstinence
timeFrame: 3 months after hospital dicharge
measure: Self-reported 7-day point prevalence tobacco abstinence
timeFrame: 1 month after hospital discharge
measure: Prolonged tobacco abstinence
timeFrame: at 1, 3, and 6 months after hospital discharge
measure: Continuous tobacco abstinence
timeFrame: Up to 6 months after hospital discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy A Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.