Post-Discharge Smoking Cessation Strategies: Helping HAND 4

Massachusetts General Hospital1,416 enrolled

Overview

This randomized controlled trial will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.

This multi-site randomized controlled trial (RCT) will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers who are admitted to 3 large hospital systems in 3 U.S. regions (MA, PA, TN). All patients will receive guideline-based tobacco cessation treatment delivered in hospital by each site's existing Tobacco Treatment Service that is directed by a study investigator. Patients who plan to quit smoking after hospital discharge will be randomly assigned to 1 of 2 post-discharge tobacco treatment interventions and followed at 1, 3, and 6 months. One arm uses bidirectional electronic referral (eReferral) to the state tobacco quitline. The other arm, Personalized Tobacco Care Management (PTCM), combines proactive messages delivered by automated interactive voice response (IVR) phone calls, text messaging, and/or email with health coaching provided by a hospital-based tobacco counselor. Both groups will receive at least 1 month of nicotine replacement therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,416

Conditions

Smoking Cessation

Interventions

Transitional Tobacco Care Management (TTCM)BEHAVIORAL

PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.

eReferral to State Tobacco Quitline (QL)BEHAVIORAL

Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.

Nicotine replacement therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * Current cigarette smoker (\>=1 cigarette in the week before admission and \>=1 cigarette/day when smoking at a baseline rate in the month prior to admission) * Admitted to a study hospital * Seen by hospital smoking counselor during inpatient stay * Plans to try to quit smoking after hospital discharge Exclusion Criteria: * Inability to give informed consent or participate in counseling due to serious cognitive or psychiatric disorder (e.g., dementia, psychosis) * Life expectancy \<12 months * Medical instability * No reliable telephone access or inability to use telephone * Non-English speaking * Pregnant, breastfeeding, to planning to become pregnant in the next 6 months.

Locations (3)

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Tobacco Abstinence, Biochemically Confirmed

Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration \<=10 ng/ml OR breath sample with a carbon monoxide concentration \<=9 ppm.

Time frame: 6 months after hospital discharge

Secondary Outcomes

Tobacco Abstinence, Self-report

Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).

Time frame: 1 month after hospital discharge

Tobacco Abstinence, Self-report

Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).

Time frame: 3 months after hospital discharge

Tobacco Abstinence, Self-report

Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).

Time frame: 6 months after hospital discharge

Engagement in Cessation Treatment

Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment.

Time frame: 1 month after hospital discharge

Engagement in Cessation Treatment

Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment

Data from ClinicalTrials.gov

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