Post-Discharge Smoking Cessation Strategies: Helping HAND 4

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Transitional Tobacco Care Management (TTCM)
* Behavioral: eReferral to State Tobacco Quitline (QL)
* Drug: Nicotine replacement therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transitional Tobacco Care Management (TTCM)<br>TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team. | Behavioral: Transitional Tobacco Care Management (TTCM)<br>* 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.<br>Drug: Nicotine replacement therapy<br>* Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.<br>|
| Active Comparator: eReferral to State Tobacco Quitline (QL)<br>Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart. | Behavioral: eReferral to State Tobacco Quitline (QL)<br>* 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.<br>Drug: Nicotine replacement therapy<br>* Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | 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 | 3 months after hospital discharge | 
| Self-reported Continuous Tobacco Abstinence Since Hospital Discharge | Number of participants who self-report having smoked no cigarettes and used no other tobacco products (cigars, little cigars, pipes, smokeless tobacco) since index hospital discharge | 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco, Cessation, Hospitalization, eReferral, Interactive Voice Response, Tobacco Quitline