About this trial
Tobacco use remains the leading cause of death in the United States and contributes to more than 7 million hospitalizations annually. Being admitted to the hospital offers the perfect opportunity to support smoking cessation. Patients are motivated to quit because of their current illness and societal guidelines recommend clinicians should counsel patients and prescribe smoking cessation pharmacotherapy (SCP) to virtually all smokers.
However, only 22% of patients are prescribed SCP while hospitalized, and only 1% are prescribed medications compatible with current guidelines. This failure is part of the reason 70-80% of hospitalized smokers eventually relapse. The relapse typically occurs within a few days of hospital discharge - well before outpatient follow-up can occur.
The investigators aim to improve smoking cessation treatment and guideline adherence by utilizing the opportunity that hospitalization provides. The investigators have created a tobacco treatment team (T3) to overcome physicians' and patients' low use of current guideline smoking cessation medications. The team members are trained in tobacco treatment and will be led by a nurse practitioner (NPT3). The team will work together and 1) prescribe individually tailored and guideline-concordant SCP; 2) counsel and motivate patients to use SCP properly; and 3) manage a mobile phone-based text-messaging system to keep patients motivated and adherent to SCP. Our preliminary data suggest that such an approach is workable and acceptable to patients, physicians, and hospital administrators.
The investigators will recruit 424 patients in the hospital who smoke with cardiopulmonary disease. These patients will be randomized to receive either usual care or personalized care with the NPT3 team. The investigators will compare rates of guideline-concordant SCP use at 1 week and exhaled carbon monoxide (eCO) verified smoking cessation at 6 months between patients randomized to the NPT3 team vs. usual care.
The investigators will also measure the project's economic value from a hospital and payer perspective. Understanding the economic value will better inform hospital and insurance policies and sustainability. Finally, acceptability, generalizability, and sustainability measures will be assessed through qualitative interviews with patients, providers, and hospital leadership.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted to Baystate Medical Center in Springfield, MA with a cardiac or pulmonary disease diagnosis will be eligible to participate in this trial.
Patients who smoke cigarettes
Speak English
myocardial infarction
Disqualifiers
We will exclude pregnant or nursing women, patients with current suicidal ideation, planned discharge to hospice or expected survival <6 months, or concurrent use of daily smoked marijuana, because this can increase exhaled carbon monoxide levels, which would confound biochemical confirmation.
Trial design
Parallel
Treatments tested in this trial
Enhanced Usual Care (EUC)
Other interventionPatients randomized to arm 1, enhanced care (EC), will receive the following intervention: 1) referral to the state quitline, 1-800-QUIT-NOW, 2) primary care physician notification of an ongoing quit attempt, and 3) enrolled in an assessment-only text message system. This text message system will assess medication use and self-reported smoking cessation outcomes, but will not provide any counseling, advice, or feedback. Participants in arm 1 will receive a text message at discharge, and then they will receive 1 text assessment at the following time points: day 7, month 1, and month 3.
Nurse Practitioner Tobacco Treatment Team (NPT3)
Other interventionPatients randomized to arm 2, personalized care (PC), will receive a multi-component, multi-disciplinary smoking cessation intervention in addition to usual care. This intervention will include three main interventions. First, a nurse practitioner will assess all patients and then prescribe tailored medications for smoking cessation based on patient preferences. Patients will also then receive a sample ad-lib nicotine replacement therapy (NRT) packet for use as needed to their prescribed medications. Second, a Tobacco Treatment Counselor (TTC) will provide personalized advice, education, and coaching to the patient and encourage medication adherence. Third, patients will be enrolled in a smoking cessation text messaging program designed to maintain motivation, encourage medication adherence, and allow communication with the team. The text message program will last for 6 months and will include assessment at the following time points: day 7, month 1, and month 3.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients using guideline concordant smoking cessation medication at 7 days
Use of varenicline or combination medications (nicotine patch and lozenge, gum, or inhaler) on the 7th day after discharge
Proportion of patients reporting smoking cessation abstinence (7 day point prevalence at 6 months)
Patients who have self-reported not using any tobacco products in the 7 days prior to assessment, then confirmed with an in-office exhaled carbon monoxide level of \<6 ppm.
Secondary outcomes
Proportion of patients using guideline concordant smoking cessation medication throughout the study time frame.
Use of varenicline or combination of medications (bupropion, nicotine patch, lozenge, gum, or inhaler) at these time points
Proportion of patients using any smoking cessation medication throughout study time frame
Use of any smoking cessation medication (bupropion, nicotine patch, lozenge, gum, or inhaler) at these time points
Proportion of patients reporting smoking cessation abstinence (7 day point prevalence at 7 days, 30days, and 90 days post- discharge)
Patients who have self-reported not using any tobacco products in the 7 days prior to assessment at these time points
Proportion of patients reporting continuous abstinence smoking cessation
Patients who have self-reported not using any tobacco products since hospital discharge
Other outcomes
Proportion of patients reporting a hospital readmission throughout the study time frame
Patients who are admitted to the hospital (full admission or observation status) with apparent life-threatening illness
Proportion of patients reporting medication side effects and cumulative medication side effects reported
Any reported side-effects to medications including but not limited to nausea, abnormal dreams, rash, insomnia, dyspepsia, hiccups, headache, and seizures.
Proportion of patients reporting E-cigarette use
Patients who endorse using any form of e- cigarettes
Proportion of patients reporting number of quit attempts
Quit attempt is defined as going \>24 hours without a cigarette in an attempt to quit; this includes the hospital-based baseline quit attempt
Sponsors and contacts
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Baystate Medical Center
Lead sponsor
University of Massachusetts, Worcester
Collaborator
Boston University
Collaborator
University of Texas at Austin
Collaborator