Smoking Cessation Clinical Trial
— STOP-NPT3Official title:
Implementing Effective Smoking Cessation Pharmacotherapy for Hospitalized Smokers With Cardiopulmonary Disease
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.
Status | Recruiting |
Enrollment | 424 |
Est. completion date | December 2027 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 We will include any patients with the following diagnoses or procedures from Baystate Medical Center in Springfield, MA: - myocardial infarction - coronary artery bypass grafting surgery - heart valve surgery - percutaneous coronary intervention (PCI) - acute coronary syndrome - heart failure - chronic obstructive pulmonary disease (COPD) - asthma exacerbation. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Baystate Medical Center | Springfield | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Baystate Medical Center | Boston University, University of Massachusetts Chan Medical School, Worcester, University of Texas at Austin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | Within 30 days, 3 months, and 6 months after hospital discharge | |
Other | 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. | Within 6 months after hospital discharge | |
Other | Proportion of patients reporting E-cigarette use | Patients who endorse using any form of e- cigarettes | At 6 months after hospital discharge | |
Other | 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 | Within 6 months after hospital discharge | |
Other | Longest period of continuous abstinence | The longest period of self-reported abstinence without a single cigarette, as measured in weeks | Within 6 months after hospital discharge | |
Other | Cigarettes smoked per day | The number of self-reported cigarettes smoked per day | At 6 months after hospital discharge | |
Primary | 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 | 7 days after hospital discharge | |
Primary | 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. | 7 day point prevalence at 6 months after hospital discharge | |
Secondary | 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 | Day -1 (at consent and while admitted), Day 0 (Discharge day), Day 30 (1 month after discharge), Day 90 (3 months after discharge), Day 180 (6 months after discharge) | |
Secondary | 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 | Day -1 (at consent and while admitted), Day 0 (Discharge day), Day 30 (1 month after discharge), Day 90 (3 months after discharge), Day 180 (6 months after discharge) | |
Secondary | 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 | 7 day point-prevalence: a. 7 days after hospital discharge b. 1 month after discharge c. 3 months after discharge | |
Secondary | Proportion of patients reporting continuous abstinence smoking cessation | Patients who have self-reported not using any tobacco products since hospital discharge | Continuous abstinence: a. 1 month after discharge b. 3 months after discharge c. 6 months after discharge |
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