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RECRUITING Phase 2 ClinicalTrials.gov

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

Sponsor: Baystate Medical Center • ClinicalTrials.gov ID: NCT05733767

Registry updated: 2026-10-01
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Description

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.

Interventions

  • Enhanced Usual Care (EUC) (Other)
    Patients 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)
    Patients 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.

Eligibility criteria

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.

Conditions

Cardiopulmonary Disease Smoking Cessation Inpatient

Locations

  • Baystate Medical Center — Springfield, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record