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Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

Study acronym: STOP-NPT3
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 12 words
    • Study description revised
  2. Notable Primary completion date: Jul 28, 2026 to Aug 28, 2027v6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Minor Primary completion date: Jul 2026 to Jul 28, 2026
    • Study completion date: Dec 2027 to Dec 30, 2027
    v4
  5. Notable Phase: Phase 4 to Phase 2v3
  6. Minor Study description expanded, about 6 words
    • Eligibility criteria expanded, about 5 words
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05733767
Lead Sponsor Baystate Medical Center
Collaborators: University of Massachusetts, Worcester, Boston University, University of Texas at Austin
Conditions
(from sponsor)
Cardiopulmonary Disease, Smoking Cessation, Inpatient
Related terms Pulmonary Heart Disease, Smoking Cessation
Enrollment 424 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov