NCT05733767 Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study
| NCT ID | NCT05733767 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Baystate Medical Center |
| Condition | Cardiopulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 424 participants |
| Start Date | 2022-11-03 |
| Primary Completion | 2027-08-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 424 participants in total. It began in 2022-11-03 with a primary completion date of 2027-08-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Quinn R Pack, MD
PRINCIPAL INVESTIGATOR
Baystate Medical Center
Frequently Asked Questions
Who can join the NCT05733767 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiopulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05733767 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05733767 currently recruiting?
Yes, NCT05733767 is actively recruiting participants. Contact the research team at quinn.pack@baystatehealth.org for enrollment information.
Where is the NCT05733767 trial being conducted?
This trial is being conducted at Springfield, United States.
Who is sponsoring the NCT05733767 clinical trial?
NCT05733767 is sponsored by Baystate Medical Center. The principal investigator is Quinn R Pack, MD at Baystate Medical Center. The trial plans to enroll 424 participants.