Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05733767

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

Led by Baystate Medical Center · Updated on 2025-12-30

424

Participants Needed

1

Research Sites

269 weeks

Total Duration

On this page

Sponsors

B

Baystate Medical Center

Lead Sponsor

U

University of Massachusetts, Worcester

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to Baystate Medical Center in Springfield, MA with a cardiac or pulmonary disease diagnosis
  • Currently smoke cigarettes
  • Speak English
  • Diagnosed with myocardial infarction
  • Have undergone coronary artery bypass grafting surgery
  • Have undergone heart valve surgery
  • Have undergone percutaneous coronary intervention (PCI)
  • Diagnosed with acute coronary syndrome
  • Diagnosed with heart failure
  • Diagnosed with chronic obstructive pulmonary disease (COPD)
  • Experiencing asthma exacerbation
Not Eligible

You will not qualify if you...

  • Pregnant or nursing women
  • Current suicidal ideation
  • Planned discharge to hospice or expected survival less than 6 months
  • Concurrent use of daily smoked marijuana due to interference with study measurements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Actively Recruiting

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Research Team

Q

Quinn R Pack, MD

CONTACT

K

Karen L Riska, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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