Recruiting
Phase 2

Smoking Cessation

Sponsor:

Baystate Medical Center

Code:

NCT05733767

Conditions

Cardiopulmonary Disease

Smoking Cessation

Inpatient

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced Usual Care (EUC)

Nurse Practitioner Tobacco Treatment Team (NPT3)

Study Details

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.

Conditions

Cardiopulmonary Disease

Smoking Cessation

Inpatient

Study ID

NCT05733767

Start date

Nov 3, 2022

Status verified date

Feb, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Aug 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

424 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Enhanced usual care (EUC)

The investigators will administer the enhanced usual care intervention to randomized patients.

experimental: Personalized Care: Nurse Practitioner led Tobacco Treatment Team (NPT3)

The investigators will administer the personalized care NPT3 intervention to randomized patients.

Interventions

Enhanced Usual Care (EUC)

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)

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.

Primary outcome measure

  • Proportion of patients using guideline concordant smoking cessation medication at 7 days [ Time Frame: 7 days after hospital discharge ]
  • Proportion of patients reporting smoking cessation abstinence (7 day point prevalence at 6 months) [ Time Frame: 7 day point prevalence at 6 months after hospital discharge ]

Central Contacts and Locations

Locations

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

More Information

Sponsor

Baystate Medical Center

Last update posted

Dec 30, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baystate Medical Center on 2025-12-30.