Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

NCT05733767 | Recruiting Phase 2 DMC

• 1 other identifier: HL15685
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Proportion of patients using guideline concordant smoking cessation medication at 7 days

  Use of varenicline or combination medications (nicotine patch and lozenge, gum, or inhaler) on the 7th day after discharge

  7 days after hospital discharge

• Proportion of patients reporting smoking cessation abstinence (7 day point prevalence at 6 months)

  Patients who have self-reported not using any tobacco products in the 7 days prior to assessment, then confirmed with an in-office exhaled carbon monoxide level of \<6 ppm.

  7 day point prevalence at 6 months after hospital discharge

Secondary Outcomes (4)

• Proportion of patients using guideline concordant smoking cessation medication throughout the study time frame.

  Day -1 (at consent and while admitted), Day 0 (Discharge day), Day 30 (1 month after discharge), Day 90 (3 months after discharge), Day 180 (6 months after discharge)

• Proportion of patients using any smoking cessation medication throughout study time frame

  Day -1 (at consent and while admitted), Day 0 (Discharge day), Day 30 (1 month after discharge), Day 90 (3 months after discharge), Day 180 (6 months after discharge)

• Proportion of patients reporting smoking cessation abstinence (7 day point prevalence at 7 days, 30days, and 90 days post- discharge)

  7 day point-prevalence: a. 7 days after hospital discharge b. 1 month after discharge c. 3 months after discharge

• Proportion of patients reporting continuous abstinence smoking cessation

  Continuous abstinence: a. 1 month after discharge b. 3 months after discharge c. 6 months after discharge

Other Outcomes (6)

• Proportion of patients reporting a hospital readmission throughout the study time frame

  Within 30 days, 3 months, and 6 months after hospital discharge

• Proportion of patients reporting medication side effects and cumulative medication side effects reported

  Within 6 months after hospital discharge

• Proportion of patients reporting E-cigarette use

  At 6 months after hospital discharge

Study Arms (2)

Enhanced usual care (EUC)

ACTIVE COMPARATOR

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

Other: Enhanced Usual Care (EUC)

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

EXPERIMENTAL

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

Other: Nurse Practitioner Tobacco Treatment Team (NPT3)

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.

Enhanced usual care (EUC)

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baystate Medical Center: lead
• University of Massachusetts Chan Medical School, Worcester: collaborator
• Boston University: collaborator
• University of Texas at Austin: collaborator

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Heart Disease; Smoking Cessation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Health Behavior; Behavior

Study Officials

• Quinn R Pack, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quinn R Pack, MD

CONTACT

413-794-4490; quinn.pack@baystatehealth.org

Karen L Riska, PhD

CONTACT

413-795-7115; karen.riska@baystatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: February 17, 2023
• Study Start: November 3, 2022
• Primary Completion (Estimated): August 28, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)