AzTrials
AzTrials

Cardiopulmonary DiseasePhase 2STOP-NPT3NCT05733767

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

A Phase 2 study testing Nurse Practitioner Tobacco Treatment Team (NPT3) in people with Cardiopulmonary Disease and Smoking Cessation, run by Baystate Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nurse Practitioner Tobacco Treatment Team (NPT3)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
1 siteUnited States
Study dates
3 Nov 2022to 30 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • heart valve surgery
  • percutaneous coronary intervention (PCI)
  • acute coronary syndrome
  • heart failure
  • chronic obstructive pulmonary disease (COPD)
  • asthma exacerbation.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Quinn Pack, MD, 413-790-0189, quinn.pack@baystatehealth.org

    Karen Riska, PhD(c), 413-795-7115, Karen.Riska@baystatehealth.org

    Recruiting

Other trials in United States

About this study

Official title: Implementing Effective Smoking Cessation Pharmacotherapy for Hospitalized Smokers With Cardiopulmonary Disease

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.

Read more

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.

Read the detailed description

This study aims to conduct a single-center, type 2, hybrid implementation-effectiveness trial, evaluating a strategy for improving prescription and uptake of smoking cessation pharmacotherapy (SCP) among smokers hospitalized for a cardiopulmonary condition. Patients will be recruited at Baystate Medical Center, Springfield MA from an electronic medical record (EMR) alert upon hospital admission indicating the patient smokes cigarettes. The investigators will then screen the EMR, and those who pass the EMR screen will be introduced to the study. Eligible, consenting patients will be randomized to one of two study arms: 1) Enhanced Usual Care (EUC) or 2) Nurse Practitioner led-Tobacco Treatment Team (NPT3) intervention. Randomization will be stratified by current smoking status (< 10 / 10+ cigarettes/day).

The investigators will evaluate the following primary implementation hypothesis: Patients randomized to the NPT3 intervention will be more likely to use guideline-concordant smoking cessation medications 7 days after hospital discharge compared to patients randomized to EUC. The primary effectiveness hypothesis is: Patients randomized to the intervention group will be more likely to quit smoking at 6 months. The investigators will evaluate the use of guideline-concordant SCP as a mediator of quit status at 6 months.

The investigators will recruit 424 patients to participate in the main clinical trial of enhanced usual care compared to the multi-component tobacco treatment team, NPT3 (Aim 1). These patients will be assessed at baseline and followed for 6 months for outcomes. Clinical outcomes will be collected up to 3 years after trial participation.

The investigators, proposed sample (n= 424 total patients) has 90% power to detect a clinically meaningful 15% improvement in smoking cessation rates at 6 months and a 99% power to detect a significant difference in guideline-concordant medication use at 1 week post-hospital discharge. A 20% smaller sample (n=340), due to low recruitment or attrition, would still achieve >80% power to find the intervention different from the control.

All analyses will be performed using an intent-to-treat approach, based upon the randomization arm, regardless of adherence to the intervention. The investigators will use logistic regression models to estimate the effect of the study arm (NPT3 vs. EUC), which will include randomization stratum and unbalanced baseline characteristics (if any.) In addition, the investigators will explore sex and socioeconomic status (SES) as modifiers of guideline-concordant SCP use and smoking cessation outcomes by including sex-by-study-arm and SES-by-study arm interaction terms. Missing data will be analyzed for patterns of missingness and imputed in sensitivity analyses as appropriate. Finally, the investigators will perform a mediation analysis to estimate the independent impact of SCP on smoking cessation outcomes.

The investigators will monitor for adverse events. All adverse events/effects will be recorded in the research record, and any reports of adverse events will be reviewed by the PI or their designees, who are available 24 hours a day. All non-serious adverse events will be reviewed in a weekly study meeting. Adverse event documentation will include a description of the event, ratings of severity and relationship to study procedures, follow-up (if any), and outcome. All serious and non-serious adverse events will be summarized in the required report to the institutional review board (IRB) and data safety monitoring board (DSMB).

Being tested
Enhanced Usual Care (EUC), Nurse Practitioner Tobacco Treatment Team (NPT3)
Medical subject headings
Pulmonary Heart Disease, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT05733767
Study groupRoleWhat they receive
Enhanced usual care (EUC)Active comparatorThe investigators will administer the enhanced usual care intervention to randomized patients.
Receives: Other: Enhanced Usual Care (EUC)
Personalized Care: Nurse Practitioner led Tobacco Treatment Team (NPT3)ExperimentalThe investigators will administer the personalized care NPT3 intervention to randomized patients.
Receives: Other: Nurse Practitioner Tobacco Treatment Team (NPT3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 7 days after hospital discharge

  2. 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.

    Measured: 7 day point prevalence at 6 months after hospital discharge

Secondary outcomes (4)
  1. Proportion of patients using guideline concordant smoking cessation medication throughout the study time frame.

    Use of varenicline or combination of medications (bupropion, nicotine patch, lozenge, gum, or inhaler) at these time points

    Measured: 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)

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

    Use of any smoking cessation medication (bupropion, nicotine patch, lozenge, gum, or inhaler) at these time points

    Measured: 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)

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

    Patients who have self-reported not using any tobacco products in the 7 days prior to assessment at these time points

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

  4. Proportion of patients reporting continuous abstinence smoking cessation

    Patients who have self-reported not using any tobacco products since hospital discharge

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study start3 Nov 2022
  3. Primary completion28 Aug 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
424 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05733767
Sponsor's protocol ID
HL15685
Acronym
STOP-NPT3
Status last verified
Sep 2026
First submitted
5 Jan 2023
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nurse Practitioner Tobacco Treatment Team (NPT3) in people with Cardiopulmonary Disease and Smoking Cessation, run by Baystate Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Quinn R Pack, MD (413-794-4490, quinn.pack@baystatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients using guideline concordant smoking cessation medication at 7 days (time frame: 7 days after hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in