Clinical trial NCT05733767: Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study
Official title: Implementing Effective Smoking Cessation Pharmacotherapy for Hospitalized Smokers with Cardiopulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cardiopulmonary Disease
Smoking Cessation
Inpatient
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
Collaborators: name: University of Massachusetts Chan Medical School, Worcester
name: Boston University
name: University of Texas at Austin
First posted: 2023-02-17
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

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.

Primary outcomes:
measure: Proportion of patients using guideline concordant smoking cessation medication at 7 days
timeFrame: 7 days after hospital discharge
measure: Proportion of patients reporting smoking cessation abstinence (7 day point prevalence at 6 months)
timeFrame: 7 day point prevalence at 6 months after hospital discharge
Secondary outcomes:
measure: Proportion of patients using guideline concordant smoking cessation medication throughout the study time frame.
timeFrame: 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)
measure: Proportion of patients using any smoking cessation medication throughout study time frame
timeFrame: 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)
measure: Proportion of patients reporting smoking cessation abstinence (7 day point prevalence at 7 days, 30days, and 90 days post- discharge)
timeFrame: 7 day point-prevalence: a. 7 days after hospital discharge b. 1 month after discharge c. 3 months after discharge
measure: Proportion of patients reporting continuous abstinence smoking cessation
timeFrame: Continuous abstinence: a. 1 month after discharge b. 3 months after discharge c. 6 months after discharge
Other outcomes:
measure: Proportion of patients reporting a hospital readmission throughout the study time frame
timeFrame: Within 30 days, 3 months, and 6 months after hospital discharge
measure: Proportion of patients reporting medication side effects and cumulative medication side effects reported
timeFrame: Within 6 months after hospital discharge
measure: Proportion of patients reporting E-cigarette use
timeFrame: At 6 months after hospital discharge
measure: Proportion of patients reporting number of quit attempts
timeFrame: Within 6 months after hospital discharge
measure: Longest period of continuous abstinence
timeFrame: Within 6 months after hospital discharge
measure: Cigarettes smoked per day
timeFrame: At 6 months after hospital discharge
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: Baystate Medical Center
name: Quinn R Pack, MD
role: PRINCIPAL_INVESTIGATOR
References: