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 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).
Source: View full study details on ClinicalTrials.gov
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