Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05733767
Study type Interventional
Source Baystate Medical Center
Contact Quinn R Pack, MD
Phone 413-794-4490
Email quinn.pack@baystatehealth.org
Status Recruiting
Phase Phase 2
Start date November 3, 2022
Completion date December 2027

See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A