Remote Smoking Cessation in Hospitalized Cardiac Patients

NCT ID: NCT05738408

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-12
• Study Completion Date: 2025-12-31

Brief Summary

The investigators are proposing to examine new strategies for helping patients hospitalized for an acute coronary event adhere to recommendations to quit smoking. The investigators are interested to see whether offering financial incentives for smoking cessation, combined with medications to ameliorate withdrawal, can significantly reduce smoking in a population for which continued smoking has disproportionately negative health effects. The proposed trial can provide significant knowledge for promoting adherence to smoking cessation guidelines in patients with cardiac disease

Detailed Description

Cigarette smoking is the leading cause of preventable death in the U.S. The effect of smoking in those with coronary artery disease (CAD) is particularly powerful given that at hospital admission, 27-36% of these patients are active smokers which is much higher than in the general population (<18%).1-3While smoking rates have declined in the U.S., this has not been observed in cardiac populations. Continued smoking after hospitalization also predicts additional negative outcomes such as lack of engagement in comprehensive secondary prevention for example cardiac rehabilitation (CR).4 Smoking may also directly impede improvements in fitness which is a critical predictor of recovery in this population and thus crucial to examine.5-7 Surprisingly, having a serious cardiac event, such as a myocardial infarction (MI) may not be enough to promote sustained cessation.8 Thus, promoting adherence to smoking cessation guidelines in this population is of utmost importance.9

Acute cardiac hospitalization does provide an ideal opportunity to intervene on smoking.10 Patients are required to abstain from smoking while hospitalized and are often motivated to quit. Unfortunately, less than a quarter of patients receive Nicotine Replacement Therapy (NRT) in-hospital and even fewer receive support after discharge. 11,12 For most patients, follow-up care may not occur for 4-6 weeks and most patients relapse to smoking within the first few weeks.11,13 Ideally, intensive intervention would be started in-hospital and continue after discharge, bridging this post-hospital gap in care.

Financial incentives (FI) for objectively verified smoking abstinence is highly effective in promoting smoking cessation in medically vulnerable populations, but, to the Investigators knowledge, has not been tested in patients with CVD.14.15 NRT is safe in cardiac patients, but is rarely prescribed or offered in a manner that maximizes efficacy (i.e., combination short and long-acting NRT).16 Building on our strong published and preliminary data, the investigators hypothesize that a combined behavioral and pharmacologic smoking cessation intervention started in hospital and continued remotely can bridge the post-hospital care gap and support patients through a critical period in cardiac recovery where risk of smoking relapse is high.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control: Usual Care

will receive standard treatment which entails referral to Vermont Quit Network. This network offers a wide range of free cessation services, including NRT and web-based modules on preparing to quit and developing a plan

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention: Financial incentives and nicotine replacement therapy intervention

an intervention where patients are assigned to financial incentives and NRT of their choice; use of CO monitor to assess abstinence

Group Type: EXPERIMENTAL

Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)

Intervention Type: BEHAVIORAL

: In the intervention condition, patients will receive both NRT plus a 12-week program of monetary incentives for verified smoking abstinence that will be implemented by our clinic staff

Interventions

Financial Incentives (FI) and Nicotine Replacement Therapy (NRT)

: In the intervention condition, patients will receive both NRT plus a 12-week program of monetary incentives for verified smoking abstinence that will be implemented by our clinic staff

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Patients will be recruited if they:

1. Hospitalization for an acute coronary event which includes myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass)

2. live within 30 miles of UVMMC and are >18 years of age

3. Current cigarette smoker (defined as reporting any use of cigarettes in the week before admission and >5 cigarette/day on average over the past 3 months)

Exclusion Criteria

Patients will be excluded if they have:

1. severe dementia/Alzheimer's disease

2. an active malignancy, excluding non-melanoma skin cancer or low-grade prostate cancer under active surveillance

3. exercise limiting vascular or neuromuscular disease

4. Non-English Speaking

5. No reliable smart-phone

6. Current, regular use of smokeless tobacco or other form of non-combusted tobacco

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sherrie Khadanga

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sherrie Khadanga, MD

Role: CONTACT

sherrie.khadanga@uvmhealth.org

802-847-2700

Diann Gaalema, PhD

Role: CONTACT

diann.gaalema@med.uvm.edu

Facility Contacts

Sherrie Khadanga

Role: primary

sherrie.khadanga@uvmhealth.org

802-847-2700

Other Identifiers

STUDY00002035

Identifier Type: -

Identifier Source: org_study_id