Clinical trial NCT05738408: Remote Smoking Cessation in Hospitalized Cardiac Patients
Official title: Remote Smoking Cessation in Hospitalized Cardiac Patients: Bridging the Post-discharge
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
secondary prevention
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Biochemical verification of smoking status
timeFrame: 3 months
Secondary outcomes:
measure: Cardiovascular Fitness
timeFrame: 3 months
Other outcomes:
measure: Smoking Characteristics
timeFrame: 3 months
measure: Smoking Characteristics
timeFrame: 3 months
measure: Smoking Characteristics
timeFrame: 3 months
measure: Smoking Characteristics
timeFrame: 3 months
measure: Smoking Status
timeFrame: 3 months
measure: Physical Function assessed by MOS SF-36
timeFrame: 3 months
measure: Quality of Life assessed by EuroQol questionnaire
timeFrame: 3 months
measure: Quality of Life assessed by MacNew Cardiac Health questionnaire
timeFrame: 3 months
measure: Depression assessed by PHQ-9 questionnaire
timeFrame: 3 months
measure: Anxiety assessed by GAD-7 Questionnaire
timeFrame: 3 months
measure: Risk Aversion Assessment
timeFrame: 3 months
measure: Health Care Contacts
timeFrame: 12 months
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References: