Remote Smoking Cessation in Hospitalized Cardiac Patients

Smoking Cessation Clinical Trial

Official title:

Remote Smoking Cessation in Hospitalized Cardiac Patients: Bridging the Post-discharge

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738408
• Other study ID #: STUDY00002035
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: University of Vermont Medical Center
• Contact: Sherrie Khadanga, MD
• Phone: 802-847-2700
• Email: sherrie.khadanga[@]uvmhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking Characteristics	Cigarettes per day (CPD) using timeline follow back methods	3 months
Other	Smoking Characteristics	Fagerstrom Test for Nicotine Dependence [FTND]	3 months
Other	Smoking Characteristics	Heaviness of Smoking Index (HSI)	3 months
Other	Smoking Characteristics	and the Minnesota Nicotine Withdrawal Scale	3 months
Other	Smoking Status	CO monitoring	3 months
Other	Physical Function assessed by MOS SF-36	The General Health Status MOS SF-36 questionnaire will be administered with special attention to the physical function component score.	3 months
Other	Quality of Life assessed by EuroQol questionnaire	EuroQol	3 months
Other	Quality of Life assessed by MacNew Cardiac Health questionnaire	disease specific MacNew Cardiac Health Status Questionnaire will be administered	3 months
Other	Depression assessed by PHQ-9 questionnaire	mood will be measured using the Patient Health Questionnaire (PHQ-9)	3 months
Other	Anxiety assessed by GAD-7 Questionnaire	the General Anxiety Disorder questionnaire (GAD-7)Questionnaire will be administered to assess anxiety	3 months
Other	Risk Aversion Assessment		3 months
Other	Health Care Contacts	Combined measure of number of Emergency Department visits and overnight hospitalizations	12 months
Primary	Biochemical verification of smoking status	Assess the efficacy of combined FI+NRT vs. UC on biochemically verified smoking abstinence	3 months
Secondary	Cardiovascular Fitness	Determine the effect of smoking status on changes in cardiovascular fitness (VO2peak).	3 months