Smoking Cessation Study

Study Overview
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Brief Summary
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This is a pilot study to determine the feasibility and success of offering smoking cessation counseling for ambulatory patients who present for scheduled cardiac catheterization.

Detailed Description
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This is a prospective randomized pilot study of feasibility and success of smoking cessation counselling for ambulatory patients who present for scheduled cardiac catheterization. Patients who meet inclusion and exclusion criteria will be eligible for enrollment and receive smoking cessation counseling. Patients will be followed for 6 months post intervention. A Usual care arm will be created using retrospective chart review.

Official Title
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Smoking Cessation Intervention for Hospitalized Heart & Vascular Center (HVC) Patients at a Dartmouth-Hitchcock Medical Center Serving a Rural Population

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Smoking Cessation Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presents to Dartmouth-Hitchcock Medical Center in Lebanon, NH as an ambulatory patient with a scheduled cardiac Catheterization smoke one or more cigarettes per day for the past 12 months OR use of electronic-cigarettes containing tobacco at least once during the past 30 days. proficient in English Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arm study, with a control arm and intervention arm. The control arm will consist of a retrospective chart review will be conducted to create a randomly selected cohort of patients that meet inclusion and exclusion criteria and did not receive smoking cessation counseling to serve as the control arm. The intervention arm will prospectively enroll to be provided with smoking cessation counseling.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking Cessation Counseling - Intervention Arm<br>Intervention arm. All patients enrolled in the study will be provided with smoking cessation counseling. | Behavioral: Smoking Cessation Counseling<br>* Smoking cessation counseling will be provided following standards set by the institution patients are receiving care at (Dartmouth-Hitchcock Medical Center).<br>|
| No Intervention: Retrospective Chart Review - Control Arm<br>Control arm. A retrospective chart review will be conducted to create a randomly selected cohort of patients that meet inclusion and exclusion criteria and did not receive smoking cessation counseling to serve as the control arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants that self-report sustained smoking cessation | Percentage of participants that self report sustained smoking cessation at 1 month. | 1 month post index procedure | 
| Percentage of participants that self-report sustained smoking cessation | Percentage of participants that self report sustained smoking cessation at 3 months. | 3 months post index procedure | 
| Percentage of participants that self-report sustained smoking cessation | Percentage of participants that self report sustained smoking cessation at 6 months. | 6 months post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants that have had at least one subsequent cardiovascular hospital admission. | Percentage of participants that have had at least one subsequent cardiovascular hospital admission at 1 month post index procedure. | 1 month post index procedure | 
| Percentage of participants that have had at least one subsequent cardiovascular hospital admission. | Percentage of participants that have had at least one subsequent cardiovascular hospital admission at 3 months post index procedure. | 3 months post index procedure | 
| Percentage of participants that have had at least one subsequent cardiovascular hospital admission. | Percentage of participants that have had at least one subsequent cardiovascular hospital admission at 6 months post index procedure. | 6 months post index procedure | 
| Percentage of participants that have had at least one emergency department presentation | Percentage of participants that have had at least one emergency department presentation following discharge for their index procedure 1 month post index procedure | 1 month post index procedure | 
| Percentage of participants that have had at least one emergency department presentation | Percentage of participants that have had at least one emergency department presentation following discharge for their index procedure 3 months post index procedure | 3 months post index procedure | 
| Percentage of participants that have had at least one emergency department presentation | Percentage of participants that have had at least one emergency department presentation following discharge for their index procedure 6 months post index procedure | 6 months post index procedure | 
| Frequency of Cardiac Events following discharge from index procedure | Frequency of cardiac events following discharge from hospitals, 1 month after index procedure. | 1 month post index procedure | 
| Frequency of Cardiac Events following discharge from index procedure | Frequency of cardiac events following discharge from hospitals, 3 months after index procedure. | 3 months post index procedure | 
| Frequency of Cardiac Events following discharge from index procedure | Frequency of cardiac events following discharge from hospitals, 6 months after index procedure. | 6 months post index procedure | 
| Percentage of participants that need subsequent coronary intervention following index procedure | Percentage of participants that need subsequent coronary intervention following index procedure at 1 month post index procedure | 1 month post index procedure | 
| Percentage of participants that need subsequent coronary intervention following index procedure | Percentage of participants that need subsequent coronary intervention following index procedure at 3 months post index procedure | 3 moths post index procedure | 
| Percentage of participants that need subsequent coronary intervention following index procedure | Percentage of participants that need subsequent coronary intervention following index procedure at 6 months post index procedure | 6 months post index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention