Smoking Cessation Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Smoking Cessation Counseling

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoking Cessation Counseling - Intervention Arm; Intervention arm. All patients enrolled in the study will be provided with smoking cessation counseling.	Behavioral: Smoking Cessation Counseling; Smoking cessation counseling will be provided following standards set by the institution patients are receiving care at (Dartmouth-Hitchcock Medical Center).
No Intervention: Retrospective Chart Review - Control Arm; 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?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Merle L Myerson, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): June 28, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention
• Other Study ID Numbers: STUDY02000943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No Plant to share individual participant data (IPD) exists at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No