Smoking Cessation Study

NCT04928781 | Withdrawn

• 1 other identifier: STUDY02000943
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Keywords

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Percentage of participants that have had at least one subsequent cardiovascular hospital admission.

  1 month post index procedure

• Percentage of participants that have had at least one subsequent cardiovascular hospital admission.

  3 months post index procedure

• Percentage of participants that have had at least one subsequent cardiovascular hospital admission.

  6 months post index procedure

• Percentage of participants that have had at least one emergency department presentation

  1 month post index procedure

• Percentage of participants that have had at least one emergency department presentation

  3 months post index procedure

Study Arms (2)

Smoking Cessation Counseling - Intervention Arm

EXPERIMENTAL

Intervention arm. All patients enrolled in the study will be provided with smoking cessation counseling.

Behavioral: Smoking Cessation Counseling

Retrospective Chart Review - Control Arm

NO INTERVENTION

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.

Interventions

Smoking Cessation Counseling BEHAVIORAL

Smoking cessation counseling will be provided following standards set by the institution patients are receiving care at (Dartmouth-Hitchcock Medical Center).

Smoking Cessation Counseling - Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Health

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Merle L Myerson

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Cardiovascular Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 16, 2021
• Study Start: June 28, 2022
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)