Clinical trial NCT04928781: Smoking Cessation Study
Official title: Smoking Cessation Intervention for Hospitalized Heart & Vascular Center (HVC) Patients at a Dartmouth-Hitchcock Medical Center Serving a Rural Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Smoking Cessation
Keywords: Percutaneous Coronary Intervention
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants that self-report sustained smoking cessation
timeFrame: 1 month post index procedure
measure: Percentage of participants that self-report sustained smoking cessation
timeFrame: 3 months post index procedure
measure: Percentage of participants that self-report sustained smoking cessation
timeFrame: 6 months post index procedure
Secondary outcomes:
measure: Percentage of participants that have had at least one subsequent cardiovascular hospital admission.
timeFrame: 1 month post index procedure
measure: Percentage of participants that have had at least one subsequent cardiovascular hospital admission.
timeFrame: 3 months post index procedure
measure: Percentage of participants that have had at least one subsequent cardiovascular hospital admission.
timeFrame: 6 months post index procedure
measure: Percentage of participants that have had at least one emergency department presentation
timeFrame: 1 month post index procedure
measure: Percentage of participants that have had at least one emergency department presentation
timeFrame: 3 months post index procedure
measure: Percentage of participants that have had at least one emergency department presentation
timeFrame: 6 months post index procedure
measure: Frequency of Cardiac Events following discharge from index procedure
timeFrame: 1 month post index procedure
measure: Frequency of Cardiac Events following discharge from index procedure
timeFrame: 3 months post index procedure
measure: Frequency of Cardiac Events following discharge from index procedure
timeFrame: 6 months post index procedure
measure: Percentage of participants that need subsequent coronary intervention following index procedure
timeFrame: 1 month post index procedure
measure: Percentage of participants that need subsequent coronary intervention following index procedure
timeFrame: 3 moths post index procedure
measure: Percentage of participants that need subsequent coronary intervention following index procedure
timeFrame: 6 months post index procedure
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Health
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Merle L Myerson
role: PRINCIPAL_INVESTIGATOR
References: