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Nurse Practitioner-Led Smoking Cessation Program for Smoking (STOP-NPT3 Trial)
Phase 2
Recruiting
Led By Quinn R Pack, MD
Research Sponsored by Baystate Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admitted to Baystate Medical Center in Springfield, MA with a cardiac or pulmonary disease diagnosis will be eligible to participate in this trial
Be older than 18 years old
Must not have
Planned discharge to hospice or expected survival <6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after hospital discharge
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to improve smoking cessation treatment by utilizing the opportunity that hospitalization provides, with a team led by a nurse practitioner, and measuring the economic value.
Who is the study for?
This trial is for patients admitted to Baystate Medical Center in Springfield, MA with heart or lung diseases who smoke cigarettes. Participants must speak English and not be pregnant, nursing, planning hospice care, have a life expectancy under 6 months, current suicidal thoughts, or use daily smoked marijuana.
What is being tested?
The study tests if a Nurse Practitioner-led Tobacco Treatment Team (NPT3) can improve smoking cessation over Enhanced Usual Care (EUC) in hospitalized smokers with cardiopulmonary disease. It measures the use of smoking cessation pharmacotherapy and checks for non-smoking status at 1 week and after 6 months using breath analysis.
What are the potential side effects?
While specific side effects are not listed for this intervention focused on counseling and support services, any potential side effects would likely stem from the smoking cessation pharmacotherapy prescribed as part of the treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am admitted to Baystate Medical Center with a heart or lung condition.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My doctors expect I have less than 6 months to live.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 day point-prevalence: a. 7 days after hospital discharge b. 1 month after discharge c. 3 months after discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 day point-prevalence: a. 7 days after hospital discharge b. 1 month after discharge c. 3 months after discharge
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of patients reporting smoking cessation abstinence (7 day point prevalence at 6 months)
Proportion of patients using guideline concordant smoking cessation medication at 7 days
Secondary study objectives
Proportion of patients reporting continuous abstinence smoking cessation
Proportion of patients reporting smoking cessation abstinence (7 day point prevalence at 7 days, 30days, and 90 days post- discharge)
Proportion of patients using any smoking cessation medication throughout study time frame
+1 moreOther study objectives
Cigarettes smoked per day
Longest period of continuous abstinence
Proportion of patients reporting E-cigarette use
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized Care: Nurse Practitioner led Tobacco Treatment Team (NPT3)Experimental Treatment1 Intervention
The investigators will administer the personalized care NPT3 intervention to randomized patients.
Group II: Enhanced usual care (EUC)Active Control1 Intervention
The investigators will administer the enhanced usual care intervention to randomized patients.
Find a Location
Who is running the clinical trial?
Baystate Medical CenterLead Sponsor
66 Previous Clinical Trials
44,073 Total Patients Enrolled
University of Massachusetts Chan Medical School, WorcesterUNKNOWN
University of Texas at AustinOTHER
374 Previous Clinical Trials
85,751 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctors expect I have less than 6 months to live.I have a history of heart or severe lung conditions treated at Baystate Medical Center.You are currently thinking about hurting yourself.You are currently using marijuana every day, which can affect the test results.I am admitted to Baystate Medical Center with a heart or lung condition.You smoke cigarettes.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced usual care (EUC)
- Group 2: Personalized Care: Nurse Practitioner led Tobacco Treatment Team (NPT3)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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