Smoking Cessation Clinical Trial
Official title:
Dissemination of Tobacco Tactics Versus 1-800-QUIT-NOW for Hospitalized Smokers
Nurse-administered smoking cessation interventions have been shown to be efficacious, but are seldom implemented due to lack of training and time. This project aims to disseminate and test the nurse-administered Tobacco Tactics intervention in 6 hospitals.
Background: Dr. Duffy has developed, tested, and refined the efficacious, nurse-administered
Tobacco Tactics intervention and has packaged it into a Toolkit for dissemination in two
Veterans Affairs (VA) hospitals. However, rigorous testing of dissemination outside of the
VA is needed.
Objectives: Using 6 community hospitals in the Trinity Health System, the objectives of this
study are to:
1. Determine provider and patient receptivity, barriers, and facilitators to implementing
the nurse-administered, inpatient Tobacco Tactics intervention versus usual care using
face-to-face feedback and surveys.
2. Compare the effectiveness of the nurse-administered, inpatient Tobacco Tactics
intervention versus usual care across hospitals, units, and patient characteristics
using biochemically confirmed 7-day point-prevalence abstinence at 6-month cessation as
the primary outcome.
3. Determine the cost-effectiveness of the nurse-administered, inpatient Tobacco Tactics
intervention versus usual care including the cost per quitter, cost per life-year
saved, and cost per quality-adjusted life-year saved.
Methods: This effectiveness study will be a cluster randomized control trial in 6 Michigan
community hospitals of which 3 will get the nurse-administered Tobacco Tactics intervention
and the other 3 will provide their usual care in accordance to how the hospital responds to
current Joint Commission on Accreditation of Healthcare Organization's (JC) standards. A
research nurse will disseminate the intervention in the 3 out of 6 sites to Master Trainers
who will teach staff nurses on all shifts on all units, until all staff nurses are trained.
The interventions will become the standard of care within the intervention sites. Research
nurses will also conduct rolling evaluation to identify barriers and facilitators to
dissemination and implement measures to ensure sustainability of the intervention. It is
expected that 7,868 inpatient smokers per year will be eligible to participate in the study
of which the investigators expect to recruit 2,350 to have sufficient power to analyze the
objectives. Descriptive statistics (means and frequency distributions) will be used to
summarize the nurses' survey results, participation rates, smokers' receipt of specific
cessation services, and satisfaction with services. Logistic regressions and t-tests will be
used to determine differences between intervention groups on satisfaction and quit rates,
respectively, with adjustment for the clustering of patients within units and hospitals.
Regression analyses will test the moderation of the effects of the interventions by patient
characteristics such as confidence in ability to quit, nicotine addiction, alcohol intake,
depression, demographics and a smoking related diagnosis such as heart disease.
Cost-effectiveness will be assessed by constructing 3 ratios including the cost per quitter,
cost per life-year saved, and the cost per quality-adjusted life-year saved.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT04617444 -
The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function
|
N/A | |
Completed |
NCT02796391 -
Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
|
Phase 2 | |
Completed |
NCT03397511 -
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City
|
N/A | |
Not yet recruiting |
NCT05188287 -
A Culturally Tailored Smartphone Application for African American Smokers
|
N/A | |
Recruiting |
NCT05264428 -
The Effect of Honey on Lessening the Withdrawal Symptoms
|
N/A | |
Recruiting |
NCT05846841 -
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
|
N/A | |
Completed |
NCT04133064 -
Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
|
N/A | |
Completed |
NCT03187730 -
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
|
Phase 4 | |
Completed |
NCT03474783 -
To Explore the Factors Affecting the Effectiveness of Smoking Cessation
|
N/A | |
Completed |
NCT04635358 -
Feasibility Study of Smoking Cessation for the Staff of a Hospital Center
|
N/A | |
Terminated |
NCT03670264 -
BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
|
N/A | |
Not yet recruiting |
NCT06307496 -
VIDeOS for Smoking Cessation
|
N/A | |
Completed |
NCT02997657 -
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT03206619 -
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
|
||
Completed |
NCT02905656 -
Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit
|
N/A | |
Completed |
NCT02562521 -
A Smoking Cessation Intervention for Yale Dining Employees
|
Phase 4 | |
Completed |
NCT02239770 -
Pharmacokinetics of Nicotine Film in Smokers
|
N/A | |
Recruiting |
NCT02422914 -
Benefits of Tobacco Free Cigarette
|
N/A |