NCT Number: NCT03612804
This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.
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Notify MeUp to 80 year
All sexes
Interventional
Not applicable
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY, New York, United States
This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
Time frame: 12 months after lung cancer screening visit
The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records. This measure only applies to patient enrollees.
Time frame: Time period from lung cancer screening through 12 months after lung cancer screening
Costs of implementing smoking cessation care from lung cancer screening to 12 months post-lung cancer screening will be monitored in both the unstructured and proactive care arms. Cost of implementing smoking cessation care is defined as the sum of the cost of behavioral counseling, cost of pharmacotherapies, and cost of intervention staff effort. This measure only applies to patient enrollees.
Time frame: 3 months after lung cancer screening visit
Binary variable for whether participant reported being either very satisfied or somewhat satisfied with VA Quitline telephone counseling. This measure only applies to patient enrollees in the proactive arm.
Time frame: 3 months after lung cancer screening visit
Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.
Time frame: 3 months after lung cancer screening visit
Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective. Patients were asked 5 questions related to smoking and screening, and an overall score based on the sum of correct answers was calculated. Scores range from 0-5 (higher scores indicate greater knowledge about harmful effects of smoking and benefits of screening). This measure only applies to patient enrollees.
Time frame: 3 months after lung cancer screening visit
Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees.
Time frame: 12 months after lung cancer screening visit
Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.
Time frame: 12 months after lung cancer screening visit
Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees.
VA Office of Research and Development
Fed
Acronym: PROACT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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