Lung Diseases, Lung Neoplasms, Smoking Reduction, Tobacco Smoking, Tobacco Use, Tomography
Conditions
Keywords
smoking cessation, lung cancer screening, telephone counseling, quitline
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALUnsigned note to provider about cessation medication prescription
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.
BEHAVIORALProactive Telephone Counseling from VA Quitline
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.
Sponsors
Fred Hutchinson Cancer Center
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
* Providers who schedule patients for a lung cancer screening at either of the two VA sites. * Patients who participate in lung cancer screening and are current smokers at the time of scheduling their screening exam.
Exclusion criteria
* Providers who currently systematically prescribe cessation support medication to all current smokers will be excluded. * Patients with urgent findings requiring biopsy/immediate attention on the screening CT will be excluded. * Patients with a prior diagnosis of lung cancer or who are receiving active therapy for any cancer, except skin cancer, will be excluded. * Patients previously diagnosed with cognitive impairment, dementia, or severe behavioral disorders, or have an indication in chart review of difficulty communicating or participating in telephone counseling sessions will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Smoking Abstinence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost of Smoking Cessation Care | 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. |
| Patients' Experience With Telephone Counseling | 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. |
| Patients' Motivational Assessment | 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. |
| Patients' Perception of Susceptibility to Harm | 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. |
| Patients' Self-efficacy Assessment | 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. |
Countries
United States
Participant flow
Recruitment details
This was a cluster-randomized trial in which providers were randomized to one of two care arms. Patient participants were assigned to an arm based on their provider's care assignment.
Pre-assignment details
142 providers and 3,503 patients were screened for eligibility. 26 providers were excluded (19 opt-out before enrolling any patients, 7 not primary care providers) and 2,675 patients were excluded (1,865 not meeting initial inclusion/exclusion criteria, 366 no show to LCS, 178 CT scan not LCS, 130 lung-RADS 4, 87 no copay coverage, 9 provider retired/withdrawn before LCS, 40 no local coordinator to enter notes/COVID complications). 116 providers and 828 patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Unstructured Care: Providers Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
Patients seen by these providers who receive lung cancer screening will be assigned to the unstructured care arm. | 47 |
| Unstructured Care: Patients Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team. | 412 |
| Proactive Care: Providers Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: 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 and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: 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.
Patients seen by these providers who receive lung cancer screening will be assigned to the proactive care arm. | 69 |
| Proactive Care: Patients Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: 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 and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: 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. | 378 |
| Total | 906 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 7 | 0 | 8 |
| Overall Study | Medication copay coverage issues | 0 | 0 | 0 | 17 |
| Overall Study | Misassignment to a proactive arm provider | 0 | 1 | 0 | 0 |
| Overall Study | Non-veteran status | 0 | 1 | 0 | 0 |
| Overall Study | Not current smoker at time of screening | 0 | 1 | 0 | 3 |
| Overall Study | Provider involved with study activities | 1 | 0 | 0 | 0 |
| Overall Study | Provider retired from VA | 0 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 7 | 0 |
Baseline characteristics
| Characteristic | Unstructured Care: Patients | Total | Proactive Care: Patients | Unstructured Care: Providers | Proactive Care: Providers |
|---|---|---|---|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 5.9 | 66.7 years STANDARD_DEVIATION 6.2 | 66.6 years STANDARD_DEVIATION 6.5 | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 56 Participants | 36 Participants | — | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 382 Participants | 718 Participants | 336 Participants | — | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 16 Participants | 6 Participants | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants | — | — |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 4 Participants | — | — |
| Race (NIH/OMB) Black or African American | 50 Participants | 154 Participants | 104 Participants | — | — |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 5 Participants | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 25 Participants | 15 Participants | — | — |
| Race (NIH/OMB) White | 346 Participants | 592 Participants | 246 Participants | — | — |
| Region of Enrollment United States | 412 Participants | 906 Participants | 378 Participants | 47 Participants | 69 Participants |
| Sex: Female, Male Female | 19 Participants | 37 Participants | 18 Participants | — | — |
| Sex: Female, Male Male | 393 Participants | 753 Participants | 360 Participants | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 7 / 422 | 0 / 0 | 8 / 406 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Self-reported Smoking Abstinence
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: 12 months after lung cancer screening visit
Population: Enrolled participants with complete outcome data. The overall number of participants analyzed is lower than enrolled participants due to missing survey/electronic medical records data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unstructured Care: Patients | Self-reported Smoking Abstinence | 50 Participants |
| Proactive Care: Patients | Self-reported Smoking Abstinence | 51 Participants |
p-value: 0.8395% CI: [0.67, 1.64]Regression, Logistic
Secondary
Cost of Smoking Cessation Care
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: Time period from lung cancer screening through 12 months after lung cancer screening
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unstructured Care: Patients | Cost of Smoking Cessation Care | 34.1 dollars | Standard Deviation 159.1 |
| Proactive Care: Patients | Cost of Smoking Cessation Care | 384.2 dollars | Standard Deviation 161.1 |
Secondary
Patients' Experience With Telephone Counseling
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
Population: Subset of participants in the Proactive Care arm who responded to the 3 month survey and rated their satisfaction with VA Quitline telephone counseling.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unstructured Care: Patients | Patients' Experience With Telephone Counseling | 34 Participants |
Secondary
Patients' Motivational Assessment
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
Population: Subset of overall sample who responded to the 12 month survey and rated their motivation to quit smoking.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unstructured Care: Patients | Patients' Motivational Assessment | 7.48 score on a scale | Standard Deviation 2.95 |
| Proactive Care: Patients | Patients' Motivational Assessment | 7.3 score on a scale | Standard Deviation 3.2 |
Secondary
Patients' Motivational Assessment
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
Population: Subset of overall sample who responded to the 3 month survey and rated their motivation to quit smoking.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unstructured Care: Patients | Patients' Motivational Assessment | 7.54 score on a scale | Standard Deviation 3.01 |
| Proactive Care: Patients | Patients' Motivational Assessment | 7.95 score on a scale | Standard Deviation 3.05 |
Secondary
Patients' Perception of Susceptibility to Harm
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
Population: Subset of overall sample who responded to the 3 month survey and rated their perceived susceptibility to the harmful effects of smoking and perception of screening as protective.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unstructured Care: Patients | Patients' Perception of Susceptibility to Harm | 1.97 score on a scale | Standard Deviation 1.11 |
| Proactive Care: Patients | Patients' Perception of Susceptibility to Harm | 2.09 score on a scale | Standard Deviation 1.02 |
Secondary
Patients' Self-efficacy Assessment
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: 3 months after lung cancer screening visit
Population: Subset of overall sample who responded to the 3 month survey and rated their self-efficacy for quitting smoking.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unstructured Care: Patients | Patients' Self-efficacy Assessment | 5.7 score on a scale | Standard Deviation 3.3 |
| Proactive Care: Patients | Patients' Self-efficacy Assessment | 6.5 score on a scale | Standard Deviation 3.1 |
Secondary
Patients' Self-efficacy Assessment
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
Population: Subset of overall sample who responded to the 12 month survey and rated their self-efficacy for quitting smoking.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unstructured Care: Patients | Patients' Self-efficacy Assessment | 5.8 score on a scale | Standard Deviation 3.4 |
| Proactive Care: Patients | Patients' Self-efficacy Assessment | 6.1 score on a scale | Standard Deviation 3.3 |