Smoking Cessation
Conditions
Keywords
Tobacco, Cessation, Hospitalization, eReferral, Interactive Voice Response, Tobacco Quitline
Brief summary
This randomized controlled trial will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.
Detailed description
This multi-site randomized controlled trial (RCT) will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers who are admitted to 3 large hospital systems in 3 U.S. regions (MA, PA, TN). All patients will receive guideline-based tobacco cessation treatment delivered in hospital by each site's existing Tobacco Treatment Service that is directed by a study investigator. Patients who plan to quit smoking after hospital discharge will be randomly assigned to 1 of 2 post-discharge tobacco treatment interventions and followed at 1, 3, and 6 months. One arm uses bidirectional electronic referral (eReferral) to the state tobacco quitline. The other arm, Personalized Tobacco Care Management (PTCM), combines proactive messages delivered by automated interactive voice response (IVR) phone calls, text messaging, and/or email with health coaching provided by a hospital-based tobacco counselor. Both groups will receive at least 1 month of nicotine replacement therapy.
Interventions
BEHAVIORALTransitional Tobacco Care Management (TTCM)
PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.
BEHAVIORALeReferral to State Tobacco Quitline (QL)
Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.
DRUGNicotine replacement therapy
Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Sponsors
University of Pittsburgh Medical Center
Vanderbilt University Medical Center
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Current cigarette smoker (\>=1 cigarette in the week before admission and \>=1 cigarette/day when smoking at a baseline rate in the month prior to admission) * Admitted to a study hospital * Seen by hospital smoking counselor during inpatient stay * Plans to try to quit smoking after hospital discharge
Exclusion criteria
* Inability to give informed consent or participate in counseling due to serious cognitive or psychiatric disorder (e.g., dementia, psychosis) * Life expectancy \<12 months * Medical instability * No reliable telephone access or inability to use telephone * Non-English speaking * Pregnant, breastfeeding, to planning to become pregnant in the next 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco Abstinence, Biochemically Confirmed | 6 months after hospital discharge | Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration \<=10 ng/ml OR breath sample with a carbon monoxide concentration \<=9 ppm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco Abstinence, Self-report | 1 month after hospital discharge | Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product). |
| Engagement in Cessation Treatment | 1 month after hospital discharge | Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment. |
| Self-reported Continuous Tobacco Abstinence Since Hospital Discharge | 6 months follow-up | Number of participants who self-report having smoked no cigarettes and used no other tobacco products (cigars, little cigars, pipes, smokeless tobacco) since index hospital discharge |
Countries
United States
Participant flow
Pre-assignment details
708 patients were randomized to TTCM arm. 2 patients were excluded post-randomization but before hospital discharge and the start of the intervention and follow-up assessment due to not meeting eligibility criteria. 708 patients were randomized to QL arm. 5 patients were excluded post-randomization but before hospital discharge and the start of the intervention and follow-up assessment due to not meeting eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| Transitional Tobacco Care Management (TTCM) TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call. At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.
Transitional Tobacco Care Management (TTCM): PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.
Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient. | 706 |
| eReferral to State Tobacco Quitline (QL) Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach. Patient may also be eligible for NRT sample. Feedback from the quitline will be sent back to the patient's medical chart.
eReferral to State Tobacco Quitline (QL): Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.
Nicotine replacement therapy: Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient. | 703 |
| Total | 1,409 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 19 | 24 |
| Overall Study | Lost to Follow-up | 141 | 141 |
| Overall Study | Withdrawal by Subject | 26 | 20 |
Baseline characteristics
| Characteristic | Transitional Tobacco Care Management (TTCM) | eReferral to State Tobacco Quitline (QL) | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 13 | 52 years STANDARD_DEVIATION 12 | 52 years STANDARD_DEVIATION 13 |
| Cigarettes smoked per day, past 30 days | 16 cigarettes/day STANDARD_DEVIATION 10 | 17 cigarettes/day STANDARD_DEVIATION 11 | 16 cigarettes/day STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Black non-Hispanic | 116 Participants | 100 Participants | 216 Participants |
| Race/Ethnicity, Customized Hispanic | 39 Participants | 43 Participants | 82 Participants |
| Race/Ethnicity, Customized Other/unknown | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 539 Participants | 550 Participants | 1089 Participants |
| Sex: Female, Male Female | 391 Participants | 393 Participants | 784 Participants |
| Sex: Female, Male Male | 315 Participants | 310 Participants | 625 Participants |
| Smoke 1st cigarette within 30 min of waking | 547 Participants | 563 Participants | 1110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 19 / 706 | 24 / 703 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Tobacco Abstinence, Biochemically Confirmed
Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration \<=10 ng/ml OR breath sample with a carbon monoxide concentration \<=9 ppm.
Time frame: 6 months after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transitional Tobacco Care Management (TTCM) | Tobacco Abstinence, Biochemically Confirmed | 110 Participants |
| eReferral to State Tobacco Quitline (QL) | Tobacco Abstinence, Biochemically Confirmed | 96 Participants |
Comparison: Two-stage multiple imputation techniques were used to estimate the missing smoking outcomes. 1st stage: we imputed missing data from surveys. 2nd stage: we imputed missing data from biochemical sample collection. Null hypothesis was no difference between arms in biochemically-validated past 7-day abstinence from cigarettes and other conventional tobacco products at 6-months. Sample of 1350 (675/group) was planned to detect a 6.5% difference (23.0% vs. 16.5%) with 84% power and 2-sided p\<0.05.p-value: 0.1995% CI: [0.92, 1.5]Chi-squared
Secondary
Engagement in Cessation Treatment
Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment.
Time frame: 1 month after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transitional Tobacco Care Management (TTCM) | Engagement in Cessation Treatment | 489 Participants |
| eReferral to State Tobacco Quitline (QL) | Engagement in Cessation Treatment | 369 Participants |
Comparison: Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.p-value: <0.000195% CI: [1.21, 1.44]Chi-squared
Secondary
Engagement in Cessation Treatment
Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment
Time frame: 3 months after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transitional Tobacco Care Management (TTCM) | Engagement in Cessation Treatment | 434 Participants |
| eReferral to State Tobacco Quitline (QL) | Engagement in Cessation Treatment | 319 Participants |
Comparison: Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.p-value: <0.000195% CI: [1.23, 1.5]Chi-squared
Secondary
Self-reported Continuous Tobacco Abstinence Since Hospital Discharge
Number of participants who self-report having smoked no cigarettes and used no other tobacco products (cigars, little cigars, pipes, smokeless tobacco) since index hospital discharge
Time frame: 6 months follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transitional Tobacco Care Management (TTCM) | Self-reported Continuous Tobacco Abstinence Since Hospital Discharge | 120 Participants |
| eReferral to State Tobacco Quitline (QL) | Self-reported Continuous Tobacco Abstinence Since Hospital Discharge | 91 Participants |
Comparison: Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.p-value: 0.03395% CI: [1.02, 1.66]Chi-squared
Secondary
Tobacco Abstinence, Self-report
Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).
Time frame: 6 months after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transitional Tobacco Care Management (TTCM) | Tobacco Abstinence, Self-report | 234 Participants |
| eReferral to State Tobacco Quitline (QL) | Tobacco Abstinence, Self-report | 202 Participants |
Comparison: Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.p-value: 0.07995% CI: [0.98, 1.29]Chi-squared
Secondary
Tobacco Abstinence, Self-report
Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).
Time frame: 1 month after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transitional Tobacco Care Management (TTCM) | Tobacco Abstinence, Self-report | 291 Participants |
| eReferral to State Tobacco Quitline (QL) | Tobacco Abstinence, Self-report | 246 Participants |
Comparison: Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.p-value: 0.00295% CI: [1.08, 1.35]Chi-squared
Secondary
Tobacco Abstinence, Self-report
Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).
Time frame: 3 months after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transitional Tobacco Care Management (TTCM) | Tobacco Abstinence, Self-report | 276 Participants |
| eReferral to State Tobacco Quitline (QL) | Tobacco Abstinence, Self-report | 218 Participants |
Comparison: Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.p-value: 0.00195% CI: [1.09, 1.37]Chi-squared