Cigarette Smoking, Tobacco Smoking, Tobacco Use Disorder
Conditions
Keywords
Cigarette smoking, Tobacco smoking, Tobacco use disorder
Brief summary
Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized each year, and hospital admission offers a teachable moment for intervention. Hospital-initiated smoking cessation intervention is effective, but only if contact continues for more than 1 month after discharge. The challenge is to translate this research into clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals can adopt. The major barrier is sustaining contact after discharge. This project tests an innovative strategy to streamline the delivery and maximize the uptake of post-discharge smoking interventions. Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of evidence-based tobacco treatment (counseling and medication) after hospital discharge, thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco abstinence. Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All subjects will receive a brief in-hospital smoking intervention and be randomly assigned at discharge to either Standard Care (passive referral to their state quitline) or Extended Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling. Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month follow-up \[primary outcome\] and other tobacco abstinence measures); (2) treatment utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine the intervention's effect on hospital readmissions and mortality in the 6 months after discharge.
Interventions
BEHAVIORALSustained Care
A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.
BEHAVIORALStandard Care
Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.
Sponsors
University of Pittsburgh
North Shore Medical Center
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cigarette smoker (smoked at least 1 cigarette in the month before hospital admission and at least 1 cigarette per day when smoking at baseline rate in the month before hospital admission) * Counseled by hospital smoking counselor during hospital stay * Plans to stop smoking tobacco products after hospital discharge * Agrees to take home a supply of smoking cessation medication after discharge * Agrees to and able to accept telephone calls after hospital discharge
Exclusion criteria
* No access to a telephone or unable to communicate by telephone * Severe psychiatric or neurologic disease precluding ability to provide informed consent and to be counseled * Pregnant, nursing, or planning to become pregnant in next 3 months * Unable to speak English * Medical instability precluding study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco Abstinence - 6 Month Follow-up | 6 months | Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Tobacco Abstinence | 1 month, 3 months, 6 months | Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months. |
| Point Prevalence Tobacco Abstinence | 1 month, 3 months, 6 months | 7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report |
| Duration of Tobacco Abstinence After Hospital Discharge | 1 month, 3 months, 6 months | Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred. |
| Use of Smoking Cessation Treatment After Hospital Discharge | 1 month, 3 months, 6 months | Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling). |
Other
| Measure | Time frame | Description |
|---|---|---|
| All-cause Hospitalizations | 12 months | Self-reported admission to a hospital in the 12 months after the index hospitalization. |
| All-cause Mortality | 6 months | Death from any cause in the 6 months after hospital discharge |
Countries
United States
Participant flow
Recruitment details
Recruitment of eligible daily smokers admitted to 3 hospitals (Massachusetts General Hospital, Boston, MA; University of Pittsburgh Medical Center, Pittsburgh, PA; and North Shore Medical Center, Salem, MA) occurred during the period 12/3/2012 - 7/18/2014
Pre-assignment details
1359 patients were enrolled in the study and randomized to Sustained Care (n=681) or Standard Care (n=678). Two patients, 1 in each group, were excluded post-randomization but before hospital discharge (when intervention began) because they were not eligible. ITT analysis was conducted on 1357 patients (Standard Care n=677, Sustained Care n=680).
Participants by arm
| Arm | Count |
|---|---|
| Standard Care At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor. | 677 |
| Sustained Care A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling. | 680 |
| Total | 1,357 |
Baseline characteristics
| Characteristic | Standard Care | Sustained Care | Total |
|---|---|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 12.4 | 49.6 years STANDARD_DEVIATION 12.8 | 49.7 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 677 participants | 680 participants | 1357 participants |
| Sex: Female, Male Female | 336 Participants | 332 Participants | 668 Participants |
| Sex: Female, Male Male | 341 Participants | 348 Participants | 689 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 677 | 0 / 680 |
| serious Total, serious adverse events | 224 / 677 | 216 / 680 |
Outcome results
Primary
Tobacco Abstinence - 6 Month Follow-up
Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Tobacco Abstinence - 6 Month Follow-up | 105 Participants |
| Sustained Care | Tobacco Abstinence - 6 Month Follow-up | 113 Participants |
Comparison: Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow-Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.p-value: >0.0595% CI: [0.84, 1.37]Chi-squared
Secondary
Continuous Tobacco Abstinence
Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.
Time frame: 1 month, 3 months, 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Care | Continuous Tobacco Abstinence | 1 month follow-up | 179 Participants |
| Standard Care | Continuous Tobacco Abstinence | 3 month follow-up | 122 Participants |
| Standard Care | Continuous Tobacco Abstinence | 6 month follow-up | 101 Participants |
| Sustained Care | Continuous Tobacco Abstinence | 3 month follow-up | 147 Participants |
| Sustained Care | Continuous Tobacco Abstinence | 1 month follow-up | 211 Participants |
| Sustained Care | Continuous Tobacco Abstinence | 6 month follow-up | 121 Participants |
p-value: >0.05Chi-squared
Secondary
Duration of Tobacco Abstinence After Hospital Discharge
Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.
Time frame: 1 month, 3 months, 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Duration of Tobacco Abstinence After Hospital Discharge | 7 days |
| Sustained Care | Duration of Tobacco Abstinence After Hospital Discharge | 14 days |
Secondary
Point Prevalence Tobacco Abstinence
7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report
Time frame: 1 month, 3 months, 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Care | Point Prevalence Tobacco Abstinence | 1 month follow-up | 217 Participants |
| Standard Care | Point Prevalence Tobacco Abstinence | 3 month follow-up | 206 Participants |
| Standard Care | Point Prevalence Tobacco Abstinence | 6 month follow-up | 180 Participants |
| Sustained Care | Point Prevalence Tobacco Abstinence | 1 month follow-up | 295 Participants |
| Sustained Care | Point Prevalence Tobacco Abstinence | 3 month follow-up | 253 Participants |
| Sustained Care | Point Prevalence Tobacco Abstinence | 6 month follow-up | 209 Participants |
Comparison: This compares at Month 1p-value: <0.001Chi-squared
Comparison: This is analysis for Month 3p-value: <0.01Chi-squared
Comparison: This is for Month 6p-value: <0.09Chi-squared
Secondary
Use of Smoking Cessation Treatment After Hospital Discharge
Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).
Time frame: 1 month, 3 months, 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Care | Use of Smoking Cessation Treatment After Hospital Discharge | 1 month follow-up | 306 Participants |
| Standard Care | Use of Smoking Cessation Treatment After Hospital Discharge | 3 month follow-up | 404 Participants |
| Standard Care | Use of Smoking Cessation Treatment After Hospital Discharge | 6 month follow-up | 448 Participants |
| Sustained Care | Use of Smoking Cessation Treatment After Hospital Discharge | 1 month follow-up | 491 Participants |
| Sustained Care | Use of Smoking Cessation Treatment After Hospital Discharge | 3 month follow-up | 554 Participants |
| Sustained Care | Use of Smoking Cessation Treatment After Hospital Discharge | 6 month follow-up | 580 Participants |
p-value: <0.001Chi-squared
Other Pre-specified
All-cause Hospitalizations
Self-reported admission to a hospital in the 12 months after the index hospitalization.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | All-cause Hospitalizations | 224 hospital admissions |
| Sustained Care | All-cause Hospitalizations | 216 hospital admissions |
p-value: >0.05Chi-squared
Other Pre-specified
All-cause Mortality
Death from any cause in the 6 months after hospital discharge
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | All-cause Mortality | 14 Participants |
| Sustained Care | All-cause Mortality | 13 Participants |
p-value: >0.05Chi-squared