Smoking Cessation
Conditions
Brief summary
Our long-term goal is to improve smoking cessation treatment for rural smokers. The objective is to assess the effectiveness of a centralized disease management program for hospitalized smokers that coordinates care across treatment settings and links smokers to existing resources. Our central hypothesis is that Centralized Disease Management (CDM) will increase the use of smoking cessation treatments and lead to greater long term smoking cessation than Counseling alone. Demonstrating the effectiveness of a disease management program and identifying the critical components of such a program will provide a basis for improving the utilization of existing smoking cessation resources while enhancing the treatment of rural hospitalized smokers.
Detailed description
The proposed study will use a randomized clinical trial design to examine the effectiveness of centralized disease management (CDM) versus counseling alone (C) for smoking cessation. Hospitalized smokers in 30 rural critical access hospitals will be randomly assigned to either CDM (n=303) or C (n=303). Participants in both arms of the study will receive in-hospital smoking cessation counseling via telephone followed by 4 outpatient telephone-based counseling calls. The content and timing of these counseling calls are designed to emulate models of smoking cessation counseling that have been previously shown to be effective for hospitalized smokers. For recipients assigned to CDM, the counseling will be streamlined to allow time on the calls for specific disease management interventions, including screening for contraindications to pharmacotherapy and linking medication choices to the smoker's insurance coverage. After completing calls with CDM participants, the Tobacco Treatment Specialists will coordinate therapy with the patient's health care providers by providing them with brief consultation reports, prepared order sheets for inpatient treatment, and outpatient prescription requests. Six months postdischarge, participants in both groups will be contacted again, and persistent or relapsed smokers will be offered another cycle of the C or CDM intervention. Assessments will be conducted at baseline and at months 3, 6, and 12. The primary outcome of interest will be biochemically verified 7-day point prevalence abstinence at 12 months. Secondary endpoints include number of quit attempts and number of cigarettes smoked (among continuing smokers), pharmacotherapy utilization, duration of pharmacotherapy utilization, and the extent of discussions with the healthcare provider. We will also examine the marginal cost-effectiveness of the intervention.
Interventions
BEHAVIORALCentralized disease management (CDM)
Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider
BEHAVIORALCounseling (C)
Counseling (C) arm will receive counseling without the care coordination services.
Sponsors
National Cancer Institute (NCI)
Edward Ellerbeck, MD, MPH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Hospitalized in a participating rural hospital * Aged 18 years or older * Smoke cigarettes on \>25 of the last 30 days * Have a home address and telephone * Willing to participate in phone assessments
Exclusion criteria
* Terminal medical condition with life expectancy \<1 year * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated | 12 months | Participant-reported 7-day point prevalence abstinence from cigarettes, validated by salivary cotinine (\< 15ng/ml) or proxy. Participants who did not respond to the survey were considered current smokers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 7-day Point Prevalence Abstinence at 3 Months, Self-reported | 3 months | 7-day point prevalence abstinence at 3 months, self-reported. Participants who did not respond were considered smokers. |
| Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported | 6 months | 7-day point prevalence abstinence at 6 months, self-reported. Participants who did not respond were considered smokers. |
| Number of Participants With 7-day Point Prevalence Abstinence at 12 Months, Self-reported | 12 months | 7-day point prevalence abstinence at 12 months, self-reported. Participants who did not respond were considered smokers. |
| Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months | 6 months | — |
| Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months | 12 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Centralized Disease Management (CDM) Experimental: 1 Centralized disease management
Centralized disease management (CDM): Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider | 310 |
| Counseling (C) Experimental: 2 Counseling alone
Counseling (C): Counseling (C) arm will receive counseling without the care coordination services. | 296 |
| Total | 606 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 11 |
| Overall Study | Incarcerated | 2 | 1 |
Baseline characteristics
| Characteristic | Centralized Disease Management (CDM) | Counseling (C) | Total |
|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 12.89 | 51.0 years STANDARD_DEVIATION 11.82 | 50.8 years STANDARD_DEVIATION 12.37 |
| Cigarettes smoked per day | 19.3 cigarettes/day STANDARD_DEVIATION 9.99 | 19.7 cigarettes/day STANDARD_DEVIATION 10.84 | 19.4 cigarettes/day STANDARD_DEVIATION 10.41 |
| Confidence to quit smoking | 7.1 units on a scale STANDARD_DEVIATION 2.61 | 6.8 units on a scale STANDARD_DEVIATION 2.45 | 7.0 units on a scale STANDARD_DEVIATION 2.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 9 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 285 Participants | 287 Participants | 572 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fagerstrom score (heavy nicotine dependence) | 142 Participants | 168 Participants | 310 Participants |
| Motivation to quit smoking | 9.3 units on a scale STANDARD_DEVIATION 1.34 | 9.2 units on a scale STANDARD_DEVIATION 1.6 | 9.3 units on a scale STANDARD_DEVIATION 1.47 |
| Planning to quit smoking in the next 30 days | 303 Participants | 285 Participants | 588 Participants |
| Previous use of quit smoking medication | 192 Participants | 199 Participants | 391 Participants |
| Quit attempted in the past 6 months | 169 Participants | 154 Participants | 323 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 12 Participants | 24 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 12 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) White | 278 Participants | 270 Participants | 548 Participants |
| Region of Enrollment United States | 310 participants | 296 participants | 606 participants |
| Sex: Female, Male Female | 194 Participants | 189 Participants | 383 Participants |
| Sex: Female, Male Male | 116 Participants | 107 Participants | 223 Participants |
| Smokes within 30 minutes of waking | 257 Participants | 244 Participants | 501 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 310 | 11 / 296 |
| other Total, other adverse events | 5 / 310 | 7 / 296 |
| serious Total, serious adverse events | 1 / 310 | 1 / 296 |
Outcome results
Primary
Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated
Participant-reported 7-day point prevalence abstinence from cigarettes, validated by salivary cotinine (\< 15ng/ml) or proxy. Participants who did not respond to the survey were considered current smokers.
Time frame: 12 months
Population: Participants who were deceased or incarcerated at month 12 were excluded from analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Centralized Disease Management (CDM) | Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated | 57 Participants |
| Counseling (C) | Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated | 48 Participants |
p-value: 0.46Chi-squared
Secondary
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months
Time frame: 12 months
Population: Includes only participants eligible to enter into Cycle 2 counseling (those who reported smoking at month 6). Excludes participants who were deceased or incarcerated at month 12, or who did not report on pharmacotherapy use.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Centralized Disease Management (CDM) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months | Any medication | 80 Participants |
| Centralized Disease Management (CDM) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months | Nicotine replacement therapy | 50 Participants |
| Centralized Disease Management (CDM) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months | Prescription medication | 46 Participants |
| Counseling (C) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months | Any medication | 68 Participants |
| Counseling (C) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months | Nicotine replacement therapy | 50 Participants |
| Counseling (C) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months | Prescription medication | 30 Participants |
Secondary
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months
Time frame: 6 months
Population: Excludes participants who were deceased or incarcerated at month 6, or who did not report on pharmacotherapy use.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Centralized Disease Management (CDM) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months | Any medication | 145 Participants |
| Centralized Disease Management (CDM) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months | Nicotine replacement therapy | 106 Participants |
| Centralized Disease Management (CDM) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months | Prescription medication | 58 Participants |
| Counseling (C) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months | Any medication | 141 Participants |
| Counseling (C) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months | Nicotine replacement therapy | 112 Participants |
| Counseling (C) | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months | Prescription medication | 45 Participants |
Secondary
Number of Participants With 7-day Point Prevalence Abstinence at 12 Months, Self-reported
7-day point prevalence abstinence at 12 months, self-reported. Participants who did not respond were considered smokers.
Time frame: 12 months
Population: Participants who were deceased or incarcerated at month 6 were excluded from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Centralized Disease Management (CDM) | Number of Participants With 7-day Point Prevalence Abstinence at 12 Months, Self-reported | 73 Participants |
| Counseling (C) | Number of Participants With 7-day Point Prevalence Abstinence at 12 Months, Self-reported | 63 Participants |
p-value: 0.48Chi-squared
Secondary
Number of Participants With 7-day Point Prevalence Abstinence at 3 Months, Self-reported
7-day point prevalence abstinence at 3 months, self-reported. Participants who did not respond were considered smokers.
Time frame: 3 months
Population: Participants who were deceased or incarcerated at month 3 were excluded from analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Centralized Disease Management (CDM) | Number of Participants With 7-day Point Prevalence Abstinence at 3 Months, Self-reported | 86 Participants |
| Counseling (C) | Number of Participants With 7-day Point Prevalence Abstinence at 3 Months, Self-reported | 70 Participants |
p-value: 0.22Chi-squared
Secondary
Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported
7-day point prevalence abstinence at 6 months, self-reported. Participants who did not respond were considered smokers.
Time frame: 6 months
Population: Participants who were deceased or incarcerated at month 6 were excluded from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Centralized Disease Management (CDM) | Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported | 64 Participants |
| Counseling (C) | Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported | 56 Participants |
p-value: 0.56Chi-squared