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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA101963-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | Experimental: 1 Centralized disease management |
|
| Experimental 2 | Experimental | Experimental: 2 Counseling alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centralized disease management (CDM) | Behavioral | Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Ellerbeck, MD, MPH | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31367875 | Derived | Ellerbeck EF, Cox LS, Hui SA, Keighley J, Hutcheson TD, Fitzgerald SA, Cupertino AP, Greiner KA, Rigotti NA, Miller NH, Rabius V, Richter KP. Impact of Adding Telephone-Based Care Coordination to Standard Telephone-Based Smoking Cessation Counseling Post-hospital Discharge: a Randomized Controlled Trial. J Gen Intern Med. 2019 Dec;34(12):2804-2811. doi: 10.1007/s11606-019-05220-2. Epub 2019 Jul 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Counseling (C) | Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who were deceased or incarcerated at month 12 were excluded from analysis. | Posted | Count of Participants | Participants | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral discomfort | Product Issues | Non-systematic Assessment | Tingling and blister associated with nicotine gum use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Fitzgerald, MPH | University of Kansas Medical Center | 913-588-3488 | sfitzgerald@kumc.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Counseling (C) | Behavioral | Counseling (C) arm will receive counseling without the care coordination services. |
|
7-day point prevalence abstinence at 6 months, self-reported. Participants who did not respond were considered smokers. |
| 6 months |
| 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. | 12 months |
| 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 |
| Counseling (C) |
Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cigarettes smoked per day | Mean | Standard Deviation | cigarettes/day |
|
| Smokes within 30 minutes of waking | Count of Participants | Participants |
|
| Fagerstrom score (heavy nicotine dependence) | The modified Fagerström test score for nicotine dependence ranges from 0 to 6. Scores of 4 or higher indicate heavy smoking dependence | Count of Participants | Participants |
|
| Motivation to quit smoking | Motivation to quit smoking scores range from 0 to 10, with 10 indicating high motivation. | Mean | Standard Deviation | units on a scale |
|
| Confidence to quit smoking | Confidence to quit smoking scores range from 0 to 10, with 10 indicating high confidence. | Mean | Standard Deviation | units on a scale |
|
| Planning to quit smoking in the next 30 days | Count of Participants | Participants |
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| Quit attempted in the past 6 months | Count of Participants | Participants |
|
| Previous use of quit smoking medication | Count of Participants | Participants |
|
| Counseling (C) |
Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services. |
|
|
|
| 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. | Participants who were deceased or incarcerated at month 3 were excluded from analysis. | Posted | Count of Participants | Participants | 3 months |
|
|
|
|
| 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. | Participants who were deceased or incarcerated at month 6 were excluded from the analysis. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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. | Participants who were deceased or incarcerated at month 6 were excluded from the analysis. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months | Excludes participants who were deceased or incarcerated at month 6, or who did not report on pharmacotherapy use. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 12 |
| 310 |
| 1 |
| 310 |
| 5 |
| 310 |
| EG001 | Counseling (C) | Experimental: 2 Counseling alone Counseling (C): Counseling (C) arm will receive counseling without the care coordination services. | 11 | 296 | 1 | 296 | 7 | 296 |
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| Dizziness | Product Issues | Non-systematic Assessment |
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| Change in affect | Product Issues | Non-systematic Assessment |
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| Sleep disturbance | Product Issues | Non-systematic Assessment |
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| Headache | Product Issues | Non-systematic Assessment |
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| Nausea | Product Issues | Non-systematic Assessment |
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| Tremors | Product Issues | Non-systematic Assessment |
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| Lightheadedness | Product Issues | Non-systematic Assessment |
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| Local skin reaction | Product Issues | Non-systematic Assessment | Itching or rash at nicotine patch site |
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| Loss of bladder control | Renal and urinary disorders | Non-systematic Assessment | One time, for a few moments |
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| Constipation | Product Issues | Non-systematic Assessment |
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| D005159 | Health Care Facilities Workforce and Services |
| Prescription medication |
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| Prescription medication |
|