Smoking CessationNCT01063972
Smoking Cessation in Rural Hospitals
A study testing Centralized disease management (CDM) and Counseling (C) in people with Smoking Cessation, run by Edward Ellerbeck, MD, MPH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Centralized disease management (CDM) and Counseling (C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Terminal medical condition with life expectancy <1 year
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Centralized Disease Management for Rural Hospitalized Smokers
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Centralized disease management (CDM), Counseling (C)
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centralized disease management (CDM)Behavioural
Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider
Counseling (C)Behavioural
Counseling (C) arm will receive counseling without the care coordination services.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Experimental: 1 Centralized disease management Receives: Behavioral: Centralized disease management (CDM) |
| Experimental 2 | Experimental | Experimental: 2 Counseling alone Receives: Behavioral: Counseling (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 3 months
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.
Measured: 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.
Measured: 12 months
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months
Measured: 6 months
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Ellerbeck, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Edward Ellerbeck, MD, MPH, University of Kansas Medical Center
- Investigators
- Edward Ellerbeck, MD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063972
- Sponsor's protocol ID
- 5R01CA101963-07
- Other IDs
- 5R01CA101963-07
- Status last verified
- Apr 2019
- First submitted
- 4 Feb 2010
- Last updated
- 8 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31367875
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized Disease Management for Rural Hospitalized Smokers
- ClinicalTrials.gov ID
- NCT01063972
- Acronym / sponsor ID
- 5R01CA101963-07
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Edward Ellerbeck, MD, MPHUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Posted 8 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Behavioral: Centralized disease management (CDM)Experimental: 1 Centralized disease management |
| Experimental 2 | Experimental | Behavioral: Counseling (C)Experimental: 2 Counseling alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Terminal medical condition with life expectancy <1 year
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Experimental 1 |
| Counseling (C)Counseling (C) arm will receive counseling without the care coordination services. | Behavioural | Experimental 2 |
Primary outcome
Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated
Time frame: 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.
5 secondary outcomes
Number of Participants With 7-day Point Prevalence Abstinence at 3 Months, Self-reported
Time frame: 3 months
Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported
Time frame: 6 months
Number of Participants With 7-day Point Prevalence Abstinence at 12 Months, Self-reported
Time frame: 12 months
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months
Time frame: 6 months
Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31367875Ellerbeck 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Ellerbeck, MD, MPH principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centralized disease management (CDM) and Counseling (C) in people with Smoking Cessation, run by Edward Ellerbeck, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01063972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.