SmokingPhase 4NCT00012948
Centralized Telephone Outreach to Assist Smoking Cessation Among Veterans
A Phase 4 study testing Telephone Care in people with Smoking and Smoking Cessation, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification of tobacco… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Telephone Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must be smokers who have a phone and who speak English. They are excluded for psychiatric instability.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification of tobacco use and provision of brief and/or intensive smoking cessation services are suboptimal. Telephone outreach (TO) may serve to increase access to counseling and medications to assist smoking cessation. From the standpoint of health systems, TO provides the opportunity for centralized oversight and quality assurance, economy of scale, and dissemination strategies that are practical to implement. At the provider level, TO addresses barriers to delivery of services such as limited time and skills. From the standpoint of the smoker, attractions of TO include accessibility, convenience, and privacy.
Read the detailed description
Background:
Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification of tobacco use and provision of brief and/or intensive smoking cessation services are suboptimal. Telephone outreach (TO) may serve to increase access to counseling and medications to assist smoking cessation. From the standpoint of health systems, TO provides the opportunity for centralized oversight and quality assurance, economy of scale, and dissemination strategies that are practical to implement. At the provider level, TO addresses barriers to delivery of services such as limited time and skills. From the standpoint of the smoker, attractions of TO include accessibility, convenience, and privacy.
Objectives:
The objectives of the study are to: 1) determine if TO increases successful quitting among veterans who smoke, compared to the distribution of written self-help materials; and 2) determine the cost-effectiveness of TO for smoking cessation for veterans who smoke.
Methods:
The study involved a population-based sample of veterans in VISN 13 who use one of the five Network VAMCs for primary care. 838 smokers were recruited, enrolled and randomly assigned to 1) written self-help materials + TO, or 2) written self-help materials alone. The behavioral intervention protocol included follow-up calls scheduled in a relapse-sensitive fashion. Use of nicotine replacement therapy (NRT) was encouraged, and prescriptions facilitated. Data was collected at baseline, 3 months, and 12 months by telephone. Information on demographic characteristics, medical and mental health histories, smoking history, intervention, and use of clinical services for smoking cessation was included. Cost data will be calculated from administrative databases, and will include 1) written materials, 2) counseling (personnel time, equipment, space), and 3) medications. The primary outcome was 6 months of prolonged abstinence from smoking, measured 12 months following intervention. Secondary analyses evaluated 3 month and 12 month point prevalent abstinence from smoking, quit attempts, and a formal cost-effectiveness analysis that will include total costs, total and marginal effects and cost-effectiveness ratios (average cost/quit and average cost/marginal quit) for TO and SH interventions.
Status:
Data collection and main outcome analyses have been completed. The main manuscript will be submitted to JAMA in October 2004. We are starting cost-effectiveness analyses.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Telephone Care
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CareProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Procedure: Telephone Care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anne M. Joseph, MD MPH, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012948
- Sponsor's protocol ID
- SUI 99-101
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
An LC, Zhu SH, Nelson DB, Arikian NJ, Nugent S, Partin MR, Joseph AM. Benefits of telephone care over primary care for smoking cessation: a randomized trial. Arch Intern Med. 2006 Mar 13;166(5):536-42. doi: 10.1001/archinte.166.5.536.
PubMed 16534040
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized Telephone Outreach to Assist Smoking Cessation Among Veterans
- ClinicalTrials.gov ID
- NCT00012948
- Acronym / sponsor ID
- SUI 99-101
- Conditions
- Smoking, Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Sep 2004 (actual)
- First posted
- 16 Mar 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification of tobacco use and provision of brief and/or intensive smoking cessation services are suboptimal. Telephone outreach (TO) may serve to increase access to counseling and medications to assist smoking cessation. From the standpoint of health systems, TO provides the opportunity for centralized oversight and quality assurance, economy of scale, and dissemination strategies that are practical to implement. At the provider level, TO addresses barriers to delivery of services such as limited time and skills. From the standpoint of the smoker, attractions of TO include accessibility, convenience, and privacy.
Detailed description
Background:
Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification of tobacco use and provision of brief and/or intensive smoking cessation services are suboptimal. Telephone outreach (TO) may serve to increase access to counseling and medications to assist smoking cessation. From the standpoint of health systems, TO provides the opportunity for centralized oversight and quality assurance, economy of scale, and dissemination strategies that are practical to implement. At the provider level, TO addresses barriers to delivery of services such as limited time and skills. From the standpoint of the smoker, attractions of TO include accessibility, convenience, and privacy.
Objectives:
The objectives of the study are to: 1) determine if TO increases successful quitting among veterans who smoke, compared to the distribution of written self-help materials; and 2) determine the cost-effectiveness of TO for smoking cessation for veterans who smoke.
Methods:
The study involved a population-based sample of veterans in VISN 13 who use one of the five Network VAMCs for primary care. 838 smokers were recruited, enrolled and randomly assigned to 1) written self-help materials + TO, or 2) written self-help materials alone. The behavioral intervention protocol included follow-up calls scheduled in a relapse-sensitive fashion. Use of nicotine replacement therapy (NRT) was encouraged, and prescriptions facilitated. Data was collected at baseline, 3 months, and 12 months by telephone. Information on demographic characteristics, medical and mental health histories, smoking history, intervention, and use of clinical services for smoking cessation was included. Cost data will be calculated from administrative databases, and will include 1) written materials, 2) counseling (personnel time, equipment, space), and 3) medications. The primary outcome was 6 months of prolonged abstinence from smoking, measured 12 months following intervention. Secondary analyses evaluated 3 month and 12 month point prevalent abstinence from smoking, quit attempts, and a formal cost-effectiveness analysis that will include total costs, total and marginal effects and cost-effectiveness ratios (average cost/quit and average cost/marginal quit) for TO and SH interventions.
Status:
Data collection and main outcome analyses have been completed. The main manuscript will be submitted to JAMA in October 2004. We are starting cost-effectiveness analyses.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Telephone Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must be smokers who have a phone and who speak English. They are excluded for psychiatric instability.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Telephone Care | Procedure or surgery | Arm 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 16534040An LC, Zhu SH, Nelson DB, Arikian NJ, Nugent S, Partin MR, Joseph AM. Benefits of telephone care over primary care for smoking cessation: a randomized trial. Arch Intern Med. 2006 Mar 13;166(5):536-42. doi: 10.1001/archinte.166.5.536.
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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.
Anne M. Joseph, MD MPH principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telephone Care in people with Smoking and Smoking Cessation, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 Apr 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00012948, 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 7 Apr 2015.