SmokingPhase 4NCT00013013
A Randomized Trial to Implement the AHCPR Smoking Cessation Guideline
A Phase 4 study testing Systems Support in people with Smoking and Smoking Cessation, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Systems Support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Aug 2001
- 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 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
Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorly developed smoking cessation programs.
Read the detailed description
Background:
Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorly developed smoking cessation programs.
Objectives:
The present study is designed to investigate the effectiveness of an organizational strategy to increase compliance with the AHCPR guideline. Short term goals of the study include increasing the rate of identification of smokers and increasing the delivery of brief smoking cessation interventions. Long term goals include reducing tobacco consumption among veterans.
Methods:
Twenty VAMC�s with active primary care clinics have been randomly assigned to either control (usual practice; UP) or intervention (organizational support; OS) groups. The intervention hospitals receive staff training and site consultation; all hospitals will receive the AHCPR guideline. Rate of identification of smokers in the medical record, smoking cessation rates, provision of smoking cessation services (e.g., NRT, counseling), and costs of NRT will be determined via telephone interviews with patients, chart review, and electronic records.
Status:
Baseline data collection is nearly complete, and the intervention period will be complete in September, 2000. We have completed telephone surveys with approximately 4500 veterans. Analysis of study data is ongoing, and manuscript preparation will begin within the next few months.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Systems Support
- 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.
Systems SupportProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Procedure: Systems Support |
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 completionAug 2001
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 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
- NCT00013013
- Sponsor's protocol ID
- CPG 97-039
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Joseph AM, Arikian NJ, An LC, Nugent SM, Sloan RJ, Pieper CF; GIFT Research Group. Results of a randomized controlled trial of intervention to implement smoking guidelines in Veterans Affairs medical centers: increased use of medications without cessation benefit. Med Care. 2004 Nov;42(11):1100-10. doi: 10.1097/00005650-200411000-00009.
PubMed 15586837
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
- A Randomized Trial to Implement the AHCPR Smoking Cessation Guideline
- ClinicalTrials.gov ID
- NCT00013013
- Acronym / sponsor ID
- CPG 97-039
- Conditions
- Smoking, Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Aug 2001 (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.
Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorly developed smoking cessation programs.
Detailed description
Background:
Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorly developed smoking cessation programs.
Objectives:
The present study is designed to investigate the effectiveness of an organizational strategy to increase compliance with the AHCPR guideline. Short term goals of the study include increasing the rate of identification of smokers and increasing the delivery of brief smoking cessation interventions. Long term goals include reducing tobacco consumption among veterans.
Methods:
Twenty VAMC�s with active primary care clinics have been randomly assigned to either control (usual practice; UP) or intervention (organizational support; OS) groups. The intervention hospitals receive staff training and site consultation; all hospitals will receive the AHCPR guideline. Rate of identification of smokers in the medical record, smoking cessation rates, provision of smoking cessation services (e.g., NRT, counseling), and costs of NRT will be determined via telephone interviews with patients, chart review, and electronic records.
Status:
Baseline data collection is nearly complete, and the intervention period will be complete in September, 2000. We have completed telephone surveys with approximately 4500 veterans. Analysis of study data is ongoing, and manuscript preparation will begin within the next few months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Systems Support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must be smokers.
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 |
|---|---|---|
| Systems Support | 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 15586837Joseph AM, Arikian NJ, An LC, Nugent SM, Sloan RJ, Pieper CF; GIFT Research Group. Results of a randomized controlled trial of intervention to implement smoking guidelines in Veterans Affairs medical centers: increased use of medications without cessation benefit. Med Care. 2004 Nov;42(11):1100-10. doi: 10.1097/00005650-200411000-00009.
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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 Systems Support 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 NCT00013013, 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.