SmokingNCT00012987
Implementing Guidelines for Smoking Cessation: A Randomized Trial of Evidence-Based Quality Improvement
A study testing Quality Improvement in people with Smoking and Smoking Cessation, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
Smoking is a serious and common health risk among veterans. Given the press of national initiatives and local incentives to improve smoking cessation care in response to VA performance measures, this study tests a widely applicable approach to clinical practice guidelines implementation, namely evidence-based quality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation, Quality Improvement
- What is being tested?
- Quality Improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Dec 2002
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VA Medical Center or outpatient clinics with at least 3000 patients.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
Smoking is a serious and common health risk among veterans. Given the press of national initiatives and local incentives to improve smoking cessation care in response to VA performance measures, this study tests a widely applicable approach to clinical practice guidelines implementation, namely evidence-based quality improvement, which is directly relevant to the translation of efficacious treatments into enhancements in VA health care policy and practice. Evidence-Based Quality Improvement (EBQI) focuses on improved provider adherence to smoking cessation guidelines and a decrease in patient smoking rates in a manner designed to produce short- and long-term health improvements and cost benefits at the organizational level.
Read the detailed description
Background:
Smoking is a serious and common health risk among veterans. Given the press of national initiatives and local incentives to improve smoking cessation care in response to VA performance measures, this study tests a widely applicable approach to clinical practice guidelines implementation, namely evidence-based quality improvement, which is directly relevant to the translation of efficacious treatments into enhancements in VA health care policy and practice. Evidence-Based Quality Improvement (EBQI) focuses on improved provider adherence to smoking cessation guidelines and a decrease in patient smoking rates in a manner designed to produce short- and long-term health improvements and cost benefits at the organizational level.
Objectives:
Adherence to smoking cessation guidelines requires practice changes at the patient, provider, and system levels to achieve optimal quit rates. The objective of this study was to evaluate the effectiveness of evidence-based quality improvement (EBQI)�an expert-designed and locally implemented clinical reorganization of smoking cessation care�on changes in smoking cessation (SC) practice among primary care providers and health outcomes among veteran smokers.
Methods:
An evidence-based quality improvement intervention comprising provision of physician and patient educational materials, local priority setting with leadership and providers, and local adaptation of expert-designed protocols was implemented in experimental VA primary care practices (n=9). VA control sites (n=9), matched on size and academic affiliation, received smoking cessation guideline copies. We randomly sampled, consented, screened and surveyed primary care patients at all 18 sites (n=1,941 smokers) and used computer-assisted telephone interviewing to assess sociodemographics, health status, function, and smoking behavior, attitudes and treatment experience. Post-intervention 12-month follow-up interviews were completed using the same measures (n=1,080). We used multiple imputation using hotdeck techniques and applied both enrollment and attrition weights to the patient-level data. We used weighted logistic regression to evaluate intervention effects, controlling for patient-level predictors of quit attempts and quit status (e.g., level of addiction, readiness to change, age, health).
Status:
The project is completed. Analysis is ongoing for manuscripts.
- Conditions
- Smoking, Smoking Cessation, Quality Improvement
- Being tested
- Quality Improvement
- 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.
Quality ImprovementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Quality Improvement |
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 completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott E Sherman, MD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CAElizabeth M. Yano, PhD MSPH, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012987
- Sponsor's protocol ID
- CPG 97-002
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sherman SE, Yano EM, York LS, Lanto AB, Chernof BA, Mittman BS. Assessing the structure of smoking cessation care in the Veterans Health Administration. Am J Health Promot. 2006 May-Jun;20(5):313-8. doi: 10.4278/0890-1171-20.5.313.
PubMed 16706001Sherman SE, Fu SS, Joseph AM, Lanto AB, Yano EM. Gender differences in smoking cessation services received among veterans. Womens Health Issues. 2005 May-Jun;15(3):126-33. doi: 10.1016/j.whi.2005.01.001.
PubMed 15894198Sherman SE, Joseph AM, Yano EM, Simon BF, Arikian N, Rubenstein LV, Parkerton P, Mittman BS. Assessing the institutional approach to implementing smoking cessation practice guidelines in veterans health administration facilities. Mil Med. 2006 Jan;171(1):80-7. doi: 10.7205/milmed.171.1.80.
PubMed 16532880Jonk YC, Sherman SE, Fu SS, Hamlett-Berry KW, Geraci MC, Joseph AM. National trends in the provision of smoking cessation aids within the Veterans Health Administration. Am J Manag Care. 2005 Feb;11(2):77-85.
PubMed 15726855Sherman SE, Yano EM, Lanto AB, Simon BF, Rubenstein LV. Smokers' interest in quitting and services received: using practice information to plan quality improvement and policy for smoking cessation. Am J Med Qual. 2005 Jan-Feb;20(1):33-9. doi: 10.1177/1062860604273776.
PubMed 15782753Meredith LS, Yano EM, Hickey SC, Sherman SE. Primary care provider attitudes are associated with smoking cessation counseling and referral. Med Care. 2005 Sep;43(9):929-34. doi: 10.1097/01.mlr.0000173566.01877.ac.
PubMed 16116358Sherman SE, Lanto AB, Nield M, Yano EM. Smoking cessation care received by veterans with chronic obstructive pulmonary disease. J Rehabil Res Dev. 2003 Sep-Oct;40(5 Suppl 2):1-12. doi: 10.1682/jrrd.2003.10.0001.
PubMed 15074449Mojica WA, Suttorp MJ, Sherman SE, Morton SC, Roth EA, Maglione MA, Rhodes SL, Shekelle PG. Smoking-cessation interventions by type of provider: a meta-analysis. Am J Prev Med. 2004 Jun;26(5):391-401. doi: 10.1016/j.amepre.2004.02.014.
PubMed 15165655Yano EM, Rubenstein LV, Farmer MM, Chernof BA, Mittman BS, Lanto AB, Simon BF, Lee ML, Sherman SE. Targeting primary care referrals to smoking cessation clinics does not improve quit rates: implementing evidence-based interventions into practice. Health Serv Res. 2008 Oct;43(5 Pt 1):1637-61. doi: 10.1111/j.1475-6773.2008.00865.x. Epub 2008 Jun 3.
PubMed 18522670Lombardero A, Campbell DG, Harris KJ, Chaney EF, Lanto AB, Rubenstein LV. Prevalence and correlates of smoking status among veterans affairs primary care patients with probable major depressive disorder. Addict Behav. 2014 Mar;39(3):538-45. doi: 10.1016/j.addbeh.2013.10.030. Epub 2013 Nov 4.
PubMed 24290879
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
- Implementing Guidelines for Smoking Cessation: A Randomized Trial of Evidence-Based Quality Improvement
- ClinicalTrials.gov ID
- NCT00012987
- Acronym / sponsor ID
- CPG 97-002
- Conditions
- Smoking, Smoking Cessation, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Dec 2002 (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 is a serious and common health risk among veterans. Given the press of national initiatives and local incentives to improve smoking cessation care in response to VA performance measures, this study tests a widely applicable approach to clinical practice guidelines implementation, namely evidence-based quality improvement, which is directly relevant to the translation of efficacious treatments into enhancements in VA health care policy and practice. Evidence-Based Quality Improvement (EBQI) focuses on improved provider adherence to smoking cessation guidelines and a decrease in patient smoking rates in a manner designed to produce short- and long-term health improvements and cost benefits at the organizational level.
Detailed description
Background:
Smoking is a serious and common health risk among veterans. Given the press of national initiatives and local incentives to improve smoking cessation care in response to VA performance measures, this study tests a widely applicable approach to clinical practice guidelines implementation, namely evidence-based quality improvement, which is directly relevant to the translation of efficacious treatments into enhancements in VA health care policy and practice. Evidence-Based Quality Improvement (EBQI) focuses on improved provider adherence to smoking cessation guidelines and a decrease in patient smoking rates in a manner designed to produce short- and long-term health improvements and cost benefits at the organizational level.
Objectives:
Adherence to smoking cessation guidelines requires practice changes at the patient, provider, and system levels to achieve optimal quit rates. The objective of this study was to evaluate the effectiveness of evidence-based quality improvement (EBQI)�an expert-designed and locally implemented clinical reorganization of smoking cessation care�on changes in smoking cessation (SC) practice among primary care providers and health outcomes among veteran smokers.
Methods:
An evidence-based quality improvement intervention comprising provision of physician and patient educational materials, local priority setting with leadership and providers, and local adaptation of expert-designed protocols was implemented in experimental VA primary care practices (n=9). VA control sites (n=9), matched on size and academic affiliation, received smoking cessation guideline copies. We randomly sampled, consented, screened and surveyed primary care patients at all 18 sites (n=1,941 smokers) and used computer-assisted telephone interviewing to assess sociodemographics, health status, function, and smoking behavior, attitudes and treatment experience. Post-intervention 12-month follow-up interviews were completed using the same measures (n=1,080). We used multiple imputation using hotdeck techniques and applied both enrollment and attrition weights to the patient-level data. We used weighted logistic regression to evaluate intervention effects, controlling for patient-level predictors of quit attempts and quit status (e.g., level of addiction, readiness to change, age, health).
Status:
The project is completed. Analysis is ongoing for manuscripts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Quality Improvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- VA Medical Center or outpatient clinics with at least 3000 patients.
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 |
|---|---|---|
| Quality Improvement | Behavioural | 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 16706001Sherman SE, Yano EM, York LS, Lanto AB, Chernof BA, Mittman BS. Assessing the structure of smoking cessation care in the Veterans Health Administration. Am J Health Promot. 2006 May-Jun;20(5):313-8. doi: 10.4278/0890-1171-20.5.313.
- Results publication: PubMed 15894198Sherman SE, Fu SS, Joseph AM, Lanto AB, Yano EM. Gender differences in smoking cessation services received among veterans. Womens Health Issues. 2005 May-Jun;15(3):126-33. doi: 10.1016/j.whi.2005.01.001.
- Results publication: PubMed 16532880Sherman SE, Joseph AM, Yano EM, Simon BF, Arikian N, Rubenstein LV, Parkerton P, Mittman BS. Assessing the institutional approach to implementing smoking cessation practice guidelines in veterans health administration facilities. Mil Med. 2006 Jan;171(1):80-7. doi: 10.7205/milmed.171.1.80.
- Results publication: PubMed 15726855Jonk YC, Sherman SE, Fu SS, Hamlett-Berry KW, Geraci MC, Joseph AM. National trends in the provision of smoking cessation aids within the Veterans Health Administration. Am J Manag Care. 2005 Feb;11(2):77-85.
- Results publication: PubMed 15782753Sherman SE, Yano EM, Lanto AB, Simon BF, Rubenstein LV. Smokers' interest in quitting and services received: using practice information to plan quality improvement and policy for smoking cessation. Am J Med Qual. 2005 Jan-Feb;20(1):33-9. doi: 10.1177/1062860604273776.
- Results publication: PubMed 16116358Meredith LS, Yano EM, Hickey SC, Sherman SE. Primary care provider attitudes are associated with smoking cessation counseling and referral. Med Care. 2005 Sep;43(9):929-34. doi: 10.1097/01.mlr.0000173566.01877.ac.
- Results publication: PubMed 15074449Sherman SE, Lanto AB, Nield M, Yano EM. Smoking cessation care received by veterans with chronic obstructive pulmonary disease. J Rehabil Res Dev. 2003 Sep-Oct;40(5 Suppl 2):1-12. doi: 10.1682/jrrd.2003.10.0001.
- Results publication: PubMed 15165655Mojica WA, Suttorp MJ, Sherman SE, Morton SC, Roth EA, Maglione MA, Rhodes SL, Shekelle PG. Smoking-cessation interventions by type of provider: a meta-analysis. Am J Prev Med. 2004 Jun;26(5):391-401. doi: 10.1016/j.amepre.2004.02.014.
- Results publication: PubMed 18522670Yano EM, Rubenstein LV, Farmer MM, Chernof BA, Mittman BS, Lanto AB, Simon BF, Lee ML, Sherman SE. Targeting primary care referrals to smoking cessation clinics does not improve quit rates: implementing evidence-based interventions into practice. Health Serv Res. 2008 Oct;43(5 Pt 1):1637-61. doi: 10.1111/j.1475-6773.2008.00865.x. Epub 2008 Jun 3.
- Results publication: PubMed 24290879Lombardero A, Campbell DG, Harris KJ, Chaney EF, Lanto AB, Rubenstein LV. Prevalence and correlates of smoking status among veterans affairs primary care patients with probable major depressive disorder. Addict Behav. 2014 Mar;39(3):538-45. doi: 10.1016/j.addbeh.2013.10.030. Epub 2013 Nov 4.
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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.
Scott E Sherman, MD MPH principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Elizabeth M. Yano, PhD MSPH principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Improvement in people with Smoking and Smoking Cessation, run by US Department of Veterans Affairs at 2 sites 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 2 sites 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?
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 NCT00012987, which also lists 10 linked publications.
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.