Cigarette SmokingNCT00816036
Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans
A study testing Smoking Cessation Guideline Implementation in people with Cigarette Smoking, run by US Department of Veterans Affairs at 4 sites in United States.
Trial summary
The primary objective of this study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Smoking Cessation Guideline Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 898 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2009to Aug 2013
- 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
- Patients: The study sample will include general medical inpatients, aged 18 or older, who smoke at least one cigarette per day on average, regardless of their willingness to quit smoking. To increase applicability of study results, the goal is to enroll patients with characteristics that reflect the full range and distribution of patients observed in clinical practice. Current smokers transferred from intensive care units (or other monitored beds) to a general medical ward will be eligible.
- Nurses: The study sample will include staff nurses who are assigned to a general medicine inpatient unit at one of the participating sites.
Who cannot join
- Hospitalization for less than 18 hours (e.g., patients admitted for overnight observation);
- Acute medical decomposition (e.g., acute respiratory failure requiring intubation, cardiac arrest, septic shock);
- Altered mental status;
- Unstable psychiatric disorder (e.g., acute psychosis);
- Dementia;
- Communication barrier (unable to speak English, hard of hearing, aphasic);
Show all 11Show fewer
- Pregnancy;
- Terminal illness (<12 month life expectancy);
- No access to a phone or the absence of a permanent address;
- Admitted for treatment of substance abuse.
- No patient will be included unless they are able to provide informed consent and agree to be contacted by telephone during follow-up (to assess smoking status).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
VA Medical Center, Omaha
Omaha, Nebraska, 68105-1873
About this study
The primary objective of this study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. If proven effective, the proposed intervention will provide a practical strategy to enhance the adoption and implementation of recommended smoking cessation procedures in VA hospitals, and will demonstrate the utility of quitlines in preventing relapse in hospitalized smokers once they leave the hospital.
Read the detailed description
Although the majority of hospitalized VA smokers receive some form of cessation counseling during hospitalization, few receive outpatient cessation counseling and/or pharmacotherapy following discharge, which are key factors associated with long-term cessation. The primary objective of this research study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. Co-primary aims are to determine whether the intervention improves the prescription of recommended pharmacotherapy for smoking cessation and the referral of patients for telephone counseling (or other outpatient cessation counseling). We will perform a quasi-experimental before-after trial in hospitalized patients, aged 18 or older, who smoke at least one cigarette per day on average. After a 6-month baseline period, we will implement the intervention and enroll a separate cohort of patients over the subsequent 6 months. The intervention will include: 1) nurse training in delivery of bedside cessation counseling, 2) use of CPRS-based practice tools (to streamline nursing assessment and documentation, to facilitate prescription of pharmacotherapy), 3) computerized referral of motivated inpatients for proactive telephone counseling, and 4) use of nursing peer leaders to provide coaching and performance feedback to ward nurses. Enrolled patients will be contacted by telephone at 3 and 6 months to assess 7-day point prevalence abstinence and prolonged abstinence (with biochemical confirmation of self-reported quitters at 6 months). We will identify barriers and facilitators to implementation by using clinician focus groups, and will assess attitudes of staff nurses toward cessation counseling by questionnaire. We will also conduct semi-structured interviews in a subsample of patients and nurses to assess perceptions of the intervention, and will use content analysis to interpret the data.
- Conditions
- Cigarette Smoking
- Being tested
- Smoking Cessation Guideline Implementation
- Keywords
- Smoking Cessation, Practice Guidelines, Inpatient, Effectiveness Trial, Veterans Administration, Relapse prevention
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation Guideline ImplementationBehavioural
- Enhanced academic detailing of staff nurses (face-to-face training, feedback on group performance, and periodic check-ins with both nurse managers and peer leaders); 2. Adaptation of the computerized information system (modified nursing admission database that includes pertinent questions about smoking, computerized "quick orders" for smoking cessation medications), 3) Patient self-management support (self-help materials, fax referral of motivated patients to state quit line), and 4) nursing peer leaders on each study unit.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | Baseline Period |
| Arm 2 | Experimental | Intervention Period Receives: Behavioral: Smoking Cessation Guideline Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point-prevalence Smoking Abstinence (6-month)
This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.
Measured: 6 months post enrollment
Secondary outcomes (2)
Referrals to Quitline
Measured: Assessed within 72 hours of hospital discharge
Prescription of Recommended Pharmacotherapy for Smoking Cessation
Measured: Assessed within 72 hours of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startMay 2009
- Primary completionJun 2013
- Study completionAug 2013
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 (3)Papers the sponsor has linked to this study.
- Other trials for Cigarette 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 898 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- National Jewish Hospital Quitline, Iowa State University
- Responsible party
- Sponsor
- Investigators
- David A. Katz, MD MSc, Principal investigator, Iowa City VA Health Care System, Iowa City, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816036
- Sponsor's protocol ID
- IIR 07-113
- Status last verified
- Apr 2014
- First submitted
- 29 Dec 2008
- Last updated
- 27 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Katz DA, Holman J, Johnson S, Hillis SL, Ono S, Stewart K, Paez M, Fu S, Grant K, Buchanan L, Prochazka A, Battaglia C, Titler M, Vander Weg MW. Implementing smoking cessation guidelines for hospitalized veterans: effects on nurse attitudes and performance. J Gen Intern Med. 2013 Nov;28(11):1420-9. doi: 10.1007/s11606-013-2464-7. Epub 2013 May 7.
PubMed 23649783Kamath AS, Vaughan Sarrazin M, Vander Weg MW, Cai X, Cullen J, Katz DA. Hospital costs associated with smoking in veterans undergoing general surgery. J Am Coll Surg. 2012 Jun;214(6):901-8.e1. doi: 10.1016/j.jamcollsurg.2012.01.056. Epub 2012 Apr 11.
PubMed 22502993Katz D, Vander Weg M, Fu S, Prochazka A, Grant K, Buchanan L, Tinkelman D, Reisinger HS, Brooks J, Hillis SL, Joseph A, Titler M. A before-after implementation trial of smoking cessation guidelines in hospitalized veterans. Implement Sci. 2009 Sep 10;4:58. doi: 10.1186/1748-5908-4-58.
PubMed 19744339
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans
- ClinicalTrials.gov ID
- NCT00816036
- Acronym / sponsor ID
- IIR 07-113
- Conditions
- Cigarette Smoking
- Keywords
- Smoking Cessation, Practice Guidelines, Inpatient, Effectiveness Trial, Veterans Administration, Relapse prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 898 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- National Jewish Hospital Quitline, Iowa State University
- Study start
- May 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 31 Dec 2008 (estimated)
- Results
- Posted 6 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. If proven effective, the proposed intervention will provide a practical strategy to enhance the adoption and implementation of recommended smoking cessation procedures in VA hospitals, and will demonstrate the utility of quitlines in preventing relapse in hospitalized smokers once they leave the hospital.
Detailed description
Although the majority of hospitalized VA smokers receive some form of cessation counseling during hospitalization, few receive outpatient cessation counseling and/or pharmacotherapy following discharge, which are key factors associated with long-term cessation. The primary objective of this research study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. Co-primary aims are to determine whether the intervention improves the prescription of recommended pharmacotherapy for smoking cessation and the referral of patients for telephone counseling (or other outpatient cessation counseling). We will perform a quasi-experimental before-after trial in hospitalized patients, aged 18 or older, who smoke at least one cigarette per day on average. After a 6-month baseline period, we will implement the intervention and enroll a separate cohort of patients over the subsequent 6 months. The intervention will include: 1) nurse training in delivery of bedside cessation counseling, 2) use of CPRS-based practice tools (to streamline nursing assessment and documentation, to facilitate prescription of pharmacotherapy), 3) computerized referral of motivated inpatients for proactive telephone counseling, and 4) use of nursing peer leaders to provide coaching and performance feedback to ward nurses. Enrolled patients will be contacted by telephone at 3 and 6 months to assess 7-day point prevalence abstinence and prolonged abstinence (with biochemical confirmation of self-reported quitters at 6 months). We will identify barriers and facilitators to implementation by using clinician focus groups, and will assess attitudes of staff nurses toward cessation counseling by questionnaire. We will also conduct semi-structured interviews in a subsample of patients and nurses to assess perceptions of the intervention, and will use content analysis to interpret the data.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –Baseline Period |
| Arm 2 | Experimental | Behavioral: Smoking Cessation Guideline ImplementationIntervention Period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients: The study sample will include general medical inpatients, aged 18 or older, who smoke at least one cigarette per day on average, regardless of their willingness to quit smoking. To increase applicability of study results, the goal is to enroll patients with characteristics that reflect the full range and distribution of patients observed in clinical practice. Current smokers transferred from intensive care units (or other monitored beds) to a general medical ward will be eligible.
- Nurses: The study sample will include staff nurses who are assigned to a general medicine inpatient unit at one of the participating sites.
Key exclusion criteria (11 listed)
- Hospitalization for less than 18 hours (e.g., patients admitted for overnight observation);
- Acute medical decomposition (e.g., acute respiratory failure requiring intubation, cardiac arrest, septic shock);
- Altered mental status;
- Unstable psychiatric disorder (e.g., acute psychosis);
- Dementia;
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 |
|---|---|---|
| Smoking Cessation Guideline Implementation1. Enhanced academic detailing of staff nurses (face-to-face training, feedback on group performance, and periodic check-ins with both nurse managers and peer leaders); 2. Adaptation of the computerized information system (modified nursing admission database that includes pertinent questions about smoking, computerized "quick orders" for smoking cessation medications), 3) Patient self-management support (self-help materials, fax referral of motivated patients to state quit line), and 4) nursing peer leaders on each study unit. | Behavioural | Arm 2 |
Primary outcome
7-day Point-prevalence Smoking Abstinence (6-month)
Time frame: 6 months post enrollment
This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.
2 secondary outcomes
Referrals to Quitline
Time frame: Assessed within 72 hours of hospital discharge
Prescription of Recommended Pharmacotherapy for Smoking Cessation
Time frame: Assessed within 72 hours of hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23649783Katz DA, Holman J, Johnson S, Hillis SL, Ono S, Stewart K, Paez M, Fu S, Grant K, Buchanan L, Prochazka A, Battaglia C, Titler M, Vander Weg MW. Implementing smoking cessation guidelines for hospitalized veterans: effects on nurse attitudes and performance. J Gen Intern Med. 2013 Nov;28(11):1420-9. doi: 10.1007/s11606-013-2464-7. Epub 2013 May 7.
- Results publication: PubMed 22502993Kamath AS, Vaughan Sarrazin M, Vander Weg MW, Cai X, Cullen J, Katz DA. Hospital costs associated with smoking in veterans undergoing general surgery. J Am Coll Surg. 2012 Jun;214(6):901-8.e1. doi: 10.1016/j.jamcollsurg.2012.01.056. Epub 2012 Apr 11.
- Results publication: PubMed 19744339Katz D, Vander Weg M, Fu S, Prochazka A, Grant K, Buchanan L, Tinkelman D, Reisinger HS, Brooks J, Hillis SL, Joseph A, Titler M. A before-after implementation trial of smoking cessation guidelines in hospitalized veterans. Implement Sci. 2009 Sep 10;4:58. doi: 10.1186/1748-5908-4-58.
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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.
David A. Katz, MD MSc principal investigator
Iowa City VA Health Care System, Iowa City, IA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation Guideline Implementation in people with Cigarette Smoking, run by US Department of Veterans Affairs at 4 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 2 inclusion and 11 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 27 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 4 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?
Yes. Results are posted in the registry (first posted 6 Aug 2014). 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?
7-day Point-prevalence Smoking Abstinence (6-month) (time frame: 6 months post enrollment). 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 NCT00816036, which also lists 3 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 27 Apr 2015.