- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00816036
Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans
April 6, 2015 updated by: US Department of Veterans Affairs
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
898
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80220
- VA Eastern Colorado Health Care System, Denver, CO
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Iowa
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Iowa City, Iowa, United States, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
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Nebraska
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Omaha, Nebraska, United States, 68105-1873
- VA Medical Center, Omaha
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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);
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Arm 1
Baseline Period
|
|
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Experimental: Arm 2
Intervention Period
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1. 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months post enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Referrals to Quitline
Time Frame: Assessed within 72 hours of hospital discharge
|
Assessed within 72 hours of hospital discharge
|
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Prescription of Recommended Pharmacotherapy for Smoking Cessation
Time Frame: Assessed within 72 hours of hospital discharge
|
Assessed within 72 hours of hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David A. Katz, MD MSc, Iowa City VA Health Care System, Iowa City, IA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kamath 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.
- Katz 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
December 29, 2008
First Submitted That Met QC Criteria
December 30, 2008
First Posted (Estimate)
December 31, 2008
Study Record Updates
Last Update Posted (Estimate)
April 27, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IIR 07-113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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