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Sponsors and Collaborators: |
Department of Veterans Affairs National Jewish Hospital Quitline Iowa State University |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00816036 |
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.
Condition | Intervention |
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Cigarette Smoking |
Behavioral: Smoking Cessation Guideline Implementation |
Study Type: | Interventional |
Study Design: | Health Services Research, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Baseline Period
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2: Experimental
Intervention Period
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Behavioral: Smoking Cessation Guideline Implementation
1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff
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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 controlled 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. 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria include: 1) hospitalization for less than 24 hours (e.g., patients admitted for overnight observation); 2) acute medical decompensation (e.g., acute respiratory failure requiring intubation, cardiac arrest, septic shock); 3) altered mental status; 4) unstable psychiatric disorder (e.g., acute psychosis); 4) dementia; 5) communication barrier (unable to speak English, hard of hearing, aphasic); 5) pregnancy; and 6) terminal illness (<12 month life expectancy). 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).
Contact: John E Holman, MA | (319) 338-0581 ext 7507 | John.Holman2@med.va.gov |
United States, Colorado | |
VA Eastern Colorado Health Care System, Denver | |
Denver, Colorado, United States, 80220 | |
VA Eastern Colorado Health Care System, Denver | |
Denver, Colorado, United States, 80220 | |
United States, Iowa | |
VA Medical Center, Iowa City | |
Iowa City, Iowa, United States, 52246-2208 | |
United States, Minnesota | |
VA Medical Center | |
Minneapolis, Minnesota, United States, 55417 | |
VA Medical Center, Minneapolis | |
Minneapolis, Minnesota, United States, 55417 | |
United States, Nebraska | |
VA Medical Center, Omaha | |
Omaha, Nebraska, United States, 68105-1873 |
Principal Investigator: | David A. Katz, MD MSc | VA Medical Center, Iowa City |
Responsible Party: | Department of Veterans Affairs ( Katz, David - Principal Investigator ) |
Study ID Numbers: | IIR 07-113 |
Study First Received: | December 29, 2008 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00816036 History of Changes |
Health Authority: | United States: Federal Government |
Smoking Cessation Practice Guidelines Inpatient |
Effectiveness Trial Veterans Administration Relapse prevention |
Nicotine polacrilex Smoking Nicotine |
Habits Smoking |