Cigarette Smoking Clinical Trial
Official title:
Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans
Verified date | April 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 898 |
Est. completion date | August 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | VA Eastern Colorado Health Care System, Denver, CO | Denver | Colorado |
United States | Iowa City VA Health Care System, Iowa City, IA | Iowa City | Iowa |
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
United States | VA Medical Center, Omaha | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Iowa State University, National Jewish Hospital Quitline |
United States,
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. — View Citation
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 — View Citation
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 performanc — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months post enrollment | No |
Secondary | Referrals to Quitline | Assessed within 72 hours of hospital discharge | No | |
Secondary | Prescription of Recommended Pharmacotherapy for Smoking Cessation | Assessed within 72 hours of hospital discharge | No |
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