Clinical trial NCT00816036: Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans
Official title: Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Smoking Cessation
Practice Guidelines
Inpatient
Effectiveness Trial
Veterans Administration
Relapse prevention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: National Jewish Hospital Quitline
name: Iowa State University
First posted: 2008-12-31
Enrollment: 898
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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).

Primary outcomes:
measure: 7-day Point-prevalence Smoking Abstinence (6-month)
timeFrame: 6 months post enrollment
Secondary outcomes:
measure: Referrals to Quitline
timeFrame: Assessed within 72 hours of hospital discharge
measure: Prescription of Recommended Pharmacotherapy for Smoking Cessation
timeFrame: Assessed within 72 hours of hospital discharge
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver, CO
state: Colorado
city: Iowa City
country: United States
facility: Iowa City VA Health Care System, Iowa City, IA
state: Iowa
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Omaha
country: United States
facility: VA Medical Center, Omaha
state: Nebraska
Study officials:
affiliation: Iowa City VA Health Care System, Iowa City, IA
name: David A. Katz, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
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 performance. J Gen Intern Med. 2013 Nov;28(11):1420-9. doi: 10.1007/s11606-013-2464-7. Epub 2013 May 7.
citation: 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.
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. doi: 10.1186/1748-5908-4-58.