Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

Cigarette Smoking Clinical Trial

Official title:

Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816036
• Other study ID #: IIR 07-113
• Status: Completed
• Phase: N/A
• First received: December 29, 2008
• Last updated: April 6, 2015
• Start date: May 2009
• Est. completion date: August 2013

Study information

• 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

Clinical 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. 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.

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.

Other known NCT identifiers

• NCT00962858

Recruitment information / eligibility

• 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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Smoking Cessation Guideline Implementation
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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Iowa State University, National Jewish Hospital Quitline

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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