Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

This study has been completed.
Sponsor:
Collaborators:
National Jewish Hospital Quitline
Iowa State University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00816036
First received: December 29, 2008
Last updated: August 5, 2014
Last verified: August 2014

December 29, 2008
August 5, 2014
May 2009
June 2013   (final data collection date for primary outcome measure)
7-day Point-prevalence Smoking Abstinence (6-month) [ Time Frame: 6 months post enrollment ] [ Designated as safety issue: No ]
This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.
7-day point-prevalence smoking abstinence [ Time Frame: 3 and 6 months post enrollment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00816036 on ClinicalTrials.gov Archive Site
  • Referrals to Quitline [ Time Frame: Assessed within 72 hours of hospital discharge ] [ Designated as safety issue: No ]
  • Prescription of Recommended Pharmacotherapy for Smoking Cessation [ Time Frame: Assessed within 72 hours of hospital discharge ] [ Designated as safety issue: No ]
Referrals to Quitline and prescription of recommended pharmacotherapy for smoking cessation [ Time Frame: Assessed at discharge ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans
Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Cigarette Smoking
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.
  • No Intervention: Arm 1
    Baseline Period
  • Experimental: Arm 2
    Intervention Period
    Intervention: Behavioral: Smoking Cessation Guideline Implementation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
898
August 2013
June 2013   (final data collection date for primary outcome measure)

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).

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816036
IIR 07-113
Yes
Department of Veterans Affairs
Department of Veterans Affairs
  • National Jewish Hospital Quitline
  • Iowa State University
Principal Investigator: David A. Katz, MD MSc VA Medical Center, Iowa City
Department of Veterans Affairs
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP