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: April 18, 2014
Last verified: April 2014
  Purpose

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
Cigarette Smoking
Behavioral: Smoking Cessation Guideline Implementation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 7-day point-prevalence smoking abstinence [ Time Frame: 3 and 6 months post enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Referrals to Quitline and prescription of recommended pharmacotherapy for smoking cessation [ Time Frame: Assessed at discharge ] [ Designated as safety issue: No ]

Enrollment: 899
Study Start Date: May 2009
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Baseline Period
Experimental: Arm 2
Intervention Period
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816036

Locations
United States, Colorado
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
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
United States, Nebraska
VA Medical Center, Omaha
Omaha, Nebraska, United States, 68105-1873
Sponsors and Collaborators
National Jewish Hospital Quitline
Iowa State University
Investigators
Principal Investigator: David A. Katz, MD MSc VA Medical Center, Iowa City
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00816036     History of Changes
Obsolete Identifiers: NCT00962858
Other Study ID Numbers: IIR 07-113
Study First Received: December 29, 2008
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Smoking Cessation
Practice Guidelines
Inpatient
Effectiveness Trial
Veterans Administration
Relapse prevention

Additional relevant MeSH terms:
Smoking
Food Habits
Habits

ClinicalTrials.gov processed this record on July 31, 2014