NCT00816036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
898

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 6, 2014

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2014

Enrollment Period

4.1 years

First QC Date

December 29, 2008

Results QC Date

July 8, 2014

Last Update Submit

April 6, 2015

Conditions

Cigarette Smoking

Keywords

Smoking CessationPractice GuidelinesInpatientEffectiveness TrialVeterans AdministrationRelapse prevention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Referrals to Quitline

    Assessed within 72 hours of hospital discharge

  • Prescription of Recommended Pharmacotherapy for Smoking Cessation

    Assessed within 72 hours of hospital discharge

Study Arms (2)

Arm 1

NO INTERVENTION

Baseline Period

Arm 2

EXPERIMENTAL

Intervention Period

Behavioral: Smoking Cessation Guideline Implementation

Interventions

Smoking Cessation Guideline ImplementationBEHAVIORAL

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.

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

VA Medical Center, Omaha

Omaha, Nebraska, 68105-1873, United States

Location

Related Publications (3)

  • 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.

    PMID: 23649783RESULT

  • 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.

    PMID: 22502993RESULT

  • 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.

    PMID: 19744339RESULT

MeSH Terms

Conditions

Cigarette SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Results Point of Contact

Title
David Katz, MD, MSc
Organization
Department of Veterans Affairs
david-katz@uiowa.edu
319-338-0581

Study Officials

  • David A. Katz, MD MSc

    Iowa City VA Health Care System, Iowa City, IA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2008

First Posted

December 31, 2008

Study Start

May 1, 2009

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

April 27, 2015

Results First Posted

August 6, 2014

Record last verified: 2014-04

Locations

US(4)