NCT01173653

Brief Summary

The emergency department (ED) serves a vital and growing role in the US health care system, responsible for both the delivery of emergent medical care and for safety-net care for populations without traditional access to health services. Uninsured populations rely significantly on the safety-net services of the ED. Between 2000-2005 the number of uninsured Americans increased from 39.6 million to 46.1 million, and this growth is expected to continue. Many health policy analysts consider the ED to be an effective place to provide preventative care. Prophylactic tetanus immunization, for example, has been a successful preventive health intervention that has become a standard of care in the ED setting. Brief smoking cessation interventions have been introduced in the ED but have not had great success based on lack of follow-up and continuity. Our study is novel in that it introduces a brief smoking intervention through use of an established, federally-funded and federally-sponsored cessation counseling resource, the National Smoking Cessation Quit Line, also available at smokefree.gov. This is a joint initiative between the Tobacco Control Research Branch of the National Cancer Institute and the Centers for Disease Control and Prevention. Since ED patients who smoke often lack the ability to use self-help cessation resources, we hypothesize that by introducing this population to the counselors on the National Smoking Cessation Quit Line (also called the 1-800-QUIT-NOW line) during the ED visit via phone, that this new brief intervention would have a realizable and significant effect on smoking cessation among the this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 19, 2012

Completed
Last Updated

December 27, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

July 29, 2010

Results QC Date

January 9, 2012

Last Update Submit

December 19, 2012

Conditions

Keywords

smokingsmoking cessationhealth behavior

Outcome Measures

Primary Outcomes (1)

  • Smoking Status at Follow up

    Patients enrolled in this study were contacted via phone to assess smoking status. Smoking status was a self-report from each subject. Primary outcome measure is the smoking status of the enrollee at the time of follow-up contact. We calculated the percentage of participants who had stopped smoking at the 6 week follow-up period in each arm

    6 weeks

Study Arms (2)

Standard EM Smoking Cessation Info

PLACEBO COMPARATOR

Patients discharged from ER receive pamphlet re: smoking cessation

Other: Smoking Cessation

Patients contact 1-800-QUIT-NOW before leaving ED

ACTIVE COMPARATOR

Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.

Other: Smoking Cessation

Interventions

Randomly introducing patients to a Department of Health program to help them quit smoking.

Standard EM Smoking Cessation Info

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years of age and older
  • Patients who are active smokers who present to the Adult ED at VUMC
  • Patients who are able to give informed verbal consent
  • Patients with stable vital signs

You may not qualify if:

  • Patients who are unable to provide consent
  • Patients who are unable to communicate verbally as determined by the treating attending physician and/or triage nurse. This includes patients with alterations in mental status, who are cognitively impaired, or are intoxicated or on drugs
  • Patients with abnormal vital signs, and triage ratings (ES1 score 1) suggesting immediate life threatening illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center - Emergency Medicine

Nashville, Tennessee, 37232-4700, United States

Location

MeSH Terms

Conditions

Smoking CessationTobacco Use CessationHealth BehaviorSmoking

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

This is a preliminary study with a convenience sample of patients at a single academic medical center. A larger multicenter trial targeting consecutive ED patients who smoke will be essential to validate the applicability of our findings.

Results Point of Contact

Title
Benjamin Heavrin, MD
Organization
Vanderbilt University Emergency Medicine Department

Study Officials

  • Ben Heavrin, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Benjamin S. Heavrin, MD, MBA

Study Record Dates

First Submitted

July 29, 2010

First Posted

August 2, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2010

Study Completion

January 1, 2011

Last Updated

December 27, 2012

Results First Posted

November 19, 2012

Record last verified: 2012-12

Locations