Combination SBIRT for Emergency Department Patients Who Drink and Smoke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Yale University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01595178
First received: May 7, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

Smoking and drinking are two of the three leading causes of preventable deaths in the United States today. Using both alcohol and tobacco significantly multiplies the risk of disease and death from myocardial infarction, COPD, and multiple cancers. Combined use of these substances is extremely common; people who drink are three times more likely than the general population to smoke, and tobacco dependent individuals are four times more likely than the general population to be alcohol-dependent.

Research has shown that there is a high prevalence of unmet substance abuse treatment need among adult Emergency Department (ED) patients. The current project aims to conduct a pilot feasibility study with 50 adult ED patients to develop a brief counseling intervention that is feasible and acceptable to patients who are both smokers and at-risk drinkers to help them reduce these behaviors.

The overarching aim of this line of research is to find the best treatment for ED patients who are combo smokers and at-risk drinkers. The study will focus on the development of an intervention that will be tested in a future larger scale randomized clinical trial.


Condition Intervention Phase
Smoking
Drinking
Behavioral: Combined BNI
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Development of a Combined Screening and Intervention Program for Emergency Department Patients Who Both Drink and Smoke

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Areas in need of help [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Descriptive summary of patient reports of areas in need of help as reported during assessments

  • Barriers and facilitators to accessing care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Descriptive summary of patient reports of barriers and facilitators encountered in trying to access needed alcohol and smoking cessation treatments

  • Counseling satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Patient reports of satisfaction with counseling modules delivered


Secondary Outcome Measures:
  • Treatment utilization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of contacts with treatment resources for alcohol and tobacco cessation

  • Reduction of consumption [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Patient self reported reductions in smoking and drinking

  • Quit attempts [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of quit attempts (smoking and drinking)


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Combined BNI
    Combination brief negotiated interview (BNI) for patients who smoke and drink
Detailed Description:

Smoking and drinking are the most common addictions in this country and frequently co-occur. Among persons who smoke and drink, there appears to be a robust dose-response relationship, with heavier drinking associated with heavier smoking and vice versa. Additionally, smokers who are more alcohol dependent often report that smoking is a common way to cope with the urge to drink.

Research has shown that there is a high prevalence of unmet substance abuse treatment need among adult Emergency Department (ED) patients. As many as 46% of ED patients have recently consumed alcohol and a significant number of the 31.6 million ED injury related visits are alcohol related. The prevalence rate of tobacco use among ED patients is reportedly as high as 40% and contributes to significant morbidity and mortality.

For many the ED is the only place they can access medical care. Although most medically-underserved individuals never seek out specialized treatment for smoking or drinking, each year over 120 million people visit an ED. Since an ED visit may be a patient's only point of contact with the health care system, it represents an important opportunity not only to treat their emergent needs, but to screen and provide this vulnerable population with appropriate alcohol and tobacco use interventions.

The intervention, built upon the Brief Negotiated Interview (BNI) model, aims to help patients reduce harmful drinking and smoking and will be initiated during an ED visit followed by 3 follow up COMBINE counseling telephone sessions post ED visit.

The specific aims of the proposed project are to:

Aim 1: To develop an effective brief intervention for smoker- drinkers that is feasible and acceptable for patients treated in the emergency department

Aim 2: To identify barriers to treatment engagement and factors that facilitate successful engagement in alcohol and smoking cessation treatment

  Eligibility

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

Inclusion Criteria:

  • Adults = or > 18 years old
  • English speaking
  • Willing and able to give informed consent
  • Current daily smoker
  • Smokes 5 or more cigarettes daily
  • Alcohol screening score =/> than 8 and =< 19

Exclusion Criteria:

  • Too ill to consent
  • Not interested in quitting drinking and smoking
  • Current use of smoking / alcohol use cessation medications / products
  • Current involvement in alcohol or smoking treatment program
  • Doe not have locator information
  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: NCT01595178

Contacts
Contact: Mary K Murphy, PhD 203-785-4363 mary.murphy@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Emergency Department Not yet recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Mary K Murphy, PhD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mary K Murphy, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01595178     History of Changes
Other Study ID Numbers: 1065276 R10701 SAEM
Study First Received: May 7, 2012
Last Updated: May 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
smoking
drinking
SBIRT
BNI
counseling intervention
emergency department
adults

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014