Combination SBIRT for Emergency Department Patients Who Drink and Smoke

Smoking Clinical Trial

Official title:

Development of a Combined Screening and Intervention Program for Emergency Department Patients Who Both Drink and Smoke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595178
• Other study ID #: 1205010294
• Status: Completed
• Phase: Early Phase 1
• Start date: June 2012
• Est. completion date: May 8, 2014

Study information

• Verified date: June 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 8, 2014
• Est. primary completion date: May 8, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drinking
• Emergencies
• Smoking

Intervention

Behavioral:
• Combined BNI
Combination brief negotiated interview (BNI) for patients who smoke and drink

Locations

Country	Name	City	State
United States	Yale New Haven Hospital Emergency Department	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Areas in need of help	Descriptive summary of patient reports of areas in need of help as reported during assessments	3 months
Primary	Barriers and facilitators to accessing care	Descriptive summary of patient reports of barriers and facilitators encountered in trying to access needed alcohol and smoking cessation treatments	3 months
Primary	Counseling satisfaction	Patient reports of satisfaction with counseling modules delivered	3 months
Secondary	Treatment utilization	Number of contacts with treatment resources for alcohol and tobacco cessation	3 months
Secondary	Reduction of consumption	Patient self reported reductions in smoking and drinking	3 months
Secondary	Quit attempts	Number of quit attempts (smoking and drinking)	3 months