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Combination SBIRT for Emergency Department Patients Who Drink and Smoke

Primary Purpose

Smoking, Drinking

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Combined BNI
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Smoking focused on measuring smoking, drinking, SBIRT, BNI, counseling intervention, emergency department, adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale New Haven Hospital Emergency Department

Outcomes

Primary Outcome Measures

Areas in need of help
Descriptive summary of patient reports of areas in need of help as reported during assessments
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
Counseling satisfaction
Patient reports of satisfaction with counseling modules delivered

Secondary Outcome Measures

Treatment utilization
Number of contacts with treatment resources for alcohol and tobacco cessation
Reduction of consumption
Patient self reported reductions in smoking and drinking
Quit attempts
Number of quit attempts (smoking and drinking)

Full Information

First Posted
May 7, 2012
Last Updated
June 24, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01595178
Brief Title
Combination SBIRT for Emergency Department Patients Who Drink and Smoke
Official Title
Development of a Combined Screening and Intervention Program for Emergency Department Patients Who Both Drink and Smoke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 8, 2014 (Actual)
Study Completion Date
May 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Drinking
Keywords
smoking, drinking, SBIRT, BNI, counseling intervention, emergency department, adults

7. Study Design

Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Combined BNI
Intervention Description
Combination brief negotiated interview (BNI) for patients who smoke and drink
Primary Outcome Measure Information:
Title
Areas in need of help
Description
Descriptive summary of patient reports of areas in need of help as reported during assessments
Time Frame
3 months
Title
Barriers and facilitators to accessing care
Description
Descriptive summary of patient reports of barriers and facilitators encountered in trying to access needed alcohol and smoking cessation treatments
Time Frame
3 months
Title
Counseling satisfaction
Description
Patient reports of satisfaction with counseling modules delivered
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Treatment utilization
Description
Number of contacts with treatment resources for alcohol and tobacco cessation
Time Frame
3 months
Title
Reduction of consumption
Description
Patient self reported reductions in smoking and drinking
Time Frame
3 months
Title
Quit attempts
Description
Number of quit attempts (smoking and drinking)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary K Murphy, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital Emergency Department
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Combination SBIRT for Emergency Department Patients Who Drink and Smoke

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