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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01197352
Other study ID # PRO10040186
Secondary ID
Status Completed
Phase N/A
First received August 20, 2010
Last updated May 18, 2012
Start date August 2010
Est. completion date February 2011

Study information

Verified date May 2012
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Young adults are in a critical period where they can be influenced to avoid a trajectory of high-risk drinking and harmful outcomes in the later adult years. The Emergency Department might offer a unique opportunity to reach young adults, if an easy to implement screening, brief intervention and referral to treatment was available. The investigators are investigating the feasibility and accuracy of ED-initiated and outpatient-continued assessment of drinking behavior in young adults using a computer-driven text messaging platform. Based on the subject's response to weekly assessments, the computer platform will send personalized motivational messages in real-time.


Description:

Greater than 45% of young adults have heavy episodic drinking (HED; 5/4 drinks per occasion form men/women), resulting in significant health risks, including injury and death. Early identification and secondary prevention of HED using screening, brief interventions and referral to treatment (SBIRT) is advocated by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) as a way to reduce injury and health consequences. Each day in the United States, there are over 2700 emergency department (ED) visits associated with alcohol, unfortunately, SBIRT is rarely performed in the ED due to time and training requirements. Our application seeks to solve this problem by integrating SBIRT into ED care through the use of ecological assessments with interventions. We will incorporate components of the NIAAA 2005 Clinicians Guide into automated weekly assessments (EA) and branching algorithms for personalized interventions (EA&I) delivered in real-time through mobile phone text messaging to young adults with a history of at-risk drinking behavior. We will assess the feasibility of EA&I to study young adults with a history of at-risk drinking and assess the variability in outcomes in patients undergoing EA&I, EA or standard care. We expect to find that this ED-initiated and outpatientcontinued platform will improve collection of drinking behavior, delivery of real-world motivational feedback and follow-up in young adults with at-risk drinking histories. We anticipate that short-term HED will be reduced in those subjects randomized to EA&I. We will use this information to support further studies with adequate power to show ED-initiated EA&I reduce long-term HED and its adverse consequences in young adults.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria:

- 18-24 years

- English speaking

- Owns a personal phone with text messaging

Exclusion Criteria:

- Pregnant

- Prisoner

- Treated for alcohol dependence or abuse

- Treated for psychiatric disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening


Intervention

Behavioral:
Motivational and Normative Feedback
Weekly feedback based on their frequency and degree of at-risk drinking behavior using normative, educational and motivational feedback
Self-Awareness
Weekly queries to raise awareness and allow self-reflection about drinking habits

Locations

Country Name City State
United States University of Pittsburgh Medical Center Emergency Department Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ability of system to collect drinking information from young adults We will report the proportion of weeks with completed drinking assessments in the EA and EA&I groups. 12 weeks No
Secondary Number of binge drinking episodes in subjects as a measure of safety and efficacy We will compare the number of binge drinking episodes between subjects in the three groups. 12 weeks Yes
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