Safety & Prevention Outcomes Study (SPOS)
Unintentional poisoning is a developing public health problem in the U.S. Unintentional poisoning (or "overdose") deaths increased 157% among adults between 1999 and 2008. There were ~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related overdoses, particularly prescription opioid overdoses, have accounted for much of this increase. There have been parallel increases in sales of opioids (with a 6 fold increase between 1997 and 2007), as well as both medical and non-medical use of prescription opioids. Prescription opioids are now among the most common of drugs used non-medically in the U.S.
The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription opioid overdose prevention intervention. We will examine therapeutic alliance, perceived satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on precursors of overdose risk behavioral change immediately post-intervention. We will compare intervention and control participants on knowledge, self-efficacy, readiness to change, and behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects on overdose risk behaviors six months post-intervention. We will compare intervention and control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and sedatives); and, 3) route of administration.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Brief Prescription Opioid Overdose Intervention in an Emergency Department|
- Overdose risk behavior [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]
- Overdose knowledge [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]
- Behavioral intentions [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]
- Substance use [ Time Frame: 6 months post-baseline ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Therapist-led brief intervention (TBI)
Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a "change plan" for each participant.
No Intervention: Enhanced usual care
Participants receive a brochure on overdose risk.
|Contact: Anna Eisenberg, MPHemail@example.com|
|United States, Michigan|
|University of Michigan Health System Emergency Department||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Anna Eisenberg, MPH 734-615-4171 firstname.lastname@example.org|
|Principal Investigator: Amy Bohnert, Ph.D.|
|Principal Investigator:||Amy Bohnert, Ph.D.||University of Michigan|