Safety & Prevention Outcomes Study

Study Overview
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Brief Summary
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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.

Official Title
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A Brief Prescription Opioid Overdose Intervention in an Emergency Department

Conditions
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Drug Overdose, Opioid-Related Disorders

Intervention / Treatment
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* Behavioral: TBI - Cohort 1
* Behavioral: TBI - Cohort 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 18-60 presenting to the ED for medical care ability to provide informed consent Additional criteria for intervention: past extramedical opioid use Exclusion Criteria: patients who do not understand English prisoners patients classified by medical staff as a Level 1 trauma (e.g., in need of immediate lifesaving procedures) patients deemed unable to provide informed consent patients treated in the ED for suicide attempt or sexual assault

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Therapist-led brief intervention (TBI) - Cohort 1<br>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. | Behavioral: TBI - Cohort 1<br> <br> |
| No Intervention: Enhanced usual care - Cohort 1<br> | |
| Active Comparator: Therapist-led brief intervention (TBI) - Cohort 2<br>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. | Behavioral: TBI - Cohort 2<br> <br> |
| No Intervention: Enhanced usual care - Cohort 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overdose Risk Behavior | This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 28 in one assessment. Results reported here as group means are for the change in sum score between baseline and follow-up, which had a possible range of -28 to 28, with lower values indicating greater decreases in overdose risk behavior. | 6 months post-baseline | 
| Overdose Knowledge | Overdose symptom knowledge was assessed using an inventory of 5 true symptoms and 2 false symptoms of overdose, and the total score created as the sum of correct answers, with a range of 0 to 7. Due to the skewed distribution, this total score was standardized by subtracting the observed responses from the overall sample mean, and then dividing by the standard deviation. This resulted in a range of -5.4 to 2.6 in this sample at the 6 month follow-up, with higher numbers indicating greater overdose symptom knowledge. Also reported here are change scores generated by subtracting the standardized sum score at 6 months from the baseline standardized sum score, which had a range of -3.0 to 6.4 in this sample. Thus, higher numbers in this change variable indicated greater improvements in overdose symptom knowledge. Negative numbers would represent a decrease in symptom knowledge. | 6 months post-baseline | 
| Behavioral Intentions | Behavioral intentions were assessed with three items that measured participant's intention to use overdose risk reduction strategies. The three strategies were (1) using opioids as prescribed, (2) reducing or avoiding use of alcohol, drugs, or non-prescribed medications, and (3) avoiding combining substances. Each item was assessed on a scale of 1 to 10, with higher numbers indicating greater intention to avoid overdose risk. | 6 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance Use - Current Opioid Misuse Measure | This measure contained 8 items from the Current Opioid Misuse Measure. Items were assessed on a scale of never (0), rarely (1), sometimes (3), often (4), and very often (5). A sum score took a range of 0 to 40, with higher numbers indicating more non-medical opioid use. For group means reported here, change scores were calculated by subtracting the baseline level of this measure from the level at 6 months follow-up. This change score has a possible range of -40 to 40, with lower values indicating greater decreases in non-medical opioid use. | 6 months post-baseline |