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Safety & Prevention Outcomes Study (SPOS)

Primary Purpose

Drug Overdose, Opioid-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TBI - Cohort 1
TBI - Cohort 2
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Overdose

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Health System Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

Therapist-led brief intervention (TBI) - Cohort 1

Enhanced usual care - Cohort 1

Therapist-led brief intervention (TBI) - Cohort 2

Enhanced usual care - Cohort 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 2, 2013
Last Updated
May 31, 2017
Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01894087
Brief Title
Safety & Prevention Outcomes Study
Acronym
SPOS
Official Title
A Brief Prescription Opioid Overdose Intervention in an Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Overdose, Opioid-Related Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapist-led brief intervention (TBI) - Cohort 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Enhanced usual care - Cohort 1
Arm Type
No Intervention
Arm Title
Therapist-led brief intervention (TBI) - Cohort 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Enhanced usual care - Cohort 2
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
TBI - Cohort 1
Intervention Type
Behavioral
Intervention Name(s)
TBI - Cohort 2
Primary Outcome Measure Information:
Title
Overdose Risk Behavior
Description
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.
Time Frame
6 months post-baseline
Title
Overdose Knowledge
Description
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.
Time Frame
6 months post-baseline
Title
Behavioral Intentions
Description
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.
Time Frame
6 months post-baseline
Secondary Outcome Measure Information:
Title
Substance Use - Current Opioid Misuse Measure
Description
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.
Time Frame
6 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Bohnert, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System Emergency Department
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27062245
Citation
Bohnert AS, Bonar EE, Cunningham R, Greenwald MK, Thomas L, Chermack S, Blow FC, Walton M. A pilot randomized clinical trial of an intervention to reduce overdose risk behaviors among emergency department patients at risk for prescription opioid overdose. Drug Alcohol Depend. 2016 Jun 1;163:40-7. doi: 10.1016/j.drugalcdep.2016.03.018. Epub 2016 Mar 26.
Results Reference
derived

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Safety & Prevention Outcomes Study

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