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Safety & Prevention Outcomes Study (SPOS)

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ClinicalTrials.gov Identifier: NCT01894087
Recruitment Status : Completed
First Posted : July 9, 2013
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Amy S.B. Bohnert, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Drug Overdose Opioid-Related Disorders Behavioral: TBI - Cohort 1 Behavioral: TBI - Cohort 2 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Brief Prescription Opioid Overdose Intervention in an Emergency Department
Study Start Date : April 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Active Comparator: Therapist-led brief intervention (TBI) - Cohort 1
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
No Intervention: Enhanced usual care - Cohort 1
Active Comparator: Therapist-led brief intervention (TBI) - Cohort 2
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
No Intervention: Enhanced usual care - Cohort 2



Primary Outcome Measures :
  1. Overdose Risk Behavior [ Time Frame: 6 months post-baseline ]
    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.

  2. Overdose Knowledge [ Time Frame: 6 months post-baseline ]
    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.

  3. Behavioral Intentions [ Time Frame: 6 months post-baseline ]
    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 :
  1. Substance Use - Current Opioid Misuse Measure [ Time Frame: 6 months post-baseline ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894087


Locations
United States, Michigan
University of Michigan Health System Emergency Department
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Amy Bohnert, Ph.D. University of Michigan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amy S.B. Bohnert, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01894087     History of Changes
Other Study ID Numbers: R49CE002099 ( U.S. NIH Grant/Contract )
First Posted: July 9, 2013    Key Record Dates
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018
Last Verified: May 2017

Additional relevant MeSH terms:
Opioid-Related Disorders
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders