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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapist-led brief intervention (TBI) - Cohort 1 | Active Comparator | 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. |
|
| Enhanced usual care - Cohort 1 | No Intervention | ||
| Therapist-led brief intervention (TBI) - Cohort 2 | Active Comparator | 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. |
|
| Enhanced usual care - Cohort 2 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBI - Cohort 1 | Behavioral |
| ||
| TBI - Cohort 2 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Bohnert, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System Emergency Department | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27062245 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapist-led Brief Intervention With Enhanced Usual Care | 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 in this condition also received the brochures given for the Enhanced Usual Care protocol. |
| FG001 | Enhanced Usual Care Only | For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapist-led Brief Intervention With Enhanced Usual Care | 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 in this condition also received the brochures given for the Enhanced Usual Care protocol. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who were retained at follow-up and had complete data for all items for this measure at baseline and follow-up | Posted | Mean | 95% Confidence Interval | Scores on a scale | 6 months post-baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapist-led Brief Intervention With Enhanced Usual Care | 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 in this condition also received the brochures given for the Enhanced Usual Care protocol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Bohnert | University of Michigan | 734-845-3638 | amybohne@med.umich.edu |
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| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| Behavioral |
|
| 6 months post-baseline |
| BG001 | Enhanced Usual Care Only | For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Enhanced Usual Care Only | For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline. |
|
|
|
| Primary | 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. | Participants retained and follow-up and with complete data on the outcome measure items at baseline and follow-up. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 6 months post-baseline |
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|
| Primary | 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. | Participants retained at follow-up and with complete item data on the outcome at baseline and follow-up | Posted | Mean | 95% Confidence Interval | Scores on a scale | 6 months post-baseline |
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|
|
|
| Secondary | 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. | Participants retained at follow-up and with complete item data on this measure at both baseline and follow-up | Posted | Mean | 95% Confidence Interval | Scores on a scale | 6 months post-baseline |
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|
| 1 |
| 102 |
| 0 |
| 102 |
| 0 |
| 102 |
| EG001 | Enhanced Usual Care Only | For Enhanced Usual Care (EUC), therapists provided two brochures: (1) an overdose prevention and response brochure, and (2) a resource brochure. The overdose prevention and response brochure included a definition of overdose, signs and symptoms, risk factors, and bystander response to overdose. The resource brochure contained information on drug,mental health and alcohol treatment, mutual help groups, local resources for obtaining naloxone, free health clinics in the area, and a suicide prevention hotline. | 0 | 102 | 0 | 102 | 0 | 102 |
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| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| Avoid combining substances |
|
| Multivariable Poisson regression of the outcome of intention to avoid or reduce opioid use, adjusting for baseline level of the outcome. | Incidence Rate Ratio | 0.76 | 2-Sided | 95 | 0.65 | 0.90 | This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of reducing or avoiding opioid use). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only. | Superiority |
| Multivariable Poisson regression of the outcome of intention to avoid combining opioids with other substances, adjusting for baseline level of the outcome. | Incidence Rate Ratio | 0.97 | 2-Sided | 95 | 0.80 | 1.19 | This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of not combining opioids with other drugs). Numerator was Therapist-Led Brief Intervention and denominator was Enhanced Usual Care only. | Superiority |