Clinical trial NCT02120612: Increasing Patient Knowledge of the Signs of Opioid Overdose and Naloxone in a Suburban Treatment Program
Official title: Increasing Patient Knowledge of the Signs of Opioid Overdose and Naloxone in a Suburban Treatment Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Dependence
Opioid Use Disorder
Keywords: Opioid Dependence
Addiction
Naloxone
Naloxone Education
Opiate Overdose Knowledge Scale
OOKS
Lead sponsor: Edward-Elmhurst Health System
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects who have been diagnosed with a DSM opioid use disorder enrolled in an outpatient treatment program for the substance use disorder.

Brief summary: The purpose of this study is to determine the effect that an educational intervention has on patient knowledge of the signs of opioid overdose and appropriate use of naloxone in a suburban outpatient treatment program.

Detailed description: The outpatient Addiction Services program at Linden Oaks will begin implementing an educational program on the signs of opioid overdose and naloxone for all patients who have a diagnosis of opiate dependence in the investigators suburban treatment program. Subjects will be recruited from that population and administered a new, empirically validated scale (i.e. the Opiate Overdose Knowledge Scale; OOKS) both pre- and post-intervention to measure the effect that the educational program has on patient knowledge.

Patients will also be surveyed (i.e. History Survey) about their experiences over the previous 12-months (e.g. exposure to opiate overdoses, access/use of naloxone) prior to treatment; and, this History Survey will then be re-administered by phone, 1-3 months after discharge. The aim is to measure whether education influences patient behavior. Finally, all subjects will be administered an empirically-validated measure to assess subject shame and guilt (i.e. Guilt and Shame Proneness Scale; GASP), and response patterns in their behavior, to evaluate whether shame and guilt predict behavior at follow-up. The investigators will compare to data (i.e. OOKS, GASP, and History Survey) from a historical control group prior to the implementation of the educational program - and, also at 1-3 month follow-up.

Eligibility criteria: Inclusion Criteria:

* Adult subjects who have been diagnosed with a DSM opioid use disorder by LOH staff.

Exclusion Criteria:

* Subjects who are deemed to have moderate to severe cognitive impairment - as assessed by standard psychiatric evaluation from Linden Oaks clinical staff - will be excluded from the study.

Primary outcomes:
measure: Opiate Overdose Knowledge Scale (OOKS)
timeFrame: 0-3 months
Secondary outcomes:
measure: History Survey
timeFrame: 0-3 months
measure: Guilt and Shame Proneness Scale (GASP)
timeFrame: 0-3 months
Other outcomes:
Locations:
city: Naperville
country: United States
facility: Linden Oaks
state: Illinois
Study officials:
affiliation: Linden Oaks Hospital
name: David C Lott, M.D.
role: PRINCIPAL_INVESTIGATOR
References: