Increasing Patient Knowledge of the Signs of Opioid Overdose and Naloxone in a Suburban Treatment Program

Completed

• Conditions: Opioid Dependence; Opioid Use Disorder
• Interventions: Other: Naloxone Education Intervention

• Registration Number: NCT02120612
• Lead Sponsor: Edward Hospital

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Status Verified: 2020-07
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Naloxone Education Intervention Group	Naloxone Education Intervention	Group to begin receiving the Naloxone Education Intervention on the signs of opioid overdose and appropriate use of naloxone.

Primary Outcome Measures

Name	Time	Method
Opiate Overdose Knowledge Scale (OOKS)	0-3 months	The Opiate Overdose Knowledge Scale (OOKS) is an empirically-validated scale that measures knowledge of: (1) the risks, warning signs, and life-saving steps to take regarding an opioid overdose; and, (2) the appropriate use of naloxone.

Secondary Outcome Measures

Name	Time	Method
Guilt and Shame Proneness Scale (GASP)	0-3 months	The Guilt and Shame Proneness Scale (GASP) is an empirically-validated measure to assess subject shame and guilt and behavioral response patterns.
History Survey	0-3 months	The History Survey assesses subjects' experiences over the previous 12-months (e.g. exposure to opiate overdoses, access/use of naloxone).

Trial Locations

Locations (1)

Linden Oaks; 🇺🇸 Naperville, Illinois, United States