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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120612
• Other study ID #: LOH32414
• Status: Completed
• Start date: April 2014
• Est. completion date: July 2020

Study information

• Verified date: July 2020
• Source: Edward-Elmhurst Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Overdose
• Opioid Dependence
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• Naloxone Education Intervention
The Naloxone Education Intervention is a curriculum that has been adapted from New York State Department of Health's, "Opioid Overdose Prevention" program for non-medical responders.

Locations

Country	Name	City	State
United States	Linden Oaks	Naperville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Edward Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate Overdose Knowledge Scale (OOKS)	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.	0-3 months
Secondary	History Survey	The History Survey assesses subjects' experiences over the previous 12-months (e.g. exposure to opiate overdoses, access/use of naloxone).	0-3 months
Secondary	Guilt and Shame Proneness Scale (GASP)	The Guilt and Shame Proneness Scale (GASP) is an empirically-validated measure to assess subject shame and guilt and behavioral response patterns.	0-3 months