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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder; Opioid Dependence
• Intervention / Treatment: Other: Naloxone Education Intervention

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60563
      • Linden Oaks

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Historical Control Group; Historical Control Group will be assessed for knowledge prior to the implementation of the educational program.
Naloxone Education Intervention Group; Group to begin receiving the Naloxone Education Intervention on the signs of opioid overdose and appropriate use of naloxone.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Edward Hospital
• Investigators: Principal Investigator: David C Lott, M.D., Linden Oaks Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: April 21, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Addiction; Naloxone; Opioid Dependence; Naloxone Education; Opiate Overdose Knowledge Scale; OOKS
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Drug Overdose; Opiate Overdose; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: LOH32414