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

July 21, 2020 updated by: Edward Hospital
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: 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.
0-3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
History Survey
Time Frame: 0-3 months
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)
Time Frame: 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.
0-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edward Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOH32414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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