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Improving Health and Employment Outcomes Through Workplace Opioid Policies

Primary Purpose

Opioid-Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice Health and Employment Opioid-related Policies
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid-Related Disorders focused on measuring Opioid Use Disorder, Construction Industry

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • members enrolled in union health funds

Exclusion Criteria:

-

Sites / Locations

  • Washington UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

participating union health fund

Arm Description

The investigators will recruit three health funds into a single arm trial. Each health fund will receive the intervention, "Workplace Opioid Prevention Guidelines." The intervention is a set of guidelines containing information and suggested changes the health fund may make to their health and safety program specifically to prevent and manage opioid abuse in their workforce. The health fund the investigators receive the intervention after completing baseline data collection. The investigators will provide assistance with using the intervention as needed over a 6 month period of time, and measure changes the health fund makes to their health and safety program based on information in the guidelines. At 6 months, the investigators will repeat baseline data collection for the efficacy trial.

Outcomes

Primary Outcome Measures

Proportion of workers with opioid misuse, opioid use disorder and opioid overdose: administrative data [primary outcome]
Problem opioid use is a composite outcome of opioid misuse, OUD, or opioid overdose. The investigators will use health and pharmacy claims data to identify workers who misused opioids (defined as multiple prescriptions of opioids in a single visit, overlapping supply of opioids, early refills), workers who received chronic opioid prescriptions (classified as 60 day supply in a 90 day period), and workers with Opioid Use Disorder (OUD) (defined as a diagnostic code for OUD or opioid overdose (ICD10=F11 or T40), or a prescription for Medication Assisted Treatment such as buprenorphine, naltrexone or methadone). (n=31500 anticipated)
Proportion of workers with opioid misuse: worker surveys
The investigators will assess workers' misuse of prescription opioids (taking more than prescribed, longer than prescribed, prescribed to someone else or for a reason other than pain), (n=1800 anticipated)

Secondary Outcome Measures

Proportion of workers with lost time: worker surveys [secondary outcome]
The investigators will assess workers' b) missed workdays due to pain/due to being high or recovering from night before, and (n=1800 anticipated)
Proportion of workers who are willing to seek help: worker surveys [secondary outcome]
The investigators will assess if workers' were struggling with opioid misuse/substance use problem, how willing the worker would be to seek help through 1) their workplace, 2) professional help (employee assistance program or behavioral health) (n=1800 anticipated)

Full Information

First Posted
May 12, 2022
Last Updated
June 20, 2022
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05387408
Brief Title
Improving Health and Employment Outcomes Through Workplace Opioid Policies
Official Title
Improving Health and Employment Outcomes Through Workplace Opioid Policies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the feasibility of implementing workplace opioid guidelines in the construction trades; define and collect measures of implementation and efficacy. The investigators will implement the intervention in three local union health funds, evaluate the implementation using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, and collect the data needed to measure the efficacy of health changes due to implementation of the intervention (workplace opioid guidelines). This is only a feasibility trial in preparation for conducting an randomized control trial. For the efficacy trial, the investigators will measure pre-post health change using two data sources: 1) administrative health claims and electronic member work hours, and 2) worker/member surveys. To monitor implementation of the intervention, the investigators will measure changes made to the health funds opioid prevention program through qualitative interviews with the health fund manager and through worker surveys for worker awareness and use of the health fund program changes pre-post implementation. The efficacy outcomes for the administrative health (and pharmacy) claims and work hours record will measure opioid prescriptions, chronic opioid use, and OUD in health claims and pharmacy data (details below). The efficacy outcomes for the worker surveys will record changes in misuse of opioids, change in missed days/work productivity, change in attitudes toward seeking help if worker was struggling with opioid misuse, and awareness and use of health fund programs (i.e. employee assistance programs, healthcare recovery services). the investigators will collect data at baseline and and after 6 months for the study of implementation and efficacy (a pre/post design, one-arm trial).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
Opioid Use Disorder, Construction Industry

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
participating union health fund
Arm Type
Other
Arm Description
The investigators will recruit three health funds into a single arm trial. Each health fund will receive the intervention, "Workplace Opioid Prevention Guidelines." The intervention is a set of guidelines containing information and suggested changes the health fund may make to their health and safety program specifically to prevent and manage opioid abuse in their workforce. The health fund the investigators receive the intervention after completing baseline data collection. The investigators will provide assistance with using the intervention as needed over a 6 month period of time, and measure changes the health fund makes to their health and safety program based on information in the guidelines. At 6 months, the investigators will repeat baseline data collection for the efficacy trial.
Intervention Type
Behavioral
Intervention Name(s)
Best Practice Health and Employment Opioid-related Policies
Intervention Description
The intervention will include information to promote policies and programs to prevent opioid abuse and aid recovery such as drug testing for opioids, health and employee assistance programs, job accommodations, and education to deliver training to prevent opioid use, and prevent stigma.
Primary Outcome Measure Information:
Title
Proportion of workers with opioid misuse, opioid use disorder and opioid overdose: administrative data [primary outcome]
Description
Problem opioid use is a composite outcome of opioid misuse, OUD, or opioid overdose. The investigators will use health and pharmacy claims data to identify workers who misused opioids (defined as multiple prescriptions of opioids in a single visit, overlapping supply of opioids, early refills), workers who received chronic opioid prescriptions (classified as 60 day supply in a 90 day period), and workers with Opioid Use Disorder (OUD) (defined as a diagnostic code for OUD or opioid overdose (ICD10=F11 or T40), or a prescription for Medication Assisted Treatment such as buprenorphine, naltrexone or methadone). (n=31500 anticipated)
Time Frame
The investigators will collect administrative data to assess change over time (change of opioid misuse and OUD at 6 months following delivery of the intervention).
Title
Proportion of workers with opioid misuse: worker surveys
Description
The investigators will assess workers' misuse of prescription opioids (taking more than prescribed, longer than prescribed, prescribed to someone else or for a reason other than pain), (n=1800 anticipated)
Time Frame
The investigators will compare change at 6 months post-intervention (change of opioid misuse) of group-level data collected from groups of health fund members.
Secondary Outcome Measure Information:
Title
Proportion of workers with lost time: worker surveys [secondary outcome]
Description
The investigators will assess workers' b) missed workdays due to pain/due to being high or recovering from night before, and (n=1800 anticipated)
Time Frame
The investigators will compare change at 6 months post-intervention (change in lost time) of group-level data collected from groups of health fund members.
Title
Proportion of workers who are willing to seek help: worker surveys [secondary outcome]
Description
The investigators will assess if workers' were struggling with opioid misuse/substance use problem, how willing the worker would be to seek help through 1) their workplace, 2) professional help (employee assistance program or behavioral health) (n=1800 anticipated)
Time Frame
The investigators will compare change at 6 months post-intervention (change of willingness to seek help) of group-level data collected from groups of health fund members.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: members enrolled in union health funds Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Marie Dale, Ph.D
Phone
314-454-8470
Email
amdale@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel F Biver, MPH
Phone
(618)971-5449
Email
sbiver@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Marie Dale, Ph.D
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Marie Dale, PhD
Phone
314-454-8470
Email
amdale@wustl.edu
First Name & Middle Initial & Last Name & Degree
Sam Biver, MPH
Phone
6189715449
Email
sbiver@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators plan to make the data from the worker surveys available to other researchers. The available data fill be de-identified surveys of a representative sample of union members from health funds collected at two time points on (1) pain and opioid use (2) missed days related to health and opioid use, (3) workers' knowledge of their health fund's benefits and policies, (4) self-reported use of benefits, and (5) attitudes toward use of opioids by self and others. This data will be made publicly available through the Helping to End Addiction Long-Term (HEAL) Initiative Central Data Repository. The investigators will work with the repository to prepare the data and accompanying instructions. The investigators will make the data publicly available as soon as is reasonably possible following publication.

Learn more about this trial

Improving Health and Employment Outcomes Through Workplace Opioid Policies

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