Improving Health and Employment Outcomes Through Workplace Opioid Policies

NCT05387408 | Completed Results

• 1 other identifier: 201912063
• Study Type: interventional
• Target: 4,939
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid-Related Disorders

Keywords

Opioid Use Disorder; Construction Industry

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

• 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=600 anticipated from 2 participating health funds)

  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 Outcomes (2)

• Proportion of Workers With Lost Time: Worker Surveys [Secondary Outcome]

  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.

• Proportion of Workers Who Are Willing to Seek Help: Worker Surveys [Secondary Outcome]

  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.

Study Arms (1)

participating union health fund

OTHER

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.

Behavioral: Best Practice Health and Employment Opioid-related Policies

Interventions

Best Practice Health and Employment Opioid-related Policies BEHAVIORAL

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.

participating union health fund

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• members enrolled in union health funds

You may not qualify if:

• none.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Only two of the planned three health funds enrolled. Only one of the enrolled health funds provided administrative data but only for the 3-year period before the intervention (baseline). . Both of the enrolled health funds collected worker surveys at baseline but due to low participation, follow-up surveys were not collected. Only one of the health funds actively participated in implementing the intervention. High time demands, lack of access to data, and to members limited the study success.

Results Point of Contact

• Title: Dr. Ann Marie Dale, Principal Investigator
• Organization: Washington University

amdale@wustl.edu

3144548470

Study Officials

• Ann Marie Dale, Ph.D

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 24, 2022
• Study Start: May 31, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Time Frame: The data is under review at the data sharing center as of 11/10/23. We anticipate the data will be available by March 2024. There is no expiration date.
• Access Criteria: The de-identified data has been shared with the Interuniversity Consortium for Political and Social Research (ICPSR) group at the University of Michigan. There is no restrictions from the research team at Washington University. Any access criteria would be at the discretion of the ICPSR group.

Locations

US (1)