Improving Health and Employment Outcomes Through Workplace Opioid Policies

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).

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders
• Intervention / Treatment: Behavioral: Best Practice Health and Employment Opioid-related Policies

Detailed Description

We will recruit three health funds to implement the opioid guidelines. Participating health funds will receive an introduction to the intervention materials and will discuss guideline adoption procedures with the research team. In order to implement the workplace opioid guidelines (intervention), each participating health fund must agree to make changes to their health fund policies and to engage employers to change some of the workplace policies. In order to evaluate the guideline implementation, the health funds must participate in baseline, 6, and 12 month interviews to describe changes in their opioid policies and programs, distribute a survey link to their members, and provide access to their health claims, pharmacy data, and employee work hour records. Participating health funds will be asked to sign a partnership agreement form, as we have done in our past intervention studies with construction partners, to show their understanding of the project and their agreement to participate in all study activities and to provide data over the course of the implementation trial.

We will use the RE-AIM framework to assess the Reach, Adoption, Implementation, and Maintenance of the intervention in each participating health fund. Reach will assess workers' awareness of policies and benefits, Adoption will identify the new policies agreed to by the board of trustees for each health fund, Implementation will describe the strategies for enacting the adopted policies and programs, and the extent these strategies are implemented, and Maintenance will identify the continued delivery of implemented policies and programs. Adoption, Implementation, and Maintenance will be assessed via periodic interviews with the health fund partners. Collection of health fund data on claims and work hours will show the feasibility of obtaining and using these data to evaluate effectiveness in the planned future study. Use of the RE-AIM framework will provide an evaluation of the extent to which the opioid guidelines are implemented, and describe barriers to implementation.

Data collection for the outcome measures will include worker surveys and health claims from the enrolled union health funds. We will analyze the data by measuring the pre-post change in the outcome measures. Participating health funds will provide access to construction workers to collect a cross-sectional sample of surveys at three points in time. We will ask our partners to distribute a link for a Redcap survey to a representative sample of their members (eligible workers) with a goal of at least 300 returned surveys per health fund at baseline. We will collect an additional 300 surveys at 6 months (and at 12 months if time allows) from each fund after initiating the intervention. We will attempt to oversample women and minorities, as they are less common in this worker population. The brief survey will ask about workers' knowledge of their health fund's benefits and policies, attitudes toward use of opioids by self and others, employment status, participation in union programs including EAP, and health-related productivity using widely used survey instruments. We will work with participating funds to obtain health claims and pharmacy data for all eligible union members for a period of at least 3 years prior to implementation of the intervention. From health claims, we will request data for demographics, dates of service, and diagnoses and procedure codes. From pharmacy data we will request the dates of prescription fill, drug name, days' supply, and fill quantity. From merged claims and pharmacy data we will identify relevant opioid use case definitions: workers who received opioid prescriptions, 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 OUD (defined as a diagnostic code of F11, poisoning T40, or prescription for MAT). We will also work with the funds to obtain employee work hour records. Using the same unique identifier as the health claims data, we will link claims and pharmacy data to the weekly or monthly work hour logs, union eligibility status (active/retired/other), and employer. We will examine loss of employment or average work hours for those who remain employed among workers who meet or do not meet one of the opioid use case definitions. We will collect other administrative data including the number of visits to the employee assistance program (EAP), the number of workers who enrolled in recovery centers, and those filing for disability benefits to compare utilization of services by workers before and after the intervention.

We will measure the change from baseline (pre-) to 6 months (post-) and 12 months (post- if time allows). The outcome measures will be from claims data (pre-post change in opioid misuse, chronic opioid use, and opioid use disorders) and from surveys (opioid misuse, lost time due to pain, and worker willingness to seek help). For claims data, we will compare the prevalence of the outcomes from 3-year period prior to the intervention compared to the 6-months after start of the intervention (collected at 6-months). For survey data, we will compare the prevalence of the outcomes from cross-sectional data collected at baseline to cross-sectional data collected at 6-months after start of the intervention. We will collect surveys from 300 members of the population, representative of the characteristics of the population, at baseline and at 6-months (and 12months if time allows).

To learn about changes each participating health fund makes to their health and safety program from using the Opioid Guidelines, we will interview the health administrator at baseline, before starting the intervention, will meet monthly with the administrator to learn about changes to their program, and conduct a final assessment. We will explore what plans the health fund wants to make to reduce opioid abuse among their members, the steps they take toward implementing changes including their strategies and response to their actions. We will also document the barriers encountered while trying to make plans and take action for change.

• Study Type: Interventional
• Enrollment (Actual): 4939
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• members enrolled in union health funds

Exclusion Criteria:

• none.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: participating union health fund; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 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)	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.

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Ann Marie Dale, Ph.D, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; Construction Industry
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 201912063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 have submitted the data for review as of 11/10/23.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No