Clinical trial NCT05387408: Improving Health and Employment Outcomes Through Workplace Opioid Policies
Official title: Improving Health and Employment Outcomes Through Workplace Opioid Policies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: Opioid Use Disorder
Construction Industry
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 4939
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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.

Eligibility criteria: Inclusion Criteria:

* members enrolled in union health funds

Exclusion Criteria:

* none.

Primary outcomes:
measure: Proportion of Workers With Opioid Misuse, Opioid Use Disorder and Opioid Overdose: Administrative Data [Primary Outcome]
timeFrame: 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).
measure: Proportion of Workers With Opioid Misuse: Worker Surveys
timeFrame: 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:
measure: Proportion of Workers With Lost Time: Worker Surveys [Secondary Outcome]
timeFrame: 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.
measure: Proportion of Workers Who Are Willing to Seek Help: Worker Surveys [Secondary Outcome]
timeFrame: 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.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ann Marie Dale, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: