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Opioid-Related DisordersNCT05387408

Improving Health and Employment Outcomes Through Workplace Opioid Policies

A study testing Best Practice Health and Employment Opioid-related Policies in people with Opioid-Related Disorders, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Opioid-Related Disorders
What is being tested?
Best Practice Health and Employment Opioid-related Policies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,939 participants
Where
1 siteUnited States
Study dates
31 May 2022to 1 Mar 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • members enrolled in union health funds

Who cannot join

  • none.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

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).

Read the 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.

Being tested
Best Practice Health and Employment Opioid-related Policies
Keywords
Opioid Use Disorder, Construction Industry
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best Practice Health and Employment Opioid-related PoliciesBehavioural

    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.

Study groups in NCT05387408
Study groupRoleWhat they receive
participating union health fundOtherThe 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.
Receives: Behavioral: Best Practice Health and Employment Opioid-related Policies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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).

  2. 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)

    Measured: 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)
  1. 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)

    Measured: 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.

  2. 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)

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start31 May 2022
  3. Primary completion1 Mar 2023
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4,939 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05387408
Sponsor's protocol ID
201912063
Status last verified
Jul 2024
First submitted
12 May 2022
Last updated
4 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice Health and Employment Opioid-related Policies in people with Opioid-Related Disorders, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Workers With Opioid Misuse, Opioid Use Disorder and Opioid Overdose: Administrative Data [Primary Outcome] (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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.

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