Improving Health and Employment Outcomes Through Workplace Opioid Policies

Opioid-Related Disorders Clinical Trial

Official title:

Improving Health and Employment Outcomes Through Workplace Opioid Policies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387408
• Other study ID #: 201912063
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: February 2023

Study information

• Verified date: June 2022
• Source: Washington University School of Medicine
• Contact: Ann Marie Dale, Ph.D
• Phone: 314-454-8470
• Email: amdale[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33300
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• members enrolled in union health funds

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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).
Primary	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)	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	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.
Secondary	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.