Trial Outcomes & Findings for Improving Health and Employment Outcomes Through Workplace Opioid Policies (NCT NCT05387408)

Last Updated: 2024-10-04

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

4939 participants

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).

Results posted on

2024-10-04

Participant Flow

We started recruiting health funds in February 2022, with 3 health funds seeking to participate by May 2022. Health Fund A enrolled at the end of May 2022, health fund B enrolled at the end of July, but health fund C never completed the enrollment so was dropped in November 2022.

Participant milestones

Participant milestones
Measure	Single Arm/ Participating Union Health Funds Enrolled health funds were to provide administrative claims (deidentified medical and pharmacy claims with a linking variable) at baseline for primary outcome. They were to invite a representative group of their members to complete the worker survey (to collect 300 surveys/health fund). Follow up data for administrative claims for 6-months and worker surveys at 6 months were to be collected after a 6-month trial of the intervention. The intervention trial was for the health fund administrator to use the Workplace Guidelines to Prevent Opioid Abuse in the Construction Trades, created as part of this R34 study and to be part of the feasibility trial for this study.
Overall Study STARTED	4939
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4939

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm/ Participating Union Health Funds Enrolled health funds were to provide administrative claims (deidentified medical and pharmacy claims with a linking variable) at baseline for primary outcome. They were to invite a representative group of their members to complete the worker survey (to collect 300 surveys/health fund). Follow up data for administrative claims for 6-months and worker surveys at 6 months were to be collected after a 6-month trial of the intervention. The intervention trial was for the health fund administrator to use the Workplace Guidelines to Prevent Opioid Abuse in the Construction Trades, created as part of this R34 study and to be part of the feasibility trial for this study.
Overall Study Lack of time and access to participants to complete the survey by the health fund administrators	4939

Baseline Characteristics

The data came from two health funds and includes claims/surveys from Fund A and surveys from Fund B.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participating Union Health Fund n=4939 Participants 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. 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.
Age, Continuous	42.6 years STANDARD_DEVIATION 11.7 • n=4939 Participants • The data came from two health funds and includes claims/surveys from Fund A and surveys from Fund B.
Sex: Female, Male Female	265 Participants n=4935 Participants • four participants did not complete the item on gender.
Sex: Female, Male Male	4670 Participants n=4935 Participants • four participants did not complete the item on gender.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=127 Participants • The health claims data from the health fund A did not collect race, however we did request race for the worker surveys from the health fund A. There were 69 worker surveys completed from health fund A, and 58 surveys completed from health fund B for a total of 127 surveys. We are presenting the race information from only the survey data.
Race (NIH/OMB) Asian	0 Participants n=127 Participants • The health claims data from the health fund A did not collect race, however we did request race for the worker surveys from the health fund A. There were 69 worker surveys completed from health fund A, and 58 surveys completed from health fund B for a total of 127 surveys. We are presenting the race information from only the survey data.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=127 Participants • The health claims data from the health fund A did not collect race, however we did request race for the worker surveys from the health fund A. There were 69 worker surveys completed from health fund A, and 58 surveys completed from health fund B for a total of 127 surveys. We are presenting the race information from only the survey data.
Race (NIH/OMB) Black or African American	6 Participants n=127 Participants • The health claims data from the health fund A did not collect race, however we did request race for the worker surveys from the health fund A. There were 69 worker surveys completed from health fund A, and 58 surveys completed from health fund B for a total of 127 surveys. We are presenting the race information from only the survey data.
Race (NIH/OMB) White	111 Participants n=127 Participants • The health claims data from the health fund A did not collect race, however we did request race for the worker surveys from the health fund A. There were 69 worker surveys completed from health fund A, and 58 surveys completed from health fund B for a total of 127 surveys. We are presenting the race information from only the survey data.
Race (NIH/OMB) More than one race	1 Participants n=127 Participants • The health claims data from the health fund A did not collect race, however we did request race for the worker surveys from the health fund A. There were 69 worker surveys completed from health fund A, and 58 surveys completed from health fund B for a total of 127 surveys. We are presenting the race information from only the survey data.
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=127 Participants • The health claims data from the health fund A did not collect race, however we did request race for the worker surveys from the health fund A. There were 69 worker surveys completed from health fund A, and 58 surveys completed from health fund B for a total of 127 surveys. We are presenting the race information from only the survey data.
Opioid misuse by claims data Opioid misuse	209 Participants n=4881 Participants • Claims data only came from health fund A.
Opioid misuse by claims data Chronic opioid use	121 Participants n=4881 Participants • Claims data only came from health fund A.
Opioid misuse by claims data Opioid use disorder	85 Participants n=4881 Participants • Claims data only came from health fund A.
Opioid misuse by worker surveys	23 Participants n=127 Participants • Each health fund shared communication and the survey link throughout their membership, through repeated communications in one or more methods (email, newsletter, word of mouth). At baseline, we collected 69 surveys from health fund A and 58 surveys from health fund B.
Lost time due to pain on worker survey	22 Participants n=127 Participants • Each health fund shared communication and the survey link throughout their membership, through repeated communications in one or more methods (email, newsletter, word of mouth). At baseline, we collected 69 surveys from health fund A and 58 surveys from health fund B.
Worker willingness to seek help if struggling with opioids	98 Participants n=127 Participants • Each health fund shared communication and the survey link throughout their membership, through repeated communications in one or more methods (email, newsletter, word of mouth). We collected 69 surveys from health fund A and 58 surveys from health fund B.

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).

Population: We were unable to collect outcome data at 6 months so are unable to analyze change from baseline.

Outcome measures

Outcome data not reported

PRIMARY outcome

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.

Population: Only two health funds participated, and each were unsuccessful to collect 300 surveys at baseline. The health funds did not attempt to collect 6 month survey data so no measure of change could be calculated.

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)

Outcome measures

Outcome data not reported

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.

The investigators will assess workers' b) missed workdays due to pain/due to being high or recovering from night before, and (n=1800 anticipated)

Outcome measures

Outcome data not reported

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.

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)

Outcome measures

Outcome data not reported

Adverse Events

Single Arm/ Participating Union Health Funds

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ann Marie Dale, Principal Investigator

Washington University

Phone: 3144548470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place