- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05492903
COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP) (COMPASS-NP)
November 21, 2025 updated by: Ryan Olson, Oregon Health and Science University
Translating an Intervention to Address Chronic Pain Among Home Care Workers
Home care workers (HCWs) are at-risk for chronic pain and associated problems, including emotional distress, opioid use and misuse, and work-related disability.
To address these issues, the proposed study will adapt an established peer-led and supportive group program to address the needs of HCWs with chronic pain.
The new program, named COMPASS for Navigating Pain (COMPASS-NP), will integrate work-based injury protections with pain education and cognitive-behavioral therapy strategies for pain self-management in order to reduce pain interference with HCWs' work and life, and advance their safety, health, and well-being.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Organizational intervention research can be all breakthrough with no follow-through.
Few effective interventions developed by scientists are widely adopted in practice.
To address this research-to-practice gap and address a socially important problem, the investigators will translate their established and disseminated COMPASS (COMmunity of Practice And Safety Support) intervention to address the needs of home care workers (HCWs) with chronic pain.
The burden of injuries and pain is great among HCWs, which places them at-risk for emotional distress, opioid use/misuse, and work-related disability.
Moreover, HCWs are predominantly low income, middle aged women.
Between 1999 and 2015 middle-aged women experienced a 471% increase in prescription opioid-related overdoses.
COMPASS is a peer-led and scripted group curriculum that produced many significant impacts on meaningful outcomes for HCWs in a randomized controlled trial (Cohen's d range = .45
to .84),
including increased safety communication with clients and hazard correction in homes.
COMPASS was subsequently adopted by the Oregon Home Care Commission, and is currently offered statewide as a paid training course to publicly funded HCWs.
While these are exceptional research-to-practice impacts, the original curriculum did not directly address chronic pain, and resulted in only small non-significant reductions in pain severity.
The investigators also found that HCWs with pain-related limitations at baseline made significant safety changes, but experienced less benefit from the intervention than workers without limitations.
An added barrier is that protective low-tech ergonomic tools (e.g., slide boards, transfer belts) are typically not funded by insurance.
The investigators' qualitative research revealed that low-wage HCWs are often forced to improvise or do without such tools.
In the translation plan, existing COMPASS lessons will be adapted for HCWs with chronic pain, and new lessons from the Pain Survival Guide (co-authored by Dr. Turk, Co-I) will integrate pain education and proven cognitive-behavioral therapy pain self-management strategies.
The investigators will also strengthen injury protections by including an online ergonomic assessment and voucher for HCWs to purchase tools.
The translated COMPASS for Navigating Pain (COMPASS-NP) intervention will be evaluated with a cluster randomized waitlist control design.
The primary hypothesis is that COMPASS-NP will reduce pain interference with work and life.
Secondary outcomes include pain/injury prevention behaviors (e.g., ergonomic tool use), injuries, pain severity, risk for opioid misuse, and worker well-being.
Regional implementation and evaluation with partners in Oregon (government), Washington (labor), and Idaho (private sector) will maximize dissemination knowledge and impact.
The 5-year project will accomplish 4 aims: 1) Adapt and pilot COMPASS-NP in Oregon; 2) Determine effects of COMPASS-NP across Oregon, Washington, and Idaho; 3) Describe the translation and implementation of COMPASS-NP across partners and systems; and 4) Disseminate COMPASS-NP knowledge, tools, and toolkits.
Study Type
Interventional
Enrollment (Estimated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years (adults)
- Employed as a home care worker
- Has chronic pain (pain lasting 3+ months and > 4 average intensity)
- The presence of pain interference with work (response of 'agree' or 'strongly agree' on single-item)
- Currently working 4 hours or more per week
- Access to the internet with a video capable device (e.g., smart phone, tablet, or computer)
Exclusion Criteria:
- Prior exposure to the original COMPASS program
- Experiencing a surgery in the prior 6 months
- Current pregnancy or intention to become pregnant during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Intervention during weeks 0-10 (10 weekly group sessions).
Follow-up with no treatment during weeks 11-20.
|
A peer-led and supportive group program (10 weekly sessions) designed to address the needs of HCWs with chronic or elevated pain.
The intervention will integrate work-based injury protections with pain education and cognitive-behavioral therapy strategies for pain self-management.
|
|
Other: Waitlist Control
Usual practice during weeks 0-10.
Intervention during weeks 11-20 (10 weekly group sessions).
|
A peer-led and supportive group program (10 weekly sessions) designed to address the needs of HCWs with chronic or elevated pain.
The intervention will integrate work-based injury protections with pain education and cognitive-behavioral therapy strategies for pain self-management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Between Groups Difference in Changes in Ratings of Pain Interference with Work
Time Frame: Changes between 0 weeks and 10 weeks
|
Work Limitations Questionnaire (1-5; 5=worst [limited all the time]).
Assesses limitations related to time, physical, mental-interpersonal, and outputs.
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Ratings of Pain Interference with Life
Time Frame: Changes between 0 weeks and 10 weeks
|
Brief Pain Inventory Subscale on pain interference (0-10; 10=worst [completely interferes]).
Interference related to general activity, walking, work, relations with other people, sleep, and enjoyment of life.
|
Changes between 0 weeks and 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Between Groups Difference in Changes in Reported Number of Pain/Injury Prevention Actions
Time Frame: Changes between 0 weeks and 10 weeks
|
Assessment questions developed by authors addressing total number of safety actions taken during the prior 10 weeks (0 to 5 or more; 0=worst [no actions taken]).
Sum of counts for five items that address new ergonomic tool use or techniques for moving objects or assisting client mobility; new ergonomic tools or techniques for housekeeping; correcting slip, trip, and fall hazards in homes; correcting "other" hazards in homes; and talking with client about improving safety.
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Reported Number of Minor Injuries
Time Frame: Changes between 0 weeks and 10 weeks
|
Question developed by authors addressing the number of minor injuries (minor cuts, bruises, back/neck pain or sprains) during the previous 10 weeks (5 or more=worst [highest possible number of reported minor injuries).
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Reported Number of Lost Work Time Injuries
Time Frame: Changes between 0 weeks and 10 weeks
|
Question developed by authors addressing the number of injuries resulting in one or more days off of work during the prior 10 weeks (0-5 or more lost work time injuries; 5 or more=worst [highest possible reported number of injuries).
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in the Rating of Average Pain Severity
Time Frame: Changes between 0 weeks and 10 weeks
|
Brief Pain Inventory item addressing average pain severity, with author-selected time anchor of during the past week (0-10; 10=worst [worst pain possible]).
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Ratings of Well-being
Time Frame: Changes between 0 weeks and 10 weeks
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-Mental Health Subscale (items 2,4, and 5 are rated 5-1; 1=worst [poor]; item 10 is rated 1-5 and reverse coded; before reverse coding 5=worst [always bothered]).
Items assess quality of life, mental health and mood/thinking, satisfaction with social relationships, and emotional problems.
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Daily Minutes of Physical Activity
Time Frame: Changes between 0 weeks and 10 weeks
|
Actigraphy sample of seven days (hip-worn) will be collected to calculate average daily minutes of physical activity (focused on combined light and moderate intensity minutes).
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Average Nightly Sleep Duration
Time Frame: Changes between 0 weeks and 10 weeks
|
Actigraphy sample of seven days (wrist-worn) will be collected to calculate average hours and minutes of sleep duration for the main sleep period each night.
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Average Nightly Sleep Efficiency
Time Frame: Changes between 0 weeks and 10 weeks
|
Actigraphy sample of seven days (wrist-worn) will be collected to calculate average sleep efficiency (percent of time in bed spent asleep) for the main sleep period.
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Pain Medication Use
Time Frame: Changes between 0 weeks and 10 weeks
|
Brief Pain Inventory item assessing frequency of pain medication use per 24 hours.
Five frequency interval options range from "not every day" to "more than 6 times per day" (more than 6 is worst [highest daily frequency]).
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Risk of Future Opioid Misuse
Time Frame: Changes between 0 weeks and 10 weeks
|
Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R; for workers not currently using opioids).
Item ratings of 0-4 (4=worst [very often]) with a total sum of 18 indicating positive for being at-risk for future opioid misuse.
|
Changes between 0 weeks and 10 weeks
|
|
Between Groups Difference in Changes in Current Opioid Misuse
Time Frame: Changes between 0 weeks and 10 weeks
|
Current Opioid Misuse Measure (COMM; for workers currently using opioid medications).
Ratings of 0-4 (4=worst [very often]) with a score of 9 or greater indicating a positive for current opioid misuse.
|
Changes between 0 weeks and 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2023
Primary Completion (Actual)
April 11, 2025
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
February 18, 2022
First Submitted That Met QC Criteria
August 4, 2022
First Posted (Actual)
August 9, 2022
Study Record Updates
Last Update Posted (Actual)
November 28, 2025
Last Update Submitted That Met QC Criteria
November 21, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- e20412
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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