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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Intervention during weeks 0-10 (10 weekly group sessions). Follow-up with no treatment during weeks 11-20.
Behavioral: COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP)
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).
Behavioral: COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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