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COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP) (COMPASS-NP)

Primary Purpose

Pain Management, Ergonomics, Wounds and Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP)
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain Management focused on measuring injury prevention, pain management, ergonomics, home care workers, total worker health, cognitive behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intervention

    Waitlist Control

    Arm Description

    Intervention during weeks 0-10 (10 weekly group sessions). Follow-up with no treatment during weeks 11-20.

    Usual practice during weeks 0-10. Intervention during weeks 11-20 (10 weekly group sessions).

    Outcomes

    Primary Outcome Measures

    Between Groups Difference in Changes in Ratings of Pain Interference with Work
    Work Limitations Questionnaire (1-5; 5=worst [limited all the time]). Assesses limitations related to time, physical, mental-interpersonal, and outputs.
    Between Groups Difference in Changes in Ratings of Pain Interference with Life
    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.

    Secondary Outcome Measures

    Between Groups Difference in Changes in Reported Number of Pain/Injury Prevention Actions
    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.
    Between Groups Difference in Changes in Reported Number of Minor Injuries
    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).
    Between Groups Difference in Changes in Reported Number of Lost Work Time Injuries
    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).
    Between Groups Difference in Changes in the Rating of Average Pain Severity
    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]).
    Between Groups Difference in Changes in Ratings of Well-being
    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.
    Between Groups Difference in Changes in Daily Minutes of Physical Activity
    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).
    Between Groups Difference in Changes in Average Nightly Sleep Duration
    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.
    Between Groups Difference in Changes in Average Nightly Sleep Efficiency
    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.
    Between Groups Difference in Changes in Pain Medication Use
    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]).
    Between Groups Difference in Changes in Risk of Future Opioid Misuse
    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.
    Between Groups Difference in Changes in Current Opioid Misuse
    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.

    Full Information

    First Posted
    February 18, 2022
    Last Updated
    August 4, 2022
    Sponsor
    Oregon Health and Science University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05492903
    Brief Title
    COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP)
    Acronym
    COMPASS-NP
    Official Title
    Translating an Intervention to Address Chronic Pain Among Home Care Workers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Oregon Health and Science University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain Management, Ergonomics, Wounds and Injuries
    Keywords
    injury prevention, pain management, ergonomics, home care workers, total worker health, cognitive behavioral therapy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    cluster-randomized waitlist control design
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Intervention during weeks 0-10 (10 weekly group sessions). Follow-up with no treatment during weeks 11-20.
    Arm Title
    Waitlist Control
    Arm Type
    Other
    Arm Description
    Usual practice during weeks 0-10. Intervention during weeks 11-20 (10 weekly group sessions).
    Intervention Type
    Behavioral
    Intervention Name(s)
    COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Between Groups Difference in Changes in Ratings of Pain Interference with Work
    Description
    Work Limitations Questionnaire (1-5; 5=worst [limited all the time]). Assesses limitations related to time, physical, mental-interpersonal, and outputs.
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Ratings of Pain Interference with Life
    Description
    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.
    Time Frame
    Changes between 0 weeks and 10 weeks
    Secondary Outcome Measure Information:
    Title
    Between Groups Difference in Changes in Reported Number of Pain/Injury Prevention Actions
    Description
    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.
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Reported Number of Minor Injuries
    Description
    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).
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Reported Number of Lost Work Time Injuries
    Description
    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).
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in the Rating of Average Pain Severity
    Description
    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]).
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Ratings of Well-being
    Description
    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.
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Daily Minutes of Physical Activity
    Description
    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).
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Average Nightly Sleep Duration
    Description
    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.
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Average Nightly Sleep Efficiency
    Description
    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.
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Pain Medication Use
    Description
    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]).
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Risk of Future Opioid Misuse
    Description
    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.
    Time Frame
    Changes between 0 weeks and 10 weeks
    Title
    Between Groups Difference in Changes in Current Opioid Misuse
    Description
    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.
    Time Frame
    Changes between 0 weeks and 10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ryan Olson, PhD
    Phone
    5034942501
    Email
    olsonry@ohsu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Courtney Donovan, MPH
    Email
    donovcou@ohsu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP)

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