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
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
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
NCT ID
NCT05492903
First Posted
February 18, 2022
Last Updated
August 4, 2022
Sponsor
Oregon Health and Science University
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
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