Community-Engaged Options to Maximize and Facilitate Opioid Reduction Through Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Washington State University
- Enrollment
- 21
- Locations
- 4
- Primary Endpoint
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating
Study Overview
Brief Summary
This study investigates how adults prescribed opioids for chronic noncancer pain respond to invitations to try non-opioid options of massage therapy, yoga therapy, chiropractic and physical therapies. Options will be available via telehealth consultation visits using a computer or smartphone with internet connection. The investigators will measure effects on pain, pain-related symptoms, and opioid use over time using a single-group design.
Detailed Description
Participants will be recruited from local primary care practices and asked to complete a baseline survey. They will then meet with a registered nurse via teleconference for a complete pain assessment. At the end of the session, participants will be asked to choose two of four available modalities for telehealth consultation. Participants will be scheduled for six telehealth sessions, once per week x six weeks with three consultations per each chosen therapy. Measurements of pain, mood, sleep, medicine use will be captured at baseline, three weeks and six weeks and examined for changes over time.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •enrollment in treatment at the CHAS Perry St or partnering clinic;
- •age greater than 18 years;
- •ability to read, speak, and write English;
- •diagnosed with a chronic, non-cancer-based painful medical condition;
- •ability to provide informed consent.
Exclusion Criteria
- •pregnancy;
- •diagnosis of a cancer-based painful medical condition;
- •any other medical or psychiatric condition that the PI or Co-PI physician of record determine might compromise safe study participation (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)
Outcomes
Primary Outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating
Time Frame: 6 weeks
Full scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Intensity Scale version 3a that measures the construct pain intensity or severity in three items for how much it hurts on average, at its worst and at its least in the past 7 days. Scale ranges from minimum "no pain" =1 to maximum "very severe" =5 pain with a possible sum of 3-15. A total sum of the 3 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome (range 40-70 after T-score conversion).
PROMIS Pain Interference Rating
Time Frame: 6 weeks
Scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference Scale that measures the construct pain interference in 8 items for how much pain interferes with a variety of activities in the past 7 days. Scale ranges from minimum "not at all" =1 to maximum "very much" =5 pain with a possible sum of 8-40. A total sum of the 8 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome.
Secondary Outcomes
- Current Opioid Misuse Measure(6 weeks)
- Spiritual Well-being Index(6 weeks)
- Interpersonal Needs Questionnaire(6 weeks)
- Depressive Symptoms Using Patient Health Questionnaire (PHQ-8)(6 weeks)
- PROMIS Self-efficacy for Managing Symptoms Short Form 4a(6 weeks)
- PROMIS Self-efficacy for Managing Emotions Short Form 4a(6 weeks)
- Anxiety Using Generalized Anxiety Disorder (GAD-7)(6 weeks)
- Interpersonal Needs Questionnaire(6 weeks)
- Current Opioid Misuse Measure(6 weeks)
- Spiritual Well-being Index(6 weeks)
Investigators
Marian Wilson
Associate Professor
Washington State University