Neck Pain Clinical Trial
— Back on TrackOfficial title:
PCORI-1609-36568 A Naturalistic Experiment Evaluating the Impact of Medicaid Treatment Reimbursement Changes on Opioid Prescribing and Patient Outcomes Among Patients With Back Pain
NCT number | NCT03393143 |
Other study ID # | R217083 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 31, 2018 |
Est. completion date | September 30, 2020 |
Verified date | January 2021 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Back on Track is a quasi-experimental, mixed-methods study of a unique natural experiment that will answer the question: what is the comparative effectiveness of different payer or health-system strategies that aim to prevent unsafe opioid prescribing? The State of Oregon is enacting a Medicaid reimbursement policy to enhance access to evidence-based non-pharmacotherapeutic treatment options while restricting reimbursement for opioids for back pain. We will assess whether the policy decreases unsafe opioid prescribing and improves patient outcomes compared with usual back pain treatment practices in a comparable state, California, that is not changing Medicaid payment policy.
Status | Completed |
Enrollment | 2748 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion criteria: 1. Adults age 18-65 years 2. Insured by Medicaid 3. Have back or neck pain (based on ICD-CM diagnosis) 4. Receive their primary health care at participating OCHIN member federally qualified health centers in Oregon and California Exclusion criteria: 1. Patients with current malignant cancer diagnosis 2. Any evidence of patient having received hospice or other end-of-life palliative care within the past year |
Country | Name | City | State |
---|---|---|---|
United States | OCHIN, Inc. | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Harvard Pilgrim Health Care, Ochin, Inc., Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain severity | Modified 10-item version of the Brief Pain Inventory-Short Form (BPI-SF), composite of pain intensity (3 items) and pain-related interference (7 items) subscales (10 items total; continuous) | Baseline to 12 months | |
Primary | Use of pain-related services | Use of pain-related services will be assessed by asking about use (Yes/no; binary) of the following pain-related services: Acupuncture, Chiropractic, Massage Therapy, Rehabilitation Therapies; Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT); Psychotherapy, Yoga Group or Class, and Stretching/Strengthening Exercise Therapy. | Baseline to 12 months | |
Primary | Patient satisfaction with health care services | Patient satisfaction with health care services will be assessed by asking the following question: How satisfied have you been with the services you've received to help you manage your pain? (0-10 scale; continuous; higher score = more satisfied) |
Baseline to 12 months | |
Primary | Negative outcomes related to pain services | Negative outcomes related to pain services will be assessed by asking the following question: Have you had any problems or bad outcomes from services that you have received or things you've done to manage your pain? (Yes/no; binary) If respond yes, a description of the problem or bad outcome is collected. | Baseline to 12 months | |
Primary | Illicit drug use | Illicit drug use will be assessed by asking the following four questions: Have you used an opioid prescription medication that was not prescribed for you by your health care provider? (Yes/no; binary) Have you used any street drugs to manage your pain? (Yes/no; binary) If respond yes, a description of the street drug(s) is collected. Have you used any other types of prescription medications that were not prescribed for you by a health care provider to manage your pain? (Yes/no; binary) If respond yes, a description of the prescription medication(s) is collected. Have you used heroin to manage your pain? (Yes/no; binary) |
Baseline to 12 months |
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