A Naturalistic Experiment Evaluating the Impact of Medicaid Treatment Reimbursement Changes on Opioid Prescribing and Patient Outcomes Among Patients With Back Pain

NCT03393143 | Completed

• 1 other identifier: R217083
• Study Type: observational
• Target: 2,748
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain; Neck Pain

Keywords

Primary Health Care; Analgesics, Opioid; Medicaid

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Oregon patients

Adult Medicaid patients with back pain who get their care in community health clinics in Oregon

California patients

Adult Medicaid patients with back pain who get their care in community health clinics in California

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient survey: Medicaid-insured adults age 18-65 years who are diagnosed with back or neck pain and receive their primary health care from participating OCHIN member federally-qualified health centers in Oregon and California. Patients may have acute or chronic pain and may be receiving long-term opioid therapy or not receiving long-term opioid therapy.

You may qualify if:

• Adults age 18-65 years
• Insured by Medicaid
• Have back or neck pain (based on ICD-CM diagnosis)
• Receive their primary health care at participating OCHIN member federally qualified health centers in Oregon and California

You may not qualify if:

• Patients with current malignant cancer diagnosis
• Any evidence of patient having received hospice or other end-of-life palliative care within the past year

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator
• OCHIN, Inc.: collaborator
• Harvard Pilgrim Health Care: collaborator

Study Sites (1)

OCHIN, Inc.

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lynn DeBar, PhD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 8, 2018
• Study Start: May 31, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)