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

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ClinicalTrials.gov Identifier: NCT03393143
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : January 11, 2021
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
OCHIN, Inc.
Harvard Pilgrim Health Care
Information provided by (Responsible Party):
Kaiser Permanente

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.

Condition or disease
Back Pain Neck Pain

Detailed Description:

Back pain is one of the most common reasons patients seek medical care, and it can have a big impact on patients' quality of life and functioning. Patients and providers are becoming more frustrated with common back pain treatments like the long-term use of opioid medications and steroid injections, which have been shown to have limited long-term impact on patients' pain and day-to-day functioning and can have safety risks.

The State of Oregon recently changed what back and neck pain treatments they cover for its Medicaid enrollees. This started to affect those insured by Medicaid in July 2016 and was implemented by January 2018. These changes ended payments for treatments like long-term opioid therapy and injections. They also expanded coverage for nondrug treatments, such as acupuncture, osteopathic or chiropractic manipulation, physical/occupational therapy, and cognitive behavioral therapy. While experts agree that opioid use must be reduced, Oregon is among the first states to try such strong measures to promote nondrug treatments and prevent the use of long-term opioid treatment for back and neck pain.

The Oregon Medicaid reimbursement changes for back and neck pain treatment create the opportunity for a "natural experiment." In this mixed-methods, observational study, we will evaluate the impact of the reimbursement changes by comparing outcomes among patients with back pain in Oregon who will have access to these expanded nondrug treatments to similar patients seen in comparable clinics in California where expanded services for back and neck pain are not covered by the type of comprehensive payer incentive undertaken in Oregon.

Specifically, we will use electronic health record, Medicaid claims data, and data obtained from a longitudinal patient survey to assess the impact of the changes on:

  • Patients' pain severity, pain related functioning, and satisfaction with care
  • Patients' use of pain-related health care services
  • Opioid use
  • Unintended consequences, such as the use of illicit drugs (While we expect the Oregon Medicaid change to result in many positive changes, limiting the use of opioids and pain reducing procedures like injections may motivate some individuals to use drugs that were not prescribed by their doctor.)

In addition, we will use qualitative research methods to characterize the facilitators and barriers experienced by patients, health care providers, and clinic administrators and staff in adopting the Medicaid reimbursement changes and their satisfaction with the constellation of available and utilized services.

Thus, this study has three components: 1) patient survey, 2) administrative data-based study (data-only), and 3) qualitative evaluation. This record focuses on the component of the study in which subjects are able to enroll - the patient survey.

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Study Type : Observational
Actual Enrollment : 2748 participants
Observational Model: Cohort
Time Perspective: Other
Official 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
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Medicaid

Group/Cohort
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



Primary Outcome Measures :
  1. Pain severity [ Time Frame: Baseline to 12 months ]
    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)

  2. Use of pain-related services [ Time Frame: Baseline to 12 months ]
    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.

  3. Patient satisfaction with health care services [ Time Frame: Baseline to 12 months ]

    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)


  4. Negative outcomes related to pain services [ Time Frame: Baseline to 12 months ]
    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.

  5. Illicit drug use [ Time Frame: Baseline to 12 months ]

    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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393143


Locations
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United States, Oregon
OCHIN, Inc.
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Kaiser Permanente
Patient-Centered Outcomes Research Institute
OCHIN, Inc.
Harvard Pilgrim Health Care
Investigators
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Principal Investigator: Lynn DeBar, PhD, MPH Kaiser Permanente
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03393143    
Other Study ID Numbers: R217083
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaiser Permanente:
Primary Health Care; Analgesics, Opioid; Medicaid
Additional relevant MeSH terms:
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Back Pain
Neck Pain
Pain
Neurologic Manifestations