Clinical trial NCT03393143: A Naturalistic Experiment Evaluating the Impact of Medicaid Treatment Reimbursement Changes on Opioid Prescribing and Patient Outcomes Among Patients With Back Pain
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Neck Pain
Keywords: Primary Health Care; Analgesics, Opioid; Medicaid
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: OCHIN, Inc.
name: Harvard Pilgrim Health Care
First posted: 2018-01-08
Enrollment: 2748
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain severity
timeFrame: Baseline to 12 months
measure: Use of pain-related services
timeFrame: Baseline to 12 months
measure: Patient satisfaction with health care services
timeFrame: Baseline to 12 months
measure: Negative outcomes related to pain services
timeFrame: Baseline to 12 months
measure: Illicit drug use
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OCHIN, Inc.
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Lynn DeBar, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: