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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)

7 gennaio 2021 aggiornato da: Kaiser Permanente

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

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.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

2748

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Oregon
      • Portland, Oregon, Stati Uniti, 97201
        • OCHIN, Inc.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain severity
Lasso di tempo: 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)
Baseline to 12 months
Use of pain-related services
Lasso di tempo: 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.
Baseline to 12 months
Patient satisfaction with health care services
Lasso di tempo: 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)

Baseline to 12 months
Negative outcomes related to pain services
Lasso di tempo: 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.
Baseline to 12 months
Illicit drug use
Lasso di tempo: 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)

Baseline to 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Lynn DeBar, PhD, MPH, Kaiser Permanente

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 maggio 2018

Completamento primario (Effettivo)

30 settembre 2020

Completamento dello studio (Effettivo)

30 settembre 2020

Date di iscrizione allo studio

Primo inviato

27 dicembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

2 gennaio 2018

Primo Inserito (Effettivo)

8 gennaio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 gennaio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 gennaio 2021

Ultimo verificato

1 gennaio 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • R217083

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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