Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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. Januar 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

2748

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain severity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Lynn DeBar, PhD, MPH, Kaiser Permanente

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

31. Mai 2018

Primärer Abschluss (Tatsächlich)

30. September 2020

Studienabschluss (Tatsächlich)

30. September 2020

Studienanmeldedaten

Zuerst eingereicht

27. Dezember 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Januar 2018

Zuerst gepostet (Tatsächlich)

8. Januar 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Januar 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Januar 2021

Zuletzt verifiziert

1. Januar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • R217083

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Rückenschmerzen

Abonnieren