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Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care

26 april 2021 bijgewerkt door: Kevin Kraemer, University of Pittsburgh

Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Non-Cancer Pain in Primary Care

The investigators will assess whether behavioral science-based interventions can "nudge" providers towards more evidence-based care for patients with acute non-cancer pain.

Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the effect of the provider-targeted behavioral interventions (opioid justification and provider comparison), individually and in combination, on initial opioid prescription, initial use of non-opioid management, and patient-reported pain and function.

Aim 2) Compare the effect of the 2 provider-targeted behavioral interventions, individually and in combination, on unsafe opioid prescribing and transition to chronic opioid therapy.

Aim 3) Assess provider satisfaction and experience with the provider-targeted behavioral interventions.

Hypotheses:

Aim 1, H1a: Compared with the guideline (usual care) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of opioid prescription and increased proportion of non-opioid management at the initial outpatient visit for acute non-cancer pain.

Aim 1, H1b: Compared with usual care (guideline) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with no difference in patient-reported pain, function, and satisfaction at 1, 6, and 12 months.

Aim 2, H2: Compared with the usual care (guideline), the addition of opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of patients receiving unsafe opioid therapy and a decreased proportion of patients transitioning to chronic opioid therapy.

Study Design: Pragmatic, cluster-randomized clinical trial in 48 primary care clinics.

Study Population: The patient population will be 19,855 opioid naïve adults who present to clinic with acute uncomplicated musculoskeletal pain or headache.

Primary and Secondary Outcomes: The primary outcome measures will be receipt of an initial opioid prescription and unsafe opioid prescribing. Secondary outcomes will be non-opioid pain management, and, in 514 patients, patient-reported pain and function.

Analytic Plan: The investigators will test for differences in the primary and secondary outcomes among the 4 intervention groups.

Once completed, the project will provide evidence that health systems and other stakeholders need to implement interventions to prevent unsafe opioid prescribing.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

22566

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • UPMC Community Medicine Incorporated

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

  1. Patient Participants

    Inclusion Criteria:

    • Age 18 years or older; ii) index outpatient encounter with International Classification of Disease (ICD)-10 code for acute neck, back, or other musculoskeletal and headache diagnosis ("acute" defined as no similar diagnosis in past 3 months).

    Exclusion Criteria:

    • Cancer diagnosis (other than non-melanoma skin cancer)
    • Receipt of opioid prescription within 12 months of index outpatient encounter
  2. Providers

Inclusion Criteria:

  • Primary care provider (MD, Doctor of Osteopathy (DO), Physician Assistant (PA), Nurse Practitioner (NP)) at participating practice

Exclusion Criteria:

  • None

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Usual Care/Guideline
The Usual Care group (also known as the Guideline group) follows the recent Center for Disease Control (CDC) guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
Gedragsmatig: Usual Care/Guideline
The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
Experimenteel: Guideline + Opioid Justification (OJ)
Providers will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition. The provider will be notified that the justification provided will be visible in the Epic EHR. The provider has the option of entering a justification or not. If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank). The provider does not need to enter a justification if they choose to cancel the opioid prescription.
Gedragsmatig: Usual Care/Guideline
The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
Gedragsmatig: Opioid Justification
Providers will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition. The provider will be notified that the justification provided will be visible in the Epic EHR. The provider has the option of entering a justification or not. If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank). The provider does not need to enter a justification if they choose to cancel the opioid prescription.
Experimenteel: Guideline + Provider Comparison (PC)
Providers will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids f or acute pain who transition to chronic opioid therapy (> 3 months). Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions , unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain. Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers.
Gedragsmatig: Usual Care/Guideline
The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
Gedragsmatig: Provider Comparison
Providers will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids or acute pain who transition to chronic opioid therapy (> 3 months). Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions, unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain. Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers.
Experimenteel: Guideline + OJ + PC
This arm will include the guideline, opioid justification, and provider comparison described above.
Gedragsmatig: Usual Care/Guideline
The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
Gedragsmatig: Opioid Justification
Providers will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition. The provider will be notified that the justification provided will be visible in the Epic EHR. The provider has the option of entering a justification or not. If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank). The provider does not need to enter a justification if they choose to cancel the opioid prescription.
Gedragsmatig: Provider Comparison
Providers will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids or acute pain who transition to chronic opioid therapy (> 3 months). Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions, unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain. Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Initial Opioid Prescription
Tijdsspanne: 1 day (assessed on day of initial qualifying clinic visit
Initial opioid prescription (yes/no) (Primary) (Hypothesis 1a). Opioid prescription at qualifying clinic visit, measured via electronic health record (EHR).
1 day (assessed on day of initial qualifying clinic visit

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Initial non-opioid management
Tijdsspanne: 1 day (assessed on day of initial qualifying clinic visit)
Initial non-opioid management (yes/no) (Secondary) (Hypothesis 1a). Defined as order for any non-opioid management strategy at baseline (e.g., non-opioid medication, physical therapy, behavioral therapy), measured via EHR.
1 day (assessed on day of initial qualifying clinic visit)
Change in Patient Reported Pain and Function
Tijdsspanne: Assessed at 1, 6, and 12 months after initial qualifying clinic visit
Change in Patient Reported Pain and Function (Secondary) (Hypothesis 1b). Measured by the 3-item Pain/Enjoyment/General Activities (PEG) instrument in clinic at baseline and via brief web survey or telephone interview
Assessed at 1, 6, and 12 months after initial qualifying clinic visit
Unsafe opioid prescribing at 3 months
Tijdsspanne: 3 months after initial qualifying clinic visit
Defined over the prior 3 months as any of: a) receipt of initial extended release/long-acting opioid for acute pain; b) > 100 morphine milligram equivalent dose per day; c) opioid prescription in patients with substance use disorder or concurrent benzodiazepine prescription.
3 months after initial qualifying clinic visit
Unsafe opioid prescribing at 6 months
Tijdsspanne: 6 months after initial qualifying clinic visit
Defined over the prior 3 months as any of: a) receipt of initial extended release/long-acting opioid for acute pain; b) > 100 morphine milligram equivalent dose per day; c) opioid prescription in patients with substance use disorder or concurrent benzodiazepine prescription.
6 months after initial qualifying clinic visit
Unsafe opioid prescribing at 12 months
Tijdsspanne: 12 months after initial qualifying clinic visit
Defined over the prior 3 months as any of: a) receipt of initial extended release/long-acting opioid for acute pain; b) > 100 morphine milligram equivalent dose per day; c) opioid prescription in patients with substance use disorder or concurrent benzodiazepine prescription.
12 months after initial qualifying clinic visit
Chronic opioid therapy at 3 months
Tijdsspanne: 3 months after initial qualifying clinic visit
Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR
3 months after initial qualifying clinic visit
Chronic opioid therapy at 6 months
Tijdsspanne: 6 months after initial qualifying clinic visit
Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR
6 months after initial qualifying clinic visit
Chronic opioid therapy at 12 months
Tijdsspanne: 12 months after initial qualifying clinic visit
Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR
12 months after initial qualifying clinic visit

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pittsburgh

Medewerkers

Patient-Centered Outcomes Research Institute
University of Utah
Geisinger Clinic

Onderzoekers

  • Hoofdonderzoeker: Kevin L Kraemer, MD, University of Pittsburgh

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 september 2018

Primaire voltooiing (Werkelijk)

31 januari 2020

Studie voltooiing (Verwacht)

31 augustus 2022

Studieregistratiedata

Eerst ingediend

29 april 2018

Eerst ingediend dat voldeed aan de QC-criteria

14 mei 2018

Eerst geplaatst (Werkelijk)

25 mei 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 april 2021

Laatste update ingediend die voldeed aan QC-criteria

26 april 2021

Laatst geverifieerd

1 april 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UOP-1609-36881

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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