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Completed

NCT Number: NCT03537573

Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute 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.

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Key information

Conditions

Acute Pain Headache Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Community Medicine Incorporated

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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
  • Providers

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Usual Care/Guideline

Behavioral

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.

Opioid Justification

Behavioral

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.

Provider Comparison

Behavioral

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.

Primary outcomes

  1. Initial Opioid Prescription

    Time frame: 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).

Secondary outcomes

  1. Initial non-opioid management

    Time frame: 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.

  2. Change in Patient Reported Pain and Function

    Time frame: 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

  3. Unsafe opioid prescribing at 3 months

    Time frame: 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.

  4. Unsafe opioid prescribing at 6 months

    Time frame: 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.

  5. Unsafe opioid prescribing at 12 months

    Time frame: 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.

  6. Chronic opioid therapy at 3 months

    Time frame: 3 months after initial qualifying clinic visit

    Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR

  7. Chronic opioid therapy at 6 months

    Time frame: 6 months after initial qualifying clinic visit

    Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR

  8. Chronic opioid therapy at 12 months

    Time frame: 12 months after initial qualifying clinic visit

    Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Geisinger Clinic
  • Patient-Centered Outcomes Research Institute
  • University of Utah

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
May 25, 2018
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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