Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
- Conditions
- Acute PainMusculoskeletal PainHeadache
- Registration Number
- NCT03537573
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22616
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Initial Opioid Prescription 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 Outcome Measures
Name Time Method Chronic opioid therapy at 6 months 6 months after initial qualifying clinic visit Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR
Chronic opioid therapy at 12 months 12 months after initial qualifying clinic visit Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR
Unsafe opioid prescribing at 3 months 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.
Unsafe opioid prescribing at 6 months 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.
Initial non-opioid management 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.
Change in Patient Reported Pain and Function 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
Unsafe opioid prescribing at 12 months 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.
Chronic opioid therapy at 3 months 3 months after initial qualifying clinic visit Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR
Trial Locations
- Locations (1)
UPMC Community Medicine Incorporated
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Community Medicine Incorporated🇺🇸Pittsburgh, Pennsylvania, United States