Clinical trial NCT03537573: Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
Official title: Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Non-Cancer Pain in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Headache
Musculoskeletal Pain
Keywords: Pragmatic clinical trial
Primary care
Provider-targeted
Behavioral intervention
Electronic health record
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Geisinger Clinic
name: University of Utah
First posted: 2018-05-25
Enrollment: 22616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 48 primary care clinics (N=19,855 patients participants anticipated) randomized to 4 arms in 2x2 factorial design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Initial Opioid Prescription
timeFrame: 1 day (assessed on day of initial qualifying clinic visit
Secondary outcomes:
measure: Initial non-opioid management
timeFrame: 1 day (assessed on day of initial qualifying clinic visit)
measure: Change in Patient Reported Pain and Function
timeFrame: Assessed at 1, 6, and 12 months after initial qualifying clinic visit
measure: Unsafe opioid prescribing at 3 months
timeFrame: 3 months after initial qualifying clinic visit
measure: Unsafe opioid prescribing at 6 months
timeFrame: 6 months after initial qualifying clinic visit
measure: Unsafe opioid prescribing at 12 months
timeFrame: 12 months after initial qualifying clinic visit
measure: Chronic opioid therapy at 3 months
timeFrame: 3 months after initial qualifying clinic visit
measure: Chronic opioid therapy at 6 months
timeFrame: 6 months after initial qualifying clinic visit
measure: Chronic opioid therapy at 12 months
timeFrame: 12 months after initial qualifying clinic visit
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Community Medicine Incorporated
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kevin L Kraemer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraemer KL, Althouse AD, Salay M, Gordon AJ, Wright E, Anisman D, Cochran G, Fischer G, Gellad WF, Hamm M, Kern M, Wasan AD. Effect of Different Interventions to Help Primary Care Clinicians Avoid Unsafe Opioid Prescribing in Opioid-Naive Patients With Acute Noncancer Pain: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2022 Jul 29;3(7):e222263. doi: 10.1001/jamahealthforum.2022.2263. eCollection 2022 Jul.