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Table 2 Primary, secondary, and other outcomes measured during the 2 years post-randomization based on EHR data, as entered into clinicaltrials.gov

From: PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment

Outcome measures
 Objective 1. Patient-days of OUD medication treatment (primary outcome) Clinic-level number of patient-days of OUD treatment with buprenorphine and XR-NTX documented in the EHR during the period from randomization until 2 years after, reported per 10,000 PC patients in the clinic in the 2 years post-randomization
 Objective 2. Acute care utilization (secondary outcome) Patient-level number of days of acute care utilization during the period from randomization until 2 years after, among patients with an OUD diagnosis documented in the EHR in the 3 years prior to randomization
Other outcome measures of implementation
 Newly diagnosed OUD (implementation reach) Clinic-level number of patients with a new International Classification of Disease (ICD) code for OUD documented in the EHR during the period from randomization until 2 years after who did not have an OUD diagnosis documented in the EHR in the 3 years prior to randomization, reported per 10,000 patients in the PC clinic in the 2 years post-randomization
 Initiationa of OUD treatment (implementation reach) Clinic-level number of patients who initiate: (1) buprenorphine or (2) XR-NTX with an OUD diagnosis as documented in the EHR during the period from randomization until 2 years after, reported per 10,000 PC patients in the clinic in the 2 years post-randomization
 Retention in OUD treatment (implementation fidelity) Clinic-level number of patients initiatinga OUD treatment during the period from randomization until 2 years after randomization as documented in the EHR, who also receive OUD treatment on 80% of days available after initiation reported per 10,000 PC patients in the clinic in the 2 years post-randomization [34]
 Naloxone prescribing (implementation fidelity) Patient-level number of prescriptions of naloxone for overdose management in the period from randomization until 2 years after, among patients with an OUD diagnosis in the 3 years prior to randomization
Other outcome measures of effectiveness
 Urgent care or ED use Patient-level number of visits to urgent care or EDs during the period from randomization until 2 years after, among patients with an OUD diagnosis documented in the EHR in the 3 years prior to randomization
 Inpatient days hospitalized Patient-level number of days hospitalized during the period from randomization until 2 years after, among patients with an OUD diagnosis documented in the EHR in the 3 years prior to randomization
  1. aInitiation of buprenorphine and XR-NTX in the context of PROUD trial outcome measures refers to an order for OUD medication treatment post-randomization with no treatment with these medications in the prior 365 days