Table 4.

USP protocol evaluation processes and outcomes for pregnant white and American Indian individuals in rural areas

Step in protocol development	Process(es)	Outcome
Metric selection	Literature review	18 metrics aligned with prior literature, evidence-based guidelines, and stakeholder input developed to test 6 hypotheses relevant to treatment of OUD in pregnancy
	Expert consultation
	Stakeholder engagement
Profile development	Adaptation from prior studies	2 regionally, culturally representative profiles created
	Expert consultation
	Stakeholder engagement
Pilot calls	USP training	Callers familiarized with protocol dialogue and refinements made to training guide to reflect sampling context
	Metric capture/Refinement of post-visit data entry forms	Reliable metric capture obtained
	Fidelity checks	Qualitative fidelity observed across USPs