| COVID-19 declared a worldwide pandemic | Original plan for a large, in-person kick-off meeting cancelled Original plan for in-person practice recruitment and training cancelled Rapid decline in in-person clinical visits Practices struggling with revenue and financial survival unable to take on new or additional work
| Delayed patient recruitment 4 months Extended practice and patient recruitment window Rather than 1 initial kick-off, offered flexible start “windows,” initially in waves of multiple practices and then eventually single practice starts Allowed more practice types, not just single-specialty primary care practices
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| Rapid expansion and reliance on telehealth | Practices stressed with need to rapidly deploy telehealth Given the 2-arm randomized study design comparing home and office induction, patients starting treatment with a telehealth induction protocol were ineligible and could not participate
| Expanded the original 2-arm study design (home vs office) to a 3-arm study design (home vs office vs telehealth) Conducted extensive conversations with funder and project officer; changed total number of participants (new power calculation: 1,200 participants for 3 arms)
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| Fewer prescriptions for opioids, so fewer potential patients with OUD in the practice | | Created comprehensive patient recruitment materials Created practice materials (website template, portal templates, EHR “dot phrases,” EHR search terms, medication and refill messages) Created other materials (newspaper articles, outreach to community organizations)
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| Rapid increase in fentanyl analogues in community | Fewer patients seeking refills on prescription opioids Increased overdose deaths Increase in new and emerging drugs combined with opioids
| Disseminated community messages, newspaper articles with local clinician quotes Conducted clinical education for practices Provided additional training on MOUD treatment protocols Included “microdosing” and bridge dosing protocols
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| COVID-19 waves alpha, delta, omicron | Clinician burnout leading to a decline in participation Practice burnout leading to withdrawal from study or decline in participation Low practice engagement Low rate of practice survey completions
| Attended to “care and feeding” of practices Instituted more robust communication and engagement; offered regular newsletters, regular optional “drop-in” video calls Tailored practice feedback reports Offered survey completion incentives Developed a StoryMapa Conducted in-person and virtual site visits Gave out practice care packages
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| Patient or clinician preference for induction method | Patients who were unwilling to be randomized to induction method (home, office, telehealth), or whose clinician chose the method, were not eligible to participate
| Modified the study design Converted to the comprehensive cohort study design with parallel enrollment into a randomized component and a nonrandomized, patient preference component
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| Ongoing primary care struggles of low payment, COVID, consolidation, shrinking workforce, and work overload | Clinician burnout Practice burnout
| Increased frequency of contact with practices—practice support Conducted ongoing practice recruitment Modified (lowered) enrollment goals Extended patient enrollment 9 months
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| “Fourth wave” of opioid epidemic: multiple drug use with cocaine, benzodiazepines, methamphetamine, xylazine | Patients were less likely to present for care Practices struggled with treatment options other than buprenorphine because patients had more than just opioid dependence, affecting patient care and also eligibility for the study
| Conducted regular educational webinars for clinicians and practice staff Focused on buprenorphine for OUD, referral to additional services for other drug use
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