Table 3 Methodological issues requiring Aim 3 pilot evaluation prior to a full-scale de-implementation trial

Recruitment randomization scalability

Monitor proposed recruitment strategy at each facility; check practicality of cluster randomization of facilities; identify issues of participation refusal or withdrawal; acceptability of randomization; number of eligible participants per month; compare clinic flow across recruitment strategies

Select most effective recruitment and randomization strategy; trial messaging to sites; discern patient, provider and cluster sample sizes; refining eligibility screening

Acceptability of intervention

Check acceptability of interventions with urologists and clinic staff at pilot sites; settings for each intervention; consent and documentation practices; tailoring strategies are acceptable; timing of intervention relative to visit

Identify acceptable components of each intervention in clinical practice; consent processes; efficient documentation practices

Feasibility in clinical practice

Assess burden on clinic staff and providers to participate; monitor clinical time and workflow; assess adherence to intervention; technical performance of EMR-based intervention(s); participants representative of those expected in full-scale trial; intervention fidelity

Time and resources needed to roll out in randomized sites; learn research and clinic administrative staff roles for trial; standardization; scheduling practices

Data collection and outcome assessment

Monitor follow up practices for patients on ADT; monitor for asymmetric attrition/retention across intervention sites; missing data; review choice of primary outcome, study design; effect variability

Willingness to participate by intervention preference; effect size; consider hybrid study; duration; full-scale protocol