Table 1.

Team-ratified changes for the IVON study design based on formative findings

Original study design	Formative assessment findings	Adjusted study design	CFIR category of change
No standard script for patient counselling by healthcare workers	Threat of misinformation and conspiracy theories	Standard patient information script to be used for all IV iron administrations	• Individuals involved
Participants only receive a signed consent form	Important to provide clear, standard reference information for both participants and family members	Participants and family to receive an illustrated flyer in simple English or local language describing the IV iron procedure, uses, and benefits	• Individuals involved • Outer setting
Expert trainers provide training only at baseline; step-down training thereafter	HCWs need expert periodic training given the novelty of the intervention	Expert trainers to provide both baseline and periodic refresher training to HCWs every 6 months	• Inner setting • Individuals involved
Study implementation focused on intervention, patient, healthcare workers, clinic	The study needs to consider all social levels for intervention success	Both study implementation and dissemination to be conducted with relevant socioecological model applications	• Implementation process