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 |