INFORM is an NIH-funded study which aims to develop and evaluate a mobile-based application that will provide pregnant patients with a “just-in-time” consent model when receiving prenatal cell-free DNA screening. The goal of introducing this consent model is to: create a more simplified information format, help balance patient needs and reduce unnecessary emotional stress, and help to reduce demands on healthcare providers.

The study will be conducted at three clinical sites (University of Florida at Jacksonville, UNC-Chapel Hill, and University of California, San Francisco) and will be divided into three stages involving 1) qualitative interviews of stakeholders 2) app development, and 3) a step-wedge clinical trial.

Stage 1
INFORM is currently in its first stage and has begun qualitative interviews with healthcare providers, patients, and clinic staff. The goal of this stage is to understand clinic workflow and gain stakeholder perspectives on the appropriate mobile application setup and information offered. This stage will conclude with the analysis of the qualitative data to develop the mobile application and pilot testing of the app. This stage is projected to be completed in 2025.

Stage 2

This stage will continue with the mobile application development and piloting. It is projected to begin and be completed between 2025 and 2026.

Stage 3

This stage will test the feasibility of using the mobile application and patient satisfaction using a step-wedge clinical trial design. It is projected to begin and be completed from 2026 to 2028.

Study Investigators:
Miriam Kuppermann, PhD, MPH and Anna Altshuler, MD, MPH (University of California, San Francisco)
Niamh Condon, DO, FACOOG (University of Florida, Jacksonville)
Asha Talati, MD, MSCR (University of North Carolina, Chapel Hill)
Study PIs:
Megan Allyse, PhD (Mayo Clinic); Marsha Michie, PhD (Case Western Reserve University)
NIH Grant Number: 1R01HG013718

Questions? If you would like more information on this study please contact: INFORMStudy@case.edu