Human Factors Evaluation of a Novel Digital Medicine System in Psychiatry

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Background: The Digital Medicine System (DMS), developed for patients with serious mental illness (SMI), integrates adherence measurement with pharmacologic treatment (by embedding an ingestible sensor in the pill), and allows for information sharing between patients, healthcare providers (HCPs) and caregivers. The DMS development process required studies to minimize cognitive burden and use-related risks and demonstrate effective use of the technology.

Methods: Human factors (HF) studies assessed the system's safe and effective use by the intended users for the intended uses. The patient interface was tested in 6 formative HF studies followed by a validation study. The HCP/caregiver interface was tested in 1 study before validation. Formative studies identified use-related risks and the cause of use problems to guide design modification. Validation of the patient and HCP/caregiver interfaces assessed risks of the final product.

Results: During the patient formative studies, design improvements were made to address problems and mitigate risks potentially caused by suboptimal system design or patient cognitive impairments. In the patient validation study, 35 patients attempted 23 user tasks, for a total of 805 attempts; 783/805 attempts were completed with success. Only 3 failures were observed on a critical task. Residual risks resistant to mitigation were found to be of low severity based on the US FDA guidance.

Conclusion: The final DMS design reflects a development methodology informed by the intended user populations. In alignment with the FDA goals for HF studies, the system was found to be safe and effective for the intended users, uses and use environments.