Protocol for a usability and pilot implementation study of a digital medical device to assess pain in non-verbal people with dementia in Portuguese residential care facilities

Objective: People living with moderate to severe dementia (PLWD) are often unable to self-report pain. This matter is of particular concern given that up to 80% experience chronic pain. Mistreated or untreated pain in PLWD is associated with symptoms such as agitation and aggression, and unnecessary use of antipsychotic agents. Further, it can also engender mental burden in formal caregivers. The PainChek^® App, a regulatory cleared class I medical device, enables the assessment and monitoring of pain in people who cannot verbalise it, such as those with moderate to severe dementia. To date there are no data on the real-world use of the PainChek^® App in Portugal. To address this gap, we report the protocol of a pilot study, which combines usability evaluation and implementation research. Methods: Usability evaluation of the PainChek^® (Portuguese) App will be guided by the ISO framework, focused on effectiveness, efficiency and user satisfaction. Implementation research will combine qualitative interviews to inform the implementation process, a longitudinal study of formal caregivers’ psychological variables, implementation outcomes, plus qualitative interviews to explore the ‘hows’ and ‘whys’ of implementation. The NASSS framework will be used as an implementation framework, together with the COM-B model and the Theoretical Domains Framework. Results: The usability and implementation studies have received ethics approval from the Egas Moniz Ethics Committee, under numbers 1367 and 64/24, respectively. Conclusion: This study is expected to inform the scale-up of the PainChek^® (Portuguese) App in real-world settings and establish a foundation for a larger effectiveness and implementation study.