Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for...

Area of Science:

• Genetics
• Digital Health
• Genomic Medicine

Background:

• High demand for genetic testing strains healthcare resources.
• Existing digital tools lack comprehensive coverage of the genetic testing journey.
• Need for innovative service delivery models in genetics.

Purpose of the Study:

• To evaluate the effectiveness of the Genetics Adviser, a digital health tool, in supporting patients through the entire genetic testing journey.
• To compare a model using Genetics Adviser plus brief counseling against standard genetic counseling alone.
• To assess patient outcomes including decisional conflict, knowledge, and satisfaction.

Main Methods:

• Randomized controlled trial involving 140 cancer patients.
• Intervention group uses Genetics Adviser for pre-test counseling, support, and results delivery, supplemented by brief genetic counseling.
• Control group receives standard genetic counseling.

Main Results:

• Primary outcome: decisional conflict.
• Secondary outcomes: knowledge, satisfaction, anxiety, quality of life, psychological impact, empowerment, acceptability, and economic impact.
• User experience assessed via patient interviews.

Conclusions:

• The study will provide insights into the effectiveness of the Genetics Adviser as an alternative service delivery model.
• Findings will inform the integration of digital health tools in genetic testing.
• Results will be disseminated through publications and conferences.