Background: Alopecia areata is a common autoimmune disease, characterized by hair loss and emotional pain, that affects 6.6 million Americans of all ages, races, and ethnicities. There are currently no treatments approved by the Federal Drug Administration for alopecia areata.
Research on alopecia areata is accelerating, and the importance of patient-centered outcomes in informing the development of treatments relevant to patients is also becoming more widely understood. Researchers find themselves at a critical juncture where they need, but lack, validated endpoints, including patient-reported outcomes. The community is being asked to participate, but is not yet prepared to meaningfully engage in and inform the design of patient-centered clinical research.
Proposed Solution to the Problem: The project team proposes to develop, deliver, evaluate, and refine a training curriculum to educate the patient community about patient-centered outcomes research (PCOR)/comparative effectiveness research (CER) and empower them to participate in the research process at every step.
Objectives: The aim of the Health and Research Ambassador (HARA) Program is to equip patient partners in all phases of the research process so that treatments developed are meaningful to patients. This project will serve as a model for how other groups can leverage existing PCORI-funded training materials and implement them in their communities with case examples specific to their populations.
Activities: Working with an existing cadre of 17 Health and Research Ambassadors (Ambassadors) cultivated during a pilot project in 2015, and experts from the National Health Council and National Centers for Health Research, NAAF will modify an existing training curriculum in PCOR/CER with case examples specific to alopecia areata. HARA participants will receive training themselves, provide input to refine the curriculum, and then engage their local alopecia areata support groups and other stakeholders in training and preparation for PCOR/CER. The project team will also test the training in one non-alopecia-areata community for feedback to demonstrate the scalability. The team will collect program evaluations, refine the training, and disseminate findings through a website, conferences, newsletters, social media, and peer health advocacy groups through overarching associations and coalitions.
Outcomes and Outputs: The project will result in a fully developed set of HARA PCOR/CER training materials, a group of 17-25 trained Ambassadors, and a patient community that is educated and ready to participate in PCOR and CER.
Patient and Stakeholder Engagement Plan: The HARA program will engage patients, family members, and members of the research and clinical community. Stakeholders will meet approximately 20 times over two years. Patient stakeholders will be involved in the following ways: Health and Research Ambassadors who are patients themselves will receive the HARA training, deliver trainings in the community, and collect evaluations to provide input and feedback on the curriculum design; and the Curriculum Development Team, which will include two patient representatives, will design, evaluate, and refine the curriculum and training methodology based on evaluation feedback. The project team will utilize existing infrastructure to reach potential Ambassadors and trainees in underserved communities to ensure the training materials are accessible to people of diverse backgrounds and education levels.