Richard J. Holden, Ph.D. - US grants

DESCRIPTION (provided by applicant): The proposed research addresses the need to provide information support to older chronic heart failure (CHF) patients and their informal caregivers. Many older patients have unmet information needs related to their home care (self-care) plans, illustrated by knowledge deficits and up to 90% nonadherence to important care activities such as medication-taking, nutrition and sodium restriction, physical activity, and monitoring and responding to symptoms. The health consequences of nonadherence are tremendous and costly. We hypothesize that health information technology (HIT), when designed and evaluated using Human Factors Engineering (HFE) principles and methods, can be useful and usable for older patients and lay caregivers who must manage the complex information needed for successful home care, health, & disease management. This proposal describes how the Principal Investigator (PI) will transition to research independence and a career in aging research, building on his expertise in HFE and HIT and developing additional expertise in the: a) health relevant characteristics of older, chronically ill patients, and b) proess of user-centered HIT design for these patients and their caregivers. The proposal describes a 3-year research project developing and testing an interactive Flight Plan HIT system using the HFE approach. Flight Plan will initially be developed for and tested by older CHF patients to support a broad array of disease-specific and general self-care activities. Research Aim 1 is the Human Factors Analysis - a combination of familiarization with the geriatric CHF domain, interviews, surveys, and in-home observations. The Human Factors Analysis will yield a realistic understanding of future Flight Plan users, their tasks, contexts of use, and needs. This understanding will be critical for evidence based design of Flight Plan. Research Aim 2 is the Design and Usability Testing of a Flight Plan prototype. The prototype will be based on Aim 1 findings and the design team's vision of a patient-centered, patient-controlled, interactive Flight Plan system. The PI's career development activities will ensure that Flight Plan conforms to HFE design principles and is clinically valid. During usability testing, older CHF patients and their lay caregivers will use the Flight Plan prototype under both controlled lab and in situ conditions. Analysis of objective and subjective usability test data will verify the usability and preliminary usefulness of Flight Plan and guide further refinement. Research Aim 3 is the Pilot Test of Flight Plan's effectiveness and user acceptance. The Pilot Test will be a pre-post randomized controlled trial with baseline and 3 months post-intervention measures of health status, CHF knowledge, and CHF self-care behavior. Flight Plan is hypothesized to improve these measures relative to usual care. Flight Plan is expected to have higher HIT acceptance than other patient-facing HIT systems. Future work will include a larger randomized controlled trial to evaluate Flight Plan's effects on older CHF patients' health outcomes as well as extension of Flight Plan to other geriatric chronic disease domains.

PROJECT SUMMARY A majority of the nearly 6 million people living with Alzheimer's disease and related dementias (ADRD) in the US are reliant upon informal (family and friend) caregivers to help manage their medications. Comorbidities are highly prevalent in people with ADRD, often requiring the management of multiple simultaneous medications and complex medication regimens. Caregivers are often untrained, under-resourced, and unsupported to perform the medication tasks people with ADRD rely upon. Studies have reported that caregiver-assisted medication management is associated with caregiver burden and stress and potentially inappropriate medication use in a third of people with ADRD. Unfortunately, most caregiver support interventions do not address ADRD caregivers' roles in managing medications for people with ADRD. Moreover, the few interventions for ADRD caregivers addressing medications do not leverage information technology (IT), despite national recognition of IT's vital role in ADRD care and caregiving. To address this gap, the intent of the proposed project is to develop an IT-based intervention to support caregivers managing medications for people with ADRD. According to the NIH Stage Model, behavioral interventions including IT solutions must be built upon a solid empirical record. Therefore, we propose to employ the three phases of user-centered design to address the first two stages of the NIH Stage Model. First, we will use a combination of user-centered design methods to conduct a user needs assessment (Stage 0) of ADRD caregivers who manage medications for people with ADRD. Second, we will use participatory co-design (Stage IA) to co-design a prototype IT intervention to support caregiver-assisted medication management collaboratively with ADRD caregivers. Third, we will conduct user testing (Stage IB) to feasibility test the prototype IT intervention with ADRD caregivers. User-centered design is the gold standard (e.g., FDA-mandated for all medical devices) process for designing products by involving representatives of the end-user population to better address user needs. Completion of the aims will lead to a hybrid efficacy/effectiveness Stage 3 randomized clinical trial of the intervention, powered to test changes in medication adherence and safety, with secondary outcomes of neuropsychiatric symptoms, acute care utilization, and caregiver burden.