Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial

Abstract

Background and Objectives Many investigators of Alzheimer’s disease and related dementias (AD/ADRD) are unfamiliar with the embedded pragmatic clinical trials (ePCTs) and the indispensable pilot phase preceding ePCTs. This paper provides a much-needed example for such a pilot phase and discusses implementation barriers and additional infrastructure and implementation strategies developed in preparation for a nationwide AD/ADRD ePCT. Research Design and Methods Two pilot trials were conducted in two hospices sequentially to refine and test Aliviado Dementia Care-Hospice Edition, a complex quality improvement intervention for advanced dementia symptom management. Readiness for the subsequent full-scale ePCT was assessed by three milestones: ≥80% training completion rate (“feasibility”), ≥80% post-training survey respondents indicating intention for practice changes (“applicability”), and at least one Aliviado care plan/assessment instrument administered in ≥75% of dementia patients admitted to home hospice within one-month post training (“fidelity”). Results Participants included 72 interdisciplinary team (IDT) members and 11 patients with AD/ADRD across the pilots. Feasibility, applicability, and fidelity outcomes (92%, 93%, and 100%, respectively) all surpassed the pre-established milestones (80%, 80%, and 75%). Main implementation challenges were related to hospice staff turnover, integration of the Aliviado toolbox materials within the electronic health records, and hospices’ limited research experience and infrastructure. Discussion and Implications This pilot phase demonstrated feasibility, applicability, and fidelity required to proceed to the full-scale ePCT. Our study findings and discussions of additional infrastructure and implementation strategies developed following the pilot phase can inform researchers and clinicians interested in conducting AD/ADRD-related pilot studies for ePTCs or quality improvement initiatives. Clinical Trial Number NCT03681119.

Functional and clinical needs of older hospice enrollees with coexisting dementia

“…There are a variety of innovations aiming to improve end‐of‐life care for PWD. Programs like Aliviado Health aim to improve dementia expertise of clinicians within hospice, home health, and long‐term care models 34–36 . The UCLA Alzheimer's & Dementia Care co‐management program shows positive end‐of‐life outcomes 37 .…”

A Pilot Observational Exploratory Study of Well-Being in Hospice Interdisciplinary Team Members

“…Participants were recruited from an IDT undergoing a quality improvement program, Aliviado Dementia Care-Hospice Edition, in the complexities of providing dementia care in the hospice setting. 31 Methodology from this study are reported in greater detail elsewhere. 31 Participants were invited to complete the survey after completion of the dementia care training of the Aliviado program.…”

“…31 Methodology from this study are reported in greater detail elsewhere. 31 Participants were invited to complete the survey after completion of the dementia care training of the Aliviado program. All data was collected between March and September 2019.…”

Ethical challenges of prospective clinical trials during the COVID-19 pandemic

“…In order to properly address these issues, we believe that the clinical research apparatus requires a new priority: embedded pragmatic clinical trials [ 57 ]. These studies, which are integrated into standard medical care using routinely collected clinical information, generate real-world evidence without the limitations associated with observational studies or the time, expense, and lack of generalizability that are barriers to conducting conventional randomized clinical trials [ 58–60 ].…”