Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial.
providence southern california; torrance
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.
Lin, Shih-Yin; Schneider, Catherine E; Bristol, Alycia A; Clancy, Maureen; Sprague, Sara A; Aldridge, Melissa; Cortes, Tara; Goldfeld, Keith S; Kutner, Jean S; Mitchell, Susan L; Shega, Joseph W; Wu, Bei; Zhu, Carolyn W; and Brody, Abraham A, "Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial." (2020). Articles, Abstracts, and Reports. 4352.