Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial. (30th December 2020)

• Record Type: Journal Article
• Authors: 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; Brody, Abraham A
• Editors: Meeks, Suzanne
• Is Part Of: Gerontologist. Volume 62:Number 2(2022)
• Page Start: 304
• Page End: 314
• Publication Date: 2020-12-30
• Subjects: ADRD -- Hospice -- Implementation science -- Interdisciplinary workforce training -- Quality assurance and performance improvement; Older people -- Periodicals; Older people -- United States -- Periodicals; 305.2605
• DOI: 10.1093/geront/gnaa220
• Languages: English
• ISSNs: 0016-9013

Abstract

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 2 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% posttraining survey respondents indicating intention for practice changes ("applicability"), and at least 1 Aliviado care plan/assessment instrument administered in ≥75% of dementia patients admitted to home hospice within 1-month posttraining ("fidelity"). Results: Participants included 72 interdisciplinary team members and 11 patients with AD/ADRD across the pilots. Feasibility, applicability, and fidelity outcomes (92%, 93%, and 100%, respectively) all surpassed the preestablished 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 Trials Registration Number: NCT03681119