Two Quasi-Experimental Pilot Trials to Inform a Nationwide Embedded Pragmatic Clinical Trial on the Aliviado Dementia Care-Hospice Edition program
Authors: Lin Shih-Yin , Schneider Catherine E. , Bristol Alycia A. , Clancy Maureen , Sprague Sara A. , Aldridge Melissa , Cortes Tara A. , Goldfeld Keith S. , Kutner Jean S. , Mitchell Susan L. , Shega Joseph W. , Wu Bei , Zhu Carolyn W. , Brody Abraham A. 
Published: June 2020

Abstract
Background: Most investigators studying Alzheimer’s disease and related dementias (AD/ADRD) are unfamiliar with embedded pragmatic clinical trials (ePCTs) and pilot studies designed to inform ePCTs. This paper provides a much-needed example for the pilot phase proceeding a nationwide AD/ADRD ePCT, reporting feasibility, applicability, and fidelity results. It also discusses implementation barriers and additional infrastructure and implementation strategies developed following the pilot phase. Methods: Two iterative, quasi-experimental pilot trials were conducted in two hospice agencies sequentially to refine and test the Aliviado Dementia Care-Hospice Edition program, a quality improvement program consisting of dementia care training; a toolbox of assessment instruments, symptom management algorithms, care plans, caregiver education sheets; and clinical workflow changes. Participants were 72 interdisciplinary team (IDT) members at the two hospices who met the eligibility criteria. To demonstrate readiness for the full ePCT, three milestones had to be met: ³80% training completion rate (“feasibility”), ³80% post-training survey respondents indicating intention for practice changes (“applicability”), and at least one Aliviado care plan/assessment instrument administered in ³75% of dementia patients admitted to home hospice within one-month post training (“fidelity”). Results: Sixty-six IDT members (92%) completed the dementia care training. Ninety-three percent of post-training survey respondents (response rate: 82%) reported that they will implement practice changes across pilots. Four patients with a primary diagnosis of advanced AD/ADRD and seven with AD/ADRD as a comorbidity were admitted to home hospice during the one-month post-training period in pilot two. All (100%) had at least one assessment instrument or care plan implemented. Main implementation challenges were related to hospice staff turnover, integration of the Aliviado toolbox materials within the electronic health record, and hospices’ limited research experience and infrastructure. Conclusions: Pilot testing established the feasibility of implementing and embedding Aliviado Dementia Care Hospice-Edition into hospice settings. The program content was applicable to hospice practices where IDT members were able to incorporate assessment instruments and dementia care plans into routine care. In proceeding to a full ePCT, we will automate implementation procedures, add mobile device point-of-care access to the toolbox materials, and incorporate strategies to strengthen long-term research partnerships with participating hospices.Trial registration: ClinicalTrials.gov: NCT03681119. Registered: September 21, 2018, https://clinicaltrials.gov/ct2/show/NCT03681119