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

Publication ,  Journal Article
Lin, S-Y; Schneider, CE; Bristol, AA; Clancy, M; Sprague, SA; Aldridge, M; Cortes, T; Goldfeld, KS; Kutner, JS; Mitchell, SL; Shega, JW; Wu, B ...
Published in: The Gerontologist
February 2022

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.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").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.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.NCT03681119.

Duke Scholars

Published In

The Gerontologist

DOI

EISSN

1758-5341

ISSN

0016-9013

Publication Date

February 2022

Volume

62

Issue

2

Start / End Page

304 / 314

Related Subject Headings

  • Pilot Projects
  • Humans
  • Hospices
  • Hospice Care
  • Gerontology
  • Dementia
  • Alzheimer Disease
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Lin, S.-Y., Schneider, C. E., Bristol, A. A., Clancy, M., Sprague, S. A., Aldridge, M., … Brody, A. A. (2022). Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial. The Gerontologist, 62(2), 304–314. https://doi.org/10.1093/geront/gnaa220
Lin, Shih-Yin, Catherine E. Schneider, Alycia A. Bristol, Maureen Clancy, Sara A. Sprague, Melissa Aldridge, Tara Cortes, et al. “Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial.The Gerontologist 62, no. 2 (February 2022): 304–14. https://doi.org/10.1093/geront/gnaa220.
Lin S-Y, Schneider CE, Bristol AA, Clancy M, Sprague SA, Aldridge M, et al. Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial. The Gerontologist. 2022 Feb;62(2):304–14.
Lin, Shih-Yin, et al. “Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial.The Gerontologist, vol. 62, no. 2, Feb. 2022, pp. 304–14. Epmc, doi:10.1093/geront/gnaa220.
Lin S-Y, Schneider CE, Bristol AA, Clancy M, Sprague SA, Aldridge M, Cortes T, Goldfeld KS, Kutner JS, Mitchell SL, Shega JW, Wu B, Zhu CW, Brody AA. Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial. The Gerontologist. 2022 Feb;62(2):304–314.
Journal cover image

Published In

The Gerontologist

DOI

EISSN

1758-5341

ISSN

0016-9013

Publication Date

February 2022

Volume

62

Issue

2

Start / End Page

304 / 314

Related Subject Headings

  • Pilot Projects
  • Humans
  • Hospices
  • Hospice Care
  • Gerontology
  • Dementia
  • Alzheimer Disease
  • 1103 Clinical Sciences