Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers

Alycia A. Bristol, Kimberly A. Convery, Victor Sotelo, Catherine E. Schneider, Shih Yin Lin, Jason Fletcher, Randall Rupper, James E. Galvin, Abraham A. Brody

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Persons living with Alzheimer's disease and related dementias (ADRD) frequently experience pain and behavioral and psychological symptoms of dementia (BPSD) which decrease quality of life (QOL) and influence caregiver burden. Home healthcare professionals however may underrecognize or lack the ability to manage BPSD. Intervention: This protocol describes an ADRD palliative quality assurance performance improvement program for home healthcare, Aliviado Dementia Care-Home Health Edition. It includes training, mentoring, and a toolbox containing intervention strategies. Methods: This embedded pragmatic clinical trial will utilize a multi-site, cluster randomized control design. Recruitment will occur from three home healthcare agencies located in New Jersey, Utah, and Florida. At each agency, care teams will be randomized as clusters and assigned to either the Aliviado Dementia Care program or usual care. We plan to enroll 345 persons living with ADRD and their informal caregiver dyads. The primary outcome will be to measure QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions. Secondary outcomes in the person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use. Secondary outcomes in caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization. Conclusion: This study will be the first large-scale embedded pragmatic clinical trial in home healthcare focused on care quality and outcomes in addressing QOL in ADRD. If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population. Trial registration: Clinical Trials.gov: NCT03255967.

Original languageEnglish (US)
Article number106005
JournalContemporary Clinical Trials
Volume93
DOIs
StatePublished - Jun 2020

Keywords

  • Behavioral and psychological symptoms of dementia
  • Dementia
  • Home healthcare
  • Informal caregivers
  • Pragmatic clinical trial
  • Quality of life

ASJC Scopus subject areas

  • Pharmacology (medical)

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