Transitioning to Remote Recruitment and Intervention: A Tale of Two Palliative Care Research Studies Enrolling Underserved Populations During COVID-19.

CONTEXT: During the COVID-19 pandemic, community-based research studies experienced prolonged shutdowns unless able to pivot to remote study procedures. OBJECTIVES: To describe the revision of two National Institutes of Health funded community-based palliative-focused clinical trials serving underserved populations to accommodate remote subject enrollment and examine its impact. METHODS: Transitioning to remote processes required multiple protocol and procedural changes including: altering informed consent processes; reducing the number of surveys administered; adding internet access as an inclusion criterion. To understand technological challenges, a screening tool was developed for one study to identify potentially eligible subjects' technology abilities and accessibility. RESULTS: Subjects' limited access to the internet and internet-enabled devices and discomfort with technology led to changes in recruitment patterns. Lack of familiarity with technology increased the amount of time it took research team members and subjects to connect remotely. Patients with significant cognitive and/or sensory deficits were at higher risk of experiencing fatigue during remote study visits leading to streamlining of data collection. A researcher-developed technology screening tool found that potential subjects were not comfortable with videoconferencing through Zoom expressing a preference for phone visits. Reduced travel time made scheduling remote study visits more efficient. CONCLUSION: Future community- and home-based palliative care trials must consider the best way to utilize remote recruitment, enrollment, and data collection processes to increase efficiency and reduce costs. Researchers should consider technology accessibility and train staff to ensure the greatest possible opportunity to recruit underserved populations who have traditionally been underrepresented in research studies.

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.

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.