Clinical trial NCT04857060: Palliative Care Educator
Official title: Meeting the Challenges of COVID-19 by Expanding the Reach of Palliative Care: Proactive Advance Care Planning With Videos for the Elderly and All Patients With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Palliative Care
Alzheimer's Disease and Related Dementias
Doctor-patient Communication
Video Decision Aids
Keywords: video decision aid
palliative care educator
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-04-23
Enrollment: 10802
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose to conduct a stepped wedge cluster randomized trial of an advance care planning (ACP) educator-led intervention among hospitalized patients aged 65 and over, or any patient with Alzheimer's Disease and Related Dementias (ADRD) and their proxy decision-makers in the ward and ICU settings of two major hospitals: Boston Medical Center and North Shore University Hospital in New York. Patient outcomes will be abstracted from electronic health records with Natural Language Processing. The effectiveness of the intervention will be evaluated by comparing the following outcomes among 9,000 hospitalized patients (Aim 1): ACP documentation; preferences for resuscitation; palliative care consults; and, hospice use. The investigators will characterize caregiver-centered outcomes of patients with ADRD, including (Aim 2): (1) knowledge, (2) confidence in future care, (3) communication satisfaction, and (4) decisional certainty in 600 caregivers of patients with ADRD admitted to the hospital. COVID-19 poses a unique dilemma for older Americans and patients with ADRD and their caregivers, who must balance their desire to live against the risk of a lonely and potentially traumatic hospital death. Video decision support is a practical, evidence-based, and innovative approach to assist patients facing such choices. If proven effective, this innovative care model can be immediately deployed across the country to improve the quality of care for millions of Americans.

Detailed description: The majority of patients aged 65 or over, and patients with Alzheimer's Disease and Related Dementias (ADRD), have never communicated their preferences to clinicians or completed advance care planning (ACP) documents. Palliative care has the potential to improve ADRD care, improve patient-clinician communication and patient-centered outcomes, while decreasing unwanted burdensome treatments and improving care at the end of life. The novel Coronavirus Disease 2019 (COVID-19) has acutely escalated the importance of integrating ACP and palliative care services into medical care. The default response to critical illness for patients with ADRD (and all others) is intubation, mechanical ventilation, and aggressive care despite having no change in mortality outcome. ADRD patients and their caregivers may prefer to avoid these interventions.

To address these gaps, the investigators have developed a COVID-19 ACP Educator-led, video-assisted palliative care intervention to improve patient-clinician communication, increase ACP documentation, and lead to more patient-centered care at the end of life. The investigators will identify all hospitalized patients aged 65 and older, and any patient with ADRD, and then an ACP Educator will proactively proceed with primary palliative care services of ACP, leveraging certified video decision aids developed by the research team. This will be considered the standard of care for all patients meeting eligibility criteria. The ACP Educator to be tested in this proposal represents a new role and proactive function for the palliative care team. The ACP Educator will work with older patients or patients with ADRD and proxy decision-makers to learn about and document patients' wishes.

Eligibility criteria: Inclusion Criteria: Aim 1

* Inpatient at study sites
* Age 65 and older

Inclusion Criteria: Aim 2 (Caregiver Survey)

* Age 18 and older
* Designated caregiver of inpatient identified in Aim 1 who are diagnosed with Alzheimer's Disease and Related Dementias or other cognitive impairments
* English or Spanish speaking

Exclusion Criteria:

* None

Primary outcomes:
measure: Identification of a Goals of Care Conversation in the Electronic Health Record (EHR) during the Index Hospitalization
timeFrame: 12 months
Secondary outcomes:
measure: Change in documentation of medical orders for resuscitation preferences in EHR
timeFrame: Baseline, 12 months
measure: Change in Caregiver knowledge of ACP
timeFrame: Baseline, 12 months
measure: Change in Caregiver confidence
timeFrame: Baseline, 12 months
measure: Change in Caregiver communication satisfaction
timeFrame: Baseline, 12 months
measure: Change in Caregiver decisional satisfaction
timeFrame: Baseline, 12 months
measure: Change in Caregiver decisional certainty
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Manhasset
country: United States
facility: Northshore University Hospital
state: New York
Study officials:
affiliation: Tufts Medical Center
name: Michael Paasche-Orlow, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lakin JR, Zupanc SN, Lindvall C, Moseley ET, Das S, Sciacca K, Cabral HJ, Burns EA, Carney MT, Itty J, Lopez S, Emmert K, Martin NJ, Lambert S, Polo J, Sanghani S, Dugas JN, Gomez M, Winter MR, Wang N, Gabry-Kalikow S, Dobie A, Amshoff M, Cucinotta T, Joel M, Caruso LB, Ramirez AM, Salerno K, Ogunneye Q, Henault L, Davis AD, Volandes A, Paasche-Orlow MK. Study protocol for Video Images about Decisions to Improve Ethical Outcomes with Palliative Care Educators (VIDEO-PCE): a pragmatic stepped wedge cluster randomised trial of older patients admitted to the hospital. BMJ Open. 2022 Jul 25;12(7):e065236. doi: 10.1136/bmjopen-2022-065236.