Palliative Care Educator

NCT ID: NCT04857060

Last Updated: 2026-01-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-10-31

Brief Summary

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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

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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.

Conditions

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Advance Care Planning Palliative Care Alzheimer's Disease and Related Dementias Doctor-patient Communication Video Decision Aids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

Subjects in this arm do not meet with ACP Educator during their index hospitalization.

Group Type NO_INTERVENTION

No interventions assigned to this group

ACP Educator led, video assisted discussion

For hospitalized patients identified by a defined EHR algorithm, an ACP Educator will meet with the patient in the hospital to provide primary palliative care services such as goals-of-care conversations and clinician communication by leveraging certified video decision aids.

Group Type EXPERIMENTAL

ACP Educator led, video assisted discussion

Intervention Type BEHAVIORAL

For hospitalized patients identified by a defined EHR algorithm, an ACP Educator will meet with the patient in the hospital to provide primary palliative care services such as goals-of-care conversations and clinician communication by leveraging certified video decision aids.

Interventions

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ACP Educator led, video assisted discussion

For hospitalized patients identified by a defined EHR algorithm, an ACP Educator will meet with the patient in the hospital to provide primary palliative care services such as goals-of-care conversations and clinician communication by leveraging certified video decision aids.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Inpatient at study sites
* Age 65 and older


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Paasche-Orlow, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Northshore University Hospital

Manhasset, New York, United States

Site Status

Countries

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United States

References

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Volandes AE, Zupanc SN, Lakin JR, Cabral HJ, Burns EA, Carney MT, Lopez S, Itty J, Emmert K, Martin NJ, Cole T, Dobie A, Cucinotta T, Joel M, Caruso LB, Henault L, Dugas JN, Astone K, Winter M, Wang N, Davis AD, Garde C, Rodriguez PM, El-Jawahri A, Moseley ET, Das S, Sciacca K, Ramirez AM, Gromova V, Lambert S, Sanghani S, Lindvall C, Paasche-Orlow MK. Video Intervention and Goals-of-Care Documentation in Hospitalized Older Adults: The VIDEO-PCE Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332556. doi: 10.1001/jamanetworkopen.2023.32556.

Reference Type DERIVED
PMID: 37695586 (View on PubMed)

Zupanc SN, Quintiliani LM, LeClair AM, Paasche-Orlow MK, Volandes A, Penumarthy A, Henault L, Itty JE, Davis AD, Lakin JR. The Sowers of Seeds: A Qualitative Analysis of the Role of Palliative Care Educators in Facilitating Goals-of-Care Conversations and Palliative Care Referrals. Am J Hosp Palliat Care. 2025 Aug;42(8):761-768. doi: 10.1177/10499091241267917. Epub 2024 Aug 28.

Reference Type DERIVED
PMID: 39196855 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35879001 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01AG072911-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-41482

Identifier Type: -

Identifier Source: org_study_id

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