Palliative Care Educator

NCT04857060 | Completed Results DMC

• 2 other identifiers: H-414821R01AG072911-01
• Study Type: interventional
• Target: 11,174
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Identification of a Goals of Care Conversation in the Electronic Health Record (EHR) During the Index Hospitalization

  Any documentation of a discussion pertaining to limitations of life sustaining treatment, palliative care, hospice, goals of care, time-limited trial, or surrogate decision makers.

  12 months

Secondary Outcomes (6)

• Change in Documentation of Medical Orders for Resuscitation Preferences in EHR

  Baseline, 12 months

• Caregiver Knowledge of ACP at 12 Months

  Baseline, 12 months

• Caregiver Confidence at 12 Months

  Baseline, 12 months

• Caregiver Communication Satisfaction at 12 Months

  Baseline, 12 months

• Caregiver Decisional Satisfaction at 12 Months

  Baseline, 12 months

Study Arms (2)

Usual Care

NO INTERVENTION

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

ACP Educator led, video assisted discussion

EXPERIMENTAL

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.

Behavioral: ACP Educator led, video assisted discussion

Interventions

ACP Educator led, video assisted discussion 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.

ACP Educator led, video assisted discussion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Northshore University Hospital

Manhasset, New York, 11030, United States

Location

Related Publications (3)

• 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.

  PMID: 39196855 DERIVED

• 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.

  PMID: 37695586 DERIVED

• 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.

  PMID: 35879001 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Stepped-wedge designs have significant limitation (partial confounding by time) and should be used sparingly. Second, we looked at GOC documentation rates during index hospitalization, long-term studies looking at care delivery suggests a shard decision-making encounter. Third, we did not analyze the quality of GOC documentation during the intervention and the usual care phases.

Results Point of Contact

• Title: Dr. Michael Paasche-Orlow
• Organization: Tufts Medical Center

michael.paasche-orlow@tuftsmedicine.org

617-636-1029

Study Officials

• Michael Paasche-Orlow, MD, MPH

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: July 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: January 12, 2026
• Results First Posted: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Outcome data will be deposited into Open Science Framework repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier. Data will remain available for a period of 5 years.
• Access Criteria: Data and supporting information will be shared with investigators working in accordance to guidelines set by the data repository. Meta-analysis data and associated phenotypic data, along with data content, format, and organization, will be made available to investigators through the Open Science Framework data repository.

Locations

US (2)