Palliative Care Educator

Palliative Care Clinical Trial

— VIDEO-PCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857060
• Other study ID #: H-41482
• Secondary ID: 1R01AG072911-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2023
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10802
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Northshore University Hospital	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in documentation of medical orders for resuscitation preferences in EHR	Presence and content of resuscitation and treatment preferences including: Full code, do not resuscitate (DNR), do not intubate (DNI), do not hospitalize (DNH), and documented preferences around feeding tubes, and dialysis.	Baseline, 12 months
Secondary	Change in Caregiver knowledge of ACP	6 investigator designed questions to assess subject's knowledge of advance care planning, scores range 0-6, higher scores indicate greater knowledge	Baseline, 12 months
Secondary	Change in Caregiver confidence	3 investigator designed questions with responses on a 5-point likert scale from lowest to highest confidence. Range of scores 3-15, higher scores are associated with more caregiver confidence.	Baseline, 12 months
Secondary	Change in Caregiver communication satisfaction	10 investigator designed questions to assess subject's satisfaction with clinician communication. Scores range from 0-10 with higher scores indicating higher confidence. Range of scores 10-100, higher scores are associated with more satisfaction with clinician communication.	Baseline, 12 months
Secondary	Change in Caregiver decisional satisfaction	12 investigator designed questions with responses on a 5-point likert scale from lowest to highest satisfaction. Range of scores 12-60, higher scores are associated with more decisional satisfaction.	Baseline, 12 months
Secondary	Change in Caregiver decisional certainty	2 investigator designed questions to assess level of certainty in decisions, scores range from 0-4 with highest scores indicating the highest certainty. Range of scores 0-8, higher scores are associated with more decisional certainty.	Baseline, 12 months