NCT Number: NCT04857060
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston Medical Center, Boston, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Aim 1
Inclusion criteria
Aim 2 (Caregiver Survey)
Exclusion criteria
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.
Time frame: 12 months
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.
Time frame: Baseline, 12 months
Medical records were reviewed for the 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. Change is measured as the number of patients with a new documented preference between baseline and 12 months.
Time frame: Baseline, 12 months
6 investigator designed questions to assess subject's knowledge of advance care planning, scores range 0-6, higher scores indicate greater knowledge
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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.
Tufts Medical Center
Other
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
Acronym: VIDEO-PCE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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