Palliative Care Clinical Trial
— VIDEO-PCEOfficial 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
Verified date | May 2023 |
Source | Tufts Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
United States | Northshore University Hospital | Manhasset | New York |
Lead Sponsor | Collaborator |
---|---|
Tufts Medical Center | National Institute on Aging (NIA) |
United States,
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 |
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