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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG072911-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | 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. |
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Inclusion Criteria: Aim 1
Inclusion Criteria: Aim 2 (Caregiver Survey)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Paasche-Orlow, MD, MPH | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| Northshore University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39196855 | Derived | 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. | |
| 37695586 | 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. |
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The phenotypic data associated with enrolled participants will be shared by depositing these data in the Open Science Framework data repository. Additional data documentation and de-identified IPD including demographics, diagnoses, and outcomes will be deposited. Resources such as study protocols and statistical analysis codes will also be made available.
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.
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.
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Of the 11,174 participants, 6,201 participants were randomized into the intervention.
This study included patients aged 65 years or older and their caregivers admitted to 1 of 14 units at two urban hospitals in New York and Boston from July 1, 2021, to October 31, 2022.
| ID | Title | Description |
|---|---|---|
| FG000 | Step 0: 2 Months Usual Care Then 14 Months 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. 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. |
| FG001 | Step 1: 4 Months Usual Care, Then 10 Months 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. 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. |
| FG002 | Step 2: 6 Months Usual Care, Then 8 Months 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. 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. |
| FG003 | Step 3: 8 Months Usual Care, Then 6 Months 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. 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. |
| FG004 | Step 4: 10 Months Usual Care, Then 4 Months 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. 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. |
| FG005 | Step 5: 12 Months Usual Care, Then 2 Months 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. 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. |
| FG006 | Step 6: 14 Months Usual Care, Then 0 Months 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control: Usual Care (Patients) |
| |||||||||||||
| Intervention:Video Discussion (Patients) |
| |||||||||||||
| Control: Usual Care (Caregiver) |
| |||||||||||||
| Intervention:Video Discussion(Caregiver) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The row population differs from the overall to show the difference between patients and caregivers. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
Adverse events were not collected because ACP is a standard part of clinical care for patients.
Adverse events were not collected because ACP is a standard part of clinical care for patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Paasche-Orlow | Tufts Medical Center | 617-636-1029 | michael.paasche-orlow@tuftsmedicine.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2022 | Feb 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Baseline, 12 months |
| Caregiver Knowledge of ACP at 12 Months | 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 |
| Caregiver Confidence at 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. | Baseline, 12 months |
| Caregiver Communication Satisfaction at 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. | Baseline, 12 months |
| Caregiver Decisional Satisfaction at 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. | Baseline, 12 months |
| 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 |
| Manhasset |
| New York |
| 11030 |
| United States |
| 35879001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Usual Care | Subjects in this arm do not meet with ACP Educator during their index hospitalization. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | The rows are different to represent both caregivers and patients included in the analysis | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The rows differ to represent patient and caregiver data | Count of Participants | Participants |
|
| Race (NIH/OMB) | The row differs to show patient and caregiver data collected | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Language | The rows differ to represent show the difference in caregiver and participant data | Number | participants |
|
| Alzheimer's disease and related dementias diagnosis | ADRD Diagnosis was only collected for patients | The row population differs from the overall since data only from patients was collected about ADRD diagnosis, and not from caregivers. | Number | participants |
|
| OG001 | Usual Care | Subjects in this arm do not meet with ACP Educator during their index hospitalization. |
|
|
| Secondary | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | 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. | There was unanticipated high variability between receiving the intervention and the caregiver survey. Furthermore, a majority of the participants in the caregiver survey did not have any contact with the intervention at all. Accordingly, the survey activity was implemented in a fashion that did not reflect the intervention. | Posted | Number | count of documentation preferences | Baseline, 12 months |
|
|
|
| Secondary | Caregiver Knowledge of ACP at 12 Months | 6 investigator designed questions to assess subject's knowledge of advance care planning, scores range 0-6, higher scores indicate greater knowledge | There were unanticipated high variability between receiving the intervention and the caregiver survey. Furthermore, many of the participants in the caregiver survey did have any contact with the intervention at all. Accordingly, the survey activity was implemented in a fashion that did not reflect the intervention. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
|
|
| Secondary | Caregiver Confidence at 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. | There was unanticipated high variability between receiving the intervention and the caregiver survey. Furthermore, a majority of the participants in the caregiver survey did not have any contact with the intervention at all. Accordingly, the survey activity was implemented in a fashion that did not reflect the intervention. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
|
|
| Secondary | Caregiver Communication Satisfaction at 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. | There were unanticipated high variability between receiving the intervention and the caregiver survey. Furthermore, many of the participants in the caregiver survey did have any contact with the intervention at all. Accordingly, the survey activity was implemented in a fashion that did not reflect the intervention. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
|
|
| Secondary | Caregiver Decisional Satisfaction at 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. | There was unanticipated high variability between receiving the intervention and the caregiver survey. Furthermore, a majority of the participants in the caregiver survey did not have any contact with the intervention at all. Accordingly, the survey activity was implemented in a fashion that did not reflect the intervention. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
|
|
| Secondary | 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. | There was unanticipated high variability between receiving the intervention and the caregiver survey. Furthermore, a majority of the participants in the caregiver survey did not have any contact with the intervention at all. Accordingly, the survey activity was implemented in a fashion that did not reflect the intervention. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care | Subjects in this arm do not meet with ACP Educator during their index hospitalization. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Unknown or not reported |
|
| Male |
|
| Unknown or not reported |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Limitation of life-sustaining treatment |
|
|
| Palliative care |
|
|
| Hospice |
|
|
| Time-limited trials |
|
|
| Missing |
|
|