Advance Care Planning, Alzheimer's Disease and Related Dementias, Doctor-patient Communication, Palliative Care, Video Decision Aids
Conditions
Keywords
video decision aid, palliative care educator
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.
Detailed 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.
Interventions
BEHAVIORALACP 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.
Sponsors
Tufts Medical Center
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of a Goals of Care Conversation in the Electronic Health Record (EHR) During the Index Hospitalization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Knowledge of ACP at 12 Months | 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 |
| Caregiver Confidence at 12 Months | 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. |
| Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | 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. |
| Caregiver Decisional Satisfaction at 12 Months | 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. |
| Caregiver Decisional Certainty | 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. |
| Caregiver Communication Satisfaction at 12 Months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of the 11,174 participants, 6,201 participants were randomized into the intervention.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6,208 |
| Usual Care Subjects in this arm do not meet with ACP Educator during their index hospitalization. | 4,985 |
| Total | 11,193 |
Baseline characteristics
| Characteristic | Usual Care | Total | ACP Educator Led, Video Assisted Discussion |
|---|---|---|---|
| Age, Continuous Caregivers | 57 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 13 |
| Age, Continuous Patient | 78 years STANDARD_DEVIATION 8 | 78 years STANDARD_DEVIATION 8 | 78 years STANDARD_DEVIATION 8 |
| Alzheimer's disease and related dementias diagnosis No | 4209 participants | 9551 participants | 5342 participants |
| Alzheimer's disease and related dementias diagnosis Yes | 570 participants | 1251 participants | 681 participants |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 18 Participants | 41 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 171 Participants | 320 Participants | 149 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 451 Participants | 999 Participants | 548 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 4200 Participants | 9537 Participants | 5337 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 128 Participants | 266 Participants | 138 Participants |
| Language English (Caregiver) | 190 participants | 362 participants | 172 participants |
| Language English (Patient) | 3864 participants | 8773 participants | 4909 participants |
| Language Other (Caregiver) | 0 participants | 0 participants | 0 participants |
| Language Other (Patient) | 548 participants | 1255 participants | 707 participants |
| Language Spanish (Caregiver) | 4 participants | 10 participants | 6 participants |
| Language Spanish (Patient) | 315 participants | 667 participants | 352 participants |
| Language Unknown or missing (Caregiver) | 0 participants | 0 participants | 0 participants |
| Language Unknown or missing (Patient) | 52 participants | 107 participants | 55 participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Caregivers Asian | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 63 Participants | 124 Participants | 61 Participants |
| Race (NIH/OMB) Caregivers More than one race | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 12 Participants | 31 Participants | 19 Participants |
| Race (NIH/OMB) Caregivers White | 110 Participants | 194 Participants | 84 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 14 Participants | 30 Participants | 16 Participants |
| Race (NIH/OMB) Patients Asian | 386 Participants | 895 Participants | 509 Participants |
| Race (NIH/OMB) Patients Black or African American | 1125 Participants | 2501 Participants | 1376 Participants |
| Race (NIH/OMB) Patients More than one race | 454 Participants | 1071 Participants | 617 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 314 Participants | 704 Participants | 390 Participants |
| Race (NIH/OMB) Patients White | 2483 Participants | 5596 Participants | 3113 Participants |
| Region of Enrollment United States | 4985 participants | 11193 participants | 6208 participants |
| Sex/Gender, Customized Caregivers Female | 129 Participants | 248 Participants | 119 Participants |
| Sex/Gender, Customized Caregivers Male | 64 Participants | 116 Participants | 52 Participants |
| Sex/Gender, Customized Caregivers Unknown or not reported | 1 Participants | 8 Participants | 7 Participants |
| Sex/Gender, Customized Patients Female | 2335 Participants | 5223 Participants | 2888 Participants |
| Sex/Gender, Customized Patients Male | 2444 Participants | 5579 Participants | 3135 Participants |
| Sex/Gender, Customized Patients Unknown or not reported | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ACP Educator Led, Video Assisted Discussion | Identification of a Goals of Care Conversation in the Electronic Health Record (EHR) During the Index Hospitalization | 3744 Participants |
| Usual Care | Identification of a Goals of Care Conversation in the Electronic Health Record (EHR) During the Index Hospitalization | 2396 Participants |
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.
Time frame: Baseline, 12 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACP Educator Led, Video Assisted Discussion | Caregiver Communication Satisfaction at 12 Months | 31 score on a scale |
| Usual Care | Caregiver Communication Satisfaction at 12 Months | 31 score on a scale |
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.
Time frame: Baseline, 12 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACP Educator Led, Video Assisted Discussion | Caregiver Confidence at 12 Months | 15 score on a scale |
| Usual Care | Caregiver Confidence at 12 Months | 15 score on a scale |
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.
Time frame: Baseline, 12 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACP Educator Led, Video Assisted Discussion | Caregiver Decisional Certainty | 2 score on a scale |
| Usual Care | Caregiver Decisional Certainty | 2 score on a scale |
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.
Time frame: Baseline, 12 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACP Educator Led, Video Assisted Discussion | Caregiver Decisional Satisfaction at 12 Months | 40 score on a scale |
| Usual Care | Caregiver Decisional Satisfaction at 12 Months | 40 score on a scale |
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
Time frame: Baseline, 12 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACP Educator Led, Video Assisted Discussion | Caregiver Knowledge of ACP at 12 Months | 4 score on a scale |
| Usual Care | Caregiver Knowledge of ACP at 12 Months | 4 score on a scale |
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.
Time frame: Baseline, 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACP Educator Led, Video Assisted Discussion | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Goals Conversation | 3562 count of documentation preferences |
| ACP Educator Led, Video Assisted Discussion | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Limitation of life-sustaining treatment | 1979 count of documentation preferences |
| ACP Educator Led, Video Assisted Discussion | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Palliative care | 2067 count of documentation preferences |
| ACP Educator Led, Video Assisted Discussion | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Hospice | 597 count of documentation preferences |
| ACP Educator Led, Video Assisted Discussion | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Time-limited trials | 105 count of documentation preferences |
| ACP Educator Led, Video Assisted Discussion | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Missing | 0 count of documentation preferences |
| Usual Care | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Time-limited trials | 20 count of documentation preferences |
| Usual Care | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Goals Conversation | 2258 count of documentation preferences |
| Usual Care | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Hospice | 461 count of documentation preferences |
| Usual Care | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Limitation of life-sustaining treatment | 1242 count of documentation preferences |
| Usual Care | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Missing | 98 count of documentation preferences |
| Usual Care | Change in Documentation of Medical Orders for Resuscitation Preferences in EHR | Palliative care | 700 count of documentation preferences |