Alzheimer Disease, Dementia, Dementia Alzheimers, Dementia Frontal, Dementia, Mixed, Dementia Severe, Dementia, Vascular, Dementia With Lewy Bodies
Conditions
Brief summary
Millions of Americans have late-stage Alzheimer's and related dementias (ADRD), causing suffering due to loss of awareness of self and family, progressive dependency, physical and neuropsychiatric symptoms, and physical, emotional and financial strain for caregivers. Investigators now propose a multi-site randomized clinical trial of the ADRD Palliative Care (ADRD-PC) program for persons with late-stage ADRD and their family caregivers, triggered during hospitalization. Investigators aim to learn if this program of dementia-specific palliative care, standardized caregiver education, and transitional care is effective to reduce burdensome hospital transfers, improve symptom treatment and control, augment supportive services, and reduce nursing home transitions for patients, and to improve caregiver outcomes of communication, shared decision-making and distress.
Detailed description
Investigators have designed the ADRD Palliative Care (ADRD-PC) program of dementia-specific palliative and transitional care, and shown its feasibility and potential efficacy. Delivered by interdisciplinary hospital palliative care teams, ADRD-PC addresses 1) prognostic awareness, 2) symptom management, 3) shared decision-making, and 4) transition to community support services. The research objective is to conduct a multi-site efficacy randomized clinical trial (RCT) of the ADRD-PC program. Investigators will enroll 424 dyads of hospitalized patients with late-stage ADRD (Global Deterioration Scale (GDS) 6-7 or GDS 5 with significant co-morbidity) with their family caregivers, and an additional 50 dyads that identify as Hispanic/Latino at 5 geographically diverse sites of the Palliative Care Research Cooperative group - University of North Carolina, University of Colorado, Massachusetts General Hospital (Harvard University), Indiana University, and Emory University. The primary hypothesis is that ADRD-PC will reduce hospital transfers (Aim 1). Additional hypotheses are that ADRD-PC will improve patient-centered outcomes of symptom treatment, symptom control, use of community palliative care or hospice, and nursing home transitions (Aim 2); and caregiver outcomes of communication, decision-making and distress (Aim 3).
Interventions
BEHAVIORALADRD-PC Program
Included in arm/group descriptions
Sponsors
National Institute on Aging (NIA)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Randomization allocation to study arms is concealed from all study personnel until the point of randomization assignment. In the ADRD-PC Study, the overall PI (Dr. Hanson) and the research staff Clinical Research Coordinators (CRC) collecting data in 30- and 60-day interviews (data source for primary outcome and most secondary outcomes) are masked to study assignment until planned study arm reveal during final analyses. CRCs will conduct 60-day electronic health record (EHR) reviews only after dyads complete study participation, as EHR content has the potential to reveal study arm assignment. As with most behavioral clinical interventions, participants and care providers cannot be masked.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
People with ADRD Inclusion Criteria: * aged 55 or older * hospitalized * have a physician-confirmed diagnosis of ADRD * staged GDS 6 or 7; or GDS 5 with additional co-morbidity defined by Charlson Comorbidity Index scored 5 or higher Caregiver Inclusion Criteria: * the adult (aged 18 or older) legally authorized representative (LAR) for healthcare and have capacity to serve in this role * support the person with ADRD * can complete interviews in English or Spanish.
Exclusion criteria
Dyads will be excluded if * the LAR is not a family caregiver * the patient currently receives palliative care or hospice * patient or caregiver would be unduly stressed * dyad is not successfully randomized.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hospital Transfers (Patients) | 60 days post index hospital discharge | Number of hospital transfers (number of emergency room visits + number of hospital admissions )/(person-days of follow-up) within 60 days after discharge from the index hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Control for Physical Symptoms (Patients) | 60 days post hospital discharge | Symptom Management at the End of Life in Dementia (SM-EOLD) - Likert scale, 9 items each scored 0-5, range of 0-45 with higher scores indicating greater symptoms. |
| Symptom Control for Neuropsychiatric Symptoms-Severity (Patients) | 60 days post hospital discharge | Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity Score - 12 items, each symptom reported as present is rated from 1 (mild) to 3 (severe). The range in this subscale is 0-36 with higher scores indicating worse symptom control. |
| Symptom Control for Neuropsychiatric Symptoms-Distress (Patients) | 60 days post hospital discharge | Neuropsychiatric Inventory Questionnaire (NPI-Q) Distress - 12 items, if the symptom was reported as present the caregiver rated the level of distress they experienced related tot he patient's symptom from 0 (not distressing) to 5 (extremely distressing). This subscale ranges from 0-60, with higher scores indicating more caregiver distress. |
| Access to Hospice (Patients) | 60 days post hospital discharge | Percent of people with ADRD who access hospice services. |
| Access to Community-based Palliative Care (Patients) | 60 days post hospital discharge | Percent of people with ADRD who access community-based palliative care services |
| Transition to Nursing Home Level of Care (Patients) | 60 days post hospital discharge | Percent of people with ADRD who transition to nursing home care |
| Symptom Treatment (Patients) | 60 days post hospital discharge | Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment |
| Documented Discussion of Goals of Care (Patients) | 60 days post hospital discharge | Percent of patients with documented discussion of overall goals of care. |
| Shared Decision-making - Hospitalization (Patients) | 60 days post hospital discharge | Percent of patients whose caregivers reported shared decision-making discussions with a healthcare provider about future hospitalization for the patient. |
| Shared Decision-making - Burdensome Treatment (Patients) | 60 days post hospital discharge | Percent of patients whose caregivers reported shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment. |
| Caregiver Distress Score (Caregivers) | 60 days post hospital discharge | Family Distress in Advanced Dementia scale - 21 item Likert scale (1=Never to 5=Always) ranges from 21 to 105 with higher scores indicating more distress. |
| Caregiver Burden (Caregiver) | 60 days post hospital discharge | Zarit Burden scale, short form - 6 items, Likert (1=never to 5=Nearly Always), range 0-24 with higher scores indicating more caregiver burden. |
| Documented Discussion of Dementia Prognosis (Patients) | 60 days post hospital discharge | Percent of patients with documented discussion of dementia prognosis in their medical record. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Condition: ADRD-PC Program Patient-family caregiver dyads randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care.
1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams.
2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions.
3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls. | 442 |
| Control Condition Patient-family caregiver dyads randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care. | 442 |
| Total | 884 |
Baseline characteristics
| Characteristic | Intervention Condition: ADRD-PC Program | Control Condition | Total |
|---|---|---|---|
| Age, Continuous Caregivers | 58.2 years STANDARD_DEVIATION 12.9 | 59.5 years STANDARD_DEVIATION 12.2 | 58.9 years STANDARD_DEVIATION 12.5 |
| Age, Continuous Patients | 82.8 years STANDARD_DEVIATION 8.03 | 82.5 years STANDARD_DEVIATION 7.78 | 82.6 years STANDARD_DEVIATION 7.89 |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 16 Participants | 18 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 205 Participants | 203 Participants | 408 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 13 Participants | 21 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 208 Participants | 200 Participants | 408 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Caregivers Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 53 Participants | 57 Participants | 110 Participants |
| Race (NIH/OMB) Caregivers More than one race | 2 Participants | 3 Participants | 5 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 | 13 Participants | 14 Participants | 27 Participants |
| Race (NIH/OMB) Caregivers White | 149 Participants | 144 Participants | 293 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Asian | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Patients Black or African American | 57 Participants | 55 Participants | 112 Participants |
| Race (NIH/OMB) Patients More than one race | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 9 Participants | 14 Participants | 23 Participants |
| Race (NIH/OMB) Patients White | 148 Participants | 146 Participants | 294 Participants |
| Region of Enrollment United States Caregivers | 221 Participants | 221 Participants | 442 Participants |
| Region of Enrollment United States Patients | 221 Participants | 221 Participants | 442 Participants |
| Sex: Female, Male Caregivers Female | 152 Participants | 154 Participants | 306 Participants |
| Sex: Female, Male Caregivers Male | 69 Participants | 67 Participants | 136 Participants |
| Sex: Female, Male Patients Female | 135 Participants | 137 Participants | 272 Participants |
| Sex: Female, Male Patients Male | 86 Participants | 84 Participants | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 41 / 221 | 0 / 221 | 40 / 221 | 0 / 221 |
| other Total, other adverse events | 0 / 221 | 24 / 221 | 0 / 221 | 40 / 221 |
| serious Total, serious adverse events | 0 / 221 | 0 / 221 | 0 / 221 | 0 / 221 |
Outcome results
Primary
Incidence of Hospital Transfers (Patients)
Number of hospital transfers (number of emergency room visits + number of hospital admissions )/(person-days of follow-up) within 60 days after discharge from the index hospitalization.
Time frame: 60 days post index hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: ADRD-PC Program | Incidence of Hospital Transfers (Patients) | 0.99 events per person day at risk |
| Control Condition | Incidence of Hospital Transfers (Patients) | 1.12 events per person day at risk |
p-value: 0.522Poisson regression
Secondary
Access to Community-based Palliative Care (Patients)
Percent of people with ADRD who access community-based palliative care services
Time frame: 60 days post hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: ADRD-PC Program | Access to Community-based Palliative Care (Patients) | 12.7 percentage of participants |
| Control Condition | Access to Community-based Palliative Care (Patients) | 5.9 percentage of participants |
p-value: 0.01Chi-squared
Secondary
Access to Hospice (Patients)
Percent of people with ADRD who access hospice services.
Time frame: 60 days post hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: ADRD-PC Program | Access to Hospice (Patients) | 17.2 percentage of participants |
| Control Condition | Access to Hospice (Patients) | 17.6 percentage of participants |
p-value: 0.977Chi-squared
Secondary
Caregiver Burden (Caregiver)
Zarit Burden scale, short form - 6 items, Likert (1=never to 5=Nearly Always), range 0-24 with higher scores indicating more caregiver burden.
Time frame: 60 days post hospital discharge
Population: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Condition: ADRD-PC Program | Caregiver Burden (Caregiver) | 7.52 score on a scale | Standard Deviation 5.44 |
| Control Condition | Caregiver Burden (Caregiver) | 7.44 score on a scale | Standard Deviation 5.19 |
p-value: 0.876t-test, 2 sided
Secondary
Caregiver Distress Score (Caregivers)
Family Distress in Advanced Dementia scale - 21 item Likert scale (1=Never to 5=Always) ranges from 21 to 105 with higher scores indicating more distress.
Time frame: 60 days post hospital discharge
Population: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Condition: ADRD-PC Program | Caregiver Distress Score (Caregivers) | 48.5 score on a scale | Standard Deviation 14 |
| Control Condition | Caregiver Distress Score (Caregivers) | 52.3 score on a scale | Standard Deviation 15.4 |
p-value: 0.012t-test, 2 sided
Secondary
Documented Discussion of Dementia Prognosis (Patients)
Percent of patients with documented discussion of dementia prognosis in their medical record.
Time frame: 60 days post hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: ADRD-PC Program | Documented Discussion of Dementia Prognosis (Patients) | 80.1 percentage of participants |
| Control Condition | Documented Discussion of Dementia Prognosis (Patients) | 14.9 percentage of participants |
p-value: <0.001Chi-squared
Secondary
Documented Discussion of Goals of Care (Patients)
Percent of patients with documented discussion of overall goals of care.
Time frame: 60 days post hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: ADRD-PC Program | Documented Discussion of Goals of Care (Patients) | 86.9 percentage of participants |
| Control Condition | Documented Discussion of Goals of Care (Patients) | 44.8 percentage of participants |
p-value: <0.001Chi-squared
Secondary
Shared Decision-making - Burdensome Treatment (Patients)
Percent of patients whose caregivers reported shared decision-making about resuscitation, ventilator use, tube feeding, antibiotics for infection treatment.
Time frame: 60 days post hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: ADRD-PC Program | Shared Decision-making - Burdensome Treatment (Patients) | 38.5 percentage of participants |
| Control Condition | Shared Decision-making - Burdensome Treatment (Patients) | 42.1 percentage of participants |
p-value: 0.531Chi-squared
Secondary
Shared Decision-making - Hospitalization (Patients)
Percent of patients whose caregivers reported shared decision-making discussions with a healthcare provider about future hospitalization for the patient.
Time frame: 60 days post hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: ADRD-PC Program | Shared Decision-making - Hospitalization (Patients) | 21.7 percentage of participants |
| Control Condition | Shared Decision-making - Hospitalization (Patients) | 25.8 percentage of participants |
p-value: 0.417Chi-squared
Secondary
Symptom Control for Neuropsychiatric Symptoms-Distress (Patients)
Neuropsychiatric Inventory Questionnaire (NPI-Q) Distress - 12 items, if the symptom was reported as present the caregiver rated the level of distress they experienced related tot he patient's symptom from 0 (not distressing) to 5 (extremely distressing). This subscale ranges from 0-60, with higher scores indicating more caregiver distress.
Time frame: 60 days post hospital discharge
Population: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Condition: ADRD-PC Program | Symptom Control for Neuropsychiatric Symptoms-Distress (Patients) | 24.9 score on a scale | Standard Deviation 13.7 |
| Control Condition | Symptom Control for Neuropsychiatric Symptoms-Distress (Patients) | 27.7 score on a scale | Standard Deviation 13.8 |
p-value: 0.045t-test, 2 sided
Secondary
Symptom Control for Neuropsychiatric Symptoms-Severity (Patients)
Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity Score - 12 items, each symptom reported as present is rated from 1 (mild) to 3 (severe). The range in this subscale is 0-36 with higher scores indicating worse symptom control.
Time frame: 60 days post hospital discharge
Population: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Condition: ADRD-PC Program | Symptom Control for Neuropsychiatric Symptoms-Severity (Patients) | 21.6 score on a scale | Standard Deviation 5.83 |
| Control Condition | Symptom Control for Neuropsychiatric Symptoms-Severity (Patients) | 21.8 score on a scale | Standard Deviation 5.87 |
p-value: 0.803t-test, 2 sided
Secondary
Symptom Control for Physical Symptoms (Patients)
Symptom Management at the End of Life in Dementia (SM-EOLD) - Likert scale, 9 items each scored 0-5, range of 0-45 with higher scores indicating greater symptoms.
Time frame: 60 days post hospital discharge
Population: Caregivers who skipped questions or did not complete the post hospital discharge follow-up interview are not included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Condition: ADRD-PC Program | Symptom Control for Physical Symptoms (Patients) | 21.0 score on a scale | Standard Deviation 9.08 |
| Control Condition | Symptom Control for Physical Symptoms (Patients) | 21.8 score on a scale | Standard Deviation 9.25 |
p-value: 0.402t-test, 2 sided
Secondary
Symptom Treatment (Patients)
Palliative Care Domain Index items - 10 items scored present vs absent, scored ranging 0-10 with higher scores indicating increased symptom treatment
Time frame: 60 days post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Condition: ADRD-PC Program | Symptom Treatment (Patients) | 8.06 score on a scale | Standard Deviation 2.14 |
| Control Condition | Symptom Treatment (Patients) | 6.49 score on a scale | Standard Deviation 2.27 |
p-value: <0.001t-test, 2 sided
Secondary
Transition to Nursing Home Level of Care (Patients)
Percent of people with ADRD who transition to nursing home care
Time frame: 60 days post hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Condition: ADRD-PC Program | Transition to Nursing Home Level of Care (Patients) | 35.7 percentage of participants |
| Control Condition | Transition to Nursing Home Level of Care (Patients) | 36.7 percentage of participants |
p-value: 0.935Chi-squared