Alzheimer Disease, Dementia
Conditions
Brief summary
The objective of this study is to generate preliminary data for a large multi-site randomized clinical trial of a model of palliative care consultation for patients with advanced dementia, and for their family caregivers.
Detailed description
Alzheimer's disease and related dementias affect 5 million Americans at an annual cost of $215 billion. Dementia is a contributing cause for 1 in 3 deaths, and is the only major cause of death with no effective prevention or treatment. Dementia-specific palliative care is needed to address the unique symptoms and treatment decisions relevant to this disease. Investigators therefore propose to develop and pilot test a model of palliative care consultation for advanced dementia patients, triggered by hospitalization for a serious acute illness. After systematic refinement of operational protocols and tools with stakeholders, they will enroll persons with advanced dementia plus an acute illness associated with high risk of death in the coming year. Patients will be enrolled with their family decision-makers (N=60 dyads) in a randomized feasibility trial. Intervention dyads will receive specialty palliative care consultation during hospital admission, plus post-discharge collaborative care by their outpatient primary care provider and a palliative care nurse practitioner. Control dyads will receive usual care. The research objective is to generate preliminary data for a large multi-site randomized controlled trial of a model of palliative care consultation for advanced dementia. Specific aims are: Aim 1: To develop a best-practice model of palliative care consultation for advanced dementia triggered by hospital admission for serious acute illness. Aim 2: To conduct a pilot randomized trial of triggered palliative care consultation for advanced dementia (versus usual care) to demonstrate the feasibility of conducting a larger randomized trial.
Interventions
BEHAVIORALSpecialty Palliative Care
Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers.
Sponsors
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of dementia from Alzheimer's or other underlying cause * Global Deterioration Scale (GDS) Stage 5, 6 or 7 * acute illness hospitalization
Exclusion criteria
* No English-speaking family decision-maker * Primary physician expects study to be too stressful for family caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) | From time of hospital discharge up to 60 days | Includes emergency department visits and hospital admissions during measure interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort End of Life in Dementia (CAD-EOLD) | 60 days | Comfort at the End of Life in Dementia (CAD-EOLD) instrument, consisting of 14 Likert-scaled items measuring comfort in the final phase of life with dementia. Scores range from 14-42, with higher scores indicting greater comfort. |
| Caregiver Strain | Interview at 60 days after hospitalization | Family Distress in Advanced Dementia instrument, a 21 item questionnaire designed to detect strain in family caregivers in dementia. Caregivers are asked a series of items about emotional distress, preparedness, and relations with healthcare providers scored 1-5, with higher scores indicting greater distress. |
| Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up | From time of hospital discharge up to 60 days | Percent of patients with referral to hospice or outpatient palliative care from discharge to 60 days follow-up from family interviews. |
| Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST) | From time of hospital discharge up to 60 days | Percent of participants with POLST (Physician Orders for Life Sustaining Treatment) form completed and signed |
| Number of Palliative Care Domains in Treatment Plan | From time of hospital discharge up to 60 days | Number of palliative care domains addressed in treatment plan, using the Palliative Care Domain score which is scored 0 (not addressed) or 1 (addressed) for each of 10 possible domains of a palliative care treatment plan -- prognosis, overall goals of care, physical symptoms, psychiatric symptoms, spiritual needs, and 5 treatment preferences: resuscitation, artificial feeding, intravenous fluids, antibiotics, and hospitalization. Scores are summed for a total possible score of 0-10, with higher scores indicating greater attention to palliative care needs in the treatment plan. |
| Number of Participants With Burdensome Treatments | From time of hospital discharge up to 60 days | Number of participants with burdensome treatments, defined as a count of participants with any use of the following treatments: feeding tube, central intravenous line, surgical procedure, intensive care transfer, ventilator use, cardiopulmonary resuscitation use at any time during the time frame of measurement. |
Countries
United States
Participant flow
Recruitment details
March 2016 to August 2017 enrolled dyads of hospitalized patients with late-stage dementia and family decision-makers.
Participants by arm
| Arm | Count |
|---|---|
| Specialty Palliative Care Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers.
Specialty Palliative Care: Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers. | 30 |
| Control Usual care. | 32 |
| Total | 62 |
Baseline characteristics
| Characteristic | Specialty Palliative Care | Total | Control |
|---|---|---|---|
| Age, Continuous | 83.0 years STANDARD_DEVIATION 8.8 | 83.9 years STANDARD_DEVIATION 8.7 | 84.7 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 59 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 15 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 44 Participants | 23 Participants |
| Region of Enrollment United States | 30 Participants | 62 Participants | 32 Participants |
| Sex: Female, Male Female | 20 Participants | 35 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 27 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 32 |
| other Total, other adverse events | 0 / 30 | 0 / 32 |
| serious Total, serious adverse events | 0 / 30 | 0 / 32 |
Outcome results
Primary
Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days)
Includes emergency department visits and hospital admissions during measure interval
Time frame: From time of hospital discharge up to 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Specialty Palliative Care | Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) | .68 events per day |
| Control | Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) | .53 events per day |
p-value: 0.415t-test, 2 sided
Secondary
Caregiver Strain
Family Distress in Advanced Dementia instrument, a 21 item questionnaire designed to detect strain in family caregivers in dementia. Caregivers are asked a series of items about emotional distress, preparedness, and relations with healthcare providers scored 1-5, with higher scores indicting greater distress.
Time frame: Interview at 60 days after hospitalization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Specialty Palliative Care | Caregiver Strain | 2.3 score on a scale | Standard Deviation 0.5 |
| Control | Caregiver Strain | 2.4 score on a scale | Standard Deviation 0.5 |
p-value: 0.409t-test, 2 sided
Secondary
Number of Palliative Care Domains in Treatment Plan
Number of palliative care domains addressed in treatment plan, using the Palliative Care Domain score which is scored 0 (not addressed) or 1 (addressed) for each of 10 possible domains of a palliative care treatment plan -- prognosis, overall goals of care, physical symptoms, psychiatric symptoms, spiritual needs, and 5 treatment preferences: resuscitation, artificial feeding, intravenous fluids, antibiotics, and hospitalization. Scores are summed for a total possible score of 0-10, with higher scores indicating greater attention to palliative care needs in the treatment plan.
Time frame: From time of hospital discharge up to 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Specialty Palliative Care | Number of Palliative Care Domains in Treatment Plan | 7.6 units on a scale | Standard Deviation 2.5 |
| Control | Number of Palliative Care Domains in Treatment Plan | 2.7 units on a scale | Standard Deviation 1.7 |
p-value: <0.001t-test, 2 sided
Secondary
Number of Participants With Burdensome Treatments
Number of participants with burdensome treatments, defined as a count of participants with any use of the following treatments: feeding tube, central intravenous line, surgical procedure, intensive care transfer, ventilator use, cardiopulmonary resuscitation use at any time during the time frame of measurement.
Time frame: From time of hospital discharge up to 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Specialty Palliative Care | Number of Participants With Burdensome Treatments | 9 Participants |
| Control | Number of Participants With Burdensome Treatments | 8 Participants |
p-value: 0.516t-test, 2 sided
Secondary
Patient Comfort End of Life in Dementia (CAD-EOLD)
Comfort at the End of Life in Dementia (CAD-EOLD) instrument, consisting of 14 Likert-scaled items measuring comfort in the final phase of life with dementia. Scores range from 14-42, with higher scores indicting greater comfort.
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Specialty Palliative Care | Patient Comfort End of Life in Dementia (CAD-EOLD) | 34.8 score on a scale | Standard Deviation 4.2 |
| Control | Patient Comfort End of Life in Dementia (CAD-EOLD) | 34.0 score on a scale | Standard Deviation 4.1 |
p-value: 0.521t-test, 2 sided
Secondary
Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST)
Percent of participants with POLST (Physician Orders for Life Sustaining Treatment) form completed and signed
Time frame: From time of hospital discharge up to 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Specialty Palliative Care | Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST) | 79 percentage of participants |
| Control | Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST) | 30 percentage of participants |
p-value: <0.001Chi-squared
Secondary
Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up
Percent of patients with referral to hospice or outpatient palliative care from discharge to 60 days follow-up from family interviews.
Time frame: From time of hospital discharge up to 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Specialty Palliative Care | Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up | 25 percentage of patients |
| Control | Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up | 3 percentage of patients |
p-value: 0.019Chi-squared