An interventional study of Specialty Palliative Care in Alzheimer Disease and Dementia, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-01-08.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Supportive care
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.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 62 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Specialty Palliative Care
Usual 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.
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
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
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
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
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
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
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
March 2016 to August 2017 enrolled dyads of hospitalized patients with late-stage dementia and family decision-makers.
| Milestone | Specialty Palliative Care | Control |
|---|---|---|
| Started | 30 | 32 |
| Completed | 26 | 31 |
| Not completed | 4 | 1 |
Includes emergency department visits and hospital admissions during measure interval
| events per day | Specialty Palliative Care | Control |
|---|---|---|
| Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) | .68 | .53 |
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.
| score on a scale | Specialty Palliative Care | Control |
|---|---|---|
| Patient Comfort End of Life in Dementia (CAD-EOLD) | 34.8 ± 4.2 | 34.0 ± 4.1 |
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.
| score on a scale | Specialty Palliative Care | Control |
|---|---|---|
| Caregiver Strain | 2.3 ± 0.5 | 2.4 ± 0.5 |
Percent of patients with referral to hospice or outpatient palliative care from discharge to 60 days follow-up from family interviews.
| percentage of patients | Specialty Palliative Care | Control |
|---|---|---|
| Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up | 25 | 3 |
Percent of participants with POLST (Physician Orders for Life Sustaining Treatment) form completed and signed
| percentage of participants | Specialty Palliative Care | Control |
|---|---|---|
| Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST) | 79 | 30 |
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.
| units on a scale | Specialty Palliative Care | Control |
|---|---|---|
| Number of Palliative Care Domains in Treatment Plan | 7.6 ± 2.5 | 2.7 ± 1.7 |
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.
| Participants | Specialty Palliative Care | Control |
|---|---|---|
| Number of Participants With Burdensome Treatments | 9 | 8 |
Collected over 60 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Specialty Palliative Care | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Control | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | Specialty Palliative Care | Control | Total |
|---|---|---|---|
| Mean | 83.0 ± 8.8 | 84.7 ± 8.7 | 83.9 ± 8.7 |
| Sex: Female, Male(Participants) | Specialty Palliative Care | Control | Total |
|---|---|---|---|
| Female | 20 | 15 | 35 |
| Male | 10 | 17 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Specialty Palliative Care | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 29 | 30 | 59 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Specialty Palliative Care | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 7 | 15 |
| White | 21 | 23 | 44 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Specialty Palliative Care | Control | Total |
|---|---|---|---|
| United States | 30 | 32 | 62 |
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Plan to share: Undecided — Data sharing plan not written
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University of North Carolina, Chapel Hill