Trial Outcomes & Findings for Triggered Palliative Care for Advanced Dementia (NCT NCT02719938)
NCT ID: NCT02719938
Last Updated: 2019-01-08
Results Overview
Includes emergency department visits and hospital admissions during measure interval
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
From time of hospital discharge up to 60 days
Results posted on
2019-01-08
Participant Flow
March 2016 to August 2017 enrolled dyads of hospitalized patients with late-stage dementia and family decision-makers.
Participant milestones
| Measure |
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.
|
Control
Usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
|
Overall Study
COMPLETED
|
26
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Triggered Palliative Care for Advanced Dementia
Baseline characteristics by cohort
| Measure |
Specialty Palliative Care
n=30 Participants
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.
|
Control
n=32 Participants
Usual care.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
83.0 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
84.7 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
83.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From time of hospital discharge up to 60 daysIncludes emergency department visits and hospital admissions during measure interval
Outcome measures
| Measure |
Specialty Palliative Care
n=30 Participants
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.
|
Control
n=32 Participants
Usual care.
|
|---|---|---|
|
Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days)
|
.68 events per day
|
.53 events per day
|
SECONDARY outcome
Timeframe: 60 daysComfort 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.
Outcome measures
| Measure |
Specialty Palliative Care
n=30 Participants
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.
|
Control
n=32 Participants
Usual care.
|
|---|---|---|
|
Patient Comfort End of Life in Dementia (CAD-EOLD)
|
34.8 score on a scale
Standard Deviation 4.2
|
34.0 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Interview at 60 days after hospitalizationFamily 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.
Outcome measures
| Measure |
Specialty Palliative Care
n=30 Participants
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.
|
Control
n=32 Participants
Usual care.
|
|---|---|---|
|
Caregiver Strain
|
2.3 score on a scale
Standard Deviation 0.5
|
2.4 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: From time of hospital discharge up to 60 daysPercent of patients with referral to hospice or outpatient palliative care from discharge to 60 days follow-up from family interviews.
Outcome measures
| Measure |
Specialty Palliative Care
n=30 Participants
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.
|
Control
n=32 Participants
Usual care.
|
|---|---|---|
|
Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up
|
25 percentage of patients
|
3 percentage of patients
|
SECONDARY outcome
Timeframe: From time of hospital discharge up to 60 daysPercent of participants with POLST (Physician Orders for Life Sustaining Treatment) form completed and signed
Outcome measures
| Measure |
Specialty Palliative Care
n=30 Participants
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.
|
Control
n=32 Participants
Usual care.
|
|---|---|---|
|
Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST)
|
79 percentage of participants
|
30 percentage of participants
|
SECONDARY outcome
Timeframe: From time of hospital discharge up to 60 daysNumber 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.
Outcome measures
| Measure |
Specialty Palliative Care
n=30 Participants
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.
|
Control
n=32 Participants
Usual care.
|
|---|---|---|
|
Number of Palliative Care Domains in Treatment Plan
|
7.6 units on a scale
Standard Deviation 2.5
|
2.7 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: From time of hospital discharge up to 60 daysNumber 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.
Outcome measures
| Measure |
Specialty Palliative Care
n=30 Participants
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.
|
Control
n=32 Participants
Usual care.
|
|---|---|---|
|
Number of Participants With Burdensome Treatments
|
9 Participants
|
8 Participants
|
Adverse Events
Specialty Palliative Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Laura C. Hanson, MD, MPH
University of North Carolina at Chapel Hill
Phone: 919-843-4096
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place