Trial Outcomes & Findings for Does Outpatient Palliative Care Improve Patient-centered Outcomes in Parkinson's Disease? (NCT NCT02533921)
NCT ID: NCT02533921
Last Updated: 2020-01-31
Results Overview
The Zarit Caregiver Burden Interview Form (ZBI) will be used to measure differences in Caregiver Distress between groups. Higher scores indicate worse outcomes. Scale ranges from 0 to 48.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
210 participants
Primary outcome timeframe
0 to 6 months
Results posted on
2020-01-31
Participant Flow
Participant milestones
| Measure |
Standard of Care
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
106
|
|
Overall Study
COMPLETED
|
88
|
95
|
|
Overall Study
NOT COMPLETED
|
16
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data was missing for one person.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=104 Participants
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
n=106 Participants
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=103 Participants • Age data was missing for one person.
|
0 Participants
n=106 Participants • Age data was missing for one person.
|
0 Participants
n=209 Participants • Age data was missing for one person.
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=103 Participants • Age data was missing for one person.
|
26 Participants
n=106 Participants • Age data was missing for one person.
|
45 Participants
n=209 Participants • Age data was missing for one person.
|
|
Age, Categorical
>=65 years
|
84 Participants
n=103 Participants • Age data was missing for one person.
|
80 Participants
n=106 Participants • Age data was missing for one person.
|
164 Participants
n=209 Participants • Age data was missing for one person.
|
|
Age, Continuous
|
70.71 years
STANDARD_DEVIATION 8.04 • n=103 Participants • Age data were not available for one participant in the "Standard of Care" Arm
|
69.52 years
STANDARD_DEVIATION 8.25 • n=106 Participants • Age data were not available for one participant in the "Standard of Care" Arm
|
70.11 years
STANDARD_DEVIATION 8.15 • n=209 Participants • Age data were not available for one participant in the "Standard of Care" Arm
|
|
Sex: Female, Male
Female
|
34 Participants
n=104 Participants
|
41 Participants
n=106 Participants
|
75 Participants
n=210 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=104 Participants
|
65 Participants
n=106 Participants
|
135 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=104 Participants
|
3 Participants
n=106 Participants
|
6 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=104 Participants
|
103 Participants
n=106 Participants
|
203 Participants
n=210 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=104 Participants
|
0 Participants
n=106 Participants
|
1 Participants
n=210 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=104 Participants
|
0 Participants
n=106 Participants
|
1 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=104 Participants
|
2 Participants
n=106 Participants
|
6 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=104 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=104 Participants
|
1 Participants
n=106 Participants
|
3 Participants
n=210 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=104 Participants
|
100 Participants
n=106 Participants
|
193 Participants
n=210 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=104 Participants
|
0 Participants
n=106 Participants
|
2 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=104 Participants
|
3 Participants
n=106 Participants
|
5 Participants
n=210 Participants
|
|
Region of Enrollment
Canada
|
33 participants
n=104 Participants
|
34 participants
n=106 Participants
|
67 participants
n=210 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=104 Participants
|
72 participants
n=106 Participants
|
143 participants
n=210 Participants
|
|
Presence of Dementia
|
30 Participants
n=104 Participants
|
30 Participants
n=106 Participants
|
60 Participants
n=210 Participants
|
|
Presence of Caregiver
|
88 Participants
n=104 Participants
|
87 Participants
n=106 Participants
|
175 Participants
n=210 Participants
|
|
Disease Duration
|
114.34 months
STANDARD_DEVIATION 79.17 • n=104 Participants
|
116.48 months
STANDARD_DEVIATION 83.70 • n=106 Participants
|
115.42 months
STANDARD_DEVIATION 81.31 • n=210 Participants
|
|
Quality of Life AD (QOL-AD)
|
34.29 units on a scale
STANDARD_DEVIATION 5.60 • n=104 Participants
|
33.89 units on a scale
STANDARD_DEVIATION 5.69 • n=106 Participants
|
34.09 units on a scale
STANDARD_DEVIATION 5.64 • n=210 Participants
|
|
Zarit Burden of Care (ZBI)
|
31.27 units on a scale
STANDARD_DEVIATION 8.06 • n=104 Participants
|
32.33 units on a scale
STANDARD_DEVIATION 8.19 • n=106 Participants
|
31.80 units on a scale
STANDARD_DEVIATION 8.12 • n=210 Participants
|
|
Hospital Anxiety and Depression Scale (HADS) - Patient Anxiety
|
7.73 units on a scale
STANDARD_DEVIATION 4.43 • n=104 Participants
|
7.57 units on a scale
STANDARD_DEVIATION 3.78 • n=106 Participants
|
7.65 units on a scale
STANDARD_DEVIATION 4.11 • n=210 Participants
|
|
Hospital Anxiety and Depression Scale (HADS) - Patient Depression
|
7.23 units on a scale
STANDARD_DEVIATION 3.74 • n=104 Participants
|
7.04 units on a scale
STANDARD_DEVIATION 3.55 • n=106 Participants
|
7.13 units on a scale
STANDARD_DEVIATION 3.64 • n=210 Participants
|
|
Hospital Anxiety and Depression Scale (HADS) - Caregiver Anxiety
|
7.72 units on a scale
STANDARD_DEVIATION 3.57 • n=104 Participants
|
7.14 units on a scale
STANDARD_DEVIATION 3.58 • n=106 Participants
|
7.43 units on a scale
STANDARD_DEVIATION 3.58 • n=210 Participants
|
|
Hospital Anxiety and Depression Scale (HADS) - Caregiver Depression
|
4.09 units on a scale
STANDARD_DEVIATION 2.79 • n=104 Participants
|
4.50 units on a scale
STANDARD_DEVIATION 3.34 • n=106 Participants
|
4.30 units on a scale
STANDARD_DEVIATION 3.07 • n=210 Participants
|
|
Montreal Cognitive Assessment (MoCA) Test for Dementia
|
23.66 units on a scale
STANDARD_DEVIATION 5.08 • n=104 Participants
|
23.96 units on a scale
STANDARD_DEVIATION 4.83 • n=106 Participants
|
23.81 units on a scale
STANDARD_DEVIATION 4.95 • n=210 Participants
|
|
Hoehn and Yar
1
|
0 Participants
n=104 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=210 Participants
|
|
Hoehn and Yar
1.5
|
0 Participants
n=104 Participants
|
2 Participants
n=106 Participants
|
2 Participants
n=210 Participants
|
|
Hoehn and Yar
2
|
34 Participants
n=104 Participants
|
25 Participants
n=106 Participants
|
59 Participants
n=210 Participants
|
|
Hoehn and Yar
2.5
|
30 Participants
n=104 Participants
|
24 Participants
n=106 Participants
|
54 Participants
n=210 Participants
|
|
Hoehn and Yar
3
|
15 Participants
n=104 Participants
|
25 Participants
n=106 Participants
|
40 Participants
n=210 Participants
|
|
Hoehn and Yar
4
|
12 Participants
n=104 Participants
|
14 Participants
n=106 Participants
|
26 Participants
n=210 Participants
|
|
Hoehn and Yar
5
|
9 Participants
n=104 Participants
|
14 Participants
n=106 Participants
|
23 Participants
n=210 Participants
|
|
Hoehn and Yar
Missing
|
4 Participants
n=104 Participants
|
2 Participants
n=106 Participants
|
6 Participants
n=210 Participants
|
PRIMARY outcome
Timeframe: 0 to 6 monthsPopulation: Available case data for for QOL AD. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.
The QOL-AD (Quality of Life in Alzheimer's Disease) survey will be used to measure the differences in the quality of life between groups.Higher numbers indicate better outcomes. The scale ranges from 4 to 52.
Outcome measures
| Measure |
Standard of Care
n=103 Participants
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
n=105 Participants
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
|---|---|---|
|
Changes in the Subjects Quality of Life (QOL)
|
-0.8446 score on a scale
Interval -1.6807 to -0.0085
|
0.6576 score on a scale
Interval -0.4299 to 1.7451
|
PRIMARY outcome
Timeframe: 0 to 6 monthsPopulation: Available case data for for ZBI. Applicable only when a caregiver is present. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.
The Zarit Caregiver Burden Interview Form (ZBI) will be used to measure differences in Caregiver Distress between groups. Higher scores indicate worse outcomes. Scale ranges from 0 to 48.
Outcome measures
| Measure |
Standard of Care
n=87 Participants
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
n=86 Participants
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
|---|---|---|
|
Changes in Caregiver Distress
|
-1.2031 score on a scale
Interval -2.47 to 0.06381
|
-2.3267 score on a scale
Interval -3.4618 to -1.1917
|
SECONDARY outcome
Timeframe: 0 to 6 monthsPopulation: Available case data for for HADS Anxiety. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.
The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21.
Outcome measures
| Measure |
Standard of Care
n=102 Participants
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
n=105 Participants
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
|---|---|---|
|
Changes in Patient Anxiety
|
-0.7318 score on a scale
Interval -1.3542 to -0.1094
|
-1.1933 score on a scale
Interval -1.7117 to -0.675
|
SECONDARY outcome
Timeframe: 0 to 6 monthsPopulation: Available case data for for HADS Depression. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.
The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21.
Outcome measures
| Measure |
Standard of Care
n=102 Participants
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
n=105 Participants
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
|---|---|---|
|
Changes in Patient Depression
|
-0.2041 score on a scale
Interval -0.725 to 0.3167
|
-0.3351 score on a scale
Interval -0.9676 to 0.2975
|
SECONDARY outcome
Timeframe: 0 to 6 monthsPopulation: Available case data for for HADS Anxiety for caregiver. Only applicable when a caregiver is present. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.
The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21.
Outcome measures
| Measure |
Standard of Care
n=88 Participants
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
n=86 Participants
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
|---|---|---|
|
Changes in Caregiver Anxiety
|
-0.5216 score on a scale
Interval -1.2056 to 0.1624
|
-1.2095 score on a scale
Interval -1.9032 to -0.5157
|
SECONDARY outcome
Timeframe: 0 to 6 monthsPopulation: Available case data for for HADS Anxiety for caregiver. Only applicable when a caregiver is present. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.
The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21.
Outcome measures
| Measure |
Standard of Care
n=88 Participants
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
n=86 Participants
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
|---|---|---|
|
Changes in Caregiver Depression
|
-0.1969 score on a scale
Interval -0.6847 to 0.291
|
-0.3576 score on a scale
Interval -0.9949 to 0.2797
|
Adverse Events
Standard of Care
Serious events: 1 serious events
Other events: 1 other events
Deaths: 2 deaths
Interdisciplinary Outpatient Palliative Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Standard of Care
n=104 participants at risk
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
n=106 participants at risk
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Left proximal humerus fracture
|
0.96%
1/104 • Number of events 1 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
0.00%
0/106 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
|
Injury, poisoning and procedural complications
Left femoral head fracture
|
0.96%
1/104 • Number of events 1 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
0.00%
0/106 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
Other adverse events
| Measure |
Standard of Care
n=104 participants at risk
Usual care as in including both a Primary Care Physician (PCP) and neurologist.
Standard of Care: Usual care defined as including both a PCP and neurologist
|
Interdisciplinary Outpatient Palliative Care
n=106 participants at risk
Usual care augmented by an outpatient interdisciplinary palliative care team.
Interdisciplinary outpatient palliative care: Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
|
|---|---|---|
|
Cardiac disorders
bradycardia
|
0.00%
0/104 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
0.94%
1/106 • Number of events 1 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
|
Respiratory, thoracic and mediastinal disorders
substernal pain/ DOE/SOB
|
0.96%
1/104 • Number of events 1 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
0.00%
0/106 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
|
Injury, poisoning and procedural complications
Facial fracture
|
0.00%
0/104 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
0.94%
1/106 • Number of events 1 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.00%
0/104 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
0.94%
1/106 • Number of events 1 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
|
Infections and infestations
Infection secondary to PEG tube insertion
|
0.00%
0/104 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
0.94%
1/106 • Number of events 1 • 1 year, or for as long as the patient was in the study if they discontinued early.
Coordinators asked patients about common adverse events, including falls and hospitalizations, at every study visit.
|
Additional Information
Benzi Kluger, MD, MS, Principal Investigator
University of Colorado
Phone: 303-724-2194
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place