Trial Outcomes & Findings for Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA (NCT NCT01532986)
NCT ID: NCT01532986
Last Updated: 2019-03-08
Results Overview
Adherence to quality measures for Parkinson's disease care during study period. We operationalized 18 quality measures: 12 were determined through chart review, and 6 were measured using patient survey data. Range and direction of score: 0 (worst) to 1 (best)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
345 participants
Primary outcome timeframe
18 months
Results posted on
2019-03-08
Participant Flow
345 participants enrolled in the study. Subjects were identified by a treating provider while receiving care at 5 Veterans Administration health systems.
13 removed before baseline survey. 4 were ineligible due to not having Parkinson's disease. This left 328 who were randomized
Participant milestones
| Measure |
Usual Care (Arm 1)
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
162
|
|
Overall Study
COMPLETED
|
143
|
138
|
|
Overall Study
NOT COMPLETED
|
23
|
24
|
Reasons for withdrawal
| Measure |
Usual Care (Arm 1)
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Overall Study
Death
|
9
|
9
|
|
Overall Study
Withdrawal by Subject
|
7
|
10
|
|
Overall Study
Physician Decision
|
7
|
5
|
Baseline Characteristics
Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA
Baseline characteristics by cohort
| Measure |
Usual Care (Arm 1)
n=166 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American/Black
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American-Indian/Alaskan Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
131 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsAdherence to quality measures for Parkinson's disease care during study period. We operationalized 18 quality measures: 12 were determined through chart review, and 6 were measured using patient survey data. Range and direction of score: 0 (worst) to 1 (best)
Outcome measures
| Measure |
Usual Care (Arm 1)
n=166 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Proportion of Measures Adhered To in the PD Guidelines
|
0.77 proportion of quality measures followed
Standard Deviation 0.16
|
0.58 proportion of quality measures followed
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: 18 monthsData collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: -0.36 (worst) to 1 (best)
Outcome measures
| Measure |
Usual Care (Arm 1)
n=166 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Health Utilities Index (HUI3)
Baseline
|
0.48 units on a scale
Standard Deviation 0.3
|
0.43 units on a scale
Standard Deviation 0.3
|
|
Health Utilities Index (HUI3)
12 months
|
0.44 units on a scale
Standard Deviation 0.3
|
0.42 units on a scale
Standard Deviation 0.3
|
|
Health Utilities Index (HUI3)
6 months
|
0.46 units on a scale
Standard Deviation 0.3
|
0.44 units on a scale
Standard Deviation 0.3
|
|
Health Utilities Index (HUI3)
18 months (final)
|
0.40 units on a scale
Standard Deviation 0.3
|
0.40 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 18 monthsData collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 0 (best) to 16 (worst)
Outcome measures
| Measure |
Usual Care (Arm 1)
n=166 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Activities of Daily Living (ADL), (Speech and Swallowing Only)
Baseline
|
4.44 units on a scale
Standard Deviation 2.9
|
4.68 units on a scale
Standard Deviation 3.1
|
|
Activities of Daily Living (ADL), (Speech and Swallowing Only)
6 months
|
4.48 units on a scale
Standard Deviation 3.0
|
4.75 units on a scale
Standard Deviation 3.1
|
|
Activities of Daily Living (ADL), (Speech and Swallowing Only)
12 months
|
4.96 units on a scale
Standard Deviation 3.2
|
5.06 units on a scale
Standard Deviation 3.1
|
|
Activities of Daily Living (ADL), (Speech and Swallowing Only)
18 months (final)
|
5.02 units on a scale
Standard Deviation 3.3
|
5.35 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 18 monthsData collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 1 (worst) to 5 (best)
Outcome measures
| Measure |
Usual Care (Arm 1)
n=166 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Medical Outcomes Study (MOS)
Baseline
|
3.91 units on a scale
Standard Error 0.9
|
4.07 units on a scale
Standard Error 0.8
|
|
Medical Outcomes Study (MOS)
6 months
|
3.93 units on a scale
Standard Error 0.9
|
3.91 units on a scale
Standard Error 0.8
|
|
Medical Outcomes Study (MOS)
12 months
|
3.91 units on a scale
Standard Error 0.9
|
4.00 units on a scale
Standard Error 0.8
|
|
Medical Outcomes Study (MOS)
18 months (final)
|
3.94 units on a scale
Standard Error 0.9
|
4.03 units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 18 monthsData collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 10 (worst) to 40 (best)
Outcome measures
| Measure |
Usual Care (Arm 1)
n=166 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
General Self-Efficacy Scale (GSES)
Baseline
|
33.97 units on a scale
Standard Error 5.1
|
34.17 units on a scale
Standard Error 5.5
|
|
General Self-Efficacy Scale (GSES)
6 months
|
34.74 units on a scale
Standard Error 4.9
|
34.34 units on a scale
Standard Error 5.6
|
|
General Self-Efficacy Scale (GSES)
12 months
|
35.07 units on a scale
Standard Error 5.1
|
34.38 units on a scale
Standard Error 5.7
|
|
General Self-Efficacy Scale (GSES)
18 months (final)
|
35.1 units on a scale
Standard Error 5.1
|
34.04 units on a scale
Standard Error 5.9
|
SECONDARY outcome
Timeframe: 18 monthsData collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 0 (worst) to 100 (best)
Outcome measures
| Measure |
Usual Care (Arm 1)
n=166 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Baseline
|
58.72 units on a scale
Standard Error 33.4
|
53.42 units on a scale
Standard Error 34.9
|
|
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
6 months
|
60.18 units on a scale
Standard Error 32.6
|
55.34 units on a scale
Standard Error 33.6
|
|
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
12 months
|
58.25 units on a scale
Standard Error 34.2
|
54.16 units on a scale
Standard Error 34.5
|
|
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
18 months (final)
|
58.55 units on a scale
Standard Error 33.6
|
53.66 units on a scale
Standard Error 35.0
|
SECONDARY outcome
Timeframe: 18 monthsData collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 1 (worst) to 5 (best)
Outcome measures
| Measure |
Usual Care (Arm 1)
n=166 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Patient Assessement of Care for Chronic Conditions (PACIC)
6 months
|
2.28 units on a scale
Standard Error 0.8
|
2.16 units on a scale
Standard Error 0.7
|
|
Patient Assessement of Care for Chronic Conditions (PACIC)
Baselin
|
2.34 units on a scale
Standard Error 0.9
|
2.15 units on a scale
Standard Error 0.8
|
|
Patient Assessement of Care for Chronic Conditions (PACIC)
12 months
|
2.32 units on a scale
Standard Error 0.8
|
2.28 units on a scale
Standard Error 0.8
|
|
Patient Assessement of Care for Chronic Conditions (PACIC)
18 months (final)
|
2.37 units on a scale
Standard Error 0.8
|
2.30 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: 18 monthsData collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Range and direction of score: 1 (worst) to 25 (best)
Outcome measures
| Measure |
Usual Care (Arm 1)
n=166 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
World Health Organization Well-Being Index (WHO-5)
Baseline
|
14.19 units on a scale
Standard Error 5.8
|
13.14 units on a scale
Standard Error 5.9
|
|
World Health Organization Well-Being Index (WHO-5)
6 months
|
15.02 units on a scale
Standard Error 5.7
|
13.93 units on a scale
Standard Error 5.9
|
|
World Health Organization Well-Being Index (WHO-5)
12 months
|
14.20 units on a scale
Standard Error 6.0
|
13.38 units on a scale
Standard Error 6.5
|
|
World Health Organization Well-Being Index (WHO-5)
18 months (final)
|
14.14 units on a scale
Standard Error 6.3
|
13.45 units on a scale
Standard Error 6.5
|
SECONDARY outcome
Timeframe: 18 monthsData collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. PHQ-2 score ranges from 0 to 4. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. Higher scores indicate detection of depressive symptoms
Outcome measures
| Measure |
Usual Care (Arm 1)
n=166 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=162 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3
18 months (final)
|
23 Participants
|
11 Participants
|
|
Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3
Baseline
|
13 Participants
|
22 Participants
|
|
Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3
6 months
|
15 Participants
|
13 Participants
|
|
Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3
12 months
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2. At baseline, this was only 13 persons in usual care and 22 persons in the intervention group
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward. Range and direction of score: 0 (best) to 27 (worst). Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points. PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2
Outcome measures
| Measure |
Usual Care (Arm 1)
n=13 Participants
Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
Intervention (Arm 2)
n=22 Participants
A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.
|
|---|---|---|
|
Patient Healthcare Questionnaire-9 (PHQ-9)
Baseline
|
12.33 units on a scale
Standard Error 4.4
|
14.45 units on a scale
Standard Error 3.9
|
|
Patient Healthcare Questionnaire-9 (PHQ-9)
6 months
|
12.96 units on a scale
Standard Error 4.8
|
13.22 units on a scale
Standard Error 4.2
|
|
Patient Healthcare Questionnaire-9 (PHQ-9)
12 months
|
12.44 units on a scale
Standard Error 4.2
|
12.97 units on a scale
Standard Error 3.6
|
|
Patient Healthcare Questionnaire-9 (PHQ-9)
18 months (final)
|
12.21 units on a scale
Standard Error 4.8
|
12.46 units on a scale
Standard Error 4.1
|
Adverse Events
Usual Care (Arm 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Intervention (Arm 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place