N/A
Completed N=328
Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA
Source: ClinicalTrials.gov NCT01532986 ↗Enrolled (actual)
328
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Proportion of Measures Adhered To in the PD Guidelines — 0.77; 0.58 proportion of quality measures followed — p=>0.05
Summary
Health care benefits and services are received through the Veterans Health Administration (VHA), a component of the United States Department of Veterans Affairs. Over 40,000 Veterans across the Veterans Health Administration are diagnosed with Parkinson's disease (PD), a chronic condition that affects motor function as well as cognition, mood, sleep, and autonomic function. There are not enough subspecialists to manage every Veteran with Parkinson's disease. However, a care model of nurse care managers as catalysts and advocates using needs assessments, evidence-based protocols, and VHA and community access coordination mechanisms to optimize Parkinson's disease care may improve quality of Parkinson's disease care and patient-centered outcomes. If efficacious, this model may be practical to disseminate via an existing VHA national consortium network for Parkinson's disease.
Objectives are (1) to implement then analyze via a randomized controlled trial whether a nurse-led, coordinated care management intervention, Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS), compared to usual care will improve adherence to evidence-based practice guidelines and improve health outcomes in Veterans with Parkinson's disease in a region of the southwest United States, and (2) to analyze extent of implementation of the CHAPS intervention and its costs to determine how the intervention can be made sustainable and disseminated throughout Veterans Affairs Medical Centers if efficacious.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Measures Adhered To in the PD Guidelines |
0.77; 0.58 | >0.05 |
| SECONDARY Health Utilities Index (HUI3) |
0.48; 0.43; 0.46; 0.44; 0.44; 0.42 | >0.05 |
| SECONDARY Activities of Daily Living (ADL), (Speech and Swallowing Only) |
4.44; 4.68; 4.48; 4.75; 4.96; 5.06 | >0.05 |
| SECONDARY Medical Outcomes Study (MOS) |
3.91; 4.07; 3.93; 3.91; 3.91; 4.00 | >0.05 |
| SECONDARY General Self-Efficacy Scale (GSES) |
33.97; 34.17; 34.74; 34.34; 35.07; 34.38 | >0.05 |
| SECONDARY Consumer Assessment of Healthcare Providers and Systems (CAHPS) |
58.72; 53.42; 60.18; 55.34; 58.25; 54.16 | >0.05 |
| SECONDARY Patient Assessement of Care for Chronic Conditions (PACIC) |
2.34; 2.15; 2.28; 2.16; 2.32; 2.28 | >0.05 |
| SECONDARY World Health Organization Well-Being Index (WHO-5) |
14.19; 13.14; 15.02; 13.93; 14.20; 13.38 | >0.05 |
| SECONDARY Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 |
13; 22; 15; 13; 11; 16 | <0.05 sig |
| SECONDARY Patient Healthcare Questionnaire-9 (PHQ-9) |
12.33; 14.45; 12.96; 13.22; 12.44; 12.97 | >0.05 |
Eligibility Criteria
Inclusion Criteria
- Veteran of the United States of America
- Receiving health care at one of five Veterans Health Administration medical centers in the southwest United States: Greater Los Angeles, Loma Linda, Long Beach, or San Diego, California, or Las Vegas, Nevada.
- Diagnosis of Parkinson's disease (PD)
- At least two ICD-9 diagnostic codes for PD (332.0) in the administrative data from October 1, 2010 - to present date or until recruitment target is met
- At least 18 years of age
- Must demonstrate capacity to provide consent for study participation.
Exclusion Criteria
- Any Veteran who is a study subject in the Deep Brain Stimulation (DBS) VA cooperative study as these subjects are not to enroll in any other study per DBS study protocol.
Data sourced from ClinicalTrials.gov (NCT01532986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.