Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA (CHAPS)
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| ClinicalTrials.gov Identifier: NCT01532986 |
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Recruitment Status :
Completed
First Posted : February 15, 2012
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease | Other: Coordinated care management for Parkinson's disease Other: Educational handout | Not Applicable |
In a 5-year randomized controlled trial, we enrolled 345 Veterans with PD that were then randomized in a 1:1 ratio to receive up to 24 months of a PD care management program, "Care Coordination for Health Promotion and Activities in Parkinson's Disease" (CHAPS), or continue with usual care. Eligible participants across 5 sites of the Southwest Parkinson's Disease Research, Education and Clinical Center (SW PADRECC): Greater Los Angeles, Las Vegas, Loma Linda, Long Beach and San Diego VISN 22 (VA Desert Pacific Healthcare Network) facilities were identified through administrative data and vetted by physicians. The multi-faceted nurse-led intervention, CHAPS, incorporated PD quality improvement (QI) tools to enhance proactive Veteran-centered care delivery. PDQI tools included: (1) a structured telephone assessment administered by a nurse care manager (NCM) to proactively identify medical problems and unmet needs; (2) problem-specific evidence-based interventions organized into treatment plans including follow-up/monitoring protocols with VA and community linkages; (3) the Siebens Domain Management ModelTM, a structural approach to improve collection and organization of health information and enrich communication among providers; (4) Siebens Health Care Notebooks prepared with Veteran self-management materials; (5) a Microsoft Access care management database, containing the CHAPS Assessment and algorithms for problem identification based on Veteran data; and (6) decision-support meetings of NCMs with movement disorder specialists. Research interviewers administer a structured telephone survey at baseline, 6, 12, 18, and 24 months. Participants were provided $25 per survey. Medical records were abstracted.
Ongoing analyses (1) measure PD quality indicator adherence, health outcomes, and health service utilization; (2) evaluate qualitative and quantitative data to summarize the extent of intervention implementation and barriers and facilitators to potential dissemination; and (3) examine costs of CHAPS care and cost offset between randomization arms to provide new knowledge to aid in future dissemination of the CHAPS Program in a "National Rollout" according to the VA Quality Enhancement Research Initiative QUERI process.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 345 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Health Services Research |
| Official Title: | Improving Quality of Care in Parkinson's Disease: A Randomized Controlled Trial |
| Actual Study Start Date : | July 9, 2012 |
| Actual Primary Completion Date : | January 31, 2017 |
| Actual Study Completion Date : | April 30, 2017 |
| Arm | Intervention/treatment |
|---|---|
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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. |
Other: Coordinated care management for Parkinson's disease
Nurse care managers will use standardized assessment tools and care coordination protocols to address unmet needs of Veterans with PD, and collaborate with these Veterans and their families, providers, and community partners to manage PD care. Other: Educational handout To minimize potential bias from participants' awareness of randomization arm assignment, the investigators will provide to all study participants (intervention arm and usual care arm) on enrollment a brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook (page 273). This information includes a definition of PD, its symptoms, and several suggestions for managing PD such as medications and regular exercise. |
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Experimental: 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. |
Other: Coordinated care management for Parkinson's disease
Nurse care managers will use standardized assessment tools and care coordination protocols to address unmet needs of Veterans with PD, and collaborate with these Veterans and their families, providers, and community partners to manage PD care. |
- Proportion of Measures Adhered To in the PD Guidelines [ Time Frame: 18 months ]
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)
- Health Utilities Index (HUI3) [ Time Frame: 18 months ]
Data 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)
- Activities of Daily Living (ADL), (Speech and Swallowing Only) [ Time Frame: 18 months ]
Data 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)
- Medical Outcomes Study (MOS) [ Time Frame: 18 months ]
Data 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)
- General Self-Efficacy Scale (GSES) [ Time Frame: 18 months ]
Data 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)
- Consumer Assessment of Healthcare Providers and Systems (CAHPS) [ Time Frame: 18 months ]
Data 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)
- Patient Assessement of Care for Chronic Conditions (PACIC) [ Time Frame: 18 months ]
Data 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)
- World Health Organization Well-Being Index (WHO-5) [ Time Frame: 18 months ]
Data 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)
- Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3 [ Time Frame: 18 months ]
Data 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
- Patient Healthcare Questionnaire-9 (PHQ-9) [ Time Frame: 18 months ]
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532986
| United States, California | |
| VA Loma Linda Healthcare System, Loma Linda, CA | |
| Loma Linda, California, United States, 92357 | |
| VA Long Beach Healthcare System, Long Beach, CA | |
| Long Beach, California, United States, 90822 | |
| VA San Diego Healthcare System, San Diego, CA | |
| San Diego, California, United States, 92161 | |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | |
| West Los Angeles, California, United States, 90073 | |
| United States, Nevada | |
| VA Southern Nevada Healthcare System, North Las Vegas, NV | |
| Las Vegas, Nevada, United States, 89106 | |
| Principal Investigator: | Karen Connor, PhD RN MBA | VA Greater Los Angeles Healthcare System, West Los Angeles, CA |
Documents provided by VA Office of Research and Development:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT01532986 |
| Other Study ID Numbers: |
NRI 11-126 |
| First Posted: | February 15, 2012 Key Record Dates |
| Results First Posted: | March 8, 2019 |
| Last Update Posted: | March 8, 2019 |
| Last Verified: | March 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Quality of Health Care Nursing Care Management Care Coordination Randomized Trials |
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |