Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA
CHAPS
Improving Quality of Care in Parkinson's Disease: A Randomized Controlled Trial
1 other identifier
interventional
345
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jul 2012
Longer than P75 for not_applicable parkinson-disease
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2012
CompletedStudy Start
First participant enrolled
July 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2017
CompletedResults Posted
Study results publicly available
March 8, 2019
CompletedMarch 8, 2019
March 1, 2019
4.6 years
January 13, 2012
March 16, 2018
March 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Measures Adhered To in the PD Guidelines
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)
18 months
Secondary Outcomes (9)
Health Utilities Index (HUI3)
18 months
Activities of Daily Living (ADL), (Speech and Swallowing Only)
18 months
Medical Outcomes Study (MOS)
18 months
General Self-Efficacy Scale (GSES)
18 months
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
18 months
- +4 more secondary outcomes
Study Arms (2)
Usual Care (Arm 1)
OTHERVeterans 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)
EXPERIMENTALA 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357, United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822, United States
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073, United States
VA Southern Nevada Healthcare System, North Las Vegas, NV
Las Vegas, Nevada, 89106, United States
Related Publications (5)
Connor K, Cheng E, Siebens HC, Lee ML, Mittman BS, Ganz DA, Vickrey B. Study protocol of "CHAPS": a randomized controlled trial protocol of Care Coordination for Health Promotion and Activities in Parkinson's Disease to improve the quality of care for individuals with Parkinson's disease. BMC Neurol. 2015 Dec 15;15:258. doi: 10.1186/s12883-015-0506-y.
PMID: 26670300RESULTConnor KI, Siebens HC, Mittman BS, Ganz DA, Barry F, McNeese-Smith DK, Cheng EM, Vickrey BG. Implementation fidelity of a nurse-led RCT-tested complex intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS) in meeting challenges in care management. BMC Neurol. 2022 Jan 24;22(1):36. doi: 10.1186/s12883-021-02481-5.
PMID: 35073865DERIVEDConnor KI, Siebens HC, Mittman BS, McNeese-Smith DK, Ganz DA, Barry F, Edwards LK, McGowan MG, Cheng EM, Vickrey BG. Stakeholder perceptions of components of a Parkinson disease care management intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS). BMC Neurol. 2020 Dec 2;20(1):437. doi: 10.1186/s12883-020-02011-9.
PMID: 33267827DERIVEDConnor KI, Siebens HC, Mittman BS, Ganz DA, Barry F, Ernst EJ, Edwards LK, McGowan MG, McNeese-Smith DK, Cheng EM, Vickrey BG. Quality and extent of implementation of a nurse-led care management intervention: care coordination for health promotion and activities in Parkinson's disease (CHAPS). BMC Health Serv Res. 2020 Aug 10;20(1):732. doi: 10.1186/s12913-020-05594-8.
PMID: 32778083DERIVEDConnor KI, Cheng EM, Barry F, Siebens HC, Lee ML, Ganz DA, Mittman BS, Connor MK, Edwards LK, McGowan MG, Vickrey BG. Randomized trial of care management to improve Parkinson disease care quality. Neurology. 2019 Apr 16;92(16):e1831-e1842. doi: 10.1212/WNL.0000000000007324. Epub 2019 Mar 22.
PMID: 30902908DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study implemented within the Veterans Administration
Results Point of Contact
- Title
- Eric M Cheng
- Organization
- VA Greater Los Angeles Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Connor, PhD RN MBA
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2012
First Posted
February 15, 2012
Study Start
July 9, 2012
Primary Completion
January 31, 2017
Study Completion
April 30, 2017
Last Updated
March 8, 2019
Results First Posted
March 8, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share