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Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA (CHAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01532986
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Coordinated care management for Parkinson's disease Other: Educational handout Not Applicable

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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)


  2. 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)


  3. 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)


  4. 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)


  5. 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)


  6. 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)


  7. 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)


  8. 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


  9. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Karen Connor, PhD RN MBA VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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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
Keywords provided by VA Office of Research and Development:
Quality of Health Care
Nursing Care Management
Care Coordination
Randomized Trials
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases