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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)

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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

Tracking Information
First Submitted Date  ICMJE January 13, 2012
First Posted Date  ICMJE February 15, 2012
Results First Submitted Date  ICMJE March 16, 2018
Results First Posted Date  ICMJE March 8, 2019
Last Update Posted Date March 8, 2019
Actual Study Start Date  ICMJE July 9, 2012
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
Change from Baseline in Adherence to the guidelines for Parkinson's disease care at 6 months [ Time Frame: 6 months ]
Guidelines for Parkinson's disease (PD) care are measureable, evidence-based indicators of PD care offered/delivered to patients. Guideline adherence is expressed as the mean across the study participant group of the per-patient percentage of applicable guideline measures for which there was adherence. (An applicable PD guideline is one for which a participant is eligible).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • Health Utilities Index (HUI) [ Time Frame: 6 months, 12 months and 18 months ]
    The Health Utilities Index (HUI) has been used in many clinical studies covering a wide range of health problems. HUI questionnaires are effective tools used to measure health status, report health-related quality of life (HRQL), and produce utility scores (ranging from 0=death to 1= perfect health) that can be used in formal cost-effectiveness analyses. The HUI provides comprehensive, reliable and valid measures of health status and HRQL.
  • General Self-Efficacy Scale (GSES) [ Time Frame: 6 months, 12 months and 18 months ]
    General Self-Efficacy Scale (GSES) The GSES is a 10-item scale that assesses perceived self-efficacy (i.e. the belief that one's actions are responsible for successful outcomes) regarding coping and adaptation abilities in both daily activities and isolated stressful events. The scaled score for each question ranges from 1 to 4. Higher scores indicate that the patient demonstrates a stronger belief in self efficacy. The GSES has been tested in a wide age range and among various chronic disease populations such as Parkinson's.
  • WHO-Five Well-being index (WHO-5) [ Time Frame: 6 months, 12 months and 18 months ]
    The WHO-Five Well-being Index covers positive mood, vitality, and general interests. The WHO-5 has been validated in the PD population as a screening tool for depression. The WHO-5 showed high validity and was sufficient in detecting depression without differences in the validity indices compared to the Beck depression inventory (the standard screening tool for PD depression).
  • PHQ-9 [ Time Frame: 6 months, 12 months and 18 months ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire which measures depressive symptoms over the previous 2 weeks. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other major depressive symptoms into a brief self report tool. There are two components of the PHQ-9; assessing symptoms and functional impairment to make an initial depression diagnosis and obtaining a severity score to help select and monitor treatment. The PHQ-9 performed comparably to the Geriatric Depression Scale (GDS) in identifying depression among primary care elderly.
  • The Consumer Assessment of Health Plans (CAHPS) [ Time Frame: 6 months, 12 months and 18 months ]
    The Consumer Assessment of Health Plans (CAHPS) is a standardized survey that asks consumers and patients to report on and evaluate their experiences with health care. The survey covers topics that are important to consumers, such as the communication skills of providers and the accessibility of services. A subset and adaptation of items from this survey will be used to determine if health care experiences change throughout the intervention.
  • Patient Assessment of Care for Chronic Conditions (PACIC) [ Time Frame: 6 months, 12 months and 18 months ]
    The Patient Assessment of Care for Chronic Conditions (PACIC) is a 20-item survey that measures specific actions or qualities of care that patients report they have experienced in health care delivery. The tool provides a consumer assessment of important aspects of care for chronic illness patients. The survey is divided into five subscales: patient activation, delivery system design/decision support, goal setting, problem solving/contextual counseling and follow-up/coordination. The overall PACIC is scored by averaging scores across all 20 items.
  • Change from Baseline in Adherence to the guidelines for Parkinson's disease care at 12 months [ Time Frame: 12 months ]
    Guidelines for Parkinson's disease (PD) care are measureable, evidence-based indicators of PD care offered/delivered to patients. Guideline adherence is expressed as the mean across the study participant group of the per-patient percentage of applicable guideline measures for which there was adherence. (An applicable PD guideline is one for which a participant is eligible).
  • Change from Baseline in Health Utilities Index (HUI) at 12 months [ Time Frame: 12 months ]
    The Health Utilities Index (HUI) has been used in many clinical studies covering a wide range of health problems. HUI questionnaires are effective tools used to measure health status, report health-related quality of life (HRQL), and produce utility scores (ranging from 0=death to 1= perfect health) that can be used in formal cost-effectiveness analyses. The HUI provides comprehensive, reliable and valid measures of health status and HRQL.
  • Change from Baseline in General Self-Efficacy Scale (GSES) at 12 months [ Time Frame: 12 months ]
    General Self-Efficacy Scale (GSES) The GSES is a 10-item scale that assesses perceived self-efficacy (i.e. the belief that one's actions are responsible for successful outcomes) regarding coping and adaptation abilities in both daily activities and isolated stressful events. The scaled score for each question ranges from 1 to 4. Higher scores indicate that the patient demonstrates a stronger belief in self efficacy. The GSES has been tested in a wide age range and among various chronic disease populations such as Parkinson's.
  • Change from Baseline in WHO-Five Well-being index (WHO-5) at 12 months [ Time Frame: 12 months ]
    The WHO-Five Well-being Index covers positive mood, vitality, and general interests. The WHO-5 has been validated in the PD population as a screening tool for depression. The WHO-5 showed high validity and was sufficient in detecting depression without differences in the validity indices compared to the Beck depression inventory (the standard screening tool for PD depression).
  • Change from Baseline in PHQ-9 at 12 months [ Time Frame: 12 months ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire which measures depressive symptoms over the previous 2 weeks. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other major depressive symptoms into a brief self report tool. There are two components of the PHQ-9; assessing symptoms and functional impairment to make an initial depression diagnosis and obtaining a severity score to help select and monitor treatment. The PHQ-9 performed comparably to the Geriatric Depression Scale (GDS) in identifying depression among primary care elderly.
  • Change from Baseline in The Consumer Assessment of Health Plans (CAHPS) at 12 months [ Time Frame: 12 months ]
    The Consumer Assessment of Health Plans (CAHPS) is a standardized survey that asks consumers and patients to report on and evaluate their experiences with health care. The survey covers topics that are important to consumers, such as the communication skills of providers and the accessibility of services. A subset and adaptation of items from this survey will be used to determine if health care experiences change throughout the intervention.
  • Change from Baseline in Patient Assessment of Care for Chronic Conditions (PACIC) at 12 months [ Time Frame: 12 months ]
    The Patient Assessment of Care for Chronic Conditions (PACIC) is a 20-item survey that measures specific actions or qualities of care that patients report they have experienced in health care delivery. The tool provides a consumer assessment of important aspects of care for chronic illness patients. The survey is divided into five subscales: patient activation, delivery system design/decision support, goal setting, problem solving/contextual counseling and follow-up/coordination. The overall PACIC is scored by averaging scores across all 20 items.
  • Change from Baseline in Adherence to the guidelines for Parkinson's disease care at 18 months [ Time Frame: 18 months ]
    Guidelines for Parkinson's disease (PD) care are measureable, evidence-based indicators of PD care offered/delivered to patients. Guideline adherence is expressed as the mean across the study participant group of the per-patient percentage of applicable guideline measures for which there was adherence. (An applicable PD guideline is one for which a participant is eligible).
  • Change from Baseline in Health Utilities Index (HUI) at 18 months [ Time Frame: 18 months ]
    The Health Utilities Index (HUI) has been used in many clinical studies covering a wide range of health problems. HUI questionnaires are effective tools used to measure health status, report health-related quality of life (HRQL), and produce utility scores (ranging from 0=death to 1= perfect health) that can be used in formal cost-effectiveness analyses. The HUI provides comprehensive, reliable and valid measures of health status and HRQL.
  • Change from Baseline in General Self-Efficacy Scale (GSES) at 18 months [ Time Frame: 18 months ]
    General Self-Efficacy Scale (GSES) The GSES is a 10-item scale that assesses perceived self-efficacy (i.e. the belief that one's actions are responsible for successful outcomes) regarding coping and adaptation abilities in both daily activities and isolated stressful events. The scaled score for each question ranges from 1 to 4. Higher scores indicate that the patient demonstrates a stronger belief in self efficacy. The GSES has been tested in a wide age range and among various chronic disease populations such as Parkinson's.
  • Change from Baseline in WHO-Five Well-being index (WHO-5) at 18 months [ Time Frame: 18 months ]
    The WHO-Five Well-being Index covers positive mood, vitality, and general interests. The WHO-5 has been validated in the PD population as a screening tool for depression. The WHO-5 showed high validity and was sufficient in detecting depression without differences in the validity indices compared to the Beck depression inventory (the standard screening tool for PD depression).
  • Change from Baseline in PHQ-9 at 18 months [ Time Frame: 18 months ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire which measures depressive symptoms over the previous 2 weeks. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other major depressive symptoms into a brief self report tool. There are two components of the PHQ-9; assessing symptoms and functional impairment to make an initial depression diagnosis and obtaining a severity score to help select and monitor treatment. The PHQ-9 performed comparably to the Geriatric Depression Scale (GDS) in identifying depression among primary care elderly.
  • Change from Baseline in The Consumer Assessment of Health Plans (CAHPS) at 18 months [ Time Frame: 18 months ]
    The Consumer Assessment of Health Plans (CAHPS) is a standardized survey that asks consumers and patients to report on and evaluate their experiences with health care. The survey covers topics that are important to consumers, such as the communication skills of providers and the accessibility of services. A subset and adaptation of items from this survey will be used to determine if health care experiences change throughout the intervention.
  • Change from Baseline in Patient Assessment of Care for Chronic Conditions (PACIC) at 18 months [ Time Frame: 18 months ]
    The Patient Assessment of Care for Chronic Conditions (PACIC) is a 20-item survey that measures specific actions or qualities of care that patients report they have experienced in health care delivery. The tool provides a consumer assessment of important aspects of care for chronic illness patients. The survey is divided into five subscales: patient activation, delivery system design/decision support, goal setting, problem solving/contextual counseling and follow-up/coordination. The overall PACIC is scored by averaging scores across all 20 items.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA
Official Title  ICMJE Improving Quality of Care in Parkinson's Disease: A Randomized Controlled Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Other: Coordinated care management for Parkinson's disease
    • Other: Educational handout
  • 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.

    Intervention: Other: Coordinated care management for Parkinson's disease
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2016)
345
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2012)
400
Actual Study Completion Date  ICMJE April 30, 2017
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01532986
Other Study ID Numbers  ICMJE NRI 11-126
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen Connor, PhD RN MBA VA Greater Los Angeles Healthcare System, West Los Angeles, CA
PRS Account VA Office of Research and Development
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP