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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01532986
First received: January 13, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 Intervention
Parkinson Disease
Other: Coordinated care management for Parkinson's disease
Other: Educational handout

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Quality of Care in Parkinson's Disease: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change from Baseline in Adherence to the guidelines for Parkinson's disease care at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Health Utilities Index (HUI) [ Time Frame: 6 months, 12 months and 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Health Utilities Index (HUI) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Health Utilities Index (HUI) at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: July 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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, and collaborating with these Veterans and their families, providers, and community partners to manage Parkinson's disease care.
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, we 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.
Arm 2
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 (PADRECC Facebook page, CHAPS kiosk in movement disorder clinics) will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Other: Educational handout
To minimize potential bias from participants' awareness of randomization arm assignment, we 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.

Detailed Description:

A series of investigations on Parkinson's disease (PD), following the Veterans Affairs Quality Enhancement Research Initiative (VA QUERI) process, have been conducted by our research team. This work has (1) developed and updated a comprehensive set of evidence-based quality indicators for PD care, (2) documented gaps in Veterans Health Administration-delivered care relative to these indicators, and (3) identified variations in care and factors associated with those variations. Under the currently-funded Veterans Affairs Health Services Research and Development Nursing Research Initiative pilot study, the Task Force of several Veterans Health Administration and community champions including key clinicians treating patients with PD at VA Medical Centers in Los Angeles, Loma Linda, Long Beach, and San Diego California; and Las Vegas, Nevada) and advocates from five local PD resource groups convened, developed, and refined assessment tools and protocols to achieve adherence to a set of 38 Parkinson's disease indicators ranked highest priority by the Task Force. A total of 26 Veterans with PD enrolled in the pilot study. Project staff administered the newly-developed PD quality improvement assessment tools to these veterans. Staff and enrolled Veterans provided ongoing feedback to refine the tools.

In a 4-year randomized controlled trial, 400 Veterans with PD are being randomized in a 1:1 ratio to receiving 18 months of a PD care management intervention, "Care Coordination for Health Promotion and Activities in Parkinson's Disease" (CHAPS) or usual care. Eligible participants at Greater Los Angeles (GLA), Las Vegas, Loma Linda, Long Beach and San Diego VISN 22 (VA Desert Pacific Healthcare Network) facilities are being identified through administrative data and vetted by physicians. The 18-month multi-faceted nurse-led intervention incorporates PD quality improvement (QI) tools to enhance proactive patient-centered care delivery. PDQI tools include a structured telephone assessment administered by a nurse to identify medical problems and unmet needs; problem-specific evidence-based interventions organized into treatment plans including follow-up/monitoring protocols; message templates and patient notebooks (Siebens Health Care Notebooks ) to enrich communication with providers; protocols to engage patients, families, and the community to enhance VA and community care for affected Veterans; Veteran self-management materials; and a care management workflow MS Access database programmed with these care coordination tools. Interviewers, blinded to randomization status, survey participants by telephone at baseline, 6, 12, and 18 months. Participants are provided $25 per survey as recognition for their time. Medical records will be abstracted at 18 months. Analyses will be conducted to measure quality indicator adherence, health outcomes, and health service utilization. A process evaluation to gain perspectives on implementation strengths and weaknesses, and a cost analysis to assess relationships between costs and program outcomes will be conducted, providing 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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, Las Vegas, Loma Linda, Long Beach, or San Diego, California
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532986

Locations
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 LA
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
Investigators
Principal Investigator: Karen Connor, PhD RN MBA VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01532986     History of Changes
Other Study ID Numbers: NRI 11-126
Study First Received: January 13, 2012
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Quality of Health Care
Nursing Care Management
Care Coordination
Randomized Trials

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 24, 2014