Overview

This trial is active, not recruiting.

Condition parkinson disease
Treatments coordinated care management for parkinson's disease, educational handout
Sponsor VA Office of Research and Development
Start date July 2012
End date January 2017
Trial size 345 participants
Trial identifier NCT01532986, NRI 11-126

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
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.
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.
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.
(Other)
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
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.

Primary Outcomes

Measure
Change from Baseline in Adherence to the guidelines for Parkinson's disease care at 18 months
time frame: 18 months

Secondary Outcomes

Measure
Health Utilities Index (HUI)
time frame: 6 months, 12 months and 18 months
General Self-Efficacy Scale (GSES)
time frame: 6 months, 12 months and 18 months
WHO-Five Well-being index (WHO-5)
time frame: 6 months, 12 months and 18 months
PHQ-9
time frame: 6 months, 12 months and 18 months
The Consumer Assessment of Health Plans (CAHPS)
time frame: 6 months, 12 months and 18 months
Patient Assessment of Care for Chronic Conditions (PACIC)
time frame: 6 months, 12 months and 18 months
Change from Baseline in Health Utilities Index (HUI) at 12 months
time frame: 12 months
Change from Baseline in General Self-Efficacy Scale (GSES) at 12 months
time frame: 12 months
Change from Baseline in WHO-Five Well-being index (WHO-5) at 12 months
time frame: 12 months
Change from Baseline in PHQ-9 at 12 months
time frame: 12 months
Change from Baseline in The Consumer Assessment of Health Plans (CAHPS) at 12 months
time frame: 12 months
Change from Baseline in Patient Assessment of Care for Chronic Conditions (PACIC) at 12 months
time frame: 12 months
Change from Baseline in Health Utilities Index (HUI) at 18 months
time frame: 18 months
Change from Baseline in General Self-Efficacy Scale (GSES) at 18 months
time frame: 18 months
Change from Baseline in WHO-Five Well-being index (WHO-5) at 18 months
time frame: 18 months
Change from Baseline in PHQ-9 at 18 months
time frame: 18 months
Change from Baseline in The Consumer Assessment of Health Plans (CAHPS) at 18 months
time frame: 18 months
Change from Baseline in Health Utilities Index (HUI) at 18 months
time frame: 24 months for the first 204 participants
Change from Baseline in Patient Assessment of Care for Chronic Conditions (PACIC) at 18 months
time frame: 18 months
Change from Baseline in General Self-Efficacy Scale (GSES) at 24 months
time frame: 24 months for the first 204 participants
Change from Baseline in WHO-Five Well-being index (WHO-5) at 24 months
time frame: 24 months for the first 204 participants
Change from Baseline in PHQ-9 at 24 months
time frame: 24 months for the first 204 participants
Change from Baseline in The Consumer Assessment of Health Plans (CAHPS) at 24 months
time frame: 24 months for the first 204 participants
Change from Baseline in Patient Assessment of Care for Chronic Conditions (PACIC) at 24 months
time frame: 24 months for the first 204 participants

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Improving Quality of Care in Parkinson's Disease: A Randomized Controlled Trial
Principal investigator Karen Connor, PhD RN MBA
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 the investigators' 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 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 5-year randomized controlled trial, a total of 345 Veterans with PD have been recruited and 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. Research interviewers, blinded to randomization status, survey participants by telephone at baseline, 6, 12, and 18 months. The first 204 participants will be administered a 24-month survey to account for a delay in intervention implementation during Year 2. Study participants are thanked for their time to completed the surveys. 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.