Clinical trial NCT05050643: High-Risk Veteran Initiative
Official title: Improving Care for Complex, High-Risk Patients in Primary Care (QUE 20-018)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multimorbidity
Keywords: Primary Health Care
Multimorbidity
Medication Adherence
Needs Assessment
Mentoring
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Veterans Health Administration Office of Primary Care
name: Veterans Health Administration Office of Patient Centered Care & Cultural Transformation
name: US Department of Veterans Affairs
name: Veterans Integrated Service Network 10
name: Veterans Integrated Service Network 12
name: VA MidSouth Healthcare Network
First posted: 2021-09-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a mixed-methods type 3 hybrid implementation-effectiveness evaluation using a Concurrent Stepped Wedge design to compare two implementation strategies to increase adoption of the EBPs in primary care in 16 sites: Evidence-Based Quality Improvement (EBQI)-Individual Consultation (EBQI-IC) and EBQI-Learning Collaborative (EBQI-LC). Each VISN will implement a single EBP \[Comprehensive Assessment and Care Planning (CACP) for High-Risk Veterans or Phone-Based Health Coaching for Medication Adherence (HCMA)\]. Implementation strategies will be randomized by site. Time periods without active implementation will serve as the usual care periods for both EBQI conditions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Veterans at high-risk for hospitalization, including those with complex care needs, represent a large population of VHA patients who often do not receive evidence-based primary care practices that would help them avoid the hospital and improve their health. The high-RIsk VETerans (RIVET) Program will implement evidence-based practices that can support VHA Primary Care teams to deliver more comprehensive and patient-centered care, better strategies to manage medications, and avoid unnecessary hospitalizations. The RIVET Program is designed to find the most effective approaches to increasing use of evidence-based practices for high-risk Veterans in primary care, provide rapid data feedback to VHA on high-risk patient care, build capacity for the implementation of evidence-based practices, and train future leaders in high-risk Veteran care.

Detailed description: The top 5% of Veterans at the highest risk for hospitalizations account for almost 50% of VHA healthcare costs, have significant multimorbidity, and are also at high risk for poor health outcomes. In the VHA, most (88%) high-risk patients are managed by general primary care teams (i.e., Patient-Aligned Care Teams; PACTs). Few PACTs, however, have implemented evidence-based practices (EBPs) known to address the most common issues among high-risk Veterans. Some evidence indicates that usual implementation strategies, such as dissemination of toolkits and training are not effective for improving uptake of EBPs. The most effective implementation strategies to achieve evidence-based care for high-risk patients, however, are unknown.

The overall impact goal of the high-RIsk VETerans (RIVET) QUERI Program is to improve VHA primary care capacity to provide comprehensive, evidence-based care for complex, high-risk Veterans. The investigators will test 2 implementation strategies to evaluate their impact on the uptake of two separate EBPs. These EPBs are 1) Comprehensive Assessment and Care Planning (CACP), and 2) Phone-Based Health Coaching for Medication Adherence (HCMA). CACP is based on the Comprehensive Geriatric Assessment and guides teams in systematically addressing patients' cognitive, functional, and social needs through a comprehensive care plan. HCMA addresses common challenges to medication adherence using a patient-centered approach through virtual encounters. Both comprehensive assessments and health coaching have demonstrated efficacy in randomized, controlled trials and have been implemented by two of the national partners in geriatrics and Whole Health teams. However, both EBPs have had low uptake in primary care. Implementing these practices in primary care has the potential to improve quality of care for the large majority of high-risk Veterans. The investigators will conduct a mixed methods type 3 hybrid effectiveness-implementation design to test the effectiveness of EBQI-IC and EBQI-LC versus usual care (national tool dissemination and training efforts) in at least 16 sites in multiple VISNs using a Concurrent Stepped Wedge design (Aim 2). The primary outcome is proportion of eligible high-risk patients that receive each EBP. The investigators will use the Practical, Robust Implementation and Sustainability Model (PRISM) framework to compare and evaluate Reach, Effectiveness, Adoption, Implementation, and costs. The investigators will then assess the Maintenance/sustainment and spread of both EBPs in primary care across all sites after the active 18-month implementation period (Aim 3).

Eligibility criteria: Inclusion Criteria:

Any VA site nationwide

Exclusion Criteria:

Not a VA site nationwide

Primary outcomes:
measure: Change in the proportion of team-assigned primary care patients in the upper 90th percentile of acute hospitalization risk (identified via VA CAN score) who received the Evidence Based Practice (EBP)
timeFrame: 18
Secondary outcomes:
measure: Number of PACT encounters from social worker, pharmacist, nurse and integrated mental health
timeFrame: 18 months
measure: Number of encounters from PACT pharmacist, social worker, nurse and integrated mental health
timeFrame: 18 months
measure: Comprehensiveness of Care questions from the RIVET Patient Survey- consisting of three items, which was sourced from the SHEP
timeFrame: 18 months
measure: Self-Management Support questions from the RIVET Patient Survey- sourced from the SHEP, which is two items in the survey.
timeFrame: 18 months
measure: PACT provider perceived support for high-risk patient care questions from the RIVET Clinician Survey- three survey items assessing confidences, skills and strain/satisfaction with caring for high-risk patients
timeFrame: 18 months
measure: Providers Discuss Medication Decisions (Patient Survey)
timeFrame: 18 months
measure: Self-Management Support (Patient Survey)
timeFrame: 18 months
measure: Total number of ambulatory care-sensitive and acute hospitalizations
timeFrame: 18 months
measure: Total number of ambulatory care-sensitive and and emergency department visits
timeFrame: 18 months
measure: Patient self-reported medication adherence This survey is a 3-item scale developed and validated in Veteran populations
timeFrame: At the beginning and end of 18-month implementation period
measure: Adherence to chronic medications (diabetes, hypertension, hyperlipidemia, mental health) (VA Pharmacy Data)
timeFrame: The 18-month implementation period
measure: Adoption of Evidence Based Practice (EBP)
timeFrame: 30-months
measure: HEDIS measures for diabetes, hypertension, hyperlipidemia management
timeFrame: The 18-month implementation period
measure: Fidelity
timeFrame: 18 months
measure: EBP Fidelity
timeFrame: 18 months
measure: Implementation costs
timeFrame: 18 months
measure: Facility adopting cost
timeFrame: 18 months
Other outcomes:
Locations:
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA
state: California
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
name: Evelyn T Chang, MD MSHS
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
name: Susan E Stockdale, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: