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High-Risk Veteran Initiative

Improving Care for Complex, High-Risk Patients in Primary Care (QUE 20-018)

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05050643
Acronym
RIVET
Enrollment
17
Registered
2021-09-20
Start date
2021-07-23
Completion date
2026-12-30
Last updated
2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multimorbidity

Keywords

Primary Health Care, Multimorbidity, Medication Adherence, Needs Assessment, Mentoring

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).

Interventions

OTHEREBQI-IC

Individual (ongoing) consultation (IC), often described as coaching or supervision, is endorsed by implementation experts as an effective implementation strategy

OTHEREBQI-LC

A Learning Collaborative is a systematic approach to process improvement based on the Institute for Healthcare Improvement Breakthrough Series Collaborative model. During the Collaborative, organizations will test and implement system changes and measure their impact. They will share their experiences to accelerate learning and broader implementation of best practices.

Sponsors

Veterans Health Administration Office of Primary Care
CollaboratorUNKNOWN
Veterans Health Administration Office of Patient Centered Care & Cultural Transformation
CollaboratorUNKNOWN
US Department of Veterans Affairs
CollaboratorFED
Veterans Integrated Service Network 10
CollaboratorUNKNOWN
Veterans Integrated Service Network 12
CollaboratorUNKNOWN
VA MidSouth Healthcare Network
CollaboratorUNKNOWN
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Any VA site nationwide

Exclusion criteria

Not a VA site nationwide

Design outcomes

Primary

MeasureTime frameDescription
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)18This primary outcome aims to measure reach of the evidence practices to implement the EBP.

Secondary

MeasureTime frameDescription
Number of encounters from PACT pharmacist, social worker, nurse and integrated mental health18 monthsThis secondary outcome will measure the impact of EBPs on the proximal care process.
Comprehensiveness of Care questions from the RIVET Patient Survey- consisting of three items, which was sourced from the SHEP18 monthsThis secondary outcome will measure patient impact due to EBPs.
Self-Management Support questions from the RIVET Patient Survey- sourced from the SHEP, which is two items in the survey.18 monthsThis secondary outcome will measure patient impacts due to EBPs .
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 patients18 monthsThis secondary outcome will measure patient impacts of EBP#1 (CACP).
Providers Discuss Medication Decisions (Patient Survey)18 monthsThis secondary outcome will measure patient impacts of due to EBPs.
Self-Management Support (Patient Survey)18 monthsThis secondary outcome will measure patient impacts of due to EBPs.
Total number of ambulatory care-sensitive and acute hospitalizations18 monthsThis secondary outcome will measure clinical quality due to EBPs.
Total number of ambulatory care-sensitive and and emergency department visits18 monthsThis secondary outcome will measure clinical quality due to EBPs.
Number of PACT encounters from social worker, pharmacist, nurse and integrated mental health18 monthsThis secondary outcome will measure the impact of EBPs on the proximal care process.
Adherence to chronic medications (diabetes, hypertension, hyperlipidemia, mental health) (VA Pharmacy Data)The 18-month implementation periodThis secondary outcome will measure clinical quality outcome of EBP#2(HCMA). Medications will be calculated via VA pharmacy fill data using Proportion of Days Covered (PDC).
Adoption of Evidence Based Practice (EBP)30-monthsProportion of staff trained on EBPs.
HEDIS measures for diabetes, hypertension, hyperlipidemia managementThe 18-month implementation periodThis secondary outcome will measure clinical quality outcome due to EBPs.
Fidelity18 monthsThe fidelity assessment tool draws from data collected from key stakeholder interviews , implementation facilitation logs , administrative documents, and weekly time diaries. The team will apply criteria to rate sites as high-, medium-, or low-fidelity on the EBQI elements.
EBP Fidelity18 monthsA composite EBP fidelity measure for each EBP will be assessed by percent of items completed.
Implementation costs18 monthsImplementation Core staff time spent in various implementation activities
Facility adopting cost18 monthsCost calculated from time incurred by facilities adopting the EBPs
Patient self-reported medication adherence This survey is a 3-item scale developed and validated in Veteran populationsAt the beginning and end of 18-month implementation periodThis survey is a 3-item scale developed and validated in Veteran populations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026