Evidence-Based Practices for High-Risk Veteran Care

(RIVET Trial)

Not currently recruiting at 2 trial locations

Overseen By Evelyn T Chang, MD MSHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Not a VA site

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the health of high-risk veterans by implementing evidence-based practices in primary care settings. It focuses on strategies to manage medications and prevent unnecessary hospital visits. The trial tests two approaches: individual consultations and learning collaboratives, known as EBQI-IC (Evidence-Based Quality Improvement Initiative for Complex Care) and EBQI-LC, to enhance care for veterans with complex needs. Veterans who often face hospital visits and have complicated healthcare needs might be a good fit for this study.

As an unphased trial, this study offers veterans the chance to contribute to innovative care strategies that could significantly improve their health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these evidence-based practices are safe for high-risk Veterans?

Research has shown that strategies like EBQI-IC and EBQI-LC have been safely used in healthcare. These methods help healthcare systems apply research to enhance care quality. Studies have found that EBQI methods effectively tailor care to meet specific patient needs, such as improving primary care and integrating mental health services, particularly for high-risk groups like Veterans.

Available sources report no safety concerns or negative effects, suggesting these methods are generally well-tolerated. Since the trial focuses on improving care practices rather than testing new drugs or medical procedures, the risks are expected to be minimal. The goal is to make healthcare more efficient and patient-centered, usually involving low-risk activities like coaching and learning collaboratives. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these trial methods because they focus on improving care for high-risk veterans using innovative implementation strategies. The individual consultation (IC) approach offers personalized coaching, which can enhance the effectiveness of existing treatments like phone-based health coaching and comprehensive care planning. Meanwhile, learning collaboratives (LC) foster a collaborative environment where healthcare providers can share insights and improve their approaches collectively. These strategies represent a shift from traditional one-size-fits-all methods to more tailored and interactive approaches, potentially leading to better patient outcomes and adherence to care plans.

What evidence suggests that this trial's treatments could be effective for high-risk Veterans?

Research shows that Evidence-Based Quality Improvement (EBQI) can significantly enhance healthcare systems by applying research findings in real-world settings. This trial compares different EBQI strategies to improve care quality for high-risk veterans. Participants will join different arms, each focusing on specific EBQI techniques. Some arms will use individual consultations, while others will employ group learning sessions to boost evidence-based practices in primary care. By focusing on medication adherence and detailed care planning, these strategies aim to reduce unnecessary hospital visits and improve overall health. Studies support that EBQI strategies effectively enhance care for high-risk veterans. ^{1 2 6 7 8}

Who Is on the Research Team?

Evelyn T Chang, MD MSHS

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Susan E Stockdale, PhD MA

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Are You a Good Fit for This Trial?

The High-Risk Veteran Initiative is for veterans at high risk of hospitalization, including those with complex care needs who are treated within VA sites in VISN 9, 10, and 12. It aims to improve primary care practices to prevent unnecessary hospital stays.

Inclusion Criteria

VA site in VISN 9,10 and 12

Exclusion Criteria

Not a VA site in VISN 9, 10 and 12

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of evidence-based practices (EBPs) including Comprehensive Assessment and Care Planning (CACP) and Phone-Based Health Coaching for Medication Adherence (HCMA) across multiple sites

18 months

Ongoing consultations and learning collaboratives

Follow-up

Participants are monitored for the maintenance and spread of EBPs in primary care after the active implementation period

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EBQI-IC
• EBQI-LC

Trial Overview The trial tests two evidence-based interventions: EBQI-LC and EBQI-IC. These are designed to enhance VHA Primary Care by providing comprehensive patient-centered care, better medication management strategies, and reducing avoidable hospitalizations.

How Is the Trial Designed?

Group I: HCMA-EBQI-IC Active Control 1 Intervention

Individual (ongoing) consultation (IC), often described as coaching or supervision, is endorsed by implementation experts as an effective implementation strategy for EBP # 2,Phone-Based Health Coaching for Medication Adherence (HCMA).

Group II: HCMA-EBQI-LC Active Control 1 Intervention

Learning collaboratives (LC) are widely used in healthcare settings, as an effective implementation strategy. The LC will be used to increase uptake of EBP # 2,Phone-Based Health Coaching for Medication Adherence (HCMA).

Group III: CACP-EBQI-IC Active Control 1 Intervention

Individual (ongoing) consultation (IC), often described as coaching or supervision, is endorsed by implementation experts as an effective implementation strategy for EBP #1, Comprehensive Assessment and Care Planning (CACP) for High-Risk Veterans.

Group IV: CACP-EBQI-LC Active Control 1 Intervention

Learning collaboratives (LC) are widely used in healthcare settings, as an effective implementation strategy. The LC will be used to increase uptake of EBP #1, Comprehensive Assessment and Care Planning (CACP) for High-Risk Veterans.

EBQI-IC is already approved in United States for the following indications:

Approved in United States as EBQI-IC for:

• Complex care needs in veterans

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Veterans Integrated Service Network 9

Collaborator

Trials

1

Recruited

20+

VA Midwest Health Care Network

Collaborator

Trials

2

Recruited

4,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

VA MidSouth Healthcare Network

Collaborator

Trials

1

Recruited

20+

Veterans Health Administration Office of Primary Care

Collaborator

Trials

1

Recruited

20+

Veterans Health Administration Office of Patient Centered Care & Cultural Transformation

Collaborator

Trials

2

Recruited

3,700+

Veterans Health Administration Geriatrics and Extended Care

Collaborator

Trials

1

Recruited

20+

Veterans Integrated Service Network 10

Collaborator

Trials

1

Recruited

20+

Veterans Integrated Service Network 12

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a study of 130 Veterans Affairs hospitals, 35% improved hospital length of stay (LOS) and 46% improved rates of discharges before noon after participating in a quality improvement (QI) collaborative.

While 60% of hospitals that improved LOS maintained their gains, only 32% sustained improvements in discharges before noon, indicating challenges in sustaining quality improvements over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Findings from a national improvement collaborative: are improvements sustained? Glasgow, JM., Davies, ML., Kaboli, PJ.[2021]

The implementation of an evidence-based guideline for managing perforated appendicitis led to a significant increase in immediate appendectomy rates from 79% to 94%, indicating improved adherence to best practices.

Postoperative care was enhanced by reducing the use of IV antibiotics after discharge from 25% to 4%, while maintaining patient outcomes, such as length of stay and rates of complications, suggesting more efficient care without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization and improvement of care for pediatric patients with perforated appendicitis. Slusher, J., Bates, CA., Johnson, C., et al.[2021]

The study evaluated the effectiveness of Evidence-Based Quality Improvement (EBQI) within the VA Women’s Health Practice-Based Research Network (WH-PBRN) through a four-site cluster randomized trial, highlighting that the existing relationships between researchers and clinicians facilitated stakeholder engagement and project buy-in.

The WH-PBRN infrastructure was found to enhance the implementation of EBQI by resolving local resource differences and promoting the sharing of adaptations, ultimately strengthening the uptake of evidence-based practices across all phases of implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice-based research networks add value to evidence-based quality improvement. Goldstein, KM., Vogt, D., Hamilton, A., et al.[2021]

The study outlines the Evidence-Based Quality Improvement (EBQI) process through a comparative case study of seven projects, highlighting key steps such as forming local partnerships, prioritizing implementation factors, and adapting evidence-based interventions (EBIs) for specific settings.

By detailing the EBQI steps and activities, the research aims to enhance the replicability of this process in future implementation studies, potentially improving the uptake of effective interventions in various community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Quality Improvement (EBQI) in the pre-implementation phase: key steps and activities. Swindle, T., Baloh, J., Landes, SJ., et al.[2023]

The Veterans Health Administration (VHA) has developed a comprehensive approach to quality cancer care by partnering with organizations like the Oncology Nursing Society, focusing on evidence-based practices that improve patient outcomes in oncology nursing.

The pilot testing of the Breast Cancer Care Quality Measures Set allowed the VHA to assess critical aspects of breast cancer care, such as symptom documentation and patient education, leading to enhanced quality assessments and ongoing improvement initiatives across its healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paths to partnership: Veterans Health Administration's Journey in pilot testing breast cancer care quality measures. Hogg, LH.[2014]

The study aims to adapt the Patient Aligned Care Teams (PACT) model specifically for women Veterans (WVs) by implementing a Women's Health PACT (WH-PACT) to provide gender-sensitive comprehensive care, addressing the unique needs of this population.

In a 12-site cluster randomized trial, the effectiveness of WH-PACT will be evaluated through various surveys and data analyses, focusing on improving chronic disease care, patient satisfaction, and overall quality of care for women Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster randomized trial of a multilevel evidence-based quality improvement approach to tailoring VA Patient Aligned Care Teams to the needs of women Veterans. Yano, EM., Darling, JE., Hamilton, AB., et al.[2018]

A comprehensive assessment of chronic pain management in a community health center revealed high primary care utilization but low referral rates to pain specialists, indicating a potential gap in specialized care for patients with chronic pain.

The study identified significant variability in opioid prescribing practices among providers and highlighted the need for improved documentation and provider education to enhance chronic pain management, leading to a multifaceted intervention plan that includes behavioral health support and specialty consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive assessment of chronic pain management in primary care: a first phase of a quality improvement initiative at a multisite Community Health Center. Anderson, D., Wang, S., Zlateva, I.[2022]

The Evidence-Based Quality Improvement (EBQI) approach has been successfully implemented in the VA's Patient Aligned Care Teams (PACT) model across three healthcare systems, with nearly all planned elements being fully or partially executed over an 18-month period.

While 14 out of 15 innovation projects were completed, there is a need for improved patient engagement in Quality Councils and consistent interdisciplinary leadership in primary care practices to enhance the effectiveness of the EBQI-PACT model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A patient-centered primary care practice approach using evidence-based quality improvement: rationale, methods, and early assessment of implementation. Rubenstein, LV., Stockdale, SE., Sapir, N., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11169220/

Impact of Evidence-Based Quality Improvement on Tailoring ... We deployed an evidence-based quality improvement (EBQI) approach to tailor PACT to meet women Veterans' needs and studied its effects on women's health (WH) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05050643

Study Details | NCT05050643 | High-Risk Veteran Initiative 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, ...

3. withpower.com withpower.com/trial/phase-6-2021-54e26

Evidence-Based Practices for High-Risk Veteran Care · ... Evidence-Based Quality Improvement (EBQI) has been shown to help healthcare systems implement research evidence into practice, which can improve care quality ...

4. reporter.nih.gov reporter.nih.gov/project-details/10181667

Project Details 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07031245

Evidence-Based Quality Improvement to Reduce VA ... The investigators propose to use evidence-based quality improvement (EBQI) to utilize collaborative leadership and PACT teamlet input to develop and pilot test ...

6. queri.research.va.gov queri.research.va.gov/about/strategic_plans/QUERIStrategicPlan-2021-2025.pdf

Quality Enhancement Research Initiative (QUERI) 2021-2025 ... Addressing health care gaps and tailoring effective practices to meet the needs of Veterans residing in rural areas, aging populations and caregivers, high-risk ...

7. link.springer.com link.springer.com/article/10.1007/s11606-024-08737-3

Enhancing Primary Care and Mental Health Integration for ... This study examines factors associated with the successful deployment of EBQI within integrated health systems to improve primary care for women Veterans with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9708973/

Evidence-Based Quality Improvement: a Scoping Review of ... EBQI is a promising strategy for integrating relevant prior scientific findings and methods systematically in the QI process.