Evidence-Based Practices for High-Risk Veteran Care

(RIVET Trial)

Recruiting at2 trial locations

Overseen by Evelyn T Chang, MD MSHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Not a VA site

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment EBQI-IC, Evidence-Based Quality Improvement Initiative for Complex Care, EBQI-LC?

Evidence-Based Quality Improvement (EBQI) has been shown to help healthcare systems implement research evidence into practice, which can improve care quality and safety. This approach has been used in various settings, including primary care and community health centers, to address complex patient needs and improve outcomes. ^{1 2 3 4 5}

How is the EBQI-IC, EBQI-LC treatment different from other treatments for high-risk veteran care?

The EBQI-IC, EBQI-LC treatment is unique because it involves a collaborative approach where researchers and local partners work together to implement evidence-based practices in clinical settings, specifically tailored to the needs of high-risk veterans. This multilevel strategy focuses on improving care by integrating research evidence into practice, which is not commonly seen in other treatments. ^{1 2 6 7 8}

Research Team

Susan E Stockdale, PhD MA

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Evelyn T Chang, MD MSHS

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• EBQI-IC (Behavioural Intervention)
• EBQI-LC (Behavioural Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

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+

Kameron Leigh Matthews

US Department of Veterans Affairs

Chief Medical Officer since 2021

MD from Johns Hopkins University

Doug Collins

US Department of Veterans Affairs

Secretary of Veterans Affairs

BA in Political Science from North Georgia College & State University

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Practice-based research networks add value to evidence-based quality improvement. [2021]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Findings from a national improvement collaborative: are improvements sustained? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Standardization and improvement of care for pediatric patients with perforated appendicitis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A patient-centered primary care practice approach using evidence-based quality improvement: rationale, methods, and early assessment of implementation. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evidence-Based Quality Improvement (EBQI) in the pre-implementation phase: key steps and activities. [2023]

7. England 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. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

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