High-Risk Veteran Initiative (RIVET)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multimorbidity
• Intervention / Treatment: Other: EBQI-IC; Other: EBQI-LC

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).

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evelyn T Chang, MD MSHS; Phone Number: 49510 (310) 478-3711; Email: Evelyn.Chang@va.gov
• Study Contact Backup: Name: Elvira E Jimenez, PhD MPH; Phone Number: 43389 (310) 478-3711; Email: Elvira.Jimenez@va.gov

Study Locations

• United States
  • California
    • Sepulveda, California, United States, 91343
      • Recruiting
      • VA Greater Los Angeles Healthcare System, Sepulveda, CA
      • Contact: Evelyn T Chang, MD MSHS; Phone Number: 49510 310-478-3711; Email: Evelyn.Chang@va.gov
      • Principal Investigator: Evelyn T Chang, MD MSHS
      • Principal Investigator: Susan E Stockdale, PhD MA
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • Active, not recruiting
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  • Washington
    • Seattle, Washington, United States, 98108-1532
      • Active, not recruiting
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Any VA site nationwide

Exclusion Criteria:

Not a VA site nationwide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CACP-EBQI-IC; 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.	Other: EBQI-IC; Individual (ongoing) consultation (IC), often described as coaching or supervision, is endorsed by implementation experts as an effective implementation strategy; Other Names: Individual Consultation
Active Comparator: CACP-EBQI-LC; 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.	Other: EBQI-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.; Other Names: Learning Collaborative
Active Comparator: HCMA-EBQI-IC; 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).	Other: EBQI-IC; Individual (ongoing) consultation (IC), often described as coaching or supervision, is endorsed by implementation experts as an effective implementation strategy; Other Names: Individual Consultation
Active Comparator: HCMA-EBQI-LC; 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).	Other: EBQI-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.; Other Names: Learning Collaborative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	This primary outcome aims to measure reach of the evidence practices to implement the EBP.	18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of PACT encounters from social worker, pharmacist, nurse and integrated mental health	This secondary outcome will measure the impact of EBPs on the proximal care process.	18 months
Number of encounters from PACT pharmacist, social worker, nurse and integrated mental health	This secondary outcome will measure the impact of EBPs on the proximal care process.	18 months
Providers Discuss Medication Decisions (Patient Survey)	This secondary outcome will measure patient impacts of due to EBPs.	18 months
Self-Management Support (Patient Survey)	This secondary outcome will measure patient impacts of due to EBPs.	18 months
Total number of ambulatory care-sensitive and acute hospitalizations	This secondary outcome will measure clinical quality due to EBPs.	18 months
Total number of ambulatory care-sensitive and and emergency department visits	This secondary outcome will measure clinical quality due to EBPs.	18 months
Adherence to chronic medications (diabetes, hypertension, hyperlipidemia, mental health) (VA Pharmacy Data)	This 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).	The 18-month implementation period
Adoption of Evidence Based Practice (EBP)	Proportion of staff trained on EBPs.	30-months
HEDIS measures for diabetes, hypertension, hyperlipidemia management	This secondary outcome will measure clinical quality outcome due to EBPs.	The 18-month implementation period
Fidelity	The 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.	18 months
Implementation costs	Implementation Core staff time spent in various implementation activities	18 months
Comprehensiveness of Care questions from the RIVET Patient Survey- consisting of three items, which was sourced from the SHEP	This secondary outcome will measure patient impact due to EBPs.	18 months
Self-Management Support questions from the RIVET Patient Survey- sourced from the SHEP, which is two items in the survey.	This secondary outcome will measure patient impacts due to EBPs .	18 months
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	This secondary outcome will measure patient impacts of EBP#1 (CACP).	18 months
Patient self-reported medication adherence This survey is a 3-item scale developed and validated in Veteran populations	This survey is a 3-item scale developed and validated in Veteran populations.	At the beginning and end of 18-month implementation period
EBP Fidelity	A composite EBP fidelity measure for each EBP will be assessed by percent of items completed.	18 months
Facility adopting cost	Cost calculated from time incurred by facilities adopting the EBPs	18 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Veterans Health Administration Office of Primary Care; Veterans Health Administration Office of Patient Centered Care & Cultural Transformation; Veterans Health Administration Geriatrics and Extended Care; Veterans Integrated Service Network 10; Veterans Integrated Service Network 12; VA Midwest Health Care Network
• Investigators: Principal Investigator: Evelyn T Chang, MD MSHS, VA Greater Los Angeles Healthcare System, Sepulveda, CA; Principal Investigator: Susan E Stockdale, PhD MA, VA Greater Los Angeles Healthcare System, Sepulveda, CA

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Primary Health Care; Medication Adherence; Needs Assessment; Multimorbidity; Mentoring
• Other Study ID Numbers: QUX 21-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No