NCT05050643

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2021Dec 2026

Study Start

First participant enrolled

July 23, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

4.2 years

First QC Date

September 9, 2021

Last Update Submit

October 22, 2025

Conditions

Keywords

Primary Health CareMultimorbidityMedication AdherenceNeeds AssessmentMentoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Number of PACT encounters from social worker, pharmacist, nurse and integrated mental health

    18 months

  • Number of encounters from PACT pharmacist, social worker, nurse and integrated mental health

    18 months

  • Comprehensiveness of Care questions from the RIVET Patient Survey- consisting of three items, which was sourced from the SHEP

    18 months

  • Self-Management Support questions from the RIVET Patient Survey- sourced from the SHEP, which is two items in the survey.

    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

    18 months

  • +12 more secondary outcomes

Study Arms (4)

CACP-EBQI-IC

ACTIVE COMPARATOR

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

CACP-EBQI-LC

ACTIVE COMPARATOR

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

HCMA-EBQI-IC

ACTIVE COMPARATOR

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

HCMA-EBQI-LC

ACTIVE COMPARATOR

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

Interventions

EBQI-ICOTHER

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

Also known as: Individual Consultation
CACP-EBQI-ICHCMA-EBQI-IC
EBQI-LCOTHER

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.

Also known as: Learning Collaborative
CACP-EBQI-LCHCMA-EBQI-LC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any VA site nationwide

You may not qualify if:

  • Not a VA site nationwide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Related Publications (1)

  • Jimenez EE, Rosland AM, Stockdale SE, Reddy A, Wong MS, Torrence N, Huynh A, Chang ET. Implementing evidence-based practices to improve primary care for high-risk patients: study protocol for the VA high-RIsk VETerans (RIVET) type III effectiveness-implementation trial. Implement Sci Commun. 2024 Jul 15;5(1):75. doi: 10.1186/s43058-024-00613-9.

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 20, 2021

Study Start

July 23, 2021

Primary Completion

September 30, 2025

Study Completion (Estimated)

December 30, 2026

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations