MultimorbidityRIVETNCT05050643
High-Risk Veteran Initiative
A study testing EBQI-IC and EBQI-LC in people with Multimorbidity, run by VA Office of Research and Development at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- EBQI-IC and EBQI-LC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jul 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any VA site nationwide
Who cannot join
- Not a VA site nationwide
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
Official title: 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.
Read the 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).
- Conditions
- Multimorbidity
- Being tested
- EBQI-IC, EBQI-LC
- Keywords
- Primary Health Care, Multimorbidity, Medication Adherence, Needs Assessment, Mentoring
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBQI-ICOther
Also called Individual Consultation
Individual (ongoing) consultation (IC), often described as coaching or supervision, is endorsed by implementation experts as an effective implementation strategy
EBQI-LCOther
Also called Learning Collaborative
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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). Receives: Other: EBQI-LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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).
Measured: 18 months
Providers Discuss Medication Decisions (Patient Survey)
This secondary outcome will measure patient impacts of due to EBPs.
Measured: 18 months
Self-Management Support (Patient Survey)
This secondary outcome will measure patient impacts of due to EBPs.
Measured: 18 months
Total number of ambulatory care-sensitive and acute hospitalizations
This secondary outcome will measure clinical quality due to EBPs.
Measured: 18 months
Total number of ambulatory care-sensitive and and emergency department visits
This secondary outcome will measure clinical quality due to EBPs.
Measured: 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.
Measured: At the beginning and end of 18-month implementation period
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).
Measured: The 18-month implementation period
Adoption of Evidence Based Practice (EBP)
Proportion of staff trained on EBPs.
Measured: 30-months
HEDIS measures for diabetes, hypertension, hyperlipidemia management
This secondary outcome will measure clinical quality outcome due to EBPs.
Measured: 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.
Measured: 18 months
EBP Fidelity
A composite EBP fidelity measure for each EBP will be assessed by percent of items completed.
Measured: 18 months
Implementation costs
Implementation Core staff time spent in various implementation activities
Measured: 18 months
Facility adopting cost
Cost calculated from time incurred by facilities adopting the EBPs
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start23 Jul 2021
- Primary completion30 Sep 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Veterans Health Administration Office of Primary Care, Veterans Health Administration Office of Patient Centered Care & Cultural Transformation, US Department of Veterans Affairs, Veterans Integrated Service Network 10, Veterans Integrated Service Network 12, VA MidSouth Healthcare Network
- Responsible party
- Sponsor
- Investigators
- Evelyn T Chang, MD MSHS, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CASusan E Stockdale, PhD MA, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050643
- Sponsor's protocol ID
- QUX 21-005
- Acronym
- RIVET
- Status last verified
- Oct 2025
- First submitted
- 9 Sep 2021
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39010160
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Complex, High-Risk Patients in Primary Care (QUE 20-018)
- ClinicalTrials.gov ID
- NCT05050643
- Acronym / sponsor ID
- RIVET / QUX 21-005
- Conditions
- Multimorbidity
- Keywords
- Primary Health Care, Multimorbidity, Medication Adherence, Needs Assessment, Mentoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Veterans Health Administration Office of Primary Care, Veterans Health Administration Office of Patient Centered Care & Cultural Transformation, US Department of Veterans Affairs, Veterans Integrated Service Network 10, Veterans Integrated Service Network 12, VA MidSouth Healthcare Network
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| CACP-EBQI-IC | Active comparator | Other: EBQI-ICIndividual (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. |
| CACP-EBQI-LC | Active comparator | Other: EBQI-LCLearning 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. |
| HCMA-EBQI-IC | Active comparator | Other: EBQI-ICIndividual (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). |
| HCMA-EBQI-LC | Active comparator | Other: EBQI-LCLearning 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any VA site nationwide
Key exclusion criteria (1 listed)
- Not a VA site nationwide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBQI-ICAlso: Individual ConsultationIndividual (ongoing) consultation (IC), often described as coaching or supervision, is endorsed by implementation experts as an effective implementation strategy | Other | CACP-EBQI-IC, HCMA-EBQI-IC |
| EBQI-LCAlso: Learning CollaborativeA 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 | CACP-EBQI-LC, HCMA-EBQI-LC |
Primary outcome
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)
Time frame: 18
This primary outcome aims to measure reach of the evidence practices to implement the EBP.
17 secondary outcomes
Number of PACT encounters from social worker, pharmacist, nurse and integrated mental health
Time frame: 18 months
Number of encounters from PACT pharmacist, social worker, nurse and integrated mental health
Time frame: 18 months
Comprehensiveness of Care questions from the RIVET Patient Survey- consisting of three items, which was sourced from the SHEP
Time frame: 18 months
Self-Management Support questions from the RIVET Patient Survey- sourced from the SHEP, which is two items in the survey.
Time frame: 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
Time frame: 18 months
Providers Discuss Medication Decisions (Patient Survey)
Time frame: 18 months
Self-Management Support (Patient Survey)
Time frame: 18 months
Total number of ambulatory care-sensitive and acute hospitalizations
Time frame: 18 months
Total number of ambulatory care-sensitive and and emergency department visits
Time frame: 18 months
Patient self-reported medication adherence This survey is a 3-item scale developed and validated in Veteran populations
Time frame: At the beginning and end of 18-month implementation period
Adherence to chronic medications (diabetes, hypertension, hyperlipidemia, mental health) (VA Pharmacy Data)
Time frame: The 18-month implementation period
Adoption of Evidence Based Practice (EBP)
Time frame: 30-months
HEDIS measures for diabetes, hypertension, hyperlipidemia management
Time frame: The 18-month implementation period
Fidelity
Time frame: 18 months
EBP Fidelity
Time frame: 18 months
Implementation costs
Time frame: 18 months
Facility adopting cost
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Derived from this study: PubMed 39010160Jimenez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBQI-IC and EBQI-LC in people with Multimorbidity, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05050643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.