EVOLV-Rx VA: Evaluating Opportunities to Decrease Low-Value Prescribing in Community Living Centers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-01

Study Completion Date

2028-12-31

Brief Summary

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The investigators developed EVOLV-Rx (Evaluating Opportunities to Decrease Low-Value Prescribing), a novel clinical support tool to detect 18 evidence-based and clinically useful low-value prescribing practices in older adults. The objective is to conduct a hybrid study to assess the effectiveness and implementation of an EVOLV-Rx-based intervention to reduce LVP among older Veterans who reside in CLCs in VISN 4.

In Aim 1, the investigators will conduct focus groups of VISN 4 CLC leaders, clinicians, Veterans, and family caregivers, where the investigators will characterize the patient, clinician, and CLC-level barriers to and facilitators of implementation; and identify and tailor strategies to optimize the intervention's adoption and implementation. In Aim 2, the investigators will conduct a hybrid type 2 effectiveness implementation trial to compare the intervention to usual care, using a stepped wedge design in five VISN 4 CLCs. The primary effectiveness outcome is the count of low-value prescribing practices per 100 Veterans. In Aim 3, the investigators will conduct an embedded process evaluation to study implementation processes, their impact on outcomes, and iteratively improve the implementation of the intervention. The investigators will also conduct semi-structured interviews of clinicians, Veterans, and family caregivers to characterize the appropriateness, feasibility, acceptability, and perceived effectiveness of the intervention and implementation strategies employed.

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Detailed Description

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Background: More than half of Veterans aged 65 years who reside in Community Living Centers (CLCs) are subject to low-value prescribing, placing them at increased risk of adverse drug events, hospitalization, and death. CLCs represent an ideal setting to safely reduce low-value prescribing; however, no intervention to broadly reduce low-value prescribing has been successfully integrated into routine care or implemented at scale across CLCs. In response, the investigators developed EVOLV-Rx (Evaluating Opportunities to Decrease Low-Value Prescribing), a novel clinical support tool to detect 18 evidence-based and clinically useful low-value prescribing practices in older adults per an expert Delphi panel and further informed by patient, caregiver, and clinician input.

Significance: The objective is to conduct a hybrid study to assess the effectiveness and implementation of an EVOLV-Rx-based intervention to reduce LVP among older Veterans who reside in CLCs in VISN 4. This study will support VA's evolution as a learning healthcare system and is aligned with VA's key strategic healthcare priority of becoming the most age-friendly healthcare system in the United States. It also aligns with two VA HSR topic areas of interest, including improving healthcare quality and value and long-term care and aging. Innovation \& Impact: EVOLV-Rx is a novel tool to detect low-value prescribing. Its unique characteristics and automated application will enable pharmacists to provide detailed recommendations to clinicians to prioritize medications for deprescribing with high clinical impact and that may be acceptably deprescribed from the perspective of patients and caregivers. EVOLV-Rx represents a substantial departure from the status quo, and its use will enhance deprescribing in CLCs and overcome several previously described implementation barriers.

Specific Aims: 1) To finalize the adaptable elements of, and implementation playbook for, the EVOLV-Rx intervention to reduce low-value prescribing for older Veterans residing in CLCs, 2) To assess the effectiveness of the EVOLV-Rx intervention to reduce low-value prescribing, 3) To evaluate and iteratively improve the implementation of the EVOLV-Rx intervention.

Methodology: Using the Theradoc clinical support platform, the intervention is an electronic EVOLV-Rx dashboard used by pharmacists to provide deprescribing recommendations to clinicians to reduce LVP as part of each Veteran's required medication review. The intervention will be translated into clinical practice in VISN 4 CLCs using a playbook of core implementation strategies previously employed in VA and additional strategies determined by key shareholders to address specific implementation barriers identified as part of the study. In Aim 1, the investigators will conduct focus groups of VISN 4 CLC leaders, clinicians, Veterans, and family caregivers, where the investigators will characterize the patient, clinician, and CLC-level barriers to and facilitators of implementation; and identify and tailor strategies to optimize the intervention's adoption and implementation. In Aim 2, the investigators will conduct a hybrid type 2 effectiveness implementation trial to compare the intervention to usual care, using a stepped wedge design in five VISN 4 CLCs. The primary effectiveness outcome is the count of low-value prescribing practices per 100 Veterans. In Aim 3, the investigators will conduct an embedded process evaluation to study implementation processes, their impact on outcomes, and iteratively improve the implementation of the intervention. The investigators will also conduct semi-structured interviews of clinicians, Veterans, and family caregivers to characterize the appropriateness, feasibility, acceptability, and perceived effectiveness of the intervention and implementation strategies employed.

Next Steps/Implementation: Leveraging VA infrastructure, the commitment of the investigators' operational partners, and the deep expertise of the research team, this proposal will result in a scalable intervention and accompanying implementation playbook to reduce low-value prescribing among Veterans receiving care in CLCs. It will also inform its deployment as a national multi-site trial to further evaluate and optimize its implementation throughout VA.

Conditions

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Low-Value Care

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

In Aim 2, the investigators will conduct a randomized hybrid type 2 effectiveness implementation study applying a stepped wedge design to compare the EVOLV-Rx intervention to usual care. In the stepped wedge design, each CLC serves as its own control rather than sites being allocated to distinct control and intervention arms. This will enable all participating CLCs to receive the intervention, as is the desire of the operational partners in VISN 4 and will enhance the power to detect differences in outcomes relative to a traditional cluster randomized design. The stepped wedge design also allows for a sequential rollout of the intervention at each CLC. (Aims 1 and 3 are qualitative, and do not involve any intervention model).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Stepped Wedge

As part of the Stepped Wedge design, each CLC serves as its own control rather than sites being allocated to distinct control and intervention arms. All sites will receive the intervention.

Group Type EXPERIMENTAL

EVOLV-Rx dashboard

Intervention Type OTHER

Using the TheraDoc® platform, the investigators will deploy a custom-designed EVOLV-Rx dashboard that incorporates all 18 components of the EVOLV-Rx metric. \[Within TheraDoc®, the dashboard will display an automated report in the form of a patient list that includes the names, locations, and specific LVP practices to which Veterans under their care are subject. Pharmacists will then query specific patients on the list as part of their required medication review. The dashboard will provide detailed clinical decision support by identifying the specific EVOLV-Rx LVP criteria met by each flagged medication and provide access to the patient's full medication list, problem list, and laboratory or testing data contained within VISTA.\] Pharmacists may use the EVOLV-Rx dashboard to track Veterans' receipt of LVP practices and quickly document actions related to the intervention, such as patient and family caregiver engagement, deprescribing LVP practices, or any other medications discontinued.

Interventions

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EVOLV-Rx dashboard

Using the TheraDoc® platform, the investigators will deploy a custom-designed EVOLV-Rx dashboard that incorporates all 18 components of the EVOLV-Rx metric. \[Within TheraDoc®, the dashboard will display an automated report in the form of a patient list that includes the names, locations, and specific LVP practices to which Veterans under their care are subject. Pharmacists will then query specific patients on the list as part of their required medication review. The dashboard will provide detailed clinical decision support by identifying the specific EVOLV-Rx LVP criteria met by each flagged medication and provide access to the patient's full medication list, problem list, and laboratory or testing data contained within VISTA.\] Pharmacists may use the EVOLV-Rx dashboard to track Veterans' receipt of LVP practices and quickly document actions related to the intervention, such as patient and family caregiver engagement, deprescribing LVP practices, or any other medications discontinued.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Veterans aged 65+ admitted to a participating VISN 4 CLC at the time of the required medication review.

Exclusion Criteria

* Veterans receiving hospice care, as the discontinuation of medications in EVOLV-Rx (e.g., benzodiazepines) may result in undue discomfort.

During both the usual care and intervention period of the study, the study coordinator will query the EVOLV-Rx dashboard weekly.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No