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

October 20, 2025 updated by: VA Office of Research and Development

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4551
        • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
        • Contact:
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas R. Radomski, MD MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

  • The coordinator will ensure the presence of inclusion/exclusion criteria via chart review and using the EVOLV-Rx dashboard, they will then flag the patient if they are receiving hospice care and should be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Count of Low-Value Practices per 100 Veterans as per the EVOLV-rx metric
Time Frame: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
The primary effectiveness outcome is the count of LVP practices per 100 Veterans as per the EVOLV-Rx metric, which the investigators will consistently assess monthly from the start of the pre-implementation usual care phase through quarter 10. Data on LVP will be obtained from the VA Corporate Data Warehouse (CDW), including BCMA data, to fully capture Veterans' duration of medication use and pertinent diagnoses incorporated in the EVOLV-Rx criteria. A low-value medication will be characterized as discontinued if its discontinuation is sustained for 7 days, as this duration is unlikely to represent a temporary discontinuation of the medication. As per RE-AIM, maintenance will be determined via the assessment of the primary effectiveness outcomes at 6 and 12 months after the start of the intervention in each step of CLCs.
Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average Count of Long-term medications
Time Frame: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
Meds used for 28+ days prior to or during CLC admission
Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
Proportion of Veterans with Polypharmacy and hyperpolypharmacy
Time Frame: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
Polypharmacy (5+ drugs), Hyperpolypharmacy (10+ drugs)
Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
Proportion of Veterans with Adverse drug reactions
Time Frame: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
All VA ED/hospital transfers will be evaluated quarterly for potential Adverse Drug Reactions (ADR) via the Naranjo algorithm, which will be applied via EHR review. The Naranjo algorithm is a 10-point questionnaire to determine whether a suspected ADR is due to a drug rather than other factors.
Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
Proportion of Veterans with Adverse drug withdrawal events
Time Frame: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
The Naranjo algorithm may also be applied to assess for adverse drug withdrawal events occurring in the period after medication withdrawal.
Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
Average Count of ED visits/hospitalizations
Time Frame: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation
As CLC residents may be transferred to the Emergency Department (ED) or hospitalized at a non-VA facility, the investigators will query both CDW and Medicare Data available through VIREC to assess the count of ED visits and hospitalizations. Count and review of ED visits/hospitalizations will be assessed retrospectively, given the delay in the availability of Medicare data.
Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas R. Radomski, MD MS, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIR 23-132
  • 1I01HX003849 (U.S. NIH Grant/Contract: VA Office of Research and Development)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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