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Low-Value CareNCT07166107

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

A study testing EVOLV-Rx dashboard in people with Low-Value Care, run by VA Office of Research and Development at 3 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Low-Value Care
What is being tested?
EVOLV-Rx dashboard
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,161 participants
Where
3 sitesUnited States
Study dates
1 Oct 2026to 31 Dec 2028
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Veterans admitted to a participating VISN 4 Community Living Center (CLC) at the time of the required medication review

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104-4551

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

  • Wilkes-Barre VA Medical Center, Wilkes-Barre, PA

    Wilkes-Barre, Pennsylvania, 18711

Other trials in United States

About this study

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.

Read the 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.

Conditions
Low-Value Care
Being tested
EVOLV-Rx dashboard
Keywords
Nursing Homes, Inappropriate Prescribing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVOLV-Rx dashboardOther

    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.

Study groups in NCT07166107
Study groupRoleWhat they receive
Stepped WedgeExperimentalAs 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.
Receives: Other: EVOLV-Rx dashboard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Count of Low-Value Practices (LVP) per 100 Veterans as per the EVOLV-rx metric

    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 Community Living Centers (CLCs).

    Measured: 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 outcomes (5)
  1. Average Count of Long-term medications

    Meds used for 28+ days prior to or during Community Living Centers (CLCs) admission

    Measured: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation

  2. Proportion of Veterans with Polypharmacy and hyperpolypharmacy

    Polypharmacy (5+ drugs), Hyperpolypharmacy (10+ drugs)

    Measured: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation

  3. Proportion of Veterans with Adverse drug reactions

    All VA emergency department (ED)/hospital transfers will be evaluated quarterly for potential Adverse Drug Reactions (ADR) via the Naranjo algorithm, which will be applied via Electronic Health Record (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.

    Measured: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation

  4. Proportion of Veterans with Adverse drug withdrawal events

    The Naranjo algorithm may also be applied to assess for adverse drug withdrawal events occurring in the period after medication withdrawal.

    Measured: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation

  5. Average Count of emergency department (ED) visits/hospitalizations

    As Community Living Centers (CLCs) residents may be transferred to the emergency department (ED) or hospitalized at a non-VA facility, the investigators will query both Corporate Data Warehouse (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.

    Measured: Baseline (starting an average of one year prior to implementation of intervention) through study completion, average time frame of 3.25 years of observation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start1 Oct 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Not applicable
Intervention model
Sequential
Model description
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).
Masking
None (open label)
Enrolment
1,161 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07166107
Sponsor's protocol ID
IIR 23-132
Other IDs
1I01HX003849
Status last verified
Oct 2026
First submitted
2 Sep 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burke RE, Hutchins F, Heintz J, Patel SR, Appel S, Norman J, Gupta A, Rose L, Werner RM. Size of the Financial Incentives in Medicare's Skilled Nursing Facility Value-Based Purchasing Program. JAMA Netw Open. 2025 Sep 2;8(9):e2533369. doi: 10.1001/jamanetworkopen.2025.33369.

    PubMed 40991286
  • Rose L, Wagner TH. The Future of the VA-The Privatization Debate. JAMA Health Forum. 2025 Sep 5;6(9):e253183. doi: 10.1001/jamahealthforum.2025.3183.

    PubMed 40971164

Questions about this trial

What is this clinical trial studying?

A study testing EVOLV-Rx dashboard in people with Low-Value Care, 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 2 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: enrolling by invitation, as of the sponsor's last update on 14 Oct 2026. 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?

Count of Low-Value Practices (LVP) 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). 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 NCT07166107, which also lists 2 linked publications.

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 14 Oct 2026.

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