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

NCT07166107 | Not Yet Recruiting DMC

• 2 other identifiers: IIR 23-1321I01HX003849
• Study Type: interventional
• Target: 1,161
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Low-Value Care

Keywords

Nursing Homes; Inappropriate Prescribing

Outcome Measures

Primary Outcomes (1)

• Count of Low-Value Practices 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 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 Outcomes (5)

• Average Count of Long-term medications

  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

  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

  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

  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

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

Study Arms (1)

Stepped Wedge

EXPERIMENTAL

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

Interventions

EVOLV-Rx dashboard 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.

Stepped Wedge

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Study Officials

• Thomas R. Radomski, MD MS

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas R Radomski, MD MS

CONTACT

(412) 360-2271; Thomas.Radomski@va.gov

Loren J Schleiden, MS

CONTACT

(412) 360-2132; Loren.Schleiden@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)