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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • EVOLV-Rx dashboard

    Other intervention

    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.

Treatment groups

1,161 Participants
are divided into 1 treatment group
Group A: Stepped WedgeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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 CLCs.

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

Secondary outcomes

1

Average Count of Long-term medications

Meds used for 28+ days prior to or during CLC admission

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
2

Proportion of Veterans with Polypharmacy and hyperpolypharmacy

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

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
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 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.

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
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.

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

Other outcomes

Sponsors and contacts

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