NCT06660979

Brief Summary

The overall goal of the proposed research is to refine and adapt and perform efficacy testing of a novel reinforcement learning-based approach to personalizing EHR-based tools for PCPs on deprescribing of high-risk medications for older adults. The trial will be conducted at Atrius Health, an integrated delivery network in Massachusetts, and will intervene upon primary care providers. The investigators will conduct a cluster randomized trial using reinforcement learning to adapt electronic health record (EHR) tools for deprescribing high-risk medications versus usual care. 70 PCPs will be randomized (i.e., 35 each to the reinforcement learning intervention and usual care \[no EHR tool\] in each arm) to the trial and follow them for approximately 30 weeks. The primary outcome will be discontinuation or ordering a dose taper for the high-risk medications for eligible patients by included primary care providers, using EHR data at Atrius. The primary hypothesis is that the personalized intervention using reinforcement learning will improve deprescribing compared with usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

August 11, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2026

Completed
Last Updated

April 2, 2026

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

October 24, 2024

Last Update Submit

March 30, 2026

Conditions

Keywords

Medication optimizationHigh-risk medications

Outcome Measures

Primary Outcomes (1)

  • Discontinuation or taper for high-risk medication

    Deprescribing will be assessed using routinely collected data from the EHR system for eligible patients flagged as in need of deprescribing. The deprescribing outcome will be a "reduction" in inappropriate prescribing, defined as either discontinuation of one the the medication classes of interest or ordering a dose taper.

    Through trial completion, up to 7 months

Secondary Outcomes (1)

  • Discontinuation of high-risk medication

    Through trial completion, up to 7 months

Study Arms (2)

Reinforcement learning intervention

EXPERIMENTAL

The intervention is a reinforcement learning program that personalizes EHR-based tools for PCPs to promote deprescribing high-risk medications over follow-up. The reinforcement learning intervention selects a tool for each provider based on an algorithm from an inventory of EHR tools and chooses tools that are predicted to motivate action for the individual provider. The effectiveness of each tool will be assessed on a selected interval based on whether a deprescribing action is taken by PCPs for eligible patients. The algorithm is trained to maximize these actions over time.

Behavioral: Reinforcement learning

Usual care

NO INTERVENTION

No EHR-based tools provided beyond those used in regular clinical practice.

Interventions

The intervention is a reinforcement learning program that personalizes EHR-based tools for PCPs to promote deprescribing high-risk medications over follow-up. The reinforcement learning intervention selects a tool for each provider based on an algorithm from an inventory of EHR tools and chooses tools that are predicted to motivate action for the individual provider. The inventory of EHR tools from which the algorithm will choose include the following potential factors: open encounter, order entry, cold-state outreach, simplification, and risk framing.

Reinforcement learning intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The trial will intervene upon primary care providers (including physicians and PCP-designated nurse practitioners and physician assistants) at Atrius Health.
  • Patients of the PCPs will be included in the intervention and analysis if they are \>/=65 years of age and have been prescribed \>/= 90 pills of high-risk medications in the prior 180 days based on EHR data.

You may not qualify if:

  • Not a primary care provider at Atrius Health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrius Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Reinforcement Machine Learning

Intervention Hierarchy (Ancestors)

Machine LearningArtificial IntelligenceAlgorithmsMathematical Concepts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 28, 2024

Study Start

August 11, 2025

Primary Completion

March 27, 2026

Study Completion

March 27, 2026

Last Updated

April 2, 2026

Record last verified: 2025-11

Locations