NUDGE-EHR Replication Trial at Mass General Brigham

NCT05538065 | Completed Results DMC

• 2 other identifiers: 2019A013684R33AG057388
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable older adults, such as confusion or sedation, leading to hospitalizations, falls, and fractures. Fortunately, most of these consequences are preventable. Physicians' lack of awareness of alternatives, ambiguous practice guidelines, and perceived pressure from patients or caregivers are among the reasons why these drugs are used more than might be optimal. Reducing inappropriate use of these drugs may be achieved through decision support tools for providers that are embedded in electronic health record (EHR) systems. While EHR strategies are widely used to support the informational needs of providers, these tools have demonstrated only modest effectiveness at improving prescribing. The effectiveness of these tools could be enhanced by leveraging principles of behavioral economics and related sciences.

Conditions

Aging; Benzodiazepine Sedative Adverse Reaction; Anticholinergic Adverse Reaction; Adverse Drug Event

Keywords

Benzodiazepine; Sedative hypnotic; Overprescribing; Anticholinergic

Outcome Measures

Primary Outcomes (1)

• Change in Inappropriate Prescribing

  This outcome is measured as a composite of 1) discontinuation of study high-risk medications (i.e., active discontinuation or lack of an order during follow-up) or 2) ordering a dose taper (for benzodiazepine or sedative hypnotics) using EHR data by the primary care provider included in the study arm. If any of these actions occurred by the primary care provider, then the patient was considered to have had a change in prescribing (i.e., a reduction in inappropriate prescribing). This outcome was measured as a binary outcome.

  Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participant

Secondary Outcomes (2)

• Quantity of High-risk Medication Prescribed

  Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participant

• Cumulative Lorazepam Milligram Equivalents Prescribed

  Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participant

Study Arms (3)

No Alert (Usual Care)

NO INTERVENTION

Providers randomized to usual care will receive no intervention.

Open Encounter + Pre-commitment

EXPERIMENTAL

There will be an enhanced EHR alert, known as a Best Practice Advisory \[BPA\], which will appear on each provider's EHR screen. We will also test a two-staged pre-commitment BPA in which the providers are prompted to discuss risks of the high-risk medications and share a handout about risks with their patients.

Other: Pre-commitment; Other: Enhanced Alert

Open Encounter + Follow-up booster

EXPERIMENTAL

There will be an enhanced EHR alert, known as a Best Practice Advisory \[BPA\], which will appear on each provider's EHR screen. We will add a boostering option in the enhanced BPA, which is a provider-directed option for a follow-up in-basket message sent 4 weeks after the BPA is triggered.

Other: Follow-up booster Alert; Other: Enhanced Alert

Interventions

Follow-up booster Alert OTHER

Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered

Open Encounter + Follow-up booster

Pre-commitment OTHER

A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.

Open Encounter + Pre-commitment

Enhanced Alert OTHER

An enhanced alert (known as a Best Practice Advisory \[BPA\]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.

Open Encounter + Follow-up booster; Open Encounter + Pre-commitment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care provider at Mass General Brigham
• Providers will receive these EHR tools for their patients who meet the following criteria:
• older adults (aged 65 years or more)
• who have been prescribed at least 90 pills of benzodiazepine or sedative hypnotic in the last 180 days.
• Outcomes will be measured on the patient level.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts General Hospital: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Lauffenburger JC, Sung M, Glynn RJ, Keller PA, Robertson T, Kim DH, Bhatkhande G, Jungo KT, Haff N, Hanken KE, Isaac T, Choudhry NK. Electronic Health Record Intervention and Deprescribing for Older Adults: A Randomized Clinical Trial. JAMA. 2026 Jan 29:e2526967. doi: 10.1001/jama.2025.26967. Online ahead of print.

  PMID: 41609788 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Results Point of Contact

• Title: Niteesh Choudhry
• Organization: Brigham and Women's Hospital

nkchoudhry@bwh.harvard.edu

617-278-0930

Study Officials

• Niteesh K Choudhry, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Niteesh K. Choudhry, MD, PhD, Professor, Harvard Medical School

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: November 10, 2022
• Primary Completion: March 15, 2024
• Study Completion: June 15, 2024
• Last Updated: May 21, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-05

Locations

US (1)