NUDGE-EHR Replication Trial at Mass General Brigham

Mass General Brigham

Status: Completed

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

Treatments: Other: Follow-up booster Alert; Other: Enhanced Alert; Other: Pre-commitment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05538065

2019A013684

R33AG057388 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This is a cluster randomized control trial (RCT) to evaluate whether newly designed EHR-based tools designed using behavioral principles reduce inappropriate prescribing and adverse outcomes among older adults. This study will be conducted in outpatient primary care practices at Mass General Brigham (MGB), specifically Massachusetts General Hospital. MGB has a fully functional EHR, EpicCare, that supports computerized ordering of medications. MGB is comprised of 150 outpatient practices with over 1,800 physicians.

In this trial, approximately 190 primary care providers at MGH will be randomized to receive usual care or an active intervention. Providers randomized to one of the 2 selected treatment arms will receive an EHR tool to guide their care of eligible patients. They will be followed for 12 months. Providers randomized to usual care will receive no newly-designed EHR tool. Providers will receive these EHR tools for their patients who meet the following criteria: 1) older adults (aged 65 years or more), and 2) who have been prescribed at least 90 pills of benzodiazepine or sedative hypnotic or have been prescribed at least one active orders of at least 90 pills of two different anticholinergics in the last 180 days.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary care provider at Mass General Brigham

Providers will receive these EHR tools for their patients who meet the following criteria:

1. older adults (aged 65 years or more)
2. 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.

Exclusion criteria

• N/A

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 3 patient groups

No Alert (Usual Care)

No Intervention group

Description:

Providers randomized to usual care will receive no intervention.

Open Encounter + Pre-commitment

Experimental group

Description:

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.

Treatment:

Other: Pre-commitment

Other: Enhanced Alert

Open Encounter + Follow-up booster

Experimental group

Description:

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.

Treatment:

Other: Enhanced Alert

Other: Follow-up booster Alert