NUDGE-EHR Replication Trial at Mass General Brigham (NUDGE-EHR)

Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging; Adverse Drug Event; Benzodiazepine Sedative Adverse Reaction; Anticholinergic Adverse Reaction
• Intervention / Treatment: Other: Pre-commitment; Other: Enhanced Alert; Other: Follow-up booster Alert

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass General Brigham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Alert (Usual Care); Providers randomized to usual care will receive no intervention.
Experimental: Open Encounter + Pre-commitment; 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; 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.; Other: Enhanced Alert; 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.
Experimental: Open Encounter + Follow-up booster; 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: Enhanced Alert; 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.; Other: Follow-up booster Alert; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in inappropriate prescribing	Composite of 1) discontinuation of study high-risk medications or 2) ordering a gradual dose taper (for benzodiazepine or sedative hypnotics) using EHR data	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of high-risk medication prescribed	Number of milligram equivalents of high-risk medications prescribed to patients in the follow-up period using EHR data	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of high-risk medication dispensed	Number of milligram equivalents of high-risk medications filled by patients, in follow-up, using pharmacy claims data	12 months
Occurrence of clinically-significant adverse drug events	Occurrence of sedation or cognitive impairment, and all-cause hospitalizations and falls or fractures, measured in administrative claims data	12 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital; National Institutes of Health (NIH); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Niteesh K Choudhry, MD, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): March 15, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Benzodiazepine; Anticholinergic; Sedative hypnotic; Overprescribing
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 2019A013684; R33AG057388 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No