Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults (NUDGE-EHR)

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: Completed
• 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; Other: Order Entry; Other: Open Encounter; Other: Cold State outreach; Other: Simplified; Other: Sign-off alert; Other: Different Risks; Other: Standard Epic Basic Alert

Detailed Description

This is an adaptive 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 and acute care practices of Atrius Health, a large integrated delivery network in eastern and central Massachusetts, which uses the Epic EHR system.

In Stage 1, approximately 200 primary care providers at Atrius Health will be randomized to receive usual care or an active intervention. Providers randomized to the active intervention will be randomly assigned to one of 15 active intervention arms. They will then be followed for 6 months. Providers randomized to one of the 15 active intervention arms will receive a newly-designed EHR tool to guide their care of eligible patients. 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 in the last 180 days.

At the end of Stage 1 follow-up, the 15 active intervention arms will be ranked based on their observed effectiveness at reducing prescribing high-risk medications and select up to the 5 more promising arms for Stage 2. In Stage 2, the providers assigned in Stage 1 to usual care will be randomized with equal probability to be assigned to one of the 5 most promising treatment arms identified or usual care. Providers randomized to one of up to the 5 selected treatment arms will receive an EHR tool to guide their care of eligible patients. After this analysis, the Stage 1 providers in the "winning" arms (i.e., the promising arms) will be randomly assigned to continue to receive their original treatment assignments or to usual care. Similarly, the Stage 1 providers assigned to treatment arms determined to be statistically inferior will be randomly assigned in equal proportions to one of the winning arms or to usual care.

After Stage 2, we will evaluate the effectiveness of the tools by comparing the effectiveness of the behavioral principles contained within the tools on outcomes, combining data across both Stages. This is our primary analytic approach.

No participant (patient or provider) provided consent for participation, as this trial received a waiver of informed consent and authorization for use of study data.

The Mass General Brigham trial described in the protocol is described in another clinicaltrials.gov record (NCT05538065).

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Braintree, Massachusetts, United States, 02184
      • Atrius Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary care provider at Atrius Health

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.

Exclusion Criteria:

• NA

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

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Base Order Entry Alert	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: Order Entry; An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Experimental: Base Open Encounter Alert	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: Open Encounter; An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Experimental: Order Entry + Follow-up booster Alert	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; Other: Order Entry; An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Experimental: Open Encounter + Follow-up booster Alert	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; Other: Open Encounter; An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Experimental: Order Entry + Cold State outreach	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: Order Entry; An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.; Other: Cold State outreach; An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Experimental: Open Encounter + Cold State outreach	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: Open Encounter; An alert will display in the electronic health record when the provider opens the chart of an eligible patient.; Other: Cold State outreach; An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Experimental: Order Entry + Simplified	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: Order Entry; An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.; Other: Simplified; The alert language itself will be simplified.
Experimental: Open Encounter + Simplified	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: Open Encounter; An alert will display in the electronic health record when the provider opens the chart of an eligible patient.; Other: Simplified; The alert language itself will be simplified.
Experimental: Order Entry + Sign-off alert	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: Order Entry; An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.; Other: Sign-off alert; An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Experimental: Open Encounter + Sign-off alert	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: Open Encounter; An alert will display in the electronic health record when the provider opens the chart of an eligible patient.; Other: Sign-off alert; An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Experimental: Order Entry + Pre-commitment	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.; Other: Order Entry; An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Experimental: Open Encounter + Pre-commitment	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.; Other: Open Encounter; An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Experimental: Order Entry + Different Risks	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: Order Entry; An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.; Other: Different Risks; Risks of the high-risk medications will be framed differently.
Experimental: Open Encounter + Different Risks	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: Open Encounter; An alert will display in the electronic health record when the provider opens the chart of an eligible patient.; Other: Different Risks; Risks of the high-risk medications will be framed differently.
Experimental: Standard Epic Basic Alert	Other: Order Entry; An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.; Other: Standard Epic Basic Alert; This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
No Intervention: No Alert (Usual Care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms	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. As noted in the Outcome Measure Time Frame below, these outcomes were measured and presented across both stages of the adaptive trial at Atrius Health rather than separately, as this was part of the pre-specified analytic plan.	22 months (2 stages)
Change in Inappropriate Prescribing by the Seven Behavioral Intervention Factors (Open Encounter Timing, Boostering, Cold-state Priming, Simplification, Sign-off Approval, Pre-commitment, and Risk Framing): Primary Analysis Approach	This outcome is measured as a binary 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 using EHR data by the primary care provider in the arm. If the provider performed any of these actions, then the patient was considered as having a change in prescribing (i.e., a reduction in inappropriate prescribing). As noted in the Time Frame below, these outcomes were measured and analyzed across both Stages of the trial in the primary analysis. The following outcomes are shown stratified by patients who were in arms containing one of the seven behavioral intervention factors and also among those in arms that did not contain an intervention factor. The primary analysis conducts analyses by intervention factor; the model treats patients in arms that do not contain any of the behavioral factors (i.e., Base Order Entry Alert, Standard Epic Basic Alert, and Usual Care) as the referent.	22 months (2 stages)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms	This outcome is measured on the patient level as the number of lorazepam milligram equivalents of high-risk medications prescribed to patients by the primary care provider included the study arm over the follow-up for the relevant adaptive trial stage, measured within the EHR system. This outcome was measured as a continuous outcome. As noted in the Outcome Measure Time Frame below, these outcomes were measured and presented across both stages of the adaptive trial at Atrius Health rather than separately, as this was part of the pre-specified analytic plan.	22 months (2 stages)
Quantity of Prescribing by the Seven Behavioral Intervention Factors (Open Encounter Timing, Boostering, Cold-state Priming, Simplification, Sign-off Approval, Pre-commitment, and Risk Framing): Primary Analysis Approach	This outcome is measured on the patient level as the number of lorazepam milligram equivalents of high-risk medications prescribed to patients by the primary care provider included the study arm over the follow-up for the relevant adaptive trial stage, measured in the EHR system. This outcome was measured as a continuous outcome. As noted in the Time Frame below, these outcomes were measured and analyzed across both Stages of the trial in the primary analysis. The following outcomes are shown stratified by patients who were in arms containing one of the seven behavioral intervention factors and also among those in arms that did not contain an intervention factor. The primary analysis conducts analyses by intervention factor; the model treats patients in arms that do not contain any of the behavioral factors (i.e., Base Order Entry Alert, Standard Epic Basic Alert, and Usual Care) as the referent.	22 months (2 stages)

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	14 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	14 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institutes of Health (NIH); Atrius Health

Publications and helpful links

General Publications

• Lauffenburger JC, Isaac T, Trippa L, Keller P, Robertson T, Glynn RJ, Sequist TD, Kim DH, Fontanet CP, Castonguay EWB, Haff N, Barlev RA, Mahesri M, Gopalakrishnan C, Choudhry NK. Rationale and design of the Novel Uses of adaptive Designs to Guide provider Engagement in Electronic Health Records (NUDGE-EHR) pragmatic adaptive randomized trial: a trial protocol. Implement Sci. 2021 Jan 7;16(1):9. doi: 10.1186/s13012-020-01078-9.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 23, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 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: 2019P002167

Drug and device information, study documents

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