NCT04284553

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 26, 2023

Completed
Last Updated

November 7, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

February 23, 2020

Results QC Date

July 6, 2023

Last Update Submit

October 16, 2024

Conditions

Keywords

BenzodiazepineSedative hypnoticOverprescribingAnticholinergic

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms

    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

    22 months (2 stages)

Study Arms (16)

Base Order Entry Alert

EXPERIMENTAL
Other: Order EntryOther: Enhanced Alert

Base Open Encounter Alert

EXPERIMENTAL
Other: Open EncounterOther: Enhanced Alert

Order Entry + Follow-up booster Alert

EXPERIMENTAL
Other: Order EntryOther: Follow-up booster AlertOther: Enhanced Alert

Open Encounter + Follow-up booster Alert

EXPERIMENTAL
Other: Open EncounterOther: Follow-up booster AlertOther: Enhanced Alert

Order Entry + Cold State outreach

EXPERIMENTAL
Other: Order EntryOther: Cold State outreachOther: Enhanced Alert

Open Encounter + Cold State outreach

EXPERIMENTAL
Other: Open EncounterOther: Cold State outreachOther: Enhanced Alert

Order Entry + Simplified

EXPERIMENTAL
Other: Order EntryOther: SimplifiedOther: Enhanced Alert

Open Encounter + Simplified

EXPERIMENTAL
Other: Open EncounterOther: SimplifiedOther: Enhanced Alert

Order Entry + Sign-off alert

EXPERIMENTAL
Other: Order EntryOther: Sign-off alertOther: Enhanced Alert

Open Encounter + Sign-off alert

EXPERIMENTAL
Other: Open EncounterOther: Sign-off alertOther: Enhanced Alert

Order Entry + Pre-commitment

EXPERIMENTAL
Other: Order EntryOther: Pre-commitmentOther: Enhanced Alert

Open Encounter + Pre-commitment

EXPERIMENTAL
Other: Open EncounterOther: Pre-commitmentOther: Enhanced Alert

Order Entry + Different Risks

EXPERIMENTAL
Other: Order EntryOther: Different RisksOther: Enhanced Alert

Open Encounter + Different Risks

EXPERIMENTAL
Other: Open EncounterOther: Different RisksOther: Enhanced Alert

Standard Epic Basic Alert

EXPERIMENTAL
Other: Order EntryOther: Standard Epic Basic Alert

No Alert (Usual Care)

NO INTERVENTION

Interventions

An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.

Base Order Entry AlertOrder Entry + Cold State outreachOrder Entry + Different RisksOrder Entry + Follow-up booster AlertOrder Entry + Pre-commitmentOrder Entry + Sign-off alertOrder Entry + SimplifiedStandard Epic Basic Alert

An alert will display in the electronic health record when the provider opens the chart of an eligible patient.

Base Open Encounter AlertOpen Encounter + Cold State outreachOpen Encounter + Different RisksOpen Encounter + Follow-up booster AlertOpen Encounter + Pre-commitmentOpen Encounter + Sign-off alertOpen Encounter + Simplified

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 AlertOrder Entry + Follow-up booster Alert

An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.

Open Encounter + Cold State outreachOrder Entry + Cold State outreach

The alert language itself will be simplified.

Open Encounter + SimplifiedOrder Entry + Simplified

An alert will display in the electronic health record when the medication is sent to sign-off for providers.

Open Encounter + Sign-off alertOrder Entry + Sign-off alert

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-commitmentOrder Entry + Pre-commitment

Risks of the high-risk medications will be framed differently.

Open Encounter + Different RisksOrder Entry + Different Risks

This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.

Standard Epic Basic 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.

Base Open Encounter AlertBase Order Entry AlertOpen Encounter + Cold State outreachOpen Encounter + Different RisksOpen Encounter + Follow-up booster AlertOpen Encounter + Pre-commitmentOpen Encounter + Sign-off alertOpen Encounter + SimplifiedOrder Entry + Cold State outreachOrder Entry + Different RisksOrder Entry + Follow-up booster AlertOrder Entry + Pre-commitmentOrder Entry + Sign-off alertOrder Entry + Simplified

Eligibility Criteria

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

You may qualify if:

  • Primary care provider at Atrius Health
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrius Health

Braintree, Massachusetts, 02184, United States

Location

Related Publications (2)

  • Lauffenburger JC, Isaac T, Trippa L, Glynn RJ, Russo M, Keller P, Robertson T, Kim DH, Bhatkhande G, Hanken KE, Haff N, Jungo KT, Crum KL, Blair MS, Brill G, Choudhry NK. Comparing Fourteen Behavioral Science Electronic Health Record Deprescribing Tools in Older Adults: NUDGE-EHR Adaptive Trial. J Am Geriatr Soc. 2025 Oct;73(10):3031-3043. doi: 10.1111/jgs.19609. Epub 2025 Jul 4.

  • 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.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Medical Order Entry Systems

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Hospital Information SystemsHospital AdministrationHealth Facility AdministrationOrganization and AdministrationHealth Services AdministrationManagement Information SystemsMedical Records Systems, ComputerizedMedical RecordsRecords

Results Point of Contact

Title
Niteesh Choudhry, MD, PhD
Organization
Brigham and Women's Hospital

Publication Agreements

PI is Sponsor Employee
Yes

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

February 23, 2020

First Posted

February 26, 2020

Study Start

October 13, 2020

Primary Completion

August 1, 2022

Study Completion

August 31, 2022

Last Updated

November 7, 2024

Results First Posted

October 26, 2023

Record last verified: 2024-10

Locations