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

Primary Purpose

Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Follow-up booster Alert
Pre-commitment
Enhanced Alert
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Aging focused on measuring Benzodiazepine, Sedative hypnotic, Overprescribing, Anticholinergic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mass General BrighamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No Alert (Usual Care)

Open Encounter + Pre-commitment

Open Encounter + Follow-up booster

Arm Description

Providers randomized to usual care will receive no intervention.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2022
Last Updated
November 14, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, National Institutes of Health (NIH), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05538065
Brief Title
NUDGE-EHR Replication Trial at Mass General Brigham
Acronym
NUDGE-EHR
Official Title
Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction, Adverse Drug Event
Keywords
Benzodiazepine, Sedative hypnotic, Overprescribing, Anticholinergic

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Alert (Usual Care)
Arm Type
No Intervention
Arm Description
Providers randomized to usual care will receive no intervention.
Arm Title
Open Encounter + Pre-commitment
Arm Type
Experimental
Arm 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.
Arm Title
Open Encounter + Follow-up booster
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Follow-up booster Alert
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Pre-commitment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Alert
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in inappropriate prescribing
Description
Composite of 1) discontinuation of study high-risk medications or 2) ordering a gradual dose taper (for benzodiazepine or sedative hypnotics) using EHR data
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quantity of high-risk medication prescribed
Description
Number of milligram equivalents of high-risk medications prescribed to patients in the follow-up period using EHR data
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Quantity of high-risk medication dispensed
Description
Number of milligram equivalents of high-risk medications filled by patients, in follow-up, using pharmacy claims data
Time Frame
12 months
Title
Occurrence of clinically-significant adverse drug events
Description
Occurrence of sedation or cognitive impairment, and all-cause hospitalizations and falls or fractures, measured in administrative claims data
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie C Lauffenburger, PharmD, PhD
Phone
617-525-8865
Email
jlauffenburger@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Niteesh K Choudhry, MD, PhD
Phone
617-278-0930
Email
nkchoudhry@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niteesh K Choudhry, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mass General Brigham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

NUDGE-EHR Replication Trial at Mass General Brigham

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