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

Primary Purpose

Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Order Entry
Open Encounter
Follow-up booster Alert
Cold State outreach
Simplified
Sign-off alert
Pre-commitment
Different Risks
Standard Epic Basic Alert
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 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

Sites / Locations

  • Atrius Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Base Order Entry Alert

Base Open Encounter Alert

Order Entry + Follow-up booster Alert

Open Encounter + Follow-up booster Alert

Order Entry + Cold State outreach

Open Encounter + Cold State outreach

Order Entry + Simplified

Open Encounter + Simplified

Order Entry + Sign-off alert

Open Encounter + Sign-off alert

Order Entry + Pre-commitment

Open Encounter + Pre-commitment

Order Entry + Different Risks

Open Encounter + Different Risks

Standard Epic Basic Alert

No Alert (Usual Care)

Arm Description

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
February 23, 2020
Last Updated
February 8, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Atrius Health, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04284553
Brief Title
Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults
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
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Atrius Health, National Institutes of Health (NIH)

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 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 Phase 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 Phase 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 Phase 2. In Phase 2, the providers assigned in Phase 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 Phase 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 Phase 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.

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
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Base Order Entry Alert
Arm Type
Experimental
Arm Title
Base Open Encounter Alert
Arm Type
Experimental
Arm Title
Order Entry + Follow-up booster Alert
Arm Type
Experimental
Arm Title
Open Encounter + Follow-up booster Alert
Arm Type
Experimental
Arm Title
Order Entry + Cold State outreach
Arm Type
Experimental
Arm Title
Open Encounter + Cold State outreach
Arm Type
Experimental
Arm Title
Order Entry + Simplified
Arm Type
Experimental
Arm Title
Open Encounter + Simplified
Arm Type
Experimental
Arm Title
Order Entry + Sign-off alert
Arm Type
Experimental
Arm Title
Open Encounter + Sign-off alert
Arm Type
Experimental
Arm Title
Order Entry + Pre-commitment
Arm Type
Experimental
Arm Title
Open Encounter + Pre-commitment
Arm Type
Experimental
Arm Title
Order Entry + Different Risks
Arm Type
Experimental
Arm Title
Open Encounter + Different Risks
Arm Type
Experimental
Arm Title
Standard Epic Basic Alert
Arm Type
Experimental
Arm Title
No Alert (Usual Care)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Order Entry
Intervention Description
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Intervention Type
Other
Intervention Name(s)
Open Encounter
Intervention Description
An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
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)
Cold State outreach
Intervention Description
An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
Intervention Type
Other
Intervention Name(s)
Simplified
Intervention Description
The alert language itself will be simplified.
Intervention Type
Other
Intervention Name(s)
Sign-off alert
Intervention Description
An alert will display in the electronic health record when the medication is sent to sign-off for providers.
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)
Different Risks
Intervention Description
Risks of the high-risk medications will be framed differently.
Intervention Type
Other
Intervention Name(s)
Standard Epic Basic Alert
Intervention Description
This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
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
14 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
14 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
14 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
14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: NA
Facility Information:
Facility Name
Atrius Health
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33413494
Citation
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.
Results Reference
derived

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

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