Trial Outcomes & Findings for NUDGE-EHR Replication Trial at Mass General Brigham (NCT NCT05538065)
NCT ID: NCT05538065
Last Updated: 2025-05-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
201 participants
Primary outcome timeframe
Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participant
Results posted on
2025-05-21
Participant Flow
Primary care providers were cluster-randomized to these arms based on data available from the electronic health record and were not recruited directly for the trial or evaluated for effectiveness outcomes. Patients were also not intervened upon nor directly enrolled into the study. As such, we received a waiver of informed consent for participation.
Primary care providers were identified from electronic health record data and cluster randomized to a study arm. Patients who sought care from these primary care providers were identified based on electronic health record data for analyses and are classified as the participants. Providers were not assessed for effectiveness outcomes.
Unit of analysis: Primary care providers
Participant milestones
| Measure |
No Alert (Usual Care)
Providers randomized to usual care will receive no intervention.
|
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.
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.
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.
|
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.
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
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
396 67
|
394 67
|
356 67
|
|
Overall Study
COMPLETED
|
396 67
|
394 67
|
356 67
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NUDGE-EHR Replication Trial at Mass General Brigham
Baseline characteristics by cohort
| Measure |
No Alert (Usual Care)
n=396 Participants
Providers randomized to usual care will receive no intervention.
|
Open Encounter + Pre-commitment
n=394 Participants
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.
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.
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.
|
Open Encounter + Follow-up Booster
n=356 Participants
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.
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
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.
|
Total
n=1146 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
73.7 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
73.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
73.6 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
275 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
799 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
347 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
364 Participants
n=5 Participants
|
348 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
1018 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
350 Participants
n=5 Participants
|
347 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
995 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participantPopulation: Patients who met eligibility criteria for inclusion in the analysis (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine, strongly anticholinergic medication, or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider who was assigned to a study arm), as measured from EHR system data.
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.
Outcome measures
| Measure |
No Alert (Usual Care)
n=396 Participants
Providers randomized to usual care will receive no intervention.
|
Open Encounter + Pre-commitment
n=394 Participants
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.
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.
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.
|
Open Encounter + Follow-up Booster
n=356 Participants
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.
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
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.
|
|---|---|---|---|
|
Change in Inappropriate Prescribing
|
106 Participants
|
145 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participantPopulation: Patients who met eligibility criteria for inclusion in the analysis (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine, strongly anticholinergic medication, or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider who was assigned to a study arm), as measured from EHR system data.
This outcome is measured on the patient level as the number of pills of high-risk medications prescribed to patients by providers over the follow-up, measured within the EHR system. This outcome was measured as a continuous outcome.
Outcome measures
| Measure |
No Alert (Usual Care)
n=396 Participants
Providers randomized to usual care will receive no intervention.
|
Open Encounter + Pre-commitment
n=394 Participants
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.
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.
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.
|
Open Encounter + Follow-up Booster
n=356 Participants
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.
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
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.
|
|---|---|---|---|
|
Quantity of High-risk Medication Prescribed
|
398.6 Number of pills
Standard Deviation 439.4
|
422.5 Number of pills
Standard Deviation 470.9
|
437.9 Number of pills
Standard Deviation 481.6
|
SECONDARY outcome
Timeframe: Each patient was assessed beginning from the date in which they were identified as eligible (i.e., meeting the inclusion criteria) until the end of a 16-month follow-up; the outcome time frame varied by participantPopulation: Patients who met eligibility criteria for inclusion in the analysis (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine, strongly anticholinergic medication, or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider who was assigned to a study arm), as measured from EHR system data.
This outcome is measured on the patient level as the number of lorazepam milligram equivalents of benzodiazepine and sedative hypnotic ("Z-drug") prescribed to patients by providers over the follow-up, measured within the EHR system. This outcome was measured as a continuous outcome.
Outcome measures
| Measure |
No Alert (Usual Care)
n=396 Participants
Providers randomized to usual care will receive no intervention.
|
Open Encounter + Pre-commitment
n=394 Participants
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.
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.
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.
|
Open Encounter + Follow-up Booster
n=356 Participants
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.
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
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.
|
|---|---|---|---|
|
Cumulative Lorazepam Milligram Equivalents Prescribed
|
238.7 lorazepam milligram equivalents
Standard Deviation 461.6
|
220.1 lorazepam milligram equivalents
Standard Deviation 413.9
|
259.7 lorazepam milligram equivalents
Standard Deviation 601.3
|
Adverse Events
No Alert (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Open Encounter + Pre-commitment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Open Encounter + Follow-up Booster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place