AgingNUDGE-EHRNCT04284553
Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults
A study testing Order Entry, Open Encounter and Follow-up booster Alert in people with Aging and Benzodiazepine Sedative Adverse Reaction, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction
- What is being tested?
- Order Entry, Open Encounter and Follow-up booster Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction, Adverse Drug Event
- Being tested
- Order Entry, Open Encounter, Follow-up booster Alert, Cold State outreach, Simplified
- Keywords
- Benzodiazepine, Sedative hypnotic, Overprescribing, Anticholinergic
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Order EntryOther
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
Open EncounterOther
An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Follow-up booster AlertOther
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
Cold State outreachOther
An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
SimplifiedOther
The alert language itself will be simplified.
Sign-off alertOther
An alert will display in the electronic health record when the medication is sent to sign-off for providers.
Pre-commitmentOther
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.
Different RisksOther
Risks of the high-risk medications will be framed differently.
Standard Epic Basic AlertOther
This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
Enhanced AlertOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Base Order Entry Alert | Experimental | Not described Receives: Other: Order Entry; Other: Enhanced Alert |
| Base Open Encounter Alert | Experimental | Not described Receives: Other: Open Encounter; Other: Enhanced Alert |
| Order Entry + Follow-up booster Alert | Experimental | Not described Receives: Other: Order Entry; Other: Follow-up booster Alert; Other: Enhanced Alert |
| Open Encounter + Follow-up booster Alert | Experimental | Not described Receives: Other: Open Encounter; Other: Follow-up booster Alert; Other: Enhanced Alert |
| Order Entry + Cold State outreach | Experimental | Not described Receives: Other: Order Entry; Other: Cold State outreach; Other: Enhanced Alert |
| Open Encounter + Cold State outreach | Experimental | Not described Receives: Other: Open Encounter; Other: Cold State outreach; Other: Enhanced Alert |
| Order Entry + Simplified | Experimental | Not described Receives: Other: Order Entry; Other: Simplified; Other: Enhanced Alert |
| Open Encounter + Simplified | Experimental | Not described Receives: Other: Open Encounter; Other: Simplified; Other: Enhanced Alert |
| Order Entry + Sign-off alert | Experimental | Not described Receives: Other: Order Entry; Other: Sign-off alert; Other: Enhanced Alert |
| Open Encounter + Sign-off alert | Experimental | Not described Receives: Other: Open Encounter; Other: Sign-off alert; Other: Enhanced Alert |
| Order Entry + Pre-commitment | Experimental | Not described Receives: Other: Order Entry; Other: Pre-commitment; Other: Enhanced Alert |
| Open Encounter + Pre-commitment | Experimental | Not described Receives: Other: Open Encounter; Other: Pre-commitment; Other: Enhanced Alert |
| Order Entry + Different Risks | Experimental | Not described Receives: Other: Order Entry; Other: Different Risks; Other: Enhanced Alert |
| Open Encounter + Different Risks | Experimental | Not described Receives: Other: Open Encounter; Other: Different Risks; Other: Enhanced Alert |
| Standard Epic Basic Alert | Experimental | Not described Receives: Other: Order Entry; Other: Standard Epic Basic Alert |
| No Alert (Usual Care) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 22 months (2 stages)
Secondary outcomes (2)
Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms
This outcome is measured on the patient level as the number of cumulative lorazepam milligram equivalents of high-risk medications prescribed to patients by Atrius providers 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.
Measured: 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 cumulative number of lorazepam milligram equivalents of high-risk medications prescribed to patients by Atrius providers 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.
Measured: 22 months (2 stages)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start13 Oct 2020
- Primary completion1 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Atrius Health, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284553
- Sponsor's protocol ID
- 2019P002167
- Acronym
- NUDGE-EHR
- Status last verified
- Oct 2024
- First submitted
- 23 Feb 2020
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40614073Lauffenburger 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.
PubMed 33413494
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults
- ClinicalTrials.gov ID
- NCT04284553
- Acronym / sponsor ID
- NUDGE-EHR / 2019P002167
- Conditions
- Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction, Adverse Drug Event
- Keywords
- Benzodiazepine, Sedative hypnotic, Overprescribing, Anticholinergic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Atrius Health, National Institutes of Health (NIH)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Posted 26 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Base Order Entry Alert | Experimental | Other: Order Entry, Other: Enhanced Alert |
| Base Open Encounter Alert | Experimental | Other: Open Encounter, Other: Enhanced Alert |
| Order Entry + Follow-up booster Alert | Experimental | Other: Order Entry, Other: Follow-up booster Alert, Other: Enhanced Alert |
| Open Encounter + Follow-up booster Alert | Experimental | Other: Open Encounter, Other: Follow-up booster Alert, Other: Enhanced Alert |
| Order Entry + Cold State outreach | Experimental | Other: Order Entry, Other: Cold State outreach, Other: Enhanced Alert |
| Open Encounter + Cold State outreach | Experimental | Other: Open Encounter, Other: Cold State outreach, Other: Enhanced Alert |
| Order Entry + Simplified | Experimental | Other: Order Entry, Other: Simplified, Other: Enhanced Alert |
| Open Encounter + Simplified | Experimental | Other: Open Encounter, Other: Simplified, Other: Enhanced Alert |
| Order Entry + Sign-off alert | Experimental | Other: Order Entry, Other: Sign-off alert, Other: Enhanced Alert |
| Open Encounter + Sign-off alert | Experimental | Other: Open Encounter, Other: Sign-off alert, Other: Enhanced Alert |
| Order Entry + Pre-commitment | Experimental | Other: Order Entry, Other: Pre-commitment, Other: Enhanced Alert |
| Open Encounter + Pre-commitment | Experimental | Other: Open Encounter, Other: Pre-commitment, Other: Enhanced Alert |
| Order Entry + Different Risks | Experimental | Other: Order Entry, Other: Different Risks, Other: Enhanced Alert |
| Open Encounter + Different Risks | Experimental | Other: Open Encounter, Other: Different Risks, Other: Enhanced Alert |
| Standard Epic Basic Alert | Experimental | Other: Order Entry, Other: Standard Epic Basic Alert |
| No Alert (Usual Care) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Order EntryAn alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient. | Other | Base Order Entry Alert, Order Entry + Cold State outreach, Order Entry + Different Risks, Order Entry + Follow-up booster Alert, Order Entry + Pre-commitment, Order Entry + Sign-off alert, Order Entry + Simplified, Standard Epic Basic Alert |
| Open EncounterAn alert will display in the electronic health record when the provider opens the chart of an eligible patient. | Other | Base Open Encounter Alert, Open Encounter + Cold State outreach, Open Encounter + Different Risks, Open Encounter + Follow-up booster Alert, Open Encounter + Pre-commitment, Open Encounter + Sign-off alert, Open Encounter + Simplified |
| Follow-up booster AlertOnce 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 + Follow-up booster Alert, Order Entry + Follow-up booster Alert |
| Cold State outreachAn in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit. | Other | Open Encounter + Cold State outreach, Order Entry + Cold State outreach |
| SimplifiedThe alert language itself will be simplified. | Other | Open Encounter + Simplified, Order Entry + Simplified |
| Sign-off alertAn alert will display in the electronic health record when the medication is sent to sign-off for providers. | Other | Open Encounter + Sign-off alert, Order Entry + Sign-off alert |
| Pre-commitmentA 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 | Open Encounter + Pre-commitment, Order Entry + Pre-commitment |
| Different RisksRisks of the high-risk medications will be framed differently. | Other | Open Encounter + Different Risks, Order Entry + Different Risks |
| Standard Epic Basic AlertThis alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality. | Other | Standard Epic Basic Alert |
| Enhanced AlertAn 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 | Base Open Encounter Alert, Base Order Entry Alert, Open Encounter + Cold State outreach, Open Encounter + Different Risks, Open Encounter + Follow-up booster Alert, Open Encounter + Pre-commitment, Open Encounter + Sign-off alert, Open Encounter + Simplified, Order Entry + Cold State outreach, Order Entry + Different Risks, Order Entry + Follow-up booster Alert, Order Entry + Pre-commitment, Order Entry + Sign-off alert, Order Entry + Simplified |
Primary outcome
Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms
Time frame: 22 months (2 stages)
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.
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
Time frame: 22 months (2 stages)
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.
2 secondary outcomes
Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms
Time frame: 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
Time frame: 22 months (2 stages)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40614073Lauffenburger 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.
- Derived from this study: PubMed 33413494Lauffenburger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Order Entry, Open Encounter and Follow-up booster Alert in people with Aging and Benzodiazepine Sedative Adverse Reaction, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms (time frame: 22 months (2 stages)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04284553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.