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| ID | Type | Description | Link |
|---|---|---|---|
| R33AG057388 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Alert (Usual Care) | No Intervention | Providers randomized to usual care will receive no intervention. | |
| Open Encounter + Pre-commitment | Experimental | 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. |
|
| Open Encounter + Follow-up booster | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up booster Alert | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inappropriate Prescribing | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of High-risk Medication Prescribed | 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. | 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 |
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Inclusion Criteria:
Providers will receive these EHR tools for their patients who meet the following criteria:
Outcomes will be measured on the patient level.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niteesh K Choudhry, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass General Brigham | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41609788 | Derived | Lauffenburger JC, Sung M, Glynn RJ, Keller PA, Robertson T, Kim DH, Bhatkhande G, Jungo KT, Haff N, Hanken KE, Isaac T, Choudhry NK. Electronic Health Record Intervention and Deprescribing for Older Adults: A Randomized Clinical Trial. JAMA. 2026 Mar 24;335(12):1060-1069. doi: 10.1001/jama.2025.26967. |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | No Alert (Usual Care) | Providers randomized to usual care will receive no intervention. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All of these baseline measures are for the patients included in analyses in the data. Data from primary care providers (the unit of randomization) was not collected at baseline nor in follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Alert (Usual Care) | Providers randomized to usual care will receive no intervention. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Inappropriate Prescribing | 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. | 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. | Posted | Count of Participants | Participants | 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 |
16 months
Deaths and adverse events are reported for patients who were included in the analyses for the trial. Deaths and adverse events were not collected, monitored, or assessed for providers. For patients, we used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. In addition, for patients, we retrospectively identified patient deaths through a retrospective review within the EHR.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Alert (Usual Care) | Providers randomized to usual care will receive no intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niteesh Choudhry | Brigham and Women's Hospital | 617-278-0930 | nkchoudhry@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2025 | Apr 29, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| Pre-commitment | Other | 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 | Other | 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 | 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. | 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | No Alert (Usual Care) | Providers randomized to usual care will receive no intervention. |
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| Secondary | Quantity of High-risk Medication Prescribed | 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. | 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. | Posted | Mean | Standard Deviation | Number of pills | 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 |
|
|
|
|
| Secondary | Cumulative Lorazepam Milligram Equivalents Prescribed | 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. | 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. | Posted | Mean | Standard Deviation | lorazepam milligram equivalents | 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 |
|
|
|
|
| 14 |
| 396 |
| 0 |
| 396 |
| 0 |
| 396 |
| EG001 | 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. | 7 | 394 | 0 | 394 | 0 | 394 |
| EG002 | 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. | 6 | 356 | 0 | 356 | 0 | 356 |
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Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons. |
| Regression, Linear |
| 272 |
Adjusted for multiple comparisons |
| Mean Difference (Final Values) |
| 38.1 |
| 2-Sided |
| 95 |
| -29.9 |
| 106.1 |
| Superiority |
Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons. |
| Regression, Linear |
Adjusted for multiple testing |
| 0.696 |
| Mean Difference (Final Values) |
| 15.1 |
| 2-Sided |
| 95 |
| -60.7 |
| 91.0 |
| Superiority |