Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults (NUDGE-EHR)
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| ClinicalTrials.gov Identifier: NCT04284553 |
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Recruitment Status :
Completed
First Posted : February 26, 2020
Last Update Posted : February 10, 2023
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Sponsor:
Brigham and Women's Hospital
Collaborators:
Atrius Health
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aging Benzodiazepine Sedative Adverse Reaction Anticholinergic Adverse Reaction Adverse Drug Event | Other: Order Entry Other: Open Encounter Other: Follow-up booster Alert Other: Cold State outreach Other: Simplified Other: Sign-off alert Other: Pre-commitment Other: Different Risks Other: Standard Epic Basic Alert Other: Enhanced Alert | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 201 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults |
| Actual Study Start Date : | October 13, 2020 |
| Actual Primary Completion Date : | August 1, 2022 |
| Actual Study Completion Date : | August 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Base Order Entry Alert |
Other: Order Entry
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient. Other: 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. |
| Experimental: Base Open Encounter Alert |
Other: Open Encounter
An alert will display in the electronic health record when the provider opens the chart of an eligible patient. Other: 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. |
| Experimental: Order Entry + Follow-up booster Alert |
Other: Order Entry
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient. Other: 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 Other: 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. |
| Experimental: Open Encounter + Follow-up booster Alert |
Other: Open Encounter
An alert will display in the electronic health record when the provider opens the chart of an eligible patient. Other: 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 Other: 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. |
| Experimental: Order Entry + Cold State outreach |
Other: Order Entry
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient. Other: Cold State outreach An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit. Other: 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. |
| Experimental: Open Encounter + Cold State outreach |
Other: Open Encounter
An alert will display in the electronic health record when the provider opens the chart of an eligible patient. Other: Cold State outreach An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit. Other: 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. |
| Experimental: Order Entry + Simplified |
Other: Order Entry
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient. Other: Simplified The alert language itself will be simplified. Other: 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. |
| Experimental: Open Encounter + Simplified |
Other: Open Encounter
An alert will display in the electronic health record when the provider opens the chart of an eligible patient. Other: Simplified The alert language itself will be simplified. Other: 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. |
| Experimental: Order Entry + Sign-off alert |
Other: Order Entry
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient. Other: Sign-off alert An alert will display in the electronic health record when the medication is sent to sign-off for providers. Other: 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. |
| Experimental: Open Encounter + Sign-off alert |
Other: Open Encounter
An alert will display in the electronic health record when the provider opens the chart of an eligible patient. Other: Sign-off alert An alert will display in the electronic health record when the medication is sent to sign-off for providers. Other: 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. |
| Experimental: Order Entry + Pre-commitment |
Other: Order Entry
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient. Other: 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. Other: 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. |
| Experimental: Open Encounter + Pre-commitment |
Other: Open Encounter
An alert will display in the electronic health record when the provider opens the chart of an eligible patient. Other: 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. Other: 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. |
| Experimental: Order Entry + Different Risks |
Other: Order Entry
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient. Other: Different Risks Risks of the high-risk medications will be framed differently. Other: 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. |
| Experimental: Open Encounter + Different Risks |
Other: Open Encounter
An alert will display in the electronic health record when the provider opens the chart of an eligible patient. Other: Different Risks Risks of the high-risk medications will be framed differently. Other: 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. |
| Experimental: Standard Epic Basic Alert |
Other: Order Entry
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient. Other: Standard Epic Basic Alert This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality. |
| No Intervention: No Alert (Usual Care) |
Primary Outcome Measures :
- Reduction in inappropriate prescribing [ Time Frame: 14 months ]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 [ Time Frame: 14 months ]Number of milligram equivalents of high-risk medications prescribed to patients in the follow-up period using EHR data
Other Outcome Measures:
- Quantity of high-risk medication dispensed [ Time Frame: 14 months ]Number of milligram equivalents of high-risk medications filled by patients, in follow-up, using pharmacy claims data
- Occurrence of clinically-significant adverse drug events [ Time Frame: 14 months ]Occurrence of sedation or cognitive impairment, and all-cause hospitalizations and falls or fractures, measured in administrative claims data
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284553
Locations
| United States, Massachusetts | |
| Atrius Health | |
| Braintree, Massachusetts, United States, 02184 | |
Sponsors and Collaborators
Brigham and Women's Hospital
Atrius Health
National Institutes of Health (NIH)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Niteesh K. Choudhry, MD, PhD, Niteesh K. Choudhry, MD, PhD, Professor, Harvard Medical School, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT04284553 |
| Other Study ID Numbers: |
2019P002167 |
| First Posted: | February 26, 2020 Key Record Dates |
| Last Update Posted: | February 10, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital:
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Benzodiazepine Sedative hypnotic Overprescribing Anticholinergic |
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders |