Adverse Drug Event, Aging, Anticholinergic Adverse Reaction, Benzodiazepine Sedative Adverse Reaction
Conditions
Keywords
Benzodiazepine, Sedative hypnotic, Overprescribing, Anticholinergic
Brief summary
Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable older adults, such as confusion or sedation, leading to hospitalizations, falls, and fractures. Fortunately, most of these consequences are preventable. Physicians' lack of awareness of alternatives, ambiguous practice guidelines, and perceived pressure from patients or caregivers are among the reasons why these drugs are used more than might be optimal. Reducing inappropriate use of these drugs may be achieved through decision support tools for providers that are embedded in electronic health record (EHR) systems. While EHR strategies are widely used to support the informational needs of providers, these tools have demonstrated only modest effectiveness at improving prescribing. The effectiveness of these tools could be enhanced by leveraging principles of behavioral economics and related sciences.
Detailed description
This is an adaptive cluster randomized control trial (RCT) to evaluate whether newly designed EHR-based tools designed using behavioral principles reduce inappropriate prescribing and adverse outcomes among older adults. This study will be conducted in outpatient and acute care practices of Atrius Health, a large integrated delivery network in eastern and central Massachusetts, which uses the Epic EHR system. In 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).
Interventions
OTHEROrder Entry
An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
OTHEROpen Encounter
An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
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
OTHERCold 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.
OTHERSimplified
The alert language itself will be simplified.
OTHERSign-off alert
An alert will display in the electronic health record when the medication is sent to sign-off for providers.
OTHERPre-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.
OTHERDifferent Risks
Risks of the high-risk medications will be framed differently.
OTHERStandard Epic Basic Alert
This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
OTHEREnhanced 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.
Sponsors
Brigham and Women's Hospital
Atrius Health
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary care provider at Atrius Health Providers will receive these EHR tools for their patients who meet the following criteria: 1. older adults (aged 65 years or more) 2. who have been prescribed at least 90 pills of benzodiazepine or sedative hypnotic in the last 180 days.
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 22 months (2 stages) | 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. |
| 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 | 22 months (2 stages) | 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. |
Countries
United States
Participant flow
Recruitment details
Atrius 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. The Mass General Brigham trial described in the protocol is a different record (NCT05538065).
Pre-assignment details
Primary care providers were identified from electronic health record data and cluster randomized to a study arm in Stage 1. Patients who sought care from these primary care providers were identified based on electronic health record data for analyses. Providers were not assessed for effectiveness outcomes. After the interim analysis, primary care providers were re-randomized to a study arm in Stage 2.
Participants by arm
| Arm | Count |
|---|---|
| Base Order Entry Alert 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.
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. | 91 |
| Base Open Encounter Alert Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
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. | 106 |
| Order Entry + Follow-up Booster Alert 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.
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. | 87 |
| Open Encounter + Follow-up Booster Alert Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
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. | 175 |
| Order Entry + Cold State Outreach 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.
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.
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. | 174 |
| Open Encounter + Cold State Outreach Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
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.
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. | 102 |
| Order Entry + Simplified 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.
Simplified: The alert language itself will be simplified.
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. | 130 |
| Open Encounter + Simplified Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Simplified: The alert language itself will be simplified.
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. | 137 |
| Order Entry + Sign-off Alert 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.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
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. | 153 |
| Open Encounter + Sign-off Alert Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Sign-off alert: An alert will display in the electronic health record when the medication is sent to sign-off for providers.
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. | 136 |
| Order Entry + Pre-commitment 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.
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. | 118 |
| Open Encounter + Pre-commitment Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
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. | 164 |
| Order Entry + Different Risks 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.
Different Risks: Risks of the high-risk medications will be framed differently.
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. | 87 |
| Open Encounter + Different Risks Open Encounter: An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
Different Risks: Risks of the high-risk medications will be framed differently.
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. | 90 |
| Standard Epic Basic Alert 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.
Standard Epic Basic Alert: This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality. | 109 |
| No Alert (Usual Care) Providers randomized to usual care will receive no EHR tool, as is current clinical practice. | 1,204 |
| Total | 3,063 |
Baseline characteristics
| Characteristic | Base Order Entry Alert | Base Open Encounter Alert | Order Entry + Follow-up Booster Alert | Open Encounter + Follow-up Booster Alert | Order Entry + Cold State Outreach | Open Encounter + Cold State Outreach | Order Entry + Simplified | Open Encounter + Simplified | Order Entry + Sign-off Alert | Open Encounter + Sign-off Alert | Order Entry + Pre-commitment | Open Encounter + Pre-commitment | Order Entry + Different Risks | Open Encounter + Different Risks | Standard Epic Basic Alert | No Alert (Usual Care) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 75.6 years STANDARD_DEVIATION 7 | 73.2 years STANDARD_DEVIATION 6.3 | 73.7 years STANDARD_DEVIATION 6.6 | 74.2 years STANDARD_DEVIATION 6.8 | 74.4 years STANDARD_DEVIATION 7.3 | 74.1 years STANDARD_DEVIATION 7.4 | 7.7 years STANDARD_DEVIATION 7.5 | 74.0 years STANDARD_DEVIATION 7.1 | 75.5 years STANDARD_DEVIATION 7.6 | 75.8 years STANDARD_DEVIATION 7.7 | 72.9 years STANDARD_DEVIATION 5.8 | 73.6 years STANDARD_DEVIATION 7.1 | 75.6 years STANDARD_DEVIATION 7.5 | 74.1 years STANDARD_DEVIATION 7.5 | 77.0 years STANDARD_DEVIATION 8.2 | 74.3 years STANDARD_DEVIATION 7 | 74.5 years STANDARD_DEVIATION 7.2 |
| Benzodiazepine quantity: Number of pills prescribed in past 180 days measured in EHR system | 187.9 number of pills prescribed STANDARD_DEVIATION 135.9 | 200.0 number of pills prescribed STANDARD_DEVIATION 118.6 | 186.9 number of pills prescribed STANDARD_DEVIATION 116.4 | 195.6 number of pills prescribed STANDARD_DEVIATION 118.2 | 222.0 number of pills prescribed STANDARD_DEVIATION 293.3 | 218.0 number of pills prescribed STANDARD_DEVIATION 233.2 | 209.9 number of pills prescribed STANDARD_DEVIATION 175.4 | 199.2 number of pills prescribed STANDARD_DEVIATION 122.6 | 214.5 number of pills prescribed STANDARD_DEVIATION 158 | 185.1 number of pills prescribed STANDARD_DEVIATION 115.7 | 227.7 number of pills prescribed STANDARD_DEVIATION 151.2 | 205.2 number of pills prescribed STANDARD_DEVIATION 145.5 | 220.3 number of pills prescribed STANDARD_DEVIATION 155.4 | 229.7 number of pills prescribed STANDARD_DEVIATION 220 | 190.5 number of pills prescribed STANDARD_DEVIATION 119.9 | 203.1 number of pills prescribed STANDARD_DEVIATION 149.4 | 205.2 number of pills prescribed STANDARD_DEVIATION 162 |
| Race/Ethnicity, Customized American Indian, Alaska Native, Native Hawaiian, or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 23 Participants | 45 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 5 Participants | 4 Participants | 5 Participants | 7 Participants | 4 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 7 Participants | 3 Participants | 2 Participants | 3 Participants | 31 Participants | 84 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 0 Participants | 3 Participants | 21 Participants | 49 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 5 Participants | 24 Participants | 47 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 5 Participants | 5 Participants | 5 Participants | 18 Participants | 2 Participants | 4 Participants | 5 Participants | 0 Participants | 5 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 50 Participants | 109 Participants |
| Race/Ethnicity, Customized White | 86 Participants | 93 Participants | 69 Participants | 163 Participants | 144 Participants | 87 Participants | 118 Participants | 126 Participants | 147 Participants | 123 Participants | 112 Participants | 149 Participants | 80 Participants | 82 Participants | 93 Participants | 1051 Participants | 2723 Participants |
| Sedative hypnotic quantity: Number of pills prescribed in past 180 days measured in EHR system | 132.1 number of pills prescribed STANDARD_DEVIATION 70.9 | 154.4 number of pills prescribed STANDARD_DEVIATION 71.3 | 143.4 number of pills prescribed STANDARD_DEVIATION 66.6 | 138.0 number of pills prescribed STANDARD_DEVIATION 64.3 | 153.3 number of pills prescribed STANDARD_DEVIATION 87.7 | 107.5 number of pills prescribed STANDARD_DEVIATION 31.5 | 130.0 number of pills prescribed STANDARD_DEVIATION 74.1 | 150.1 number of pills prescribed STANDARD_DEVIATION 76.5 | 145.0 number of pills prescribed STANDARD_DEVIATION 53.6 | 154.9 number of pills prescribed STANDARD_DEVIATION 81.9 | 172.7 number of pills prescribed STANDARD_DEVIATION 73.2 | 136.8 number of pills prescribed STANDARD_DEVIATION 55.3 | 146.8 number of pills prescribed STANDARD_DEVIATION 64.7 | 150.7 number of pills prescribed STANDARD_DEVIATION 64.9 | 162.3 number of pills prescribed STANDARD_DEVIATION 100.7 | 147.6 number of pills prescribed STANDARD_DEVIATION 73.7 | 147.1 number of pills prescribed STANDARD_DEVIATION 72.3 |
| Sex: Female, Male Female | 67 Participants | 73 Participants | 53 Participants | 129 Participants | 145 Participants | 56 Participants | 87 Participants | 110 Participants | 101 Participants | 100 Participants | 80 Participants | 106 Participants | 58 Participants | 44 Participants | 73 Participants | 759 Participants | 2041 Participants |
| Sex: Female, Male Male | 24 Participants | 33 Participants | 34 Participants | 46 Participants | 29 Participants | 46 Participants | 43 Participants | 27 Participants | 52 Participants | 36 Participants | 38 Participants | 58 Participants | 29 Participants | 46 Participants | 36 Participants | 445 Participants | 1022 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 91 | 2 / 106 | 1 / 87 | 2 / 175 | 0 / 174 | 1 / 102 | 4 / 130 | 5 / 137 | 1 / 153 | 11 / 136 | 2 / 118 | 6 / 164 | 0 / 87 | 0 / 90 | 2 / 109 | 18 / 1,204 |
| other Total, other adverse events | 0 / 91 | 0 / 106 | 0 / 87 | 0 / 175 | 0 / 174 | 0 / 102 | 0 / 130 | 0 / 137 | 0 / 153 | 0 / 136 | 0 / 118 | 0 / 164 | 0 / 87 | 0 / 90 | 0 / 109 | 0 / 1,204 |
| serious Total, serious adverse events | 0 / 91 | 0 / 106 | 0 / 87 | 0 / 175 | 0 / 174 | 0 / 102 | 0 / 130 | 0 / 137 | 0 / 153 | 0 / 136 | 0 / 118 | 1 / 164 | 0 / 87 | 0 / 90 | 0 / 109 | 0 / 1,204 |
Outcome results
Primary
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.
Time frame: 22 months (2 stages)
Population: Patients who met eligibility criteria for inclusion in the analysis (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine 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 across Stages 1 and 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Base Order Entry Alert | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 35.2 percentage of patients |
| Base Open Encounter Alert | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 33 percentage of patients |
| Order Entry + Follow-up Booster Alert | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 35.6 percentage of patients |
| Open Encounter + Follow-up Booster Alert | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 40.6 percentage of patients |
| Order Entry + Cold State Outreach | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 25.9 percentage of patients |
| Open Encounter + Cold State Outreach | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 39.2 percentage of patients |
| Order Entry + Simplified | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 42.3 percentage of patients |
| Open Encounter + Simplified | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 38 percentage of patients |
| Order Entry + Sign-off Alert | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 27.5 percentage of patients |
| Open Encounter + Sign-off Alert | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 29.4 percentage of patients |
| Order Entry + Pre-commitment | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 33.9 percentage of patients |
| Open Encounter + Pre-commitment | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 45.1 percentage of patients |
| Order Entry + Different Risks | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 28.7 percentage of patients |
| Open Encounter + Different Risks | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 32.2 percentage of patients |
| Standard Epic Basic Alert | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 30.3 percentage of patients |
| No Alert (Usual Care) | Change in Inappropriate Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 33.6 percentage of patients |
Primary
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.
Time frame: 22 months (2 stages)
Population: Patients who met eligibility criteria for inclusion in the analyses (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider in the trial), as measured in the EHR across Stages 1 and 2. These groups are not mutually exclusive as the study arms could contain multiple intervention factors (e.g., Open Encounter Timing and Boostering); thus, the overall total exceeds 3063.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Base Order Entry Alert | 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 | 33.1 percentage of patients |
| Base Open Encounter Alert | 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 | 38.9 percentage of patients |
| Order Entry + Follow-up Booster Alert | 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 | 30.8 percentage of patients |
| Open Encounter + Follow-up Booster Alert | 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 | 40.1 percentage of patients |
| Order Entry + Cold State Outreach | 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 | 28.4 percentage of patients |
| Open Encounter + Cold State Outreach | 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 | 40.4 percentage of patients |
| Order Entry + Simplified | 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 | 30.5 percentage of patients |
| Open Encounter + Simplified | 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 | 33.5 percentage of patients |
Comparison: Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the trial and adjusting for provider-level clustering.95% CI: [0.97, 1.49]
Comparison: Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.95% CI: [0.83, 1.59]
Comparison: Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.95% CI: [0.61, 1.16]
Comparison: Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.95% CI: [0.88, 1.64]
Comparison: Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.95% CI: [0.52, 0.98]
Comparison: Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.95% CI: [0.89, 1.64]
Comparison: Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.95% CI: [0.55, 1.19]
Secondary
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.
Time frame: 22 months (2 stages)
Population: Among eligible study population included (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider assigned to that study arm), as measured from the EHR system across Stages 1 and 2 of the trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Base Order Entry Alert | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 64.5 Cumulative lorazepam mg equivalents | Standard Deviation 87.6 |
| Base Open Encounter Alert | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 119.8 Cumulative lorazepam mg equivalents | Standard Deviation 179.7 |
| Order Entry + Follow-up Booster Alert | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 94.4 Cumulative lorazepam mg equivalents | Standard Deviation 176.5 |
| Open Encounter + Follow-up Booster Alert | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 104.7 Cumulative lorazepam mg equivalents | Standard Deviation 170 |
| Order Entry + Cold State Outreach | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 156.6 Cumulative lorazepam mg equivalents | Standard Deviation 207.5 |
| Open Encounter + Cold State Outreach | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 146.3 Cumulative lorazepam mg equivalents | Standard Deviation 425.3 |
| Order Entry + Simplified | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 114.2 Cumulative lorazepam mg equivalents | Standard Deviation 181.6 |
| Open Encounter + Simplified | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 110.0 Cumulative lorazepam mg equivalents | Standard Deviation 160.3 |
| Order Entry + Sign-off Alert | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 114.6 Cumulative lorazepam mg equivalents | Standard Deviation 188.7 |
| Open Encounter + Sign-off Alert | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 93.6 Cumulative lorazepam mg equivalents | Standard Deviation 147 |
| Order Entry + Pre-commitment | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 107.0 Cumulative lorazepam mg equivalents | Standard Deviation 180.8 |
| Open Encounter + Pre-commitment | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 121.1 Cumulative lorazepam mg equivalents | Standard Deviation 196.7 |
| Order Entry + Different Risks | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 82.0 Cumulative lorazepam mg equivalents | Standard Deviation 90.2 |
| Open Encounter + Different Risks | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 118.0 Cumulative lorazepam mg equivalents | Standard Deviation 166.5 |
| Standard Epic Basic Alert | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 123.6 Cumulative lorazepam mg equivalents | Standard Deviation 214.4 |
| No Alert (Usual Care) | Quantity of Prescribing by Study Arm: Descriptive Comparison Across Study Arms | 114.4 Cumulative lorazepam mg equivalents | Standard Deviation 194.9 |
Secondary
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.
Time frame: 22 months (2 stages)
Population: Patients who met eligibility criteria for inclusion in the analyses (adults ≥65 years, who were prescribed ≥90 pills of benzodiazepine or sedative hypnotic in the last 180 days and had an office or telemedicine visit with a primary care provider in the trial), as measured in the EHR across Stages 1 and 2. These groups are not mutually exclusive as the study arms could contain multiple intervention factors (e.g., Open Encounter Timing and Boostering); thus, the overall total exceeds 3063.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Base Order Entry Alert | 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 | 114.5 Cumulative lorazepam mg equivalents | Standard Deviation 215.1 |
| Base Open Encounter Alert | 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 | 101.3 Cumulative lorazepam mg equivalents | Standard Deviation 171.9 |
| Order Entry + Follow-up Booster Alert | 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 | 152.8 Cumulative lorazepam mg equivalents | Standard Deviation 305.9 |
| Open Encounter + Follow-up Booster Alert | 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 | 112.0 Cumulative lorazepam mg equivalents | Standard Deviation 170.7 |
| Order Entry + Cold State Outreach | 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 | 104.7 Cumulative lorazepam mg equivalents | Standard Deviation 170.4 |
| Open Encounter + Cold State Outreach | 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 | 115.2 Cumulative lorazepam mg equivalents | Standard Deviation 190 |
| Order Entry + Simplified | 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 | 100.3 Cumulative lorazepam mg equivalents | Standard Deviation 135.4 |
| Open Encounter + Simplified | 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 | 111.9 Cumulative lorazepam mg equivalents | Standard Deviation 191.8 |
Comparison: Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.95% CI: [-17.6, 21.2]
Comparison: Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.95% CI: [-41.8, 17.5]
Comparison: Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.95% CI: [11.6, 67.4]
Comparison: Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.95% CI: [-30.4, 26.9]
Comparison: Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.95% CI: [-37.6, 17.4]
Comparison: Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.95% CI: [-24.1, 32.5]
Comparison: Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.95% CI: [-45.5, 21.5]