Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults

Not Applicable

Completed

Conditions: Adverse Drug Event
Aging
Benzodiazepine Sedative Adverse Reaction
Anticholinergic Adverse Reaction

Interventions: Other: Open Encounter
Other: Order Entry
Other: Follow-up booster Alert
Other: Enhanced Alert
Other: Simplified
Other: Different Risks
Other: Cold State outreach
Other: Sign-off alert
Other: Pre-commitment
Other: Standard Epic Basic Alert

Registration Number: NCT04284553

Lead Sponsor: Brigham and Women's Hospital

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 216

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Encounter + Sign-off alert	Open Encounter	-
Base Order Entry Alert	Order Entry	-
Base Open Encounter Alert	Open Encounter	-
Order Entry + Follow-up booster Alert	Follow-up booster Alert	-
Open Encounter + Cold State outreach	Open Encounter	-
Base Order Entry Alert	Enhanced Alert	-
Base Open Encounter Alert	Enhanced Alert	-
Order Entry + Cold State outreach	Enhanced Alert	-
Open Encounter + Simplified	Simplified	-
Order Entry + Different Risks	Different Risks	-
Order Entry + Cold State outreach	Order Entry	-
Open Encounter + Different Risks	Different Risks	-
Standard Epic Basic Alert	Order Entry	-
Order Entry + Follow-up booster Alert	Order Entry	-
Order Entry + Follow-up booster Alert	Enhanced Alert	-
Open Encounter + Follow-up booster Alert	Open Encounter	-
Open Encounter + Follow-up booster Alert	Follow-up booster Alert	-
Open Encounter + Cold State outreach	Cold State outreach	-
Order Entry + Simplified	Simplified	-
Order Entry + Sign-off alert	Order Entry	-
Order Entry + Sign-off alert	Sign-off alert	-
Order Entry + Sign-off alert	Enhanced Alert	-
Open Encounter + Follow-up booster Alert	Enhanced Alert	-
Order Entry + Cold State outreach	Cold State outreach	-
Order Entry + Simplified	Order Entry	-
Open Encounter + Sign-off alert	Sign-off alert	-
Open Encounter + Sign-off alert	Enhanced Alert	-
Order Entry + Pre-commitment	Order Entry	-
Order Entry + Pre-commitment	Enhanced Alert	-
Open Encounter + Pre-commitment	Pre-commitment	-
Standard Epic Basic Alert	Standard Epic Basic Alert	-
Open Encounter + Cold State outreach	Enhanced Alert	-
Order Entry + Simplified	Enhanced Alert	-
Open Encounter + Simplified	Open Encounter	-
Open Encounter + Simplified	Enhanced Alert	-
Open Encounter + Pre-commitment	Open Encounter	-
Open Encounter + Pre-commitment	Enhanced Alert	-
Order Entry + Different Risks	Order Entry	-
Order Entry + Pre-commitment	Pre-commitment	-
Order Entry + Different Risks	Enhanced Alert	-
Open Encounter + Different Risks	Open Encounter	-
Open Encounter + Different Risks	Enhanced Alert	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.