Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
206

Summary

Conditions
  • Adverse Drug Event
  • Aging
  • Anticholinergic Adverse Reaction
  • Benzodiazepine Sedative Adverse Reaction
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 H...

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.

Tracking Information

NCT #
NCT04284553
Collaborators
  • Atrius Health
  • National Institutes of Health (NIH)
Investigators
Not Provided