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Clinical Trials/NCT05218343
NCT05218343CompletedNot Applicable

Modifying Default Dosing During Electronic Prescribing to Impact Prescribing of High-risk Drugs in Hospitalized Elderly Patients: A Cluster Randomized Controlled Trial With Crossover

Icahn School of Medicine at Mount Sinai2 sites in 1 country8,640 target enrollmentStarted: February 16, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
8,640
Locations
2
Primary Endpoint
Prescription rate of modified default dose for eight high-risk drugs

Study Overview

Brief Summary

This study will assess whether a modification in the default dose and frequency (the first option a provider sees) during electronic prescribing of a high-risk drug can impact prescribing behavior and subsequent changes in average dose for the targeted high-risk drug, when prescribed to a hospitalized patient aged ≥65 years. In this cluster randomized crossover (CRXO) trial we will randomize a non-intrusive "nudge" intervention, which involves modifying the default dose for high-risk drugs when prescribed electronically to hospitalized patients aged ≥65 years. The CRXO trial involves 10 sites in an urban health system: five sites will start the trial under the intervention/control during a first time period (T1) after which they switch intervention/control status (T2). The primary outcome is prescription rate of a lower default dose (i.e. the geriatric standard) for 8 high-risk drugs. This study will inform the effectiveness of EHR-based "nudge" interventions to reduce inappropriate prescribing of high-risk drugs for elderly patients.

Analyses ongoing, expected to finalize spring 2023

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Double (Participant, Care Provider)

Masking Description

Participants and care providers will be unaware of the intervention. However, prescribers will be able to prescribe all available doses, without any restrictions

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • a patient must be hospitalized
  • 65-years old or older
  • receive one of the targeted medications

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Prescription rate of modified default dose for eight high-risk drugs

Time Frame: 24 weeks

Rate at which the modified default dose (geriatric standard) and frequency for eight high-risk drugs are prescribed.

Secondary Outcomes

  • Drug-specific prescription rate(24 weeks)
  • Mean per-patient dose(24 weeks)
  • Rate of 30-day readmissions(30 days post-discharge regarding hospitalization during which a high-risk drug was prescribed)
  • Length of hospital stay(24 weeks)
  • Cost of hospital stay(24 weeks)
  • Spillover effects to patients aged <65(24 weeks)
  • Rate of inpatient falls(24 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jashvant Poeran

Associate Professor Depts. of Population Health Science & Policy / Orthopedics / Medicine Director, Center for Clinical and Outcomes Research

Icahn School of Medicine at Mount Sinai

Study Sites (2)

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