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OpenTrials
Completed

NCT Number: NCT05218343

An Intuitive, Non-intrusive, Approach to Reduce Patient Harm From Inappropriate Dosing of High-risk Drugs in Older Adult Patients Across an Urban Safety Net Hospital System

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

EHR-based "nudge" interventions

Behavioral

Change/introduction of default drug and frequency during electronic prescribing of high-risk drugs for a patient aged ≥65 years

Primary outcomes

  1. 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

  1. Drug-specific prescription rate

    Time frame: 24 weeks

    Drug-specific prescription rate of the modified default dose for each of the eight high-risk medications and type of order (frequency/type of order).

  2. Mean per-patient dose

    Time frame: 24 weeks

    Mean per-patient dose of the relevant individual high-risk drugs.

  3. Rate of inpatient falls

    Time frame: 24 weeks

    Inpatient falls (with and without injury)

  4. Rate of 30-day readmissions

    Time frame: 30 days post-discharge regarding hospitalization during which a high-risk drug was prescribed

    30-day readmission rates for patients aged ≥65 years who received any of the eight high-risk drugs during their hospitalization.

  5. Length of hospital stay

    Time frame: 24 weeks

    Duration of hospitalization in days for patients aged ≥65 years who received any of the eight high-risk drugs during their hospitalization.

  6. Cost of hospital stay

    Time frame: 24 weeks

    Cost of hospitalization in USD for patients aged ≥65 years who received any of the eight high-risk drugs during their hospitalization.

  7. Spillover effects to patients aged <65

    Time frame: 24 weeks

    The rate of prescriptions of the newly defaulted (geriatric) dose for any of the eight high-risk drugs among patients aged <65 years.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • New York City Health and Hospitals Corporation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2022
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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