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

NCT ID: NCT05218343

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-16

Study Completion Date

2022-08-02

Brief Summary

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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

Detailed Description

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Conditions

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Potentially Inappropriate Medications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This cluster randomized crossover (CRXO) trial involves 10 sites in an urban health system: five clinics will start the trial under the intervention/control during a first time period (T1) then will switch to intervention/control status (T2). The primary outcome is prescription rate of a lower default dose for 8 high-risk drugs.

Other inputs used for trial design were: baseline rate of prescriptions meeting the geriatric standard (sources: local data, Geriatrics At Your Fingertips), within-period intraclass correlation coefficient (ICC, correlation between two randomly chosen observations in the same cluster), cluster autocorrelation (ratio of between-period ICC to within-period ICC), and coefficient of variation of cluster sizes (required when unequal sample size per cluster is expected). The aim is for ≥80% power to detect a ≥50% increase in prescriptions meeting the geriatric standard; this is based on previous studies and on the researchers' preliminary data on Trazodone.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

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

Study Groups

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Control

No change in default dose or frequency selected for the eight targeted drugs

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

The first option a prescriber sees when prescribing any of eight high-risk drugs for elderly hospitalized patients will be modified; the first frequency option a prescriber sees will be modified as well. Providers retain the ability to prescribe any dose or frequency.

Group Type EXPERIMENTAL

EHR-based "nudge" interventions

Intervention Type BEHAVIORAL

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

Interventions

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EHR-based "nudge" interventions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- none
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York City Health and Hospitals Corporation

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Jashvant Poeran

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jashvant Poeran, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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NYC Health+Hospitals

New York, New York, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO-21-0383

Identifier Type: -

Identifier Source: org_study_id

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