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

NCT05218343 | Completed

• 1 other identifier: GCO-21-0383
• Study Type: interventional
• Target: 8,640
• Locations: 1 country
• Sites: 2

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

Conditions

Potentially Inappropriate Medications

Keywords

Electronic Health Records; Hospital Medication Systems; Geriatrics; Pharmacy; Electronic Prescribing; High-risk drugs

Outcome Measures

Primary Outcomes (1)

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

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

  24 weeks

Secondary Outcomes (7)

• Drug-specific prescription rate

  24 weeks

• Mean per-patient dose

  24 weeks

• Rate of inpatient falls

  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

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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.

Behavioral: EHR-based "nudge" interventions

Interventions

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

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- none

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• New York City Health and Hospitals Corporation: collaborator

Study Sites (2)

NYC Health+Hospitals

New York, New York, 10013, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Jashvant Poeran, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and care providers will be unaware of the intervention. However, prescribers will be able to prescribe all available doses, without any restrictions
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Depts. of Population Health Science & Policy / Orthopedics / Medicine Director, Center for Clinical and Outcomes Research

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: February 16, 2022
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)