Potentially Inappropriate MedicationsNCT05218343
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
A study testing EHR-based "nudge" interventions in people with Potentially Inappropriate Medications, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Potentially Inappropriate Medications
- What is being tested?
- EHR-based "nudge" interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,640 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2022to 2 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- a patient must be hospitalized
- 65-years old or older
- receive one of the targeted medications
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYC Health+Hospitals
New York, New York, 10013
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official 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
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
- Being tested
- EHR-based "nudge" interventions
- Keywords
- Electronic Health Records, Hospital Medication Systems, Geriatrics, Pharmacy, Electronic Prescribing, High-risk drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR-based "nudge" interventionsBehavioural
Change/introduction of default drug and frequency during electronic prescribing of high-risk drugs for a patient aged ≥65 years
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: EHR-based "nudge" interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (7)
Drug-specific prescription rate
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).
Measured: 24 weeks
Mean per-patient dose
Mean per-patient dose of the relevant individual high-risk drugs.
Measured: 24 weeks
Rate of inpatient falls
Inpatient falls (with and without injury)
Measured: 24 weeks
Rate of 30-day readmissions
30-day readmission rates for patients aged ≥65 years who received any of the eight high-risk drugs during their hospitalization.
Measured: 30 days post-discharge regarding hospitalization during which a high-risk drug was prescribed
Length of hospital stay
Duration of hospitalization in days for patients aged ≥65 years who received any of the eight high-risk drugs during their hospitalization.
Measured: 24 weeks
Cost of hospital stay
Cost of hospitalization in USD for patients aged ≥65 years who received any of the eight high-risk drugs during their hospitalization.
Measured: 24 weeks
Spillover effects to patients aged <65
The rate of prescriptions of the newly defaulted (geriatric) dose for any of the eight high-risk drugs among patients aged <65 years.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start16 Feb 2022
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Inappropriate MedicationsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 8,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- New York City Health and Hospitals Corporation
- Responsible party
- Principal investigator, Jashvant Poeran, Icahn School of Medicine at Mount Sinai
- Investigators
- Jashvant Poeran, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218343
- Sponsor's protocol ID
- GCO-21-0383
- Status last verified
- Mar 2023
- First submitted
- 20 Jan 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD was not something including in the IRB application process. Only aggregated data will be disseminated.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05218343
- Acronym / sponsor ID
- GCO-21-0383
- Conditions
- Potentially Inappropriate Medications
- Keywords
- Electronic Health Records, Hospital Medication Systems, Geriatrics, Pharmacy, Electronic Prescribing, High-risk drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,640 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- New York City Health and Hospitals Corporation
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No change in default dose or frequency selected for the eight targeted drugs |
| Intervention | Experimental | Behavioral: EHR-based "nudge" interventionsThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- a patient must be hospitalized
- 65-years old or older
- receive one of the targeted medications
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHR-based "nudge" interventionsChange/introduction of default drug and frequency during electronic prescribing of high-risk drugs for a patient aged ≥65 years | Behavioural | Intervention |
Primary outcome
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.
7 secondary outcomes
Drug-specific prescription rate
Time frame: 24 weeks
Mean per-patient dose
Time frame: 24 weeks
Rate of inpatient falls
Time frame: 24 weeks
Rate of 30-day readmissions
Time frame: 30 days post-discharge regarding hospitalization during which a high-risk drug was prescribed
Length of hospital stay
Time frame: 24 weeks
Cost of hospital stay
Time frame: 24 weeks
Spillover effects to patients aged <65
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No. Sharing IPD was not something including in the IRB application process. Only aggregated data will be disseminated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jashvant Poeran, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR-based "nudge" interventions in people with Potentially Inappropriate Medications, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription rate of modified default dose for eight high-risk drugs (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.