EHR Nudges for Overmedication

(HRPP Trial)

Not currently recruiting at 1 trial location

Overseen By Stephen D Persell, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two electronic health record (EHR) alerts, known as "nudges," to help doctors reduce the prescription of risky medications to older adults, particularly those with dementia or memory problems. These nudges either remind doctors to review medication plans or prompt them to justify the need for a risky medication. The goal is to make medication use safer and reduce related issues like adverse reactions and falls. This trial suits individuals receiving care at Northwestern Medicine or UPMC clinics who have been prescribed multiple potentially risky medications. As an unphased trial, it offers participants the chance to contribute to innovative approaches that could enhance medication safety for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on helping doctors reduce high-risk medication use, so it's best to discuss your specific situation with the trial team.

What prior data suggests that these EHR-based nudges are safe for clinicians and patients?

Research has shown that electronic health record (EHR) nudges, like the ones under study, are safe for use in healthcare settings. In earlier studies, doctors responded well to these nudges, and no major problems were reported from their use.

These nudges alert doctors when they prescribe or renew medications that might be risky for older adults. The alerts remind doctors to discuss medications with their patients, aiming to reduce unnecessary or risky prescriptions. This method focuses on changing how doctors prescribe medications, rather than directly affecting patients' health, which helps ensure safety.

Overall, past research suggests that EHR nudges are a safe way to manage the use of high-risk medications in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to tackle overmedication through Electronic Health Record (EHR) nudges. Unlike traditional methods that rely heavily on clinician judgment and guidelines, the commitment nudge and justification nudge aim to directly influence clinician behavior at the point of prescribing. The commitment nudge uses EHR alerts to remind clinicians to discuss high-risk polypharmacy with patients, while the justification nudge requires clinicians to provide a written reason for high-risk prescriptions, making the process more transparent and accountable. These approaches could lead to more mindful prescribing practices, potentially reducing the risks associated with overmedication in older adults.

What evidence suggests that this trial's treatments could be effective for reducing high-risk polypharmacy in older adults?

This trial will evaluate different electronic health record (EHR) nudges to reduce overmedication in older adults. One arm will use a "Commitment nudge," prompting doctors to discuss medication safety with patients during their next visit. Studies have shown that this approach increases doctors' awareness and proactivity in managing prescriptions. Another arm will use a "Justification nudge," requiring doctors to explain why they prescribe a risky medication, encouraging reconsideration of adding more drugs to a patient's list. Both types of reminders aim to enhance medication safety for older adults, particularly those with dementia or memory issues. Additionally, one arm will focus solely on clinician education. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for older adults at high risk of polypharmacy, especially those with dementia or cognitive impairment. It's being conducted in Northwestern Medicine or UPMC primary care clinics that specialize in Internal Medicine, Family Medicine, General Practice, or Geriatrics.

Inclusion Criteria

Patients must be affiliated with Northwestern Medicine or UPMC primary care clinic in Internal Medicine, Family Medicine, General Practice, or Geriatrics.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of EHR-based commitment and justification nudges to reduce high-risk polypharmacy

18 months

Ongoing EHR interactions

Observation

Observation period to assess persistence of effects from the intervention

12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinical decision support (CDS)-Commitment nudge
• Clinical decision support (CDS)-Justification nudge
• Clinician education

Trial Overview The trial tests two EHR-based nudges designed to help doctors reduce risky multiple medication use among elderly patients. Clinics are randomly chosen to receive either no nudges, one type of nudge (commitment or justification), or both for 18 months and then observed for another year.

How Is the Trial Designed?

Group I: Justification nudge Experimental Treatment 2 Interventions

The justification nudge will be an EHR alert triggered for patients with high-risk polypharmacy when a clinician begins to renew or newly prescribe a medication that causes a high-risk criterion to be fulfilled (i.e., a medication meeting causing 1 of the 7 high-risk polypharmacy criteria/primary study measures to be met). This alert will inform the clinician of the high-risk nature of the prescription and request a free-text justification for starting or renewing the medication. This written justification will appear in the EHR in a section of that encounter that other EHR users can see.

Group II: Commitment nudge + Justification nudge Experimental Treatment 3 Interventions

This study arm will receive both the commitment nudge and the justification nudge.

Group III: Commitment nudge Experimental Treatment 2 Interventions

The commitment nudge will be an EHR alert that is triggered when a clinician renews or orders a qualifying medication in any Epic encounter (including non-face-to-face encounters) for a patient aged 65 or greater who meets criteria for high-risk polypharmacy. When triggered, the commitment nudge will offer the clinician a choice option that sets a reminder to discuss polypharmacy at the patient's next visit date.

Group IV: Clinician education only Experimental Treatment 1 Intervention

Online clinician education

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

A targeted educational intervention was effective in improving the adoption of clinical decision support (CDS) systems among 478 healthcare providers who were previously overriding these systems, with 34% of them starting to review prescription drug monitoring programs (PDMP) after receiving educational messages.

This study highlights that low-resource strategies, like sending educational messages via email or EHR chat, can significantly enhance the effectiveness of CDS in preventing medical errors and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted messaging to improve the adoption of clinical decision support for prescription drug monitoring program use. Sommers, S., Tolle, H., Napier, C., et al.[2023]

The use of nudge theory in clinical decision support systems (CDSS) could help bridge the gap between existing healthcare evidence and actual clinical practice, potentially improving patient outcomes.

Integrating nudges with electronic health records and artificial intelligence may enhance clinician adherence to guidelines, especially in areas lacking robust evidence, by standardizing behavior in uncertain clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging within learning health systems: next generation decision support to improve cardiovascular care. Chen, Y., Harris, S., Rogers, Y., et al.[2022]

A systematic review of 39 studies found that nudges, particularly those that frame information, change default options, or enable choice, can effectively improve clinical decision-making among healthcare providers.

Most studies were conducted in the USA, with 36% being randomized controlled trials, indicating a need for more rigorous research to confirm the effectiveness of nudges compared to other interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of clinician-directed nudges in healthcare contexts. Last, BS., Buttenheim, AM., Timon, CE., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9411452/

Development of High-Risk Geriatric Polypharmacy ... Examples of clinical decision support nudges shown to physicians. a Commitment Nudge b Justification Nudge. DISCUSSION. This work represents ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03791580

Reducing High-Risk Geriatric Polypharmacy Via EHR ... This pilot-phase study is intended to test clinicians' perceptions of EHR-based nudges designed to reduce high-risk polypharmacy among patients aged 65 years or ...

3. withpower.com withpower.com/trial/phase-polypharmacy-5-2023-87b39

EHR Nudges for Overmedication (HRPP Trial) The use of nudge theory in clinical decision support systems (CDSS) could help bridge the gap between existing healthcare evidence and actual clinical practice, ...

4. clinicaltrials.gov clinicaltrials.gov/show/NCT03791580

Reducing High-Risk Geriatric Polypharmacy Via EHR ... This pilot-phase study is intended to test clinicians' perceptions of EHR-based nudges designed to reduce high-risk polypharmacy among patients ...

5. link.springer.com link.springer.com/article/10.1007/s11606-021-07296-1

Development of High-Risk Geriatric Polypharmacy ... Examples of the appearance of the justification and commitment nudges as well the patient message associated with the commitment nudge are shown ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/60/NCT05656560/SAP_000.pdf

Version 1.0 Page 1 of 16 Statistical Analysis Plan We will also investigate all clinician-reported adverse events or unanticipated problems for all study clinical decision support (CDS). 1. Safety measure for ...

7. omicsdi.org omicsdi.org/dataset/biostudies-literature/S-EPMC9411452

Development of High-Risk Geriatric Polypharmacy Electronic ... Physicians received EHR alerts when renewing or prescribing certain high-risk medications when criteria were met. One practice received a "commitment nudge" ...