PolypharmacyHRPPNCT05656560
Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial
A study testing Clinical decision support (CDS)-Commitment nudge, Clinician education and Clinical decision support (CDS)-Justification nudge in people with Polypharmacy, run by Northwestern University at 2 sites in United States.
Trial summary
High-risk polypharmacy is common among older adults in the United States, is particularly dangerous for individuals with dementia or cognitive impairment, and is associated with harms such as adverse drug reactions, falls, and higher costs of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Clinical decision support (CDS)-Commitment nudge, Clinician education and Clinical decision support (CDS)-Justification nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jun 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Northwestern Medicine or UPMC primary care clinic: Internal Medicine, Family Medicine, or General Practice or Geriatrics
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Medicine
Chicago, Illinois, 60611
UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records
High-risk polypharmacy is common among older adults in the United States, is particularly dangerous for individuals with dementia or cognitive impairment, and is associated with harms such as adverse drug reactions, falls, and higher costs of care. This project aims to test in a pragmatic clinic-randomized controlled trial two electronic health record-based behavioral economic nudges to help clinicians reduce high-risk polypharmacy among their older adult patients and in the subgroup with dementia or cognitive impairment.
The main questions this trial aims to answer are:
Read more
Aim 1: To evaluate the effects of an EHR-based commitment nudge, a justification nudge, and the combination of both nudges on a composite measure of high-risk polypharmacy via a pragmatic randomized controlled trial. The investigators will use cluster randomization in which primary care clinics are randomized to receive 0, 1, or 2 nudges using a factorial design. The nudges will run for 18 months, followed by 12 months of observation to assess persistence of effects.
Aim 2: To qualitatively and quantitatively assess clinician experiences with the EHR-based nudges, including their acceptability and effects on workflow. At the conclusion of the intervention period, the investigators will perform semi-structured interviews and field a clinician survey.
- Conditions
- Polypharmacy
- Being tested
- Clinical decision support (CDS)-Commitment nudge, Clinician education, Clinical decision support (CDS)-Justification nudge
- Keywords
- clinical decision support, electronic health record, behavioral economics, high-risk geriatric polypharmacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support (CDS)-Commitment nudgeBehavioural
Also called Commitment nudge
EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy
Clinician educationOther
Brief, online education module for primary care clinicians
Clinical decision support (CDS)-Justification nudgeBehavioural
Also called Justification nudge
EHR clinical decision support alerts-clinician rational for high risk polypharmacy
| Study group | Role | What they receive |
|---|---|---|
| Clinician education only | Other | Online clinician education Receives: Other: Clinician education |
| Commitment nudge | Experimental | 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. Receives: Behavioral: Clinical decision support (CDS)-Commitment nudge; Other: Clinician education |
| Justification nudge | Experimental | 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. Receives: Other: Clinician education; Behavioral: Clinical decision support (CDS)-Justification nudge |
| Commitment nudge + Justification nudge | Experimental | This study arm will receive both the commitment nudge and the justification nudge. Receives: Behavioral: Clinical decision support (CDS)-Commitment nudge; Other: Clinician education; Behavioral: Clinical decision support (CDS)-Justification nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)
The composite of the 7 high-risk polypharmacy measures (Secondary outcomes #6-12)
Measured: 18 months
Secondary outcomes (11)
The rate of Emergency Department visits per patient -all cause
Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter during the look back period.
Measured: 18 months
The rate of Emergency Department visits per patient-Adverse drug event (ADE)-specific
Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter for ADE during the look back period.
Measured: 18 months
The rate of hospital admissions per patient-all cause
Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for any reason during the look back period.
Measured: 18 months
The rate of hospital admissions per patient-ADE-specific
Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for ADE during the look back period.
Measured: 18 months
The percentage of HRPP patients with a fall condition-drug interaction
Denominator: All older adult patients with HRPP with a fall marker. Numerator: Patients with an active eligible fall risk medication on medication list.
Measured: 18 months
The percentage of HRPP patients with a fall drug-drug interaction
Denominator: All older adult patients with HRPP. Numerator: Patients with greater than or equal to 3 active eligible fall risk medications.
Measured: 18 months
The percentage of HRPP patients with Heart failure-NSAID interaction
Denominator: All older adult patients with HRPP with a CHF marker. Numerator: Patients with an active eligible NSAID medication.
Measured: 18 months
The percentage of HRPP patients with Heart Failure-thiazolidinedione interaction
Denominator: All older adults with HRPP with a CHF marker. Numerator: Patients with an active eligible thiazolidinedione medication.
Measured: 18 months
The percentage of HRPP patients with Heart failure with reduced ejection fraction- non-dihydropyridine calcium channel blocker interaction
Denominator: All older adults with HRPP with CHFlowEF marker. Numerator: Patients with an active eligible calcium channel blocker medication.
Measured: 18 months
The percentage of HRPP patients with CKD-glyburide/glimepiride interaction
Denominator: All older adults with HRPP with most-recent eGFR <60. Numerator: Patients with an active eligible glyburide-containing medication.
Measured: 18 months
The percentage of HRPP patients with CKD-NSAID interaction
Denominator: All older adults with HRPP with most-recent eGFR < 30. Numerator: Patients with an active eligible NSAID medication.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start8 Jun 2023
- Primary completion11 May 2026
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Pittsburgh Medical Center, University of Southern California, University of California, Los Angeles
- Responsible party
- Principal investigator, Stephen Persell, MD, MPH, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656560
- Sponsor's protocol ID
- STU00213231
- Other IDs
- R01AG070054
- Acronym
- HRPP
- Status last verified
- May 2026
- First submitted
- 17 Nov 2022
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records
- ClinicalTrials.gov ID
- NCT05656560
- Acronym / sponsor ID
- HRPP / STU00213231
- Conditions
- Polypharmacy
- Keywords
- clinical decision support, electronic health record, behavioral economics, high-risk geriatric polypharmacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 786 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Pittsburgh Medical Center, University of Southern California, University of California, Los Angeles
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 19 Dec 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.
High-risk polypharmacy is common among older adults in the United States, is particularly dangerous for individuals with dementia or cognitive impairment, and is associated with harms such as adverse drug reactions, falls, and higher costs of care. This project aims to test in a pragmatic clinic-randomized controlled trial two electronic health record-based behavioral economic nudges to help clinicians reduce high-risk polypharmacy among their older adult patients and in the subgroup with dementia or cognitive impairment.
The main questions this trial aims to answer are:
Aim 1: To evaluate the effects of an EHR-based commitment nudge, a justification nudge, and the combination of both nudges on a composite measure of high-risk polypharmacy via a pragmatic randomized controlled trial. The investigators will use cluster randomization in which primary care clinics are randomized to receive 0, 1, or 2 nudges using a factorial design. The nudges will run for 18 months, followed by 12 months of observation to assess persistence of effects.
Aim 2: To qualitatively and quantitatively assess clinician experiences with the EHR-based nudges, including their acceptability and effects on workflow. At the conclusion of the intervention period, the investigators will perform semi-structured interviews and field a clinician survey.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clinician education only | Other | Other: Clinician educationOnline clinician education |
| Commitment nudge | Experimental | Behavioral: Clinical decision support (CDS)-Commitment nudge, Other: Clinician educationThe 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. |
| Justification nudge | Experimental | Other: Clinician education, Behavioral: Clinical decision support (CDS)-Justification nudgeThe 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. |
| Commitment nudge + Justification nudge | Experimental | Behavioral: Clinical decision support (CDS)-Commitment nudge, Other: Clinician education, Behavioral: Clinical decision support (CDS)-Justification nudgeThis study arm will receive both the commitment nudge and the justification nudge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Northwestern Medicine or UPMC primary care clinic: Internal Medicine, Family Medicine, or General Practice or Geriatrics
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 |
|---|---|---|
| Clinical decision support (CDS)-Commitment nudgeAlso: Commitment nudgeEHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy | Behavioural | Commitment nudge, Commitment nudge + Justification nudge |
| Clinician educationBrief, online education module for primary care clinicians | Other | Clinician education only, Commitment nudge, Commitment nudge + Justification nudge, Justification nudge |
| Clinical decision support (CDS)-Justification nudgeAlso: Justification nudgeEHR clinical decision support alerts-clinician rational for high risk polypharmacy | Behavioural | Commitment nudge + Justification nudge, Justification nudge |
Primary outcome
The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)
Time frame: 18 months
The composite of the 7 high-risk polypharmacy measures (Secondary outcomes #6-12)
11 secondary outcomes
The rate of Emergency Department visits per patient -all cause
Time frame: 18 months
The rate of Emergency Department visits per patient-Adverse drug event (ADE)-specific
Time frame: 18 months
The rate of hospital admissions per patient-all cause
Time frame: 18 months
The rate of hospital admissions per patient-ADE-specific
Time frame: 18 months
The percentage of HRPP patients with a fall condition-drug interaction
Time frame: 18 months
The percentage of HRPP patients with a fall drug-drug interaction
Time frame: 18 months
The percentage of HRPP patients with Heart failure-NSAID interaction
Time frame: 18 months
The percentage of HRPP patients with Heart Failure-thiazolidinedione interaction
Time frame: 18 months
The percentage of HRPP patients with Heart failure with reduced ejection fraction- non-dihydropyridine calcium channel blocker interaction
Time frame: 18 months
The percentage of HRPP patients with CKD-glyburide/glimepiride interaction
Time frame: 18 months
The percentage of HRPP patients with CKD-NSAID interaction
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support (CDS)-Commitment nudge, Clinician education and Clinical decision support (CDS)-Justification nudge in people with Polypharmacy, run by Northwestern University 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 1 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure) (time frame: 18 months). 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 26 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.