FallNCT03791580
Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase
A study testing Commitment nudge and Justification nudge in people with Fall and Congestive Heart Failure, run by RAND at 1 site in United States.
Trial summary
Polypharmacy is common among older adults in the United States and is associated with harms such as adverse drug reactions and higher costs of care. This pilot-phase project is designed to test two electronic health record (EHR)-based behavioral economic nudges to help primary care clinicians reduce the rate of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fall, Congestive Heart Failure, Chronic Kidney Failure
- What is being tested?
- Commitment nudge and Justification nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 1 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care clinicians practicing in one of the participating Northwestern-affiliated practices
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Polypharmacy is common among older adults in the United States and is associated with harms such as adverse drug reactions and higher costs of care. This pilot-phase project is designed to test two electronic health record (EHR)-based behavioral economic nudges to help primary care clinicians reduce the rate of high-risk polypharmacy among their older adult patients.
Read the detailed description
Polypharmacy increases the likelihood of being prescribed and harmed by high-risk medications. As noted in the 2014 National Action Plan for Adverse Drug Event (ADE) Prevention, polypharmacy both increases the likelihood of being prescribed high-risk medications and increases the likelihood that these high-risk medications will lead to adverse drug events. 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 more, thereby enabling investigators to refine the nudges, and to generate outcomes data that will inform power calculations for a subsequent larger study (the main study) of the nudges' effectiveness.
In this pilot-phase study, the investigators will deploy 2 EHR-based behavioral nudges (a commitment nudge and a justification nudge) among 18 or more primary care clinicians in 3 primary care practices (6 clinicians or more per practice) affiliated with Northwestern University for approximately 4 months. The 3 practices participating in the pilot will be a convenience sample of Northwestern-affiliated practices known to study investigators.
The investigators will randomly assign each of the 3 participating pilot practices to 1 of 3 arms: (1) commitment nudge, (2) justification nudge, or (3) both commitment and justification nudges. Randomization will be at the practice level, without replacement, thus assigning exactly 1 practice to each arm. All participating clinicians within a given practice will receive the same nudges.
Northwestern-affiliated practices that do not participate in the pilot will constitute a fourth arm of this pilot study.
The investigators will ask leaders of participating practices for their qualitative observations on how clinicians and patients experience the nudges (e.g., how the nudges affect workflows). The investigators also will collect data on the outcome measures before and during the approximately 4-month pilot period and compare these data to contemporaneous outcomes measures generated by Northwestern-affiliated practices that do not participate in the pilot.
- Being tested
- Commitment nudge, Justification nudge
- Keywords
- Polypharmacy, Primary Health Care, Economics, Behavioral, Deprescriptions, Decision Support Systems, Clinical, Electronic Health Records, Geriatrics
- Medical subject headings
- Heart Failure, Kidney Failure, Chronic, Drug-Related Side Effects and Adverse Reactions, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commitment nudgeBehavioural
The commitment nudge will ask clinicians to commit to discussing high-risk polypharmacy at the next office visit with patients who have high-risk polypharmacy. Clinicians who commit will receive a reminder just before the next office visit begins. The patient will also receive notification of the commitment via EHR patient portal.
This nudge will be operationalized via two sequential clinician-facing EHR best practice alerts (BPAs): the first at time of opening any encounter (including encounters other than a face-to-face office visit, e.g., medication refills), and the second (contingent on making a commitment to discuss high-risk polypharmacy) at time of opening the subsequent encounter for a face-to-face office visit. Each of these BPAs will describe the specific high-risk polypharmacy criterion (or criteria) the patient meets, the specific harms associated with the medication(s) triggering the criterion/criteria, and lower-risk alternative treatment strategies.
Justification nudgeBehavioural
The justification nudge will ask clinicians who prescribe or renew a drug that meets high-risk polypharmacy criteria (in the context of the patient's other medications) to write a brief justification for prescribing this high-risk medication. This written justification will be recorded in the patient's medical record. The best practice alert requesting the justification will also describe the specific high-risk polypharmacy criterion (or criteria) the patient meets, the specific harms associated with the medication(s) triggering the criterion/criteria, and lower-risk alternative treatment strategies.
| Study group | Role | What they receive |
|---|---|---|
| Commitment nudge | Experimental | Primary care clinicians in the practice assigned to this arm will receive only the commitment nudge. Receives: Behavioral: Commitment nudge |
| Justification nudge | Experimental | Primary care clinicians in the practice assigned to this arm will receive only the justification nudge. Receives: Behavioral: Justification nudge |
| Commitment + Justification nudges | Experimental | Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge. Receives: Behavioral: Commitment nudge; Behavioral: Justification nudge |
| Non-participating | No intervention | Primary care clinicians in Northwestern-affiliated practices other than the 3 pilot-participating practices will not receive any study interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-risk polypharmacy criterion: Fall condition-drug interaction
Denominator: count of patients aged >=65 years AND who have >=1 fall marker within the prior 2 years (ICD-10 codes for falls or hip fractures; OR who are recorded in the EHR as being high-risk for falls). Numerator: count of patients in the denominator who have 5+ medications in their EHR med list AND who have >=1 medication in their EHR med list that is a tricyclic antidepressant, Z-drug (e.g., zolpidem), benzodiazepine, antipsychotic, anticonvulsant, SSRI/SNRI, or opioid.
Measured: 28 months
High-risk polypharmacy criterion: Fall drug-drug interaction
Denominator: count of patients aged >=65 years. Numerator: count of patients in the denominator who have 5+ meds AND who have >=3 medications in their EHR med list that are tricyclic antidepressants, Z-drugs (e.g., zolpidem), benzodiazepines, antipsychotics, anticonvulsants, SSRIs/SNRIs, or opioids.
Measured: 28 month
High-risk polypharmacy criterion: CKD-glyburide/glimepiride interaction
Denominator: count of patients aged >=65 years AND who have most-recent estimated glomerular filtration rate (eGFR) < 60 as estimated by the Cockcroft-Gault equation. Numerator: count of patients in the denominator who have 5+ meds AND glyburide or glimepiride in their EHR med list.
Measured: 28 months
High-risk polypharmacy criterion: CKD-NSAID interaction
Denominator: count of patients aged >=65 years AND who have most-recent eGFR < 30 as estimated by the Cockcroft-Gault equation. Numerator: count of patients in the denominator who have 5+ meds AND a systemically-absorbed non-steroidal anti-inflammatory drug (NSAID) in their EHR med list.
Measured: 28 months
High-risk polypharmacy criterion: CHF-NSAID interaction
Denominator: count of patients aged >=65 years AND who have 5+ meds AND congestive heart failure (identified via ICD-10 code within prior 2 years). Numerator: count of patients in the denominator who have a systemically-absorbed non-steroidal anti-inflammatory drug (NSAID) in their EHR med list.
Measured: 28 months
High-risk polypharmacy criterion: CHF-non-dihydropyridine calcium channel blocker interaction
Denominator: count of patients aged >=65 years AND who have low-ejection-fraction congestive heart failure (identified via ICD-10 code within prior 2 years). Numerator: count of patients in the denominator who have 5+ meds AND a non-dihydropyridine calcium channel blocker in their EHR med list.
Measured: 28 months
High-risk polypharmacy criterion: CHF-thiazolidinedione interaction
Denominator: count of patients aged >=65 years AND who have low-ejection-fraction congestive heart failure (identified via ICD-10 code within prior 2 years). Numerator: count of patients in the denominator who have 5+ meds AND a thiazolidinedione in their EHR med list.
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Feb 2019
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
Why it stopped: NIA funded the first phase of the R21. The clinical trial never began as the R33 was not supported.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- 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
- Model description
- The investigators will randomly assign each of the 3 participating pilot practices to 1 of 3 arms: (1) commitment nudge, (2) justification nudge, or (3) both commitment and justification nudges. Randomization will be at the practice level, without replacement, thus assigning exactly 1 practice to each arm. All participating clinicians within a given practice will receive the same nudges. Northwestern-affiliated practices that do not participate in the pilot will constitute a fourth arm of this pilot study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of California, Los Angeles, University of Southern California, University of Pittsburgh, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Mark W Friedberg, MD, MPP, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791580
- Sponsor's protocol ID
- STU00207210
- Other IDs
- R21AG057396
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2018
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase
- ClinicalTrials.gov ID
- NCT03791580
- Acronym / sponsor ID
- STU00207210
- Keywords
- Polypharmacy, Primary Health Care, Economics, Behavioral, Deprescriptions, Decision Support Systems, Clinical, Electronic Health Records, Geriatrics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NIA funded the first phase of the R21. The clinical trial never began as the R33 was not supported.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Northwestern University, University of California, Los Angeles, University of Southern California, University of Pittsburgh, National Institute on Aging (NIA)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 2 Jan 2019 (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.
Polypharmacy is common among older adults in the United States and is associated with harms such as adverse drug reactions and higher costs of care. This pilot-phase project is designed to test two electronic health record (EHR)-based behavioral economic nudges to help primary care clinicians reduce the rate of high-risk polypharmacy among their older adult patients.
Detailed description
Polypharmacy increases the likelihood of being prescribed and harmed by high-risk medications. As noted in the 2014 National Action Plan for Adverse Drug Event (ADE) Prevention, polypharmacy both increases the likelihood of being prescribed high-risk medications and increases the likelihood that these high-risk medications will lead to adverse drug events. 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 more, thereby enabling investigators to refine the nudges, and to generate outcomes data that will inform power calculations for a subsequent larger study (the main study) of the nudges' effectiveness.
In this pilot-phase study, the investigators will deploy 2 EHR-based behavioral nudges (a commitment nudge and a justification nudge) among 18 or more primary care clinicians in 3 primary care practices (6 clinicians or more per practice) affiliated with Northwestern University for approximately 4 months. The 3 practices participating in the pilot will be a convenience sample of Northwestern-affiliated practices known to study investigators.
The investigators will randomly assign each of the 3 participating pilot practices to 1 of 3 arms: (1) commitment nudge, (2) justification nudge, or (3) both commitment and justification nudges. Randomization will be at the practice level, without replacement, thus assigning exactly 1 practice to each arm. All participating clinicians within a given practice will receive the same nudges.
Northwestern-affiliated practices that do not participate in the pilot will constitute a fourth arm of this pilot study.
The investigators will ask leaders of participating practices for their qualitative observations on how clinicians and patients experience the nudges (e.g., how the nudges affect workflows). The investigators also will collect data on the outcome measures before and during the approximately 4-month pilot period and compare these data to contemporaneous outcomes measures generated by Northwestern-affiliated practices that do not participate in the pilot.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The investigators will randomly assign each of the 3 participating pilot practices to 1 of 3 arms: (1) commitment nudge, (2) justification nudge, or (3) both commitment and justification nudges. Randomization will be at the practice level, without replacement, thus assigning exactly 1 practice to each arm. All participating clinicians within a given practice will receive the same nudges. Northwestern-affiliated practices that do not participate in the pilot will constitute a fourth arm of this pilot study.
| Arm | Type | Receives |
|---|---|---|
| Commitment nudge | Experimental | Behavioral: Commitment nudgePrimary care clinicians in the practice assigned to this arm will receive only the commitment nudge. |
| Justification nudge | Experimental | Behavioral: Justification nudgePrimary care clinicians in the practice assigned to this arm will receive only the justification nudge. |
| Commitment + Justification nudges | Experimental | Behavioral: Commitment nudge, Behavioral: Justification nudgePrimary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge. |
| Non-participating | No intervention | –Primary care clinicians in Northwestern-affiliated practices other than the 3 pilot-participating practices will not receive any study interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care clinicians practicing in one of the participating Northwestern-affiliated practices
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 |
|---|---|---|
| Commitment nudgeThe commitment nudge will ask clinicians to commit to discussing high-risk polypharmacy at the next office visit with patients who have high-risk polypharmacy. Clinicians who commit will receive a reminder just before the next office visit begins. The patient will also receive notification of the commitment via EHR patient portal. This nudge will be operationalized via two sequential clinician-facing EHR best practice alerts (BPAs): the first at time of opening any encounter (including encounters other than a face-to-face office visit, e.g., medication refills), and the second (contingent on making a commitment to discuss high-risk polypharmacy) at time of opening the subsequent encounter for a face-to-face office visit. Each of these BPAs will describe the specific high-risk polypharmacy criterion (or criteria) the patient meets, the specific harms associated with the medication(s) triggering the criterion/criteria, and lower-risk alternative treatment strategies. | Behavioural | Commitment + Justification nudges, Commitment nudge |
| Justification nudgeThe justification nudge will ask clinicians who prescribe or renew a drug that meets high-risk polypharmacy criteria (in the context of the patient's other medications) to write a brief justification for prescribing this high-risk medication. This written justification will be recorded in the patient's medical record. The best practice alert requesting the justification will also describe the specific high-risk polypharmacy criterion (or criteria) the patient meets, the specific harms associated with the medication(s) triggering the criterion/criteria, and lower-risk alternative treatment strategies. | Behavioural | Commitment + Justification nudges, Justification nudge |
Primary outcome
High-risk polypharmacy criterion: Fall condition-drug interaction
Time frame: 28 months
Denominator: count of patients aged >=65 years AND who have >=1 fall marker within the prior 2 years (ICD-10 codes for falls or hip fractures; OR who are recorded in the EHR as being high-risk for falls). Numerator: count of patients in the denominator who have 5+ medications in their EHR med list AND who have >=1 medication in their EHR med list that is a tricyclic antidepressant, Z-drug (e.g., zolpidem), benzodiazepine, antipsychotic, anticonvulsant, SSRI/SNRI, or opioid.
High-risk polypharmacy criterion: Fall drug-drug interaction
Time frame: 28 month
Denominator: count of patients aged >=65 years. Numerator: count of patients in the denominator who have 5+ meds AND who have >=3 medications in their EHR med list that are tricyclic antidepressants, Z-drugs (e.g., zolpidem), benzodiazepines, antipsychotics, anticonvulsants, SSRIs/SNRIs, or opioids.
High-risk polypharmacy criterion: CKD-glyburide/glimepiride interaction
Time frame: 28 months
Denominator: count of patients aged >=65 years AND who have most-recent estimated glomerular filtration rate (eGFR) < 60 as estimated by the Cockcroft-Gault equation. Numerator: count of patients in the denominator who have 5+ meds AND glyburide or glimepiride in their EHR med list.
High-risk polypharmacy criterion: CKD-NSAID interaction
Time frame: 28 months
Denominator: count of patients aged >=65 years AND who have most-recent eGFR < 30 as estimated by the Cockcroft-Gault equation. Numerator: count of patients in the denominator who have 5+ meds AND a systemically-absorbed non-steroidal anti-inflammatory drug (NSAID) in their EHR med list.
High-risk polypharmacy criterion: CHF-NSAID interaction
Time frame: 28 months
Denominator: count of patients aged >=65 years AND who have 5+ meds AND congestive heart failure (identified via ICD-10 code within prior 2 years). Numerator: count of patients in the denominator who have a systemically-absorbed non-steroidal anti-inflammatory drug (NSAID) in their EHR med list.
High-risk polypharmacy criterion: CHF-non-dihydropyridine calcium channel blocker interaction
Time frame: 28 months
Denominator: count of patients aged >=65 years AND who have low-ejection-fraction congestive heart failure (identified via ICD-10 code within prior 2 years). Numerator: count of patients in the denominator who have 5+ meds AND a non-dihydropyridine calcium channel blocker in their EHR med list.
High-risk polypharmacy criterion: CHF-thiazolidinedione interaction
Time frame: 28 months
Denominator: count of patients aged >=65 years AND who have low-ejection-fraction congestive heart failure (identified via ICD-10 code within prior 2 years). Numerator: count of patients in the denominator who have 5+ meds AND a thiazolidinedione in their EHR med list.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Mark W Friedberg, MD, MPP principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commitment nudge and Justification nudge in people with Fall and Congestive Heart Failure, run by RAND at 1 site 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: withdrawn, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
High-risk polypharmacy criterion: Fall condition-drug interaction (time frame: 28 months). The study lists 7 primary outcomes in all. 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 19 Dec 2025.