<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03791580</url>
  </required_header>
  <id_info>
    <org_study_id>STU00207210</org_study_id>
    <secondary_id>R21AG057396</secondary_id>
    <nct_id>NCT03791580</nct_id>
  </id_info>
  <brief_title>Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase</brief_title>
  <official_title>Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAND</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>RAND</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Polypharmacy is common among older adults in the United States and is associated with harms&#xD;
      such as adverse drug reactions and higher costs of care. This pilot-phase project is designed&#xD;
      to test two electronic health record (EHR)-based behavioral economic nudges to help primary&#xD;
      care clinicians reduce the rate of high-risk polypharmacy among their older adult patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Polypharmacy increases the likelihood of being prescribed and harmed by high-risk&#xD;
      medications. As noted in the 2014 National Action Plan for Adverse Drug Event (ADE)&#xD;
      Prevention, polypharmacy both increases the likelihood of being prescribed high-risk&#xD;
      medications and increases the likelihood that these high-risk medications will lead to&#xD;
      adverse drug events. This pilot-phase study is intended to test clinicians' perceptions of&#xD;
      EHR-based nudges designed to reduce high-risk polypharmacy among patients aged 65 years or&#xD;
      more, thereby enabling investigators to refine the nudges, and to generate outcomes data that&#xD;
      will inform power calculations for a subsequent larger study (the main study) of the nudges'&#xD;
      effectiveness.&#xD;
&#xD;
      In this pilot-phase study, the investigators will deploy 2 EHR-based behavioral nudges (a&#xD;
      commitment nudge and a justification nudge) among 18 or more primary care clinicians in 3&#xD;
      primary care practices (6 clinicians or more per practice) affiliated with Northwestern&#xD;
      University for approximately 4 months. The 3 practices participating in the pilot will be a&#xD;
      convenience sample of Northwestern-affiliated practices known to study investigators.&#xD;
&#xD;
      The investigators will randomly assign each of the 3 participating pilot practices to 1 of 3&#xD;
      arms: (1) commitment nudge, (2) justification nudge, or (3) both commitment and justification&#xD;
      nudges. Randomization will be at the practice level, without replacement, thus assigning&#xD;
      exactly 1 practice to each arm. All participating clinicians within a given practice will&#xD;
      receive the same nudges.&#xD;
&#xD;
      Northwestern-affiliated practices that do not participate in the pilot will constitute a&#xD;
      fourth arm of this pilot study.&#xD;
&#xD;
      The investigators will ask leaders of participating practices for their qualitative&#xD;
      observations on how clinicians and patients experience the nudges (e.g., how the nudges&#xD;
      affect workflows). The investigators also will collect data on the outcome measures before&#xD;
      and during the approximately 4-month pilot period and compare these data to contemporaneous&#xD;
      outcomes measures generated by Northwestern-affiliated practices that do not participate in&#xD;
      the pilot.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>High-risk polypharmacy criterion: Fall condition-drug interaction</measure>
    <time_frame>28 months</time_frame>
    <description>Denominator: count of patients aged &gt;=65 years AND who have &gt;=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 &gt;=1 medication in their EHR med list that is a tricyclic antidepressant, Z-drug (e.g., zolpidem), benzodiazepine, antipsychotic, anticonvulsant, SSRI/SNRI, or opioid.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High-risk polypharmacy criterion: Fall drug-drug interaction</measure>
    <time_frame>28 month</time_frame>
    <description>Denominator: count of patients aged &gt;=65 years. Numerator: count of patients in the denominator who have 5+ meds AND who have &gt;=3 medications in their EHR med list that are tricyclic antidepressants, Z-drugs (e.g., zolpidem), benzodiazepines, antipsychotics, anticonvulsants, SSRIs/SNRIs, or opioids.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High-risk polypharmacy criterion: CKD-glyburide/glimepiride interaction</measure>
    <time_frame>28 months</time_frame>
    <description>Denominator: count of patients aged &gt;=65 years AND who have most-recent estimated glomerular filtration rate (eGFR) &lt; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High-risk polypharmacy criterion: CKD-NSAID interaction</measure>
    <time_frame>28 months</time_frame>
    <description>Denominator: count of patients aged &gt;=65 years AND who have most-recent eGFR &lt; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High-risk polypharmacy criterion: CHF-NSAID interaction</measure>
    <time_frame>28 months</time_frame>
    <description>Denominator: count of patients aged &gt;=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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High-risk polypharmacy criterion: CHF-non-dihydropyridine calcium channel blocker interaction</measure>
    <time_frame>28 months</time_frame>
    <description>Denominator: count of patients aged &gt;=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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High-risk polypharmacy criterion: CHF-thiazolidinedione interaction</measure>
    <time_frame>28 months</time_frame>
    <description>Denominator: count of patients aged &gt;=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.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Fall</condition>
  <condition>Congestive Heart Failure</condition>
  <condition>Chronic Kidney Failure</condition>
  <condition>Adverse Drug Event</condition>
  <arm_group>
    <arm_group_label>Commitment nudge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary care clinicians in the practice assigned to this arm will receive only the commitment nudge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Justification nudge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary care clinicians in the practice assigned to this arm will receive only the justification nudge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Commitment + Justification nudges</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-participating</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Primary care clinicians in Northwestern-affiliated practices other than the 3 pilot-participating practices will not receive any study interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Commitment nudge</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>Commitment + Justification nudges</arm_group_label>
    <arm_group_label>Commitment nudge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Justification nudge</intervention_name>
    <description>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.</description>
    <arm_group_label>Commitment + Justification nudges</arm_group_label>
    <arm_group_label>Justification nudge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary care clinicians practicing in one of the participating Northwestern-affiliated&#xD;
             practices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark W Friedberg, MD, MPP</last_name>
    <role>Principal Investigator</role>
    <affiliation>RAND</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>June 12, 2019</last_update_submitted>
  <last_update_submitted_qc>June 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polypharmacy</keyword>
  <keyword>Primary Health Care</keyword>
  <keyword>Economics, Behavioral</keyword>
  <keyword>Deprescriptions</keyword>
  <keyword>Decision Support Systems, Clinical</keyword>
  <keyword>Electronic Health Records</keyword>
  <keyword>Geriatrics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 6, 2023</submitted>
    <submission_canceled>February 6, 2023</submission_canceled>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03791580
org study id: STU00207210
secondary id: R21AG057396
nct id: NCT03791580
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
intervention 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.
primary purpose: Health Services Research
masking: None (Open Label)
measure: High-risk polypharmacy criterion: Fall condition-drug interaction
time frame: 28 months
description: 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.
measure: High-risk polypharmacy criterion: Fall drug-drug interaction
time frame: 28 month
description: 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.
measure: High-risk polypharmacy criterion: CKD-glyburide/glimepiride interaction
time frame: 28 months
description: 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.
measure: High-risk polypharmacy criterion: CKD-NSAID interaction
time frame: 28 months
description: 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.
measure: High-risk polypharmacy criterion: CHF-NSAID interaction
time frame: 28 months
description: 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.
measure: High-risk polypharmacy criterion: CHF-non-dihydropyridine calcium channel blocker interaction
time frame: 28 months
description: 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.
measure: High-risk polypharmacy criterion: CHF-thiazolidinedione interaction
time frame: 28 months
description: 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.
arm group label: Commitment nudge
arm group type: Experimental
description: Primary care clinicians in the practice assigned to this arm will receive only the commitment nudge.
arm group label: Justification nudge
arm group type: Experimental
description: Primary care clinicians in the practice assigned to this arm will receive only the justification nudge.
arm group label: Commitment + Justification nudges
arm group type: Experimental
description: Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge.
arm group label: Non-participating
arm group type: No Intervention
description: Primary care clinicians in Northwestern-affiliated practices other than the 3 pilot-participating practices will not receive any study interventions.
intervention type: Behavioral
intervention name: Commitment nudge
description: 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.
arm group label: Commitment + Justification nudges
arm group label: Commitment nudge
intervention type: Behavioral
intervention name: Justification nudge
description: 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.
arm group label: Commitment + Justification nudges
arm group label: Justification nudge
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark W Friedberg, MD, MPP
role: Principal Investigator
affiliation: RAND
facility: 
country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Heart Failure
mesh term: Drug-Related Side Effects and Adverse Reactions
sharing ipd: No
submitted: February 6, 2023
submission canceled: February 6, 2023