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Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase

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ClinicalTrials.gov Identifier: NCT03791580
Recruitment Status : Enrolling by invitation
First Posted : January 1, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Northwestern University
University of California, Los Angeles
University of Southern California
University of Pittsburgh
National Institute on Aging (NIA)
Information provided by (Responsible Party):
RAND

Brief 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 high-risk polypharmacy among their older adult patients.

Condition or disease Intervention/treatment Phase
Fall Congestive Heart Failure Chronic Kidney Failure Adverse Drug Event Behavioral: Commitment nudge Behavioral: Justification nudge Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase
Estimated Study Start Date : February 11, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 1, 2019

Arm Intervention/treatment
Experimental: Commitment nudge
Primary care clinicians in the practice assigned to this arm will receive only the commitment nudge.
Behavioral: Commitment nudge

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.


Experimental: Justification nudge
Primary care clinicians in the practice assigned to this arm will receive only the justification nudge.
Behavioral: Justification nudge
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.

Experimental: Commitment + Justification nudges
Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge.
Behavioral: Commitment nudge

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.


Behavioral: Justification nudge
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.

No Intervention: Non-participating
Primary care clinicians in Northwestern-affiliated practices other than the 3 pilot-participating practices will not receive any study interventions.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary care clinicians practicing in one of the participating Northwestern-affiliated practices

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791580


Locations
United States, Illinois
Northwestern Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
RAND
Northwestern University
University of California, Los Angeles
University of Southern California
University of Pittsburgh
National Institute on Aging (NIA)
Investigators
Principal Investigator: Mark W Friedberg, MD, MPP RAND

Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT03791580     History of Changes
Other Study ID Numbers: STU00207210
R21AG057396 ( U.S. NIH Grant/Contract )
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RAND:
Polypharmacy
Primary Health Care
Economics, Behavioral
Deprescriptions
Decision Support Systems, Clinical
Electronic Health Records
Geriatrics

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Drug-Related Side Effects and Adverse Reactions
Kidney Failure, Chronic
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Chemically-Induced Disorders
Renal Insufficiency, Chronic