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

Primary Purpose

Fall, Congestive Heart Failure, Chronic Kidney Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Commitment nudge
Justification nudge
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fall focused on measuring Polypharmacy, Primary Health Care, Economics, Behavioral, Deprescriptions, Decision Support Systems, Clinical, Electronic Health Records, Geriatrics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • Northwestern Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Commitment nudge

Justification nudge

Commitment + Justification nudges

Non-participating

Arm Description

Primary care clinicians in the practice assigned to this arm will receive only the commitment nudge.

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

Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge.

Primary care clinicians in Northwestern-affiliated practices other than the 3 pilot-participating practices will not receive any study interventions.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2018
Last Updated
June 12, 2019
Sponsor
RAND
Collaborators
Northwestern University, University of California, Los Angeles, University of Southern California, University of Pittsburgh, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03791580
Brief Title
Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase
Official Title
Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Northwestern University, University of California, Los Angeles, University of Southern California, University of Pittsburgh, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fall, Congestive Heart Failure, Chronic Kidney Failure, Adverse Drug Event
Keywords
Polypharmacy, Primary Health Care, Economics, Behavioral, Deprescriptions, Decision Support Systems, Clinical, Electronic Health Records, Geriatrics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Commitment nudge
Arm Type
Experimental
Arm Description
Primary care clinicians in the practice assigned to this arm will receive only the commitment nudge.
Arm Title
Justification nudge
Arm Type
Experimental
Arm Description
Primary care clinicians in the practice assigned to this arm will receive only the justification nudge.
Arm Title
Commitment + Justification nudges
Arm Type
Experimental
Arm Description
Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge.
Arm Title
Non-participating
Arm Type
No Intervention
Arm 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(s)
Commitment nudge
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Justification nudge
Intervention 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.
Primary Outcome Measure Information:
Title
High-risk polypharmacy criterion: Fall condition-drug interaction
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.
Time Frame
28 months
Title
High-risk polypharmacy criterion: Fall drug-drug interaction
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.
Time Frame
28 month
Title
High-risk polypharmacy criterion: CKD-glyburide/glimepiride interaction
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.
Time Frame
28 months
Title
High-risk polypharmacy criterion: CKD-NSAID interaction
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.
Time Frame
28 months
Title
High-risk polypharmacy criterion: CHF-NSAID interaction
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.
Time Frame
28 months
Title
High-risk polypharmacy criterion: CHF-non-dihydropyridine calcium channel blocker interaction
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.
Time Frame
28 months
Title
High-risk polypharmacy criterion: CHF-thiazolidinedione interaction
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.
Time Frame
28 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary care clinicians practicing in one of the participating Northwestern-affiliated practices Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W Friedberg, MD, MPP
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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