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临床试验/NCT05656560
NCT05656560进行中(未招募)不适用

Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records

Northwestern University4 个研究点 分布在 1 个国家目标入组 786 人开始时间: 2023年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
786
试验地点
4
主要终点
The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Northwestern Medicine or UPMC primary care clinic: Internal Medicine, Family Medicine, or General Practice or Geriatrics

排除标准

  • 未提供

研究组 & 干预措施

Clinician education only

Other

Online clinician education

干预措施: Clinician education (Other)

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.

干预措施: Clinical decision support (CDS)-Commitment nudge (Behavioral)

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.

干预措施: Clinician education (Other)

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.

干预措施: Clinician education (Other)

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.

干预措施: Clinical decision support (CDS)-Justification nudge (Behavioral)

Commitment nudge + Justification nudge

Experimental

This study arm will receive both the commitment nudge and the justification nudge.

干预措施: Clinical decision support (CDS)-Commitment nudge (Behavioral)

Commitment nudge + Justification nudge

Experimental

This study arm will receive both the commitment nudge and the justification nudge.

干预措施: Clinician education (Other)

Commitment nudge + Justification nudge

Experimental

This study arm will receive both the commitment nudge and the justification nudge.

干预措施: Clinical decision support (CDS)-Justification nudge (Behavioral)

结局指标

主要结局

The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)

时间窗: 18 months

The composite of the 7 high-risk polypharmacy measures (Secondary outcomes #6-12)

次要结局

  • The percentage of HRPP patients with Heart Failure-thiazolidinedione interaction(18 months)
  • The percentage of HRPP patients with CKD-NSAID interaction(18 months)
  • The rate of Emergency Department visits per patient -all cause(18 months)
  • The rate of hospital admissions per patient-all cause(18 months)
  • The percentage of HRPP patients with a fall condition-drug interaction(18 months)
  • The percentage of HRPP patients with Heart failure with reduced ejection fraction- non-dihydropyridine calcium channel blocker interaction(18 months)
  • The percentage of HRPP patients with CKD-glyburide/glimepiride interaction(18 months)
  • The rate of Emergency Department visits per patient-Adverse drug event (ADE)-specific(18 months)
  • The percentage of HRPP patients with Heart failure-NSAID interaction(18 months)
  • The rate of hospital admissions per patient-ADE-specific(18 months)
  • The percentage of HRPP patients with a fall drug-drug interaction(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Persell, MD, MPH

Professor; Director, Center for Primary Care Innovation

Northwestern University

研究点 (4)

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