Reducing Costs by Deprescribing Medications

Study Overview
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Brief Summary
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The purpose of the study is to implement a pharmacist-led deprescribing intervention for adults 65 and older taking 10 or more medications at University of Texas (UT) Physicians clinics and to assess the effect of the pharmacist intervention on the incidence of adverse drug reactions, emergency room visits, and hospitalizations as well as costs to the patient and to the healthcare system in adults 65 and older taking 10 or more medications treated at UT Physicians.

Official Title
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Reducing Healthcare Costs in Older Adults by Deprescribing Unnecessary, Harmful, and Costly Medications

Conditions
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Polypharmacy, Deprescribing, Adverse Drug Reaction

Intervention / Treatment
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* Behavioral: Deprescribing Intervention
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - taking 10 or more regular medications Exclusion Criteria: not receiving primary care at UT Physicians

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deprescribing Intervention<br> | Behavioral: Deprescribing Intervention<br>* An individualized deprescribing intervention will be created by a pharmacist working with a patient to identify harmful, costly, and unnecessary medications to be reduced. The intervention will include a plan and monitoring for up to 3 months to reduce medication use.<br>|
| Active Comparator: Usual Care<br> | Behavioral: Usual Care<br>* The usual care arm will receive the current standard of care, which includes medication reconciliation by a clinic nurse at the time of their appointment. Nurses review all medications and answer medication-related questions, and refer medication questions to the healthcare provider for further discussion when necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Reactions (ADR) | Patient-reported side effects and adverse events potentially attributable to medication, rated for the likelihood of ADR by an independent reviewer based on the Naranjo algorithm. | 3 months post enrollment | 
| Adverse Drug Reactions | Patient-reported side effects and adverse events potentially attributable to medication, rated for the likelihood of ADR by an independent reviewer based on the Naranjo algorithm. | 6 months post enrollment | 
| Adverse Drug Reactions | Patient-reported side effects and adverse events potentially attributable to medication, rated for the likelihood of ADR by an independent reviewer based on the Naranjo algorithm. | 12 months post enrollment | 
| Healthcare Cost | Healthcare cost based on utilization of clinic visits, emergency room visits, and hospitalizations, based on patient report with specific costs obtained when possible from the Health Information Exchange. | 3 months post enrollment | 
| Healthcare Cost | Healthcare cost based on utilization of clinic visits, emergency room visits, and hospitalizations, based on patient report with specific costs obtained when possible from the Health Information Exchange. | 6 months post enrollment | 
| Healthcare Cost | Healthcare cost based on utilization of clinic visits, emergency room visits, and hospitalizations, based on patient report with specific costs obtained when possible from the Health Information Exchange. | 12 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication use | Number and name of each medication a participant is taking. | At enrollment | 
| Medication cost | Average wholesale price of each medication taken by a participant, determined using reference software. | 3 months post enrollment | 
| Medication cost | Average wholesale price of each medication taken by a participant, determined using reference software. | 6 months post enrollment | 
| Medication cost | Average wholesale price of each medication taken by a participant, determined using reference software. | 12 months post enrollment | 
| QOL | Quality of life as measured by the EQ5D scale.This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine. | Baseline | 
| QOL | Quality of life as measured by the EQ5D scale.This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine. | 12 months post enrollment |