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OpenTrials
Completed

NCT Number: NCT04553107

Reducing Costs by Deprescribing Medications

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.

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Key information

Conditions

Polypharmacy Adverse Drug Reaction Chemically-Induced Disorders Deprescribing Drug-Related Side Effects and Adverse Reactions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • taking 10 or more regular medications

Exclusion criteria

  • not receiving primary care at UT Physicians

Treatment and study plan

Deprescribing Intervention

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. Adverse Drug Reactions (ADR)

    Time frame: 3 months post enrollment

    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.

  2. Adverse Drug Reactions

    Time frame: 6 months post enrollment

    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. Adverse Drug Reactions

    Time frame: 12 months post enrollment

    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.

  4. Healthcare Cost

    Time frame: 3 months post enrollment

    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.

  5. Healthcare Cost

    Time frame: 6 months post enrollment

    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. Healthcare Cost

    Time frame: 12 months post enrollment

    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.

Secondary outcomes

  1. Medication use

    Time frame: At enrollment

    Number and name of each medication a participant is taking.

  2. Medication cost

    Time frame: 3 months post enrollment

    Average wholesale price of each medication taken by a participant, determined using reference software.

  3. Medication cost

    Time frame: 6 months post enrollment

    Average wholesale price of each medication taken by a participant, determined using reference software.

  4. Medication cost

    Time frame: 12 months post enrollment

    Average wholesale price of each medication taken by a participant, determined using reference software.

  5. QOL

    Time frame: Baseline

    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.

  6. QOL

    Time frame: 12 months post enrollment

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Blue Cross Blue Shield

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2020
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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