Reducing Costs by Deprescribing Medications

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

Study Overview

• Status: Completed
• Conditions: Deprescribing; Polypharmacy; Adverse Drug Reaction
• Intervention / Treatment: Behavioral: Deprescribing Intervention; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- taking 10 or more regular medications

Exclusion Criteria:

• not receiving primary care at UT Physicians

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Behavioral: Usual Care; 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.
Experimental: Deprescribing Intervention	Behavioral: Deprescribing Intervention; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Blue Cross Blue Shield
• Investigators: Principal Investigator: Holly M Holmes, MD,MS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 2019-410

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No