Reducing Costs by Deprescribing Medications

Polypharmacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553107
• Other study ID #: 2019-410
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: November 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• taking 10 or more regular medications

Exclusion Criteria:

• not receiving primary care at UT Physicians

Related Conditions & MeSH terms

• Adverse Drug Reaction
• Deprescribing
• Drug-Related Side Effects and Adverse Reactions
• Polypharmacy

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Blue Cross Blue Shield

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Medication use	Number and name of each medication a participant is taking.	At enrollment
Secondary	Medication cost	Average wholesale price of each medication taken by a participant, determined using reference software.	3 months post enrollment
Secondary	Medication cost	Average wholesale price of each medication taken by a participant, determined using reference software.	6 months post enrollment
Secondary	Medication cost	Average wholesale price of each medication taken by a participant, determined using reference software.	12 months post enrollment
Secondary	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
Secondary	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