Reducing Costs by Deprescribing Medications

NCT04553107 | Completed

• 1 other identifier: 2019-410
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polypharmacy; Deprescribing; Adverse Drug Reaction

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Medication use

  At enrollment

• Medication cost

  3 months post enrollment

• Medication cost

  6 months post enrollment

• Medication cost

  12 months post enrollment

• QOL

  Baseline

Study Arms (2)

Deprescribing Intervention

EXPERIMENTAL

Behavioral: Deprescribing Intervention

Usual Care

ACTIVE COMPARATOR

Behavioral: Usual Care

Interventions

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.

Deprescribing Intervention

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.

Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- taking 10 or more regular medications

You may not qualify if:

• not receiving primary care at UT Physicians

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Blue Cross Blue Shield: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Holly M Holmes, MD,MS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: December 9, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

US (1)