Adverse Drug Reaction, Deprescribing, Polypharmacy
Conditions
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.
Interventions
BEHAVIORALDeprescribing 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.
BEHAVIORALUsual 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.
Sponsors
Blue Cross Blue Shield
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- taking 10 or more regular medications
Exclusion criteria
* not receiving primary care at UT Physicians
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Drug Reactions (ADR) | 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. |
| Adverse Drug Reactions | 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. |
| Healthcare Cost | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication use | At enrollment | Number and name of each medication a participant is taking. |
| Medication cost | 3 months post enrollment | Average wholesale price of each medication taken by a participant, determined using reference software. |
| QOL | 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. |
Countries
United States
Outcome results
None listed