Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial
Authors: Hossain Sheikh Rubana , Samant Akanksha N , Balsamo Briana C , Hawley Chelsea E , Zanchelli Michael C , Zhu Carolyn , Venegas Maria D , Robertson Marina , McCullough Megan B , Beizer Judith L , Boockvar Kenneth S , Siu Albert L , Moo Lauren R , Hung William W 
Published: November 2024

Background
Older adults are more likely to have multiple chronic conditions, be prescribed multiple medications, and be more susceptible to adverse drug reactions (ADRs) to their medications. In addition, older adults often use over-the-counter medications and supplements, further complicating their medication regimens. Complex medication regimens are potentially harmful to older adults. Interventions aimed at reducing medication discrepancy in the ambulatory clinic setting, such as reviews of medication lists and the implementation of “brown bag” reconciliation, continue to be challenging, with limited success. Pharmacist-led interventions to improve appropriate medication use in older adults have demonstrated effectiveness in reducing ADRs. Video visits have the potential to provide direct visualization of medications in older adults’ homes, thereby reducing medication discrepancy and increasing medication adherence. Pharmacist-led management of older adults’ medication regimens may improve appropriate medication use in older adults.

Objective
The objective of this study is to examine the effect of pharmacist-led medication through home televisits compared to usual care on appropriate medication use, medication discrepancies, medication adherence, and ADRs.

Methods
We will conduct a 2-site cluster randomized controlled trial (RCT). The intervention will be a pharmacist-led home televisit including medication reconciliation and assessment of actual medication use. The cluster RCT was iteratively adapted after a pilot test. The primary outcome of medication appropriateness of the intervention will be measured using the STOPP (Screening Tool of Older Persons’ Prescriptions) criteria for potentially inappropriate medications (PIMs) at 6 months. Medication lists obtained will be compared against electronic medical records (EMRs) by a clinician to establish discrepancies in medications. The clinician will review medications using the validated Medication Appropriateness Index (MAI).

Results
This project has been peer-reviewed and selected for support by the Veterans Affairs (VA) Health Services Research Service. The pilot phase of the study was completed December 2021 with 20 veterans and was primarily informed by the Steinman model of the prescribing process adapted to include system- and provider-level factors. The last date of enrollment was August 6, 2021. We anticipate the completion of the ongoing trial in spring 2025. The first results are expected to be submitted for publication in 2025.

Conclusions
The cluster RCT will provide evidence on medication management through televisits. If found effective in improving the use of medications, the intervention has the potential to impact older adults with multiple chronic conditions and polypharmacy.

Trial Registration
ClinicalTrials.gov NCT04340570; https://clinicaltrials.gov/study/NCT04340570

International Registered Report Identifier (IRRID)
PRR1-10.2196/65141