Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial

BackgroundOlder 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, fur...

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Main Authors: Sheikh Rubana Hossain, Akanksha N Samant, Briana C Balsamo, Chelsea E Hawley, Michael C Zanchelli, Carolyn Zhu, Maria D Venegas, Marina Robertson, Megan B McCullough, Judith L Beizer, Kenneth S Boockvar, Albert L Siu, Lauren R Moo, William W Hung
Format: Article
Language:English
Published: JMIR Publications 2025-02-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2025/1/e65141
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author Sheikh Rubana Hossain
Akanksha N Samant
Briana C Balsamo
Chelsea E Hawley
Michael C Zanchelli
Carolyn Zhu
Maria D Venegas
Marina Robertson
Megan B McCullough
Judith L Beizer
Kenneth S Boockvar
Albert L Siu
Lauren R Moo
William W Hung
author_facet Sheikh Rubana Hossain
Akanksha N Samant
Briana C Balsamo
Chelsea E Hawley
Michael C Zanchelli
Carolyn Zhu
Maria D Venegas
Marina Robertson
Megan B McCullough
Judith L Beizer
Kenneth S Boockvar
Albert L Siu
Lauren R Moo
William W Hung
author_sort Sheikh Rubana Hossain
collection DOAJ
description BackgroundOlder 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. ObjectiveThe 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. MethodsWe 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). ResultsThis 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. ConclusionsThe 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 RegistrationClinicalTrials.gov NCT04340570; https://clinicaltrials.gov/study/NCT04340570 International Registered Report Identifier (IRRID)PRR1-10.2196/65141
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spelling doaj-art-2cf1a38caf34411286fe5921694887be2025-02-05T19:15:32ZengJMIR PublicationsJMIR Research Protocols1929-07482025-02-0114e6514110.2196/65141Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled TrialSheikh Rubana Hossainhttps://orcid.org/0009-0001-8084-8460Akanksha N Samanthttps://orcid.org/0009-0008-1179-1115Briana C Balsamohttps://orcid.org/0009-0007-0323-4012Chelsea E Hawleyhttps://orcid.org/0000-0002-6136-8189Michael C Zanchellihttps://orcid.org/0009-0004-1249-4471Carolyn Zhuhttps://orcid.org/0000-0002-2318-715XMaria D Venegashttps://orcid.org/0000-0002-2740-2267Marina Robertsonhttps://orcid.org/0009-0006-1473-1113Megan B McCulloughhttps://orcid.org/0000-0002-3387-1967Judith L Beizerhttps://orcid.org/0009-0008-1136-9336Kenneth S Boockvarhttps://orcid.org/0000-0003-1165-5558Albert L Siuhttps://orcid.org/0000-0001-6330-8502Lauren R Moohttps://orcid.org/0000-0003-2951-8674William W Hunghttps://orcid.org/0009-0004-8283-3643 BackgroundOlder 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. ObjectiveThe 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. MethodsWe 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). ResultsThis 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. ConclusionsThe 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 RegistrationClinicalTrials.gov NCT04340570; https://clinicaltrials.gov/study/NCT04340570 International Registered Report Identifier (IRRID)PRR1-10.2196/65141https://www.researchprotocols.org/2025/1/e65141
spellingShingle Sheikh Rubana Hossain
Akanksha N Samant
Briana C Balsamo
Chelsea E Hawley
Michael C Zanchelli
Carolyn Zhu
Maria D Venegas
Marina Robertson
Megan B McCullough
Judith L Beizer
Kenneth S Boockvar
Albert L Siu
Lauren R Moo
William W Hung
Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial
JMIR Research Protocols
title Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial
title_full Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial
title_fullStr Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial
title_full_unstemmed Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial
title_short Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial
title_sort effect of medication management at home via pharmacist led home televisits protocol for a cluster randomized controlled trial
url https://www.researchprotocols.org/2025/1/e65141
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