- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340570
Effect of Medication Management at Home Via Pharmacy Home Televisits
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Older adults are more likely to suffer from multiple chronic conditions, to be prescribed multiple medications, and are more susceptible to adverse effects of medications. In addition, older adults often use over-the-counter medications and supplements, further complicating their medication regimen. Complex medication regimens are potentially harmful to older adults due to potential drug interactions, potentially inappropriate prescribing or over-the-counter drug use, and medication non-adherence that may lead to poor control of chronic disease. Interventions aimed at reducing medication discrepancy in the ambulatory clinic setting, such as the review of written medication lists, and implementation of "brown bag" reconciliation (asking patients to bring in all medication bottles for review in the clinic) continues to be challenging and have limited success. Clinical pharmacist led interventions to improve appropriate medication use in older adults, including the application of the START/STOPP criteria, have demonstrated effectiveness in reducing adverse drug events. With the increased capability of VA telemedicine to reach Veteran in their homes, delivering medication management via televisit by clinical pharmacists has the potential to yield similar benefits for a larger number of older Veterans.
Telemedicine is an increasingly vital component within VHA to increase access and improve quality of care. By extending care beyond brick-and-mortar clinics, telemedicine increases the reach of care teams and is more convenient for patients, resulting in improved patient satisfaction. Using the capability of telemedicine to reach patients' homes, the investigators propose to examine the effect of medication management by clinical pharmacists via home video televisits, as home video visits have the potential to provide direct visualization of medications in older adults' homes, thereby reducing medication discrepancy and increasing medication adherence. Pharmacist management for older adult medication regimen may also improve appropriate medication use in older adults through direct pharmacist-patient interview and education. In support of this application, preliminary data from the team of investigators demonstrate acceptability of video televisits by older adults, that there is good uptake by patients and VA providers, and that video televisits into the home are feasible.
In this study, the investigators aim to develop a protocol for pharmacy home televisits for medication management in older adults who have multiple chronic conditions and are on multiple medications. The investigators will then conduct a randomized trial to examine the effect of these televisits on appropriate medication use, medication discrepancies, adherence and adverse drug events. The investigators anticipate that a pharmacist led medication management home televisit intervention will lead to reduction in potentially inappropriate use of medication, reduction in medication discrepancies, increased medication adherence and reduced adverse drug events in older adults compared to older adults receiving usual care. The investigators will also examine the potential challenges in implementing the intervention so that the study findings may inform future implementation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Bedford, Massachusetts, United States, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
-
-
New York
-
The Bronx, New York, United States, 10468-3904
- James J. Peters VA Medical Center, Bronx, NY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Had at least 1 VA primary care visit within past year
- At least 2 chronic conditions
- At least 5 daily medications
Exclusion Criteria:
- Dementia diagnosis
- Lacks capacity for informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Receives pharmacist home televisit for medication management
|
Pharmacist led home based televisit for medication management
|
|
No Intervention: Usual Care
Usual care for outpatient medication management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of subjects with Potentially inappropriate medication use
Time Frame: 6 months
|
Potentially inappropriate medication use (PIM) assessed by blinded reviewer.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication Appropriateness
Time Frame: 6 months
|
Measured using Medication Appropriateness Index
|
6 months
|
|
Adverse drug events
Time Frame: 6 months
|
Assessed from subject survey and chart review and rated as preventable vs. nonpreventable
|
6 months
|
|
Medication self efficacy
Time Frame: 6 months
|
Measured using patient reported "Medication Understanding Use and Self-Efficacy Scale"
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: William W Hung, MD AB MPH, James J. Peters Veterans Affairs Medical Center
- Principal Investigator: Lauren Rachel Moo, MD, VA Bedford HealthCare System, Bedford, MA
Publications and helpful links
General Publications
- Hawley CE, Wagner C, Venegas MD, Genovese N, Triantafylidis LK, McCullough MB, Beizer JL, Hung WW, Moo LR. Connecting the disconnected: Leveraging an in-home team member for video visits for older adults. J Am Geriatr Soc. 2024 May;72(5):1408-1419. doi: 10.1111/jgs.18663. Epub 2023 Nov 13.
- Hossain SR, Samant AN, Balsamo BC, Hawley CE, Zanchelli MC, Zhu C, Venegas MD, Robertson M, McCullough MB, Beizer JL, Boockvar KS, Siu AL, Moo LR, Hung WW. Effect of Medication Management at Home via Pharmacist-Led Home Televisits: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 5;14:e65141. doi: 10.2196/65141.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 18-286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Deprescribing
-
University of MichiganUniversity of SydneyCompletedDeprescribingUnited States
-
Université Catholique de LouvainEBPracticenet; Fonds National de la Recherche scientifique (FNRS)RecruitingBenzodiazepines DeprescribingBelgium
-
Wake Forest University Health SciencesCompleted
-
Monash UniversityNational University Hospital, Singapore; Guardian; NTUC Unity; Watsons; Kwong Wai... and other collaboratorsCompleted
-
Brigham and Women's HospitalNational Institute on Aging (NIA); University of Southern CaliforniaNot yet recruitingDeprescribing | Statin Prescribing
-
Université Catholique de LouvainEBPracticenet; Fonds National de la Recherche scientifique (FNRS)RecruitingBenzodiazepine DeprescribingBelgium
-
Magi ClaveriaFundacio d'Atencio PrimariaActive, not recruiting
-
Bright Vision HospitalUnknownDeprescribing | Multi-disciplinary | RoundsSingapore
-
Nantes University HospitalFondation de France; Nantes UniversityRecruitingDeprescribing | Palliative Care | OncologyFrance
-
University of AmsterdamCompletedDeprescribing | Fall | Fall Injury | Fall Patients | Accidental FallNetherlands
Clinical Trials on Medication management via televisit to home
-
Applied Science Private UniversityCompleted
-
Providence Health & ServicesTerminated
-
University of PittsburghCompletedMedication Management
-
US Department of Veterans AffairsCompleted
-
Dilla UniversityNot yet recruiting
-
HES-SO Valais-WallisPolytechnic of Leiria; Institute for Primary Health Care BIHAM, University...WithdrawnPolypharmacy | Multiple Chronic Conditions
-
MedStar Georgetown University HospitalMedstar Health Research InstituteUnknownHypertension | Ischemic StrokeUnited States
-
University of Massachusetts, WorcesterNational Institute on Aging (NIA); University of Utah; Boston CollegeCompletedPalliative Care | Interdisciplinary Communication | Caregivers | Deprescriptions | Hospices | Poly Pharmacy | Prescription Drug OveruseUnited States
-
Xiang GuScience and Technology Department of Jiangsu Province; Yangzhou Municipal Health...UnknownChronic Heart FailureChina
-
University of PatrasEnrolling by invitation