Effect of Medication Management at Home Via Pharmacy Home Televisits

Telemedicine Clinical Trial

Official title:

Effect of Medication Management at Home Via Pharmacy Home Televisits

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04340570
• Other study ID #: IIR 18-286
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Sheikh Hossain, MPH
• Phone: (718) 858-9000
• Email: sheikh.hossain[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Older Veterans, particularly those with multiple chronic conditions requiring complex medication regimens, are more susceptible to adverse effects of medications. In this study, the investigators will examine the effect of a pharmacist led medication management intervention delivered by home televisit on improving medication use. The investigators anticipate that televisit to home by pharmacist for medication management may enhance use of medications at home by Veterans particularly those with complex medication regimens.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 376
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deprescribing
• Polypharmacy
• Telemedicine

Intervention

Behavioral:
• Medication management via televisit to home
Pharmacist led home based televisit for medication management

Locations

Country	Name	City	State
United States	VA Bedford HealthCare System, Bedford, MA	Bedford	Massachusetts
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with Potentially inappropriate medication use	Potentially inappropriate medication use (PIM) assessed by blinded reviewer.	6 months
Secondary	Medication Appropriateness	Measured using Medication Appropriateness Index	6 months
Secondary	Adverse drug events	Assessed from subject survey and chart review and rated as preventable vs. nonpreventable	6 months
Secondary	Medication self efficacy	Measured using patient reported "Medication Understanding Use and Self-Efficacy Scale"	6 months