Assessment of Medherent Medication Management Device and Adherence Platform

NCT ID: NCT03775044

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2023-03-31

Brief Summary

This study uses a stepped wedge designs to estimate the effect of using the Medherent Medication Management Device on medication adherence for a population of 150 individuals who are diagnosed with serious mental illness.

Detailed Description

Individuals suffering from Serious Mental Illnesses (SMI) such as schizophrenia, bipolar disorder or depressive disorders are at risk for serious adverse psychiatric, other health, and social outcomes. Essential to controlling chronic psychiatric and health disorders is adherence to medications that are prescribed to address the symptoms and causes of these health conditions. Medication adherence is particularly challenging for those with SMI. Good adherence is defined as 80% or more of medication taken, whereas the average patient with schizophrenia or bipolar disorder takes 50-70% of prescribed medications. For individuals with SMI, important barriers to adherence include cognitive impairments and lack of illness insight, meaning that they are not aware of the symptoms and consequences of their illness. Inquiries about drug intake by psychiatrists, relatives, or others has been linked to greater adherence. Positive relationships with physicians, psychiatrists and their staff have been found to be significant predictors of good adherence in SMI patients, while difficulties in building a therapeutic alliance and poor clinical-patient relationship are significant predictors of nonadherence. Failure to recognize nonadherence may prompt physicians to misattribute poor outcomes to treatment failure, leading to inappropriate dosage increases or unnecessary medication switches. Moreover, non- adherence in SMI patients is associated with greater economic and social burden, due to higher hospitalization rates, longer hospital stays, more emergency room and emergency psychiatric visits, greater risk of suicide and violence towards others, and higher rates of deleterious psychotic relapses.

The Medherent© Medication Management Device (MMD) is a tool developed by Terrapin Pharmacy to improve medication adherence through the integration of medication dispensing and prompts to consumers to take medications, with real-time electronic feedback to care managers about consumers' adherence behaviors and daily health status. This MMD builds on adherence interventions proven effective in SMI patients and enables care managers to expand the number of individuals that they can care for effectively.

This study uses a stepped-wedge design with 150 individuals across all study sites and approximately 150 individuals to answer the following aims:

1. Measure the effect of the Medherent platform and interventions on adherence and medication use.

1. Measure change in adherence by triangulating self-report data, clinician observation, biological measures, chart reviews and clinical outcomes before and after exposure to the Medherent intervention. Medherent device data will also be used to measure the consumer levels of adherence to medications.

2. Document pharmacy interaction issues (e.g. arranging refill times, responsiveness to prescription changes), device fail rate, and remaining user interface issues (e.g. acceptability of adherence prompts, operating system issues).

2. Measure the effect of Medherent use on clinical outcomes and health service costs.

1. Change in clinical relationships, attitudes about medications, and acute care service use (e.g. hospitalizations and emergency department visits) will be measured by consumer interviews, chart reviews, Medherent dispensing data, and claims data (Medicaid)

2. Using Medicaid data, pharmacy data, and agency clinical data we will develop a cost model for Medherent users before and after enrollment and develop a matched comparison group using other Maryland Medicaid recipients who have not been enrolled in the Medherent treatment arm to measure changes in health service utilization and the corresponding costs.

Conditions

Mental Health Disorder; Medication Adherence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental: Medherent Device

All participants get the Medherent device. There is only one arm to this study.

Group Type: EXPERIMENTAL

Medherent Device

Intervention Type: DEVICE

The Medherent Medication Management Device (MMD) is intended to enable patients to self-manage their medication at home when it may otherwise require assistance.

Interventions

Medherent Device

The Medherent Medication Management Device (MMD) is intended to enable patients to self-manage their medication at home when it may otherwise require assistance.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Currently be a client of a participating community mental health agency
• Have a diagnoses mental illness
• Currently be prescribed a psychotropic medication for the purpose of treatment a mental illness
• Be able to consent to participants in the study
• Be over 18 years old and under 80 years old

Exclusion Criteria

• Under 18 years old.
• Over 80 years old.
• Unable to consent to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland

OTHER

Sponsor Role: collaborator

Terrapin Pharmacy

INDUSTRY

Sponsor Role: lead

Responsible Party

Joel F. Feldman

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Feldman, JD

Role: PRINCIPAL_INVESTIGATOR

Terrapin Pharmacy

Locations

Terrapin Pharmacy

Annapolis, Maryland, United States

Countries

United States

Other Identifiers

1R44MH116765-01

Identifier Type: NIH

Identifier Source: org_study_id

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