Clinical trial NCT03775044: Assessment of Medherent Medication Management Device and Adherence Platform
Official title: Assessment of Medherent Medication Management Device and Adherence Platform
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Disorder
Medication Adherence
Keywords: Telemedicine
Medication Adherence
Mental Health Issue
Lead sponsor: Terrapin Pharmacy
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland
First posted: 2018-12-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a stepped wedge design where all individuals receive the intervention but at different time points after enrollment in the study. Each person will have two observations before the intervention and three observations after the intervention. Health service use data will be collected for two years prior to enrollment and two years after enrollment.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in Brief Evaluation of Medication Influences and Beliefs (BEMIB) Adherence Measure
timeFrame: Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month)
measure: Voils two-part measure of medication nonadherence
timeFrame: Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month)
measure: Change in Medication Records
timeFrame: Change between weekly adherence from enrollment/baseline compared with weekly adherence for the year after receiving the Medherent Machine
measure: Chart review of clinical records for change in level of adherence support
timeFrame: Change level of adherence support from enrollment/baseline compared to adherence support for the year after receiving the Medherent Machine (e.g. Treatment)
measure: Pharmacy interaction outcomes: Refill Times
timeFrame: Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment)
measure: Pharmacy interaction outcomes: Medherent device fail/error rate
timeFrame: Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment)
Secondary outcomes:
measure: Psychiatric Acute Events
timeFrame: Measured from two years prior to Medherent device installation through 1 year after device installation.
measure: Costs of Services
timeFrame: Measured from two years prior to Medherent device installation through 1 year after device installation.
Other outcomes:
Locations:
city: Annapolis
country: United States
facility: Terrapin Pharmacy
state: Maryland
Study officials:
affiliation: Terrapin Pharmacy
name: Joel Feldman, JD
role: PRINCIPAL_INVESTIGATOR
References: