Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03775044 |
| Other study ID # |
1R44MH116765-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2019 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Terrapin Pharmacy |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
