Telepharmacy Robotic Medicine Delivery Unit TRMDU Assessment

Study Overview
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Brief Summary
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The objective of this study is to evaluate whether use of TRMDU in addition to medication review leads to improved outcomes and reduced health care costs for patients when compared with medication review alone. The study will be conducted in patients assigned to Department of Defense (DOD) Warrior Transition Units (WTU's), similar DOD units, and VA polytrauma centers.

Detailed Description
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The military has been witnessing an increased number of patients with combat related impairments such as traumatic brain injury, post traumatic stress disorder and polytrauma which has lead to sub optimal medication self management. TRMDU is a medical device developed by INRange Systems Inc. that delivers medications and emits a sound alert to assist the patient. It can be used in a hospital, clinic, or residential setting. It can be remotely accessed by the health care professionals, and it allows physicians and other prescribers to remotely change scheduling or adjust prescriptions. Use of TRMDU in hospital settings is expected to improve outcomes by improving medication self management, increasing adherence, reducing medication errors, and thereby associated costs. Further, it may contribute to overall improvement in a patient's psychological well-being and quality of life.

Official Title
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Evaluation of a Telepharmacy Robotic Medicine Delivery Unit in Warrior Transition Unit Patients With Traumatic Brain Injury, Post-Traumatic Stress Disorder, or Polytrauma

Conditions
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Traumatic Brain Injury, Posttraumatic Stress Disorders, Trauma, Combat Disorders, Pain

Intervention / Treatment
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* Device: TMRDU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be At least 18 years of age Alert and oriented to person , place and time Primarily use English language for written and oral communication Have diagnosis of Traumatic Brain Injury(TBI) Multiple Traumatic Brain Injury (MTBI), Post Traumatic Stress Disorder (PTSD) or Polytrauma. Taking at least 4 chronic prescription medications Living in a participating WTU or enrolled in Tampa Veterans Administration polytrauma outpatient treatment facility at the time of enrollment Achieve a minimum score of 24 on Mini-Mental State Examination Exclusion Criteria: If patients meet following criteria they are excluded from the study Disabilities preventing safe use of the TRMDU Projected life expectancy of less than 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMRDU<br>Telepharmacy Robotic Medicine Delivery Unit (TMRDU) group will receive TMRDU plus medication management | Device: TMRDU<br>* The TMRDU will assist study subjects with taking their medications as prescribed by notifying them when the next dose is due and tracking whether and when it was taken.<br>* Other names: Electronic Medication Management Assistant, (EMMA) (R);|
| No Intervention: Control<br>Control arm will receive only medication management, no TMRDU. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Pill counts and self report (Morisky 8-item) | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity and type of pain | Short-Form McGill Pain Questionnaire; 15 descriptors rated on intensity of 0=none to 3=severe | Three months | 
| Psychological well-being | Profile of Moods Brief Scale; scores of 6 subscales range from 0-20, with higher scores indicating higher distress, except for one subscale which is negatively scored. | Three months | 
| Health related quality of life | Short-Form 36; 8 domains of general health with higher scores indicating less disability | Three months | 
| Total cost of care | Six-month medication and medical cost of care will be extracted from the DOD prescription and medical claims databases | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telepharmacy Robotic Medicine Delivery Unit, Brain Injuries, Stress Disorders, Combat disorders, Polytrauma, Adherence