Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment

University of Illinois at Chicago

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Conditions

Traumatic Brain Injury Posttraumatic Stress Disorders Trauma Combat Disorders Pain

Interventions

TMRDUDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Naval Hospital Camp Pendleton

Camp Pendleton, California, United States

James A Haley VA Hospital and Polytrauma Facility

Tampa, Florida, United States

Ireland Army Community Hospital

Fort Knox, Kentucky, United States

Outcomes

Primary Outcomes

Adherence

Pill counts and self report (Morisky 8-item)

Time frame: Six months

Secondary Outcomes

Intensity and type of pain

Short-Form McGill Pain Questionnaire; 15 descriptors rated on intensity of 0=none to 3=severe

Time frame: 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.

Time frame: Three months

Health related quality of life

Short-Form 36; 8 domains of general health with higher scores indicating less disability

Time frame: 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

Time frame: Six months

Data from ClinicalTrials.gov

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