Clinical trial NCT01007006: Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment
Official title: Evaluation of a Telepharmacy Robotic Medicine Delivery Unit in Warrior Transition Unit Patients With Traumatic Brain Injury, Post-Traumatic Stress Disorder, or Polytrauma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Posttraumatic Stress Disorders
Trauma
Combat Disorders
Pain
Keywords: Telepharmacy Robotic Medicine Delivery Unit
Brain Injuries
Stress Disorders
Combat disorders
Polytrauma
Adherence
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2009-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence
timeFrame: Six months
Secondary outcomes:
measure: Intensity and type of pain
timeFrame: Three months
measure: Psychological well-being
timeFrame: Three months
measure: Health related quality of life
timeFrame: Three months
measure: Total cost of care
timeFrame: Six months
Other outcomes:
Locations:
city: Camp Pendleton
country: United States
facility: Naval Hospital Camp Pendleton
state: California
city: Tampa
country: United States
facility: James A Haley VA Hospital and Polytrauma Facility
state: Florida
city: Fort Knox
country: United States
facility: Ireland Army Community Hospital
state: Kentucky
Study officials:
affiliation: University of Illinois at Chicago
name: Daniel R Touchette, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia College of Nursing
name: Jill M Winters, PhD
role: PRINCIPAL_INVESTIGATOR
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