Combat Disorders, Pain, Posttraumatic Stress Disorders, Trauma, Traumatic Brain Injury
Conditions
Keywords
Telepharmacy Robotic Medicine Delivery Unit, Brain Injuries, Stress Disorders, Combat disorders, Polytrauma, Adherence
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.
Interventions
DEVICETMRDU
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.
Sponsors
U.S. Army Medical Research and Development Command
University of Illinois at Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | Six months | Pill counts and self report (Morisky 8-item) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity and type of pain | Three months | Short-Form McGill Pain Questionnaire; 15 descriptors rated on intensity of 0=none to 3=severe |
| Psychological well-being | Three months | 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. |
| Health related quality of life | Three months | Short-Form 36; 8 domains of general health with higher scores indicating less disability |
| Total cost of care | Six months | Six-month medication and medical cost of care will be extracted from the DOD prescription and medical claims databases |
Countries
United States
Outcome results
None listed