Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment
Recruitment status was Not yet recruiting
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.
Traumatic Brain Injury
Posttraumatic Stress Disorders
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|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|
- Adherence as measured by pill counts and self report (Morisky 8-item) [ Time Frame: Baseline, one, two and three months ] [ Designated as safety issue: Yes ]
- Pain, psychological well-being, health related quality of life, cost [ Time Frame: Baseline, one, two, three months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Telepharmacy Robotic Medicine Delivery Unit (TMRDU) group will receive TMRDU plus medication management
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.
Other Name: Electronic Medication Management Assistant, (EMMA) (R)
No Intervention: Control
Control arm will receive only medication management, no TMRDU.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007006
|Contact: Daniel R Touchette, Pharm.D., MAemail@example.com|
|Contact: Jill M Winters, PhDfirstname.lastname@example.org|
|United States, California|
|Naval Hospital Camp Pendleton||Not yet recruiting|
|Camp Pendleton, California, United States, 92055|
|Contact: Caine Kras, Pharm D 760-725-3278 email@example.com|
|United States, Florida|
|James A Haley VA Hospital and Polytrauma Facility||Not yet recruiting|
|Tampa, Florida, United States, 33613|
|Contact: Stephen G Scott, DO 813-972-7506 firstname.lastname@example.org|
|United States, Kentucky|
|Ireland Army Community Hospital||Not yet recruiting|
|Fort Knox, Kentucky, United States, 40121|
|Contact: Kevin W Roberts|
|Principal Investigator:||Daniel R Touchette, MA||University of Illinois at Chicago|
|Principal Investigator:||Jill M Winters, PhD||Columbia College of Nursing|