Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01007006

Collaborator

U.S. Army Medical Research and Development Command (U.S. Fed)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Posttraumatic Stress Disorders Trauma Combat Disorders Pain	Device: TMRDU	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Anticipated Study Start Date :

Dec 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TMRDU Telepharmacy Robotic Medicine Delivery Unit (TMRDU) group will receive TMRDU plus medication management	Device: TMRDU 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 Names: Electronic Medication Management Assistant, (EMMA) (R)
No Intervention: Control Control arm will receive only medication management, no TMRDU.

Arm

Intervention/Treatment

Experimental: TMRDU

Telepharmacy Robotic Medicine Delivery Unit (TMRDU) group will receive TMRDU plus medication management

Device: TMRDU

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 Names:

Electronic Medication Management Assistant, (EMMA) (R)

No Intervention: Control

Control arm will receive only medication management, no TMRDU.

Outcome Measures

Primary Outcome Measures

Adherence [Six months]
Pill counts and self report (Morisky 8-item)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naval Hospital Camp Pendleton	Camp Pendleton	California	United States	92055
2	James A Haley VA Hospital and Polytrauma Facility	Tampa	Florida	United States	33613
3	Ireland Army Community Hospital	Fort Knox	Kentucky	United States	40121

Sponsors and Collaborators

University of Illinois at Chicago
U.S. Army Medical Research and Development Command

Investigators

Principal Investigator: Daniel R Touchette, MA, University of Illinois at Chicago
Principal Investigator: Jill M Winters, PhD, Columbia College of Nursing