Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment

Not Applicable

Withdrawn

• Conditions: Posttraumatic Stress Disorders; Pain; Traumatic Brain Injury; Trauma; Combat Disorders
• Interventions: Device: TMRDU

• Registration Number: NCT01007006
• Lead Sponsor: University of Illinois at Chicago

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.

Study Timeline

• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Study Start: 2010-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adherence	Six months	Pill counts and self report (Morisky 8-item)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

James A Haley VA Hospital and Polytrauma Facility; 🇺🇸 Tampa, Florida, United States

Naval Hospital Camp Pendleton; 🇺🇸 Camp Pendleton, California, United States

Ireland Army Community Hospital; 🇺🇸 Fort Knox, Kentucky, United States