Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment - Full Text View

Sponsor:	University of Illinois
Collaborator:	U.S. Army Medical Research and Materiel Command
Information provided by:	University of Illinois
ClinicalTrials.gov Identifier:	NCT01007006

Purpose

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	Intervention
Traumatic Brain Injury Posttraumatic Stress Disorders Trauma Combat Disorders Pain	Device: TMRDU

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Traumatic Brain Injury Wounds

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Pain, psychological well-being, health related quality of life, cost [ Time Frame: Baseline, one, two, three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	165
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)

Arms	Assigned Interventions
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 Name: Electronic Medication Management Assistant, (EMMA) (R)
No Intervention: Control Control arm will receive only medication management, no TMRDU.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007006

Contacts

Contact: Daniel R Touchette, Pharm.D., MA	3123553204	drtouche@uic.edu
Contact: Jill M Winters, PhD	4149614202	jwinters@ccon.edu

Locations

United States, California
Naval Hospital Camp Pendleton	Not yet recruiting
Camp Pendleton, California, United States, 92055
Contact: Caine Kras, Pharm D 760-725-3278 caine.kras@med.navy.mil
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 steven.scott@va.gov
United States, Kentucky
Ireland Army Community Hospital	Not yet recruiting
Fort Knox, Kentucky, United States, 40121
Contact: Kevin W Roberts

Sponsors and Collaborators

University of Illinois

U.S. Army Medical Research and Materiel Command

Investigators

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

More Information

Additional Information:

Institute for healthcare improvement "Preventing adverse drug events" Retrieved June 22, 2009 This link exits the ClinicalTrials.gov site

National Council on Patient Information and Education. (2008). "Public policy & adherence." Retrieved July 20, 2008 This link exits the ClinicalTrials.gov site

Publications:

Bates DW. Preventing medication errors: a summary. Am J Health Syst Pharm. 2007 Jul 15;64(14 Suppl 9):S3-9; quiz S24-6. Erratum in: Am J Health Syst Pharm. 2007 Aug 15;64(16):1678.

Cantor JB, Ashman T, Gordon W, Ginsberg A, Engmann C, Egan M, Spielman L, Dijkers M, Flanagan S. Fatigue after traumatic brain injury and its impact on participation and quality of life. J Head Trauma Rehabil. 2008 Jan-Feb;23(1):41-51.

Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: updating the cost-of-illness model. J Am Pharm Assoc (Wash). 2001 Mar-Apr;41(2):192-9.

Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. No abstract available.

Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22.

Krousel-Wood M, Islam T, Webber LS, Re RN, Morisky DE, Muntner P. New medication adherence scale versus pharmacy fill rates in seniors with hypertension. Am J Manag Care. 2009 Jan;15(1):59-66.

Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. Epub 2006 Nov 13.

McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. Review. Erratum in: JAMA. 2003 Jun 25;289(24):3242.

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-7.

Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54.

Nathan A, Goodyer L, Lovejoy A, Rashid A. 'Brown bag' medication reviews as a means of optimizing patients' use of medication and of identifying potential clinical problems. Fam Pract. 1999 Jun;16(3):278-82.

O'Connor PJ. Improving medication adherence: challenges for physicians, payers, and policy makers. Arch Intern Med. 2006 Sep 25;166(17):1802-4. No abstract available.

Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. Review. No abstract available.

Sakthong P, Chabunthom R, Charoenvisuthiwongs R. Psychometric properties of the Thai version of the 8-item Morisky Medication Adherence Scale in patients with type 2 diabetes. Ann Pharmacother. 2009 May;43(5):950-7. Epub 2009 Apr 14.

Svarstad BL, Chewning BA, Sleath BL, Claesson C. The Brief Medication Questionnaire: a tool for screening patient adherence and barriers to adherence. Patient Educ Couns. 1999 Jun;37(2):113-24.

Touchette DR, Burns AL, Bough MA, Blackburn JC. Survey of medication therapy management programs under Medicare part D. J Am Pharm Assoc (2003). 2006 Nov-Dec;46(6):683-91.

van Mil JW, Westerlund LO, Hersberger KE, Schaefer MA. Drug-related problem classification systems. Ann Pharmacother. 2004 May;38(5):859-67. Epub 2004 Mar 30. Review.

Vasterling JJ, Proctor SP, Amoroso P, Kane R, Heeren T, White RF. Neuropsychological outcomes of army personnel following deployment to the Iraq war. JAMA. 2006 Aug 2;296(5):519-29.

Burkhart PV, Sabaté E. Adherence to long-term therapies: evidence for action. J Nurs Scholarsh. 2003;35(3):207. No abstract available.

Responsible Party:	Daniel R.Touchette, University of Illinois at Chicago
ClinicalTrials.gov Identifier:	NCT01007006 History of Changes
Other Study ID Numbers:	07247003, W81XWH-09-1-0092
Study First Received:	November 2, 2009
Last Updated:	November 3, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Illinois:

Telepharmacy Robotic Medicine Delivery Unit
Brain Injuries
Stress Disorders

Combat disorders
Polytrauma
Adherence

Additional relevant MeSH terms:

Combat Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Injuries
Anxiety Disorders
Mental Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012