Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment

Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01007006
• Other study ID #: 2009-0936
• Secondary ID: W81XWH-09-1-0092
• Status: Withdrawn
• Phase: N/A
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Combat Disorders
• Disease
• Pain
• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Naval Hospital Camp Pendleton	Camp Pendleton	California
United States	Ireland Army Community Hospital	Fort Knox	Kentucky
United States	James A Haley VA Hospital and Polytrauma Facility	Tampa	Florida

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (24)

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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. doi: 10.1097/01.HTR.0000308720.70288.af. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

McNair, D., M. Lorr, et al. (1992). POMS Manual

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

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. — View Citation

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. — View Citation

National Council on Patient Information and Education. (2008).

O'Connor PJ. Improving medication adherence: challenges for physicians, payers, and policy makers. Arch Intern Med. 2006 Sep 25;166(17):1802-4. — View Citation

Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. Review. — View Citation

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. doi: 10.1345/aph.1L453. Epub 2009 Apr 14. — View Citation

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. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Pill counts and self report (Morisky 8-item)	Six months
Secondary	Intensity and type of pain	Short-Form McGill Pain Questionnaire; 15 descriptors rated on intensity of 0=none to 3=severe	Three months
Secondary	Psychological well-being	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.	Three months
Secondary	Health related quality of life	Short-Form 36; 8 domains of general health with higher scores indicating less disability	Three months
Secondary	Total cost of care	Six-month medication and medical cost of care will be extracted from the DOD prescription and medical claims databases	Six months

External Links

•   Institute for healthcare improvement "Preventing adverse drug events" Retrieved June 22, 2009
•   National Council on Patient Information and Education. (2008). "Public policy & adherence." Retrieved July 20, 2008