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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-09-1-0092 | Other Grant/Funding Number | Department of Defense |
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Unable to gain approval from commanding Army and Navy officers to conduct study.
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMRDU | Experimental | Telepharmacy Robotic Medicine Delivery Unit (TMRDU) group will receive TMRDU plus medication management |
|
| Control | No Intervention | Control arm will receive only medication management, no TMRDU. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMRDU | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Pill counts and self report (Morisky 8-item) | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity and type of pain | Short-Form McGill Pain Questionnaire; 15 descriptors rated on intensity of 0=none to 3=severe | Three months |
| 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. |
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Inclusion Criteria: Subjects must be
Exclusion Criteria: If patients meet following criteria they are excluded from the study
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| Name | Affiliation | Role |
|---|---|---|
| Daniel R Touchette, MA | University of Illinois at Chicago | Principal Investigator |
| Jill M Winters, PhD | Columbia College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Hospital Camp Pendleton | Camp Pendleton | California | 92055 | United States | ||
| James A Haley VA Hospital and Polytrauma Facility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17617512 | Background | Bates DW. Preventing medication errors: a summary. Am J Health Syst Pharm. 2007 Jul 15;64(14 Suppl 9):S3-9; quiz S24-6. doi: 10.2146/ajhp070190. | |
| 18219234 | Background | 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. |
| Label | URL |
|---|---|
| National Council on Patient Information and Education. (2008). "Public policy \& adherence." Retrieved July 20, 2008 | View source |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013313 | Stress Disorders, Post-Traumatic |
| D014947 | Wounds and Injuries |
| D003130 | Combat Disorders |
| D010146 | Pain |
| D001930 | Brain Injuries |
| D040921 | Stress Disorders, Traumatic |
| D009104 | Multiple Trauma |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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|
| Three months |
| Health related quality of life | Short-Form 36; 8 domains of general health with higher scores indicating less disability | Three months |
| 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 |
| Tampa |
| Florida |
| 33613 |
| United States |
| Ireland Army Community Hospital | Fort Knox | Kentucky | 40121 | United States |
| 11297331 | Background | 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. doi: 10.1016/s1086-5802(16)31229-3. |
| 1202204 | Background | 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. doi: 10.1016/0022-3956(75)90026-6. No abstract available. |
| 15229303 | Background | 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. doi: 10.1056/NEJMoa040603. |
| Background | Institute for Healthcare Improvement. (2009). Prevent adverse drug events (medication reconciliation). |
| 19146365 | Background | 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. |
| 17101639 | Background | 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. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13. |
| 12472329 | Background | McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. doi: 10.1001/jama.288.22.2868. |
| 3670870 | Background | Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8. |
| 18453793 | Background | 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. doi: 10.1111/j.1751-7176.2008.07572.x. |
| 10439982 | Background | 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. doi: 10.1093/fampra/16.3.278. |
| 17000934 | Background | O'Connor PJ. Improving medication adherence: challenges for physicians, payers, and policy makers. Arch Intern Med. 2006 Sep 25;166(17):1802-4. doi: 10.1001/archinte.166.17.1802. No abstract available. |
| 16079372 | Background | Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available. |
| 19366872 | Background | 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. |
| 14528539 | Background | 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. doi: 10.1016/s0738-3991(98)00107-4. |
| 17176683 | Background | 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. doi: 10.1331/1544-3191.46.6.683.touchette. |
| 15054145 | Background | van Mil JW, Westerlund LO, Hersberger KE, Schaefer MA. Drug-related problem classification systems. Ann Pharmacother. 2004 May;38(5):859-67. doi: 10.1345/aph.1D182. Epub 2004 Mar 30. |
| 16882958 | Background | 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. doi: 10.1001/jama.296.5.519. |
| Background | Institute for Healthcare Improvement. (2009). |
| 14562485 | Background | Burkhart PV, Sabate E. Adherence to long-term therapies: evidence for action. J Nurs Scholarsh. 2003;35(3):207. No abstract available. |
| Background | McNair, D., M. Lorr, et al. (1992). POMS Manual |
| Background | National Council on Patient Information and Education. (2008). |
| Background | Ware, J. E., K. K. Snow, et al. (1993). SF36 health survey: Manual and interpretation guide. Boston. MA, New England Medical Center |
| D020196 | Trauma, Nervous System |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |