NCT01007006

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

November 2, 2009

Last Update Submit

July 24, 2019

Conditions

Traumatic Brain InjuryPosttraumatic Stress DisordersTraumaCombat DisordersPain

Keywords

Telepharmacy Robotic Medicine Delivery UnitBrain InjuriesStress DisordersCombat disordersPolytraumaAdherence

Outcome Measures

Primary Outcomes (1)

  • Adherence

    Pill counts and self report (Morisky 8-item)

    Six months

Secondary Outcomes (4)

  • Intensity and type of pain

    Three months

  • Psychological well-being

    Three months

  • Health related quality of life

    Three months

  • Total cost of care

    Six months

Study Arms (2)

TMRDU

EXPERIMENTAL

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

Device: TMRDU

Control

NO INTERVENTION

Control arm will receive only medication management, no TMRDU.

Interventions

TMRDUDEVICE

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.

Also known as: Electronic Medication Management Assistant, (EMMA) (R)
TMRDU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Disabilities preventing safe use of the TRMDU
  • Projected life expectancy of less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Naval Hospital Camp Pendleton

Camp Pendleton, California, 92055, United States

Location

James A Haley VA Hospital and Polytrauma Facility

Tampa, Florida, 33613, United States

Location

Ireland Army Community Hospital

Fort Knox, Kentucky, 40121, United States

Location

Related Publications (24)

  • 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.

    PMID: 17617512BACKGROUND

  • 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.

    PMID: 18219234BACKGROUND

  • 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.

    PMID: 11297331BACKGROUND

  • 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.

    PMID: 1202204BACKGROUND

  • 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.

    PMID: 15229303BACKGROUND

  • Institute for Healthcare Improvement. (2009). Prevent adverse drug events (medication reconciliation).

    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.

    PMID: 19146365BACKGROUND

  • 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.

    PMID: 17101639BACKGROUND

  • 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.

    PMID: 12472329BACKGROUND

  • Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

    PMID: 3670870BACKGROUND

  • 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.

    PMID: 18453793BACKGROUND

  • 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.

    PMID: 10439982BACKGROUND

  • 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.

    PMID: 17000934BACKGROUND

  • 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.

    PMID: 16079372BACKGROUND

  • 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.

    PMID: 19366872BACKGROUND

  • 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.

    PMID: 14528539BACKGROUND

  • 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.

    PMID: 17176683BACKGROUND

  • 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.

    PMID: 15054145BACKGROUND

  • 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.

    PMID: 16882958BACKGROUND

  • Institute for Healthcare Improvement. (2009).

    BACKGROUND

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

    PMID: 14562485BACKGROUND

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Brain Injuries, TraumaticStress Disorders, Post-TraumaticWounds and InjuriesCombat DisordersPainBrain InjuriesStress Disorders, TraumaticMultiple Trauma

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemTrauma and Stressor Related DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel R Touchette, MA

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

  • Jill M Winters, PhD

    Columbia College of Nursing

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacy

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 3, 2009

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

US(3)