Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment
24. juli 2019 oppdatert av: Daniel R. Touchette, University of Illinois at Chicago
Evaluation of a Telepharmacy Robotic Medicine Delivery Unit in Warrior Transition Unit Patients With Traumatic Brain Injury, Post-Traumatic Stress Disorder, or Polytrauma
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.
Studieoversikt
Status
Tilbaketrukket
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
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Camp Pendleton, California, Forente stater, 92055
- Naval Hospital Camp Pendleton
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Florida
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Tampa, Florida, Forente stater, 33613
- James A Haley VA Hospital and Polytrauma Facility
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Kentucky
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Fort Knox, Kentucky, Forente stater, 40121
- Ireland Army Community Hospital
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: TMRDU
Telepharmacy Robotic Medicine Delivery Unit (TMRDU) group will receive TMRDU plus medication management
|
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.
Andre navn:
|
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Ingen inngripen: Control
Control arm will receive only medication management, no TMRDU.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence
Tidsramme: Six months
|
Pill counts and self report (Morisky 8-item)
|
Six months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intensity and type of pain
Tidsramme: Three months
|
Short-Form McGill Pain Questionnaire; 15 descriptors rated on intensity of 0=none to 3=severe
|
Three months
|
|
Psychological well-being
Tidsramme: 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.
|
Three months
|
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Health related quality of life
Tidsramme: Three months
|
Short-Form 36; 8 domains of general health with higher scores indicating less disability
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Three months
|
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Total cost of care
Tidsramme: Six months
|
Six-month medication and medical cost of care will be extracted from the DOD prescription and medical claims databases
|
Six months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Daniel R Touchette, MA, University of Illinois at Chicago
- Hovedetterforsker: Jill M Winters, PhD, Columbia College of Nursing
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- 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. 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. doi: 10.1097/01.HTR.0000308720.70288.af.
- 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.
- 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.
- Institute for Healthcare Improvement. (2009). Prevent adverse drug events (medication reconciliation).
- 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. doi: 10.1001/jama.296.21.joc60162. 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. doi: 10.1001/jama.288.22.2868. Erratum In: JAMA. 2003 Jun 25;289(24):3242.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Institute for Healthcare Improvement. (2009).
- Burkhart PV, Sabate E. Adherence to long-term therapies: evidence for action. J Nurs Scholarsh. 2003;35(3):207. No abstract available.
- McNair, D., M. Lorr, et al. (1992). POMS Manual
- National Council on Patient Information and Education. (2008).
- Ware, J. E., K. K. Snow, et al. (1993). SF36 health survey: Manual and interpretation guide. Boston. MA, New England Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. desember 2010
Primær fullføring (Forventet)
1. desember 2011
Studiet fullført (Forventet)
1. desember 2011
Datoer for studieregistrering
Først innsendt
2. november 2009
Først innsendt som oppfylte QC-kriteriene
2. november 2009
Først lagt ut (Anslag)
3. november 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juli 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juli 2019
Sist bekreftet
1. juli 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske prosesser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Sår og skader
- Kraniocerebralt traume
- Traumer, nervesystemet
- Traumer og stressorerelaterte lidelser
- Sykdom
- Hjerneskader
- Stresslidelser, traumatiske
- Stresslidelser, posttraumatisk
- Hjerneskader, traumatiske
- Kampforstyrrelser
Andre studie-ID-numre
- 2009-0936
- W81XWH-09-1-0092 (Annet stipend/finansieringsnummer: Department of Defense)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .