Brief Summary

A drug interaction (DI) is the mutual action of two drugs in a way that they can increase their action, even to a toxic level, or reduce it to its minimum. People elder than 65 years old have theirs biological ability to metabolized and eliminate drugs impaired. Even more, they tend to suffer from many diseases, are treated for many physicians, and receive many drugs for those conditions. If hospitalized older people are prone to receive a greater number of drugs. This scenario is the worst to suffer from adverse drug events and DI, which in turn compromise more the health and even life of hospitalized older people. Many computerized strategies have been developed to prevent those problems. In this trial the investigators use on line software to early detect DI that could endanger health or life of hospitalized older patients.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

3,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2009

Geographic Reach

1 country

2 active sites

Status

unknown

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

1.5 years study duration

First Submitted

Initial submission to the registry

February 20, 2009

Completed

5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed

3 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed

Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

1.5 years

First QC Date

February 20, 2009

Last Update Submit

August 3, 2009

Conditions

Drug Interactions

Keywords

Drug interactionsDrug interaction softwareOlder patientsHospitalization

Outcome Measures

Primary Outcomes (1)

Early detect DI in hospitalized elder patients
One year and 6 months

Study Arms (1)

Hospitalized patients

Patients elder than 65 years old hospitalized for any reason.

Other: on line software to detect DI early on

Interventions

on line software to detect DI early onOTHER

Patients hospital records will be reviewed on the day of admission to assess all their indication using on line software to early detect drug interactions.

Also known as: Software are available on:, http://www.medscape.com/druginfo/druginterchecker, http://www.medicamentosrothlin.com.ar/

Hospitalized patients

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Hospitalized patients older than 65 years old

You may qualify if:

Hospitalization
years old or more

You may not qualify if:

None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Universidad Nacional de Córdobalead

Study Sites (2)

Clínica Privada Colombo

Córdoba, Córdoba Province, x5000, Argentina

RECRUITING

Hospital Nacional de Clínicas

Córdoba, Córdoba Province, x5009, Argentina

NOT YET RECRUITING

Related Publications (17)

Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, Cadoret C, Fish LS, Garber L, Kelleher M, Bates DW. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003 Mar 5;289(9):1107-16. doi: 10.1001/jama.289.9.1107.
PMID: 12622580BACKGROUND
Fattinger K, Roos M, Vergeres P, Holenstein C, Kind B, Masche U, Stocker DN, Braunschweig S, Kullak-Ublick GA, Galeazzi RL, Follath F, Gasser T, Meier PJ. Epidemiology of drug exposure and adverse drug reactions in two swiss departments of internal medicine. Br J Clin Pharmacol. 2000 Feb;49(2):158-67. doi: 10.1046/j.1365-2125.2000.00132.x.
PMID: 10671911BACKGROUND
Juurlink DN, Mamdani M, Kopp A, Laupacis A, Redelmeier DA. Drug-drug interactions among elderly patients hospitalized for drug toxicity. JAMA. 2003 Apr 2;289(13):1652-8. doi: 10.1001/jama.289.13.1652.
PMID: 12672733BACKGROUND
Doubova Dubova SV, Reyes-Morales H, Torres-Arreola Ldel P, Suarez-Ortega M. Potential drug-drug and drug-disease interactions in prescriptions for ambulatory patients over 50 years of age in family medicine clinics in Mexico City. BMC Health Serv Res. 2007 Sep 19;7:147. doi: 10.1186/1472-6963-7-147.
PMID: 17880689BACKGROUND
Peral Aguirregoitia J, Lertxundi Etxebarria U, Martinez Bengoechea MJ, Mora Atorrasagasti O, Franco Lamela E, Gabilondo Zelaia I. [Prospective assessment of drug interactions in hospitalized patients using a computer programme]. Farm Hosp. 2007 Mar-Apr;31(2):93-100. doi: 10.1016/s1130-6343(07)75719-7. Spanish.
PMID: 17590117BACKGROUND
Becker ML, Visser LE, van Gelder T, Hofman A, Stricker BH. Increasing exposure to drug-drug interactions between 1992 and 2005 in people aged > or = 55 years. Drugs Aging. 2008;25(2):145-52. doi: 10.2165/00002512-200825020-00006.
PMID: 18257601BACKGROUND
Preskorn SH, Silkey B, Shah R, Neff M, Jones TL, Choi J, Golbeck AL. Complexity of medication use in the Veterans Affairs healthcare system: Part I: Outpatient use in relation to age and number of prescribers. J Psychiatr Pract. 2005 Jan;11(1):5-15. doi: 10.1097/00131746-200501000-00002.
PMID: 15650617BACKGROUND
Marin MJ, Cecilio LC, Perez AE, Santella F, Silva CB, Goncalves Filho JR, Roceti LC. [Use of medicines by the elderly in a Family Health Program unit in Brazil]. Cad Saude Publica. 2008 Jul;24(7):1545-55. doi: 10.1590/s0102-311x2008000700009. Portuguese.
PMID: 18670678BACKGROUND
Medeiros-Souza P, Santos-Neto LL, Kusano LT, Pereira MG. Diagnosis and control of polypharmacy in the elderly. Rev Saude Publica. 2007 Dec;41(6):1049-53. doi: 10.1590/s0034-89102006005000050. Epub 2007 Dec 4.
PMID: 17992356BACKGROUND
Bjorkman IK, Fastbom J, Schmidt IK, Bernsten CB; Pharmaceutical Care of the Elderly in Europe Research (PEER) Group. Drug-drug interactions in the elderly. Ann Pharmacother. 2002 Nov;36(11):1675-81. doi: 10.1345/aph.1A484.
PMID: 12398558BACKGROUND
Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, Laffel G, Sweitzer BJ, Shea BF, Hallisey R, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA. 1995 Jul 5;274(1):29-34.
PMID: 7791255BACKGROUND
Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003 Dec 8-22;163(22):2716-24. doi: 10.1001/archinte.163.22.2716.
PMID: 14662625BACKGROUND
Tulner LR, Frankfort SV, Gijsen GJ, van Campen JP, Koks CH, Beijnen JH. Drug-drug interactions in a geriatric outpatient cohort: prevalence and relevance. Drugs Aging. 2008;25(4):343-55. doi: 10.2165/00002512-200825040-00007.
PMID: 18361544BACKGROUND
Bates DW, Leape LL, Cullen DJ, Laird N, Petersen LA, Teich JM, Burdick E, Hickey M, Kleefield S, Shea B, Vander Vliet M, Seger DL. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998 Oct 21;280(15):1311-6. doi: 10.1001/jama.280.15.1311.
PMID: 9794308BACKGROUND
Durieux P, Trinquart L, Colombet I, Nies J, Walton R, Rajeswaran A, Rege Walther M, Harvey E, Burnand B. Computerized advice on drug dosage to improve prescribing practice. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD002894. doi: 10.1002/14651858.CD002894.pub2.
PMID: 18646085BACKGROUND
Egger T, Dormann H, Ahne G, Runge U, Neubert A, Criegee-Rieck M, Gassmann KG, Brune K. Identification of adverse drug reactions in geriatric inpatients using a computerised drug database. Drugs Aging. 2003;20(10):769-76. doi: 10.2165/00002512-200320100-00005.
PMID: 12875612BACKGROUND
Blix HS, Viktil KK, Moger TA, Reikvam A. Identification of drug interactions in hospitals--computerized screening vs. bedside recording. J Clin Pharm Ther. 2008 Apr;33(2):131-9. doi: 10.1111/j.1365-2710.2007.00893.x.
PMID: 18315778BACKGROUND

Study Officials

Gabriel S Iraci, MD, Prof
Catedra de Farmacología, Hospital Nacional de Clínicas, Universidad Nacional de Córdoba
PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel S Iraci, MD, Prof

CONTACT

54 0351 489 9454 gabysi_01@yahoo.com

Hilda L Montrul, MD, Prof

CONTACT

54 0351 4337033 hmontrull@fibertel.com.ar

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER

Study Record Dates

First Submitted

February 20, 2009

First Posted

February 25, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

AR(2)

Study for Early Detection of Drug Interactions in Older Hospitalized Patients Using on Line Software

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Hospitalized patients

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (17)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Hospitalized patients

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (17)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations