PROPOSE : PReoperative Optimization of Pharmacotherapy in frail Older patients with use of STRIP assistant.|
|- candidate number||23958|
|- NTR Number||NTR5750|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-feb-2016|
|- Secondary IDs||METC-protocolnummer 14-430/C|
|- Public Title||PROPOSE : PReoperative Optimization of Pharmacotherapy in frail Older patients with use of STRIP assistant.|
|- Scientific Title||Preoperative optimization of pharmacotherapy in frail older patients with polypharmacy with the use of STRIP assistant: a clustered randomized trial. |
|- hypothesis||In frail older preoperative patients with polypharmacy, evaluation of medication, with the aid of the STRIP assistant, will identify potentially inappropriate medications and potentially prescribing omissions.|
Optimization of pharmacotherapy will result in lower morbidity and mortality.
|- Healt Condition(s) or Problem(s) studied||Geriatrics, Surgery|
|- Inclusion criteria||Age above 70 years with polypharmacy (5 of more different drugs) and planned for elective otorhinolaryngological, oral, maxillofacial, cardial, gynecological or colorectal surgery |
|- Exclusion criteria||Exclusie criteria: Patients under the age of 70 years. No polypharmacy. When information about the use of drugs was not available before the visit at the outpatient clinic. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||13-okt-2014|
|- planned closingdate||31-dec-2016|
|- Target number of participants||100|
|- Interventions||The intervention consists of a written pharmacotherapeutic advice, which will be generated by application of the STRIP assistant. The STRIP Assistant is an online software system (i.e. electronic version of the STRIP) developed to aid general practitioners and pharmacists to conduct a quick pharmacotherapeutic analysis. |
Input for the STRIP assistant are the patient’s medication, medical history, vital signs and relevant laboratory results. The application of the STRIP assistant will be performed by an independent, clinically experienced resident, who is not involved in patient care at that moment. The written advice will be provided in a fixed format to the resident who performs the preoperative geriatric screening and will be used in the generation of the preoperative advice for the surgeon, including advice concerning medication.
|- Primary outcome||The primary outcome measure is the efficacy of the use of the STRIP assistant as a tool for polypharmacy optimization in addition to usual care in frail elderly patients in the clinical setting. The efficacy will be defined as the number of Potentially Inappropriate Medications (PIM’s) and Potentially Prescribing Omissions (PPO’s) identified per patient, compared to the ‘usual care’. |
|- Secondary outcome||The number of missed, inadequate and potential deleterious advices will also be reported. Also, well-known ADRs, interactions and dose adjustments will be noted.
Moreover, we want to investigate whether preoperative optimization of polypharmacy involving the STRIP assistant in older patients positively affects the postoperative morbidity, functionality and mortality 3 months and 1 year postoperatively when compared to the usual care.
To determine whether the intervention can define PIMs and PPOs, the preoperative medication will be independently reviewed on appropriateness (i.e. presence of PIM’s and PPO’s) by an expert panel in a selection of patients from both groups. This panel consists of at least a geriatrician/pharmacologist and a pharmacist/pharmacologist and will also evaluate the number of appropriate, indifferent or potential harmful decisions.
|- Timepoints||At the visit for preoperative screening the PPO’s and PIM’s will be defined. At the day of surgery and three months postoperatively it will be checked whether the given advice concerning changes in medication is followed by the surgeon.
Three months postoperatively also morbidity and functionality will be measured with a Mini Mental State Examination (MMSE), Geriatric Depression Scale (GDS), BMI, mobility and fall risk, vital signs, hand grip strength, the time needed to walk 4 meters and an electrocardiography
Three months and one year after visiting mortality will be scored.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Marijke Boersma, |
|- CONTACT for SCIENTIFIC QUERIES||Drs. Marijke Boersma, |
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Department of Geriatrics|
(Source(s) of Monetary or Material Support)
|- Publications||1. Beijer HJ1, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci. 2002 Apr;24(2):46-54., pp. 24(2): 46-54.|
2. Williams, C.M. Using medications appropriately in older adults. Am Fam Physician. 2002 Nov 15;66(10):1917-24.
3. Wahab MS1, Nyfort-Hansen K, Kowalski SR. Inappropriate prescribing in hospitalised Australian elderly as determined by the STOPP criteria. Int J Clin Pharm. 2012 Dec;34(6):855-62.
4. Hamilton H, Gallagher P, Ryan C, et al. Potentially inappropriate medications defined by STOPP criteria and the risk of adverse drug events in older hospitalized patients. Arch Intern Med . 2011 Jun 13; 171 (11): 1013-9.
5. Dalleur O, Spinewine A, Henrard S, Losseau C, Speybroeck N, Boland B. Inappropriate prescribing and related hospital admissions in frail older persons according to the STOPP and START criteria. Drugs Aging. 2012 Oct;29(10):829-37.
6. Gallagher P, Baeyens J-P, Topinkova E, et al. Inter-rater reliability of STOPP (Screening Tool of Older Persons’ Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) criteria amongst physicians in six European countries. Age Ageing. 2009 Sep 1; 38 (5): 603-6.
7. Drenth-van Maanen AC1, van Marum RJ, Knol W, van der Linden CM, Jansen PA. Prescribing optimization method for improving prescribing in elderly patients receiving polypharmacy: results of application to case histories by general practitioners. Drugs Aging. 2009;26(8):687-701.
8. Patterson SM, Cadogan CA, Kerse N, Cardwell CR, Bradley MC, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people (Review), The Cochrane Library. 2014; Issue 10.
9. Carolina J. P. W. Keijsers, MD, Adriaan B. D. van Doorn, Anouk van Kalles, MD, Dick J. de Wildt, PharmD, PhD,§ Jacobus R. B. J. Brouwers, PharmD, PhD, Henrieke J. van de Kamp, BSc, Paul A. F. Jansen, MD, PhD. Structured Pharmaceutical Analysis of the Systematic Tool to Reduce Inappropriate Prescribing Is an Effective Method for Final-Year Medical Students to Improve Polypharmacy Skills: A Randomized Controlled Trial. J Am Geriatr Soc. 2014 Jul;62(7):1353-9.
|- Brief summary||A randomized controlled single center study in UMC Utrecht, The Netherlands. |
Aim of the study is to investigate the effectiveness of STRIP assistant in the identification of potentially inappropriate medications and potentially prescribing omissions.
Patients above 70 years with polypharmacy and scheduled for elective surgery will visit the outpatient clinic for pre-operative geriatric screening. A written pharmacotherapeutic advice, generated by application of the STRIP assistant, will be provided in a fixed format to the resident who performs the preoperative geriatric screening.
Primary outcome is the number of Potentially Inappropriate Medications (PIM’s) and Potentially Prescribing Omissions (PPO’s) identified per patient, compared to the ‘usual care’. Secondary outcome is the number of missed, inadequate and potential deleterious advices and mortality, morbidity and functionality 3 months and one year after surgery.
|- Main changes (audit trail)|
|- RECORD||12-feb-2016 - 22-mei-2016|
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