- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02782156
Process Evaluation Standardised Nurse-led Approach for Risk Screening and Decrease of Alcohol Withdrawal in ENT
Evaluation of the Standardised Nurse-led Approach for Risk Screening and Decrease of Alcohol Withdrawal Among Adult Inpatients With Alcohol Dependence in an Ear, Nose, Throat and Jaw Surgery Department
In ear, nose, throat (ENT) and jaw surgery departments, up to 60% of patients suffer from alcohol dependence (Allen et al., 2009), and may develop an alcohol withdrawal syndrome (AWS) when undergoing sur-gery. Caring for these patients creates a major challenge for all persons involved: Health care staff is not only challenged by the primary illness but also by increased risk of life-threatening complications (infection, bleeding, cardiopulmonary dysfunction, impaired wound healing, re-operation), higher mortality rate, and longer duration of hospitalization due to preoperative alcohol use and the development of an AWS (Delgado-Rodriguez, Gomez-Ortega, Mariscal-Ortiz, Palma-Perez, & Sillero-Arenas, 2003; Eyer et al., 2011; Foy, Kay, & Taylor, 1997; Genther & Gourin, 2012; Kuo et al., 2008; Mayo-Smith et al., 2004; McCusker, Cole, Abrahamowicz, Primeau, & Belzile, 2002; Neyman, Gourin, & Terris, 2005; O'Brien et al., 2007). Moreover, nearly five percent of all patients with an AWS develop an alcohol withdrawal delirium (AWD) which, without any therapy, will end lethally in 15% of all cases. With adequate medical and other interventions lethality is about two percent (Diener, 2003; Wright, Myrick, Henderson, Peters, & Malcolm, 2006). Additionally, the occurrence of an AWS and / or AWD represents a threatening, time-intensive and complex situation for family members (Repper-DeLisi et al., 2008; Yu et al., 2012).
Since 2011, in addition to patients undergoing short-term surgery, also patients with oncological diagnoses are hospitalized in the ENT and Jaw Surgery Department at the University Hospital Basel (USB). These patients are in need of prolonged surgical treatments and resulting longer periods of abstinence from food and drink, including alcohol and other substances, increase the risk of alcohol withdrawal. For instance, in the ENT and Jaw Surgery Department, in 2011, 74 out of 910 inpatients were at risk for or already experienced an AWD and 47 of them needed permanent supervision to guarantee their safety. Bridging the period of abstinence by drinking alcohol pre- and postoperatively is a suboptimal option for these patients due to the relatively long surgical treatment. This situation called for action: based on positive experiences within the dementia-delirium-programme of USB (Hasemann & Pretto, 2006), an evidence-based approach to screen for, detect and treat AWS and / or AWD in ENT and jaw surgery patients was developed and implemented (Hasemann, 2013). Now, this new approach needs to be evaluated.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The aims of the proposed study are to describe patient trajectories and to evaluate the processes and structures of the nurse-led approach in the ENT and Jaw Surgery Department at USB. The following research questions were generated:
Aim 1): Who are the patients captured with the algorithm, what are their risk factors, and how are the patient trajectories in terms of decisions, development, start, duration and ending of AWS and / or AWD? Specific questions asked:
- Which are demographic and medical characteristics of patients?
- How many patients are at risk for AWD / AWS?
- Which decisions do patients make?
- What is the time of onset, duration and ending of AWS and / or AWD?
- Were additional resources used to guarantee safety of patients?
Aim 2): How is the prevention algorithm adhered to? Specific questions asked:
- How many patients were risk-assessed by a nurse at hospital admission?
- How many patients or those who should have been asked were eventually asked to agree to substitution therapy?
- How many patients at risk were assessed using the Clinical Institute Withdrawal Assessment (CIWA)-Ar?
- How many times was the delirium expert consultation service contacted due to reasons stated in algorithm?
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Basel, Švýcarsko, 4031
- University Hospital Basel
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Adult patient (18 years and older)
- Patient hospitalized with an ENT or jaw carcinoma with required hospitalization for 72 hours and beyond.
Exclusion Criteria:
- non Swiss German speaking patient
- patient being deaf in both ears
- patients with known dementia in history
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Nurses' and doctors' adherence to the patients' surveillance algorithm
Časové okno: baseline until hospital discharge; hospital stay will last 72 hours minimum over a retrospective period of two years
|
Percentage of fulfilled steps of the algorithm
|
baseline until hospital discharge; hospital stay will last 72 hours minimum over a retrospective period of two years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of patients developping alcohol withdrawal delirium under surveillance algorithm
Časové okno: baseline until hospital discharge over a retrospective period of two years; hospital stay will last 72 hours minimum
|
Percentage of patients in the substitution programme developping withdrawal delirium
|
baseline until hospital discharge over a retrospective period of two years; hospital stay will last 72 hours minimum
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Wolfgang Hasemann, PhD, University Hospital, Basel, Switzerland
Publikace a užitečné odkazy
Obecné publikace
- Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.
- O'Brien JM Jr, Lu B, Ali NA, Martin GS, Aberegg SK, Marsh CB, Lemeshow S, Douglas IS. Alcohol dependence is independently associated with sepsis, septic shock, and hospital mortality among adult intensive care unit patients. Crit Care Med. 2007 Feb;35(2):345-50. doi: 10.1097/01.CCM.0000254340.91644.B2.
- Bleich S, Sperling W, Wiltfang J, Maler JM, Kornhuber J. [Excitatory neurotransmission in alcoholism]. Fortschr Neurol Psychiatr. 2003 Jul;71 Suppl 1:S36-44. doi: 10.1055/s-2003-40504. German.
- Corfee FA. Alcohol withdrawal in the critical care unit. Aust Crit Care. 2011 May;24(2):110-6. doi: 10.1016/j.aucc.2010.08.005. Epub 2010 Sep 25.
- Foy A, Kay J, Taylor A. The course of alcohol withdrawal in a general hospital. QJM. 1997 Apr;90(4):253-61. doi: 10.1093/qjmed/90.4.253.
- Galvin R, Brathen G, Ivashynka A, Hillbom M, Tanasescu R, Leone MA; EFNS. EFNS guidelines for diagnosis, therapy and prevention of Wernicke encephalopathy. Eur J Neurol. 2010 Dec;17(12):1408-18. doi: 10.1111/j.1468-1331.2010.03153.x.
- Kuo YR, Jeng SF, Lin KM, Hou SJ, Su CY, Chien CY, Hsueh KL, Huang EY. Microsurgical tissue transfers for head and neck reconstruction in patients with alcohol-induced mental disorder. Ann Surg Oncol. 2008 Jan;15(1):371-7. doi: 10.1245/s10434-007-9506-5. Epub 2007 Nov 1.
- Mayo-Smith MF, Beecher LH, Fischer TL, Gorelick DA, Guillaume JL, Hill A, Jara G, Kasser C, Melbourne J; Working Group on the Management of Alcohol Withdrawal Delirium, Practice Guidelines Committee, American Society of Addiction Medicine. Management of alcohol withdrawal delirium. An evidence-based practice guideline. Arch Intern Med. 2004 Jul 12;164(13):1405-12. doi: 10.1001/archinte.164.13.1405. Erratum In: Arch Intern Med. 2004 Oct 11;164(18):2068. Dosage error in article text.
- Nagel M, Ferbert A. [Diseases due to alcoholism]. Fortschr Neurol Psychiatr. 2005 Aug;73(8):470-82; quiz 483-4. doi: 10.1055/s-2004-830191. No abstract available. German.
- National Clinical Guideline Centre (UK). Alcohol Use Disorders: Diagnosis and Clinical Management of Alcohol-Related Physical Complications [Internet]. London: Royal College of Physicians (UK); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK65576/
- Neyman KM, Gourin CG, Terris DJ. Alcohol withdrawal prophylaxis in patients undergoing surgical treatment of head and neck squamous cell carcinoma. Laryngoscope. 2005 May;115(5):786-90. doi: 10.1097/01.MLG.0000160085.98289.E8.
- Allen NE, Beral V, Casabonne D, Kan SW, Reeves GK, Brown A, Green J; Million Women Study Collaborators. Moderate alcohol intake and cancer incidence in women. J Natl Cancer Inst. 2009 Mar 4;101(5):296-305. doi: 10.1093/jnci/djn514. Epub 2009 Feb 24.
- Awissi DK, Lebrun G, Coursin DB, Riker RR, Skrobik Y. Alcohol withdrawal and delirium tremens in the critically ill: a systematic review and commentary. Intensive Care Med. 2013 Jan;39(1):16-30. doi: 10.1007/s00134-012-2758-y. Epub 2012 Nov 27.
- Becker U, Deis A, Sorensen TI, Gronbaek M, Borch-Johnsen K, Muller CF, Schnohr P, Jensen G. Prediction of risk of liver disease by alcohol intake, sex, and age: a prospective population study. Hepatology. 1996 May;23(5):1025-9. doi: 10.1002/hep.510230513.
- Delgado-Rodriguez M, Gomez-Ortega A, Mariscal-Ortiz M, Palma-Perez S, Sillero-Arenas M. Alcohol drinking as a predictor of intensive care and hospital mortality in general surgery: a prospective study. Addiction. 2003 May;98(5):611-6. doi: 10.1046/j.1360-0443.2003.00353.x.
- Genther DJ, Gourin CG. The effect of alcohol abuse and alcohol withdrawal on short-term outcomes and cost of care after head and neck cancer surgery. Laryngoscope. 2012 Aug;122(8):1739-47. doi: 10.1002/lary.23348. Epub 2012 May 7.
- Kraemer KL, Mayo-Smith MF, Calkins DR. Independent clinical correlates of severe alcohol withdrawal. Subst Abus. 2003 Dec;24(4):197-209. doi: 10.1023/a:1026099426602.
- Repper-DeLisi J, Stern TA, Mitchell M, Lussier-Cushing M, Lakatos B, Fricchione GL, Quinlan J, Kane M, Berube R, Blais M, Capasso V, Pathan F, Karson A, Bierer M. Successful implementation of an alcohol-withdrawal pathway in a general hospital. Psychosomatics. 2008 Jul-Aug;49(4):292-9. doi: 10.1176/appi.psy.49.4.292.
- Spies CD, Dubisz N, Funk W, Blum S, Muller C, Rommelspacher H, Brummer G, Specht M, Hannemann L, Striebel HW, et al. Prophylaxis of alcohol withdrawal syndrome in alcohol-dependent patients admitted to the intensive care unit after tumour resection. Br J Anaesth. 1995 Dec;75(6):734-9. doi: 10.1093/bja/75.6.734.
- Yu YH, Chen AC, Hu CC, Hsieh PH, Ueng SW, Lee MS. Acute delirium and poor compliance in total hip arthroplasty patients with substance abuse disorders. J Arthroplasty. 2012 Sep;27(8):1526-9. doi: 10.1016/j.arth.2011.12.003. Epub 2012 Feb 8.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EKNZ 2014-318
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Syndrom abstinenčních látek
-
GlaxoSmithKlineZatím nenabíráme
-
Charite University, Berlin, GermanyNáborSyndrom postintenzivní péčeNěmecko
-
Unravel Biosciences, Inc.NáborPitt Hopkinsův syndromKolumbie
-
Lokman Hekim UniversityDokončenoSubakromiální impingement syndrom | Syndrom nárazového ramene | Syndrom nárazu rotátorové manžetyTurecko (Türkiye)
-
Cairo UniversityDokončeno
-
Cairo UniversityDokončeno
-
Neuren Pharmaceuticals LimitedNáborPhelan-McDermidův syndromSpojené státy
-
Ministry of Public Health, Democratic Republic...National Institutes of Health (NIH); Oregon Health and Science University; National... a další spolupracovníciDokončenoSyndrom neurotoxicity, Cassava | Syndrom neurotoxicity, kyanát | Syndrom neurotoxicity, kyanid | Syndrom neurotoxicity, thiokyanátKongo, Demokratická republika
-
Cliniques universitaires Saint-Luc- Université...UkončenoSyndrom multiorgánové dysfunkce | SEPTICKÝ ŠOK | SYNDROM SEPSEBelgie
-
University of California, Los AngelesBoston Children's Hospital; Duke University; Children's Hospital Medical Center...NáborBohring-Opitzův syndrom | Genová mutace ASXL1 | Syndrom Shashi-Pena | Genová mutace ASXL2 | Bainbridge-Ropersův syndrom | Genová mutace ASXL3Spojené státy
Klinické studie na Process evaluation
-
Jiangsu HengRui Medicine Co., Ltd.Aktivní, ne nábor
-
Chinese University of Hong KongZatím nenabírámeHepatektomie | Mezipříčný procesní blok | Kvalita obnovy (QoR-15)
-
Zimmer BiometStaženoDegenerativní onemocnění ploténekSpojené státy
-
MedtronicNeuroDokončenoHyperaktivní močový měchýř | Syndrom naléhavosti | Urgentní inkontinence močiSpojené státy, Holandsko, Kanada, Spojené království
-
Assistance Publique - Hôpitaux de ParisDokončenoNemoci dýchacích cest | Chronické a akutní respirační selháníFrancie
-
Assistance Publique Hopitaux De MarseilleNeznámýKvalita života | Periferní paralýza obličejeFrancie
-
PfizerNáborNemoci dýchacích cest | COVID-19 | Zápal plic | Plicní onemocnění | Koronavirové onemocnění 2019 | Coronavirus Disease 2019 (COVID-19) | Infekce covid-19 | Infekce horních cest dýchacích | Infekce dýchacích cest | COVID-19 (koronavirová nemoc 2019) | Infekce COVID-19 SARS-CoV-2Belgie
-
The University of Texas Health Science Center,...Texas Woman's UniversityDokončenoTraumatické zranění mozku | Získané poranění mozku | Náhodné pádySpojené státy
-
University Hospital, LilleFondation ApicilDokončenoAnestézie | Nociceptivní bolestFrancie
-
Chinese University of Hong KongNáborChronická pooperační bolestHongkong