Process Evaluation Standardised Nurse-led Approach for Risk Screening and Decrease of Alcohol Withdrawal in ENT

NCT02782156 | Completed

• 1 other identifier: EKNZ 2014-318
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Withdrawal Syndrome

Keywords

Process Evaluation; alcohol withdrawal syndrome

Outcome Measures

Primary Outcomes (1)

• Nurses' and doctors' adherence to the patients' surveillance algorithm

  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

Secondary Outcomes (1)

• Percentage of patients developping alcohol withdrawal delirium under surveillance algorithm

  baseline until hospital discharge over a retrospective period of two years; hospital stay will last 72 hours minimum

Interventions

Process evaluation OTHER

Adherence to screening and action algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patient hospitalized with an ENT or jaw carcinoma

You may qualify if:

• Adult patient (18 years and older)
• Patient hospitalized with an ENT or jaw carcinoma with required hospitalization for 72 hours and beyond.

You may not qualify if:

• non Swiss German speaking patient
• patient being deaf in both ears
• patients with known dementia in history

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Basel, 4031, Switzerland

Location

Related Publications (20)

• 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.

  PMID: 12947542 BACKGROUND

• 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.

  PMID: 20870419 BACKGROUND

• 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.

  PMID: 23159157 BACKGROUND

• 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.

  PMID: 9307759 BACKGROUND

• 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.

  PMID: 20642790 BACKGROUND

• 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.

  PMID: 17973172 BACKGROUND

• 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.

  PMID: 15249349 BACKGROUND

• 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.

  PMID: 16052441 BACKGROUND

• 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/

  PMID: 22876380 BACKGROUND

• 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.

  PMID: 15867640 BACKGROUND

• 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.

  PMID: 19244173 RESULT

• 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.

  PMID: 23184039 RESULT

• 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.

  PMID: 8621128 RESULT

• 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.

  PMID: 12751978 RESULT

• 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.

  PMID: 22566069 RESULT

• 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.

  PMID: 14574086 RESULT

• 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.

  PMID: 17205003 RESULT

• 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.

  PMID: 18621934 RESULT

• 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.

  PMID: 8672322 RESULT

• 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.

  PMID: 22325962 RESULT

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Wolfgang Hasemann, PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: May 25, 2016
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

CH (1)