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

NCT ID: NCT02782156

Last Updated: 2016-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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?

Conditions

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Substance Withdrawal Syndrome

Study Design

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Study Time Perspective

RETROSPECTIVE

Interventions

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Process evaluation

Adherence to screening and action algorithm

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfgang Hasemann, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, Basel, Switzerland

Site Status

Countries

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Switzerland

References

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Reference Type BACKGROUND
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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.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Reference Type RESULT
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Other Identifiers

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EKNZ 2014-318

Identifier Type: -

Identifier Source: org_study_id

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