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

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ClinicalTrials.gov Identifier: NCT02782156
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.


Condition or disease Intervention/treatment
Substance Withdrawal Syndrome Other: Process evaluation

Detailed Description:

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?
Study Design
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Study Type : Observational
Actual Enrollment : 89 participants
Time Perspective: Retrospective
Official Title: 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
Study Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : June 2016
Groups and Cohorts
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Intervention Details:
  • Other: Process evaluation
    Adherence to screening and action algorithm

Outcome Measures
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Primary Outcome Measures :
  1. Nurses' and doctors' adherence to the patients' surveillance algorithm [ Time Frame: 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


Secondary Outcome Measures :
  1. Percentage of patients developping alcohol withdrawal delirium under surveillance algorithm [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patient hospitalized with an ENT or jaw carcinoma
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782156


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Wolfgang Hasemann, PhD University Hospital, Basel, Switzerland
More Information
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Publications of Results:

Other Publications:

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02782156    
Other Study ID Numbers: EKNZ 2014-318
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Basel, Switzerland:
Process Evaluation
alcohol withdrawal syndrome
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders