Clinical trial NCT02782156: Process Evaluation Standardised Nurse-led Approach for Risk Screening and Decrease of Alcohol Withdrawal in ENT
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Withdrawal Syndrome
Keywords: Process Evaluation
alcohol withdrawal syndrome
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patient hospitalized with an ENT or jaw carcinoma

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.

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?

Eligibility 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

Primary outcomes:
measure: Nurses' and doctors' adherence to the patients' surveillance algorithm
timeFrame: baseline until hospital discharge; hospital stay will last 72 hours minimum over a retrospective period of two years
Secondary outcomes:
measure: Percentage of patients developping alcohol withdrawal delirium under surveillance algorithm
timeFrame: baseline until hospital discharge over a retrospective period of two years; hospital stay will last 72 hours minimum
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Wolfgang Hasemann, PhD
role: PRINCIPAL_INVESTIGATOR
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