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Completed

NCT Number: NCT02782156

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Process evaluation

Other

Adherence to screening and action algorithm

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 25, 2016
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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