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

July 11, 2016 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult patient hospitalized with an ENT or jaw carcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline until hospital discharge; hospital stay will last 72 hours minimum over a retrospective period of two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline until hospital discharge over a retrospective period of two years; hospital stay will last 72 hours minimum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Wolfgang Hasemann, PhD, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

May 20, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 2014-318

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Substance Withdrawal Syndrome

Clinical Trials on Process evaluation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe