Substance Withdrawal SyndromeNCT02782156
Process Evaluation Standardised Nurse-led Approach for Risk Screening and Decrease of Alcohol Withdrawal in ENT
An observational study of Substance Withdrawal Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Withdrawal Syndrome
- What is being tested?
- Process evaluation
- How many people
- 89 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patient hospitalized with an ENT or jaw carcinoma
Who may be able to join
- Adult patient (18 years and older)
- Patient hospitalized with an ENT or jaw carcinoma with required hospitalization for 72 hours and beyond.
Who cannot join
- non Swiss German speaking patient
- patient being deaf in both ears
- patients with known dementia in history
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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?
- Conditions
- Substance Withdrawal Syndrome
- Being tested
- Process evaluation
- Keywords
- Process Evaluation, alcohol withdrawal syndrome
- Medical subject headings
- Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Process evaluationOther
Adherence to screening and action algorithm
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurses' and doctors' adherence to the patients' surveillance algorithm
Percentage of fulfilled steps of the algorithm
Measured: baseline until hospital discharge; hospital stay will last 72 hours minimum over a retrospective period of two years
Secondary outcomes (1)
Percentage of patients developping alcohol withdrawal delirium under surveillance algorithm
Percentage of patients in the substitution programme developping withdrawal delirium
Measured: baseline until hospital discharge over a retrospective period of two years; hospital stay will last 72 hours minimum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Substance Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Hasemann, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782156
- Sponsor's protocol ID
- EKNZ 2014-318
- Status last verified
- Jul 2016
- First submitted
- 15 Jun 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bleich S, Sperling W, Wiltfang J, Maler JM, Kornhuber J. [Excitatory neurotransmission in alcoholism]. Fortschr Neurol Psychiatr. 2003 Jul;71 Suppl 1:S36-44. doi: 10.1055/s-2003-40504. German.
PubMed 12947542Corfee 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.
PubMed 20870419Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.
PubMed 23159157Foy A, Kay J, Taylor A. The course of alcohol withdrawal in a general hospital. QJM. 1997 Apr;90(4):253-61. doi: 10.1093/qjmed/90.4.253.
PubMed 9307759Galvin R, Brathen G, Ivashynka A, Hillbom M, Tanasescu R, Leone MA; EFNS. EFNS guidelines for diagnosis, therapy and prevention of Wernicke encephalopathy. Eur J Neurol. 2010 Dec;17(12):1408-18. doi: 10.1111/j.1468-1331.2010.03153.x.
PubMed 20642790Kuo YR, Jeng SF, Lin KM, Hou SJ, Su CY, Chien CY, Hsueh KL, Huang EY. Microsurgical tissue transfers for head and neck reconstruction in patients with alcohol-induced mental disorder. Ann Surg Oncol. 2008 Jan;15(1):371-7. doi: 10.1245/s10434-007-9506-5. Epub 2007 Nov 1.
PubMed 17973172Mayo-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.
PubMed 15249349Nagel 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.
PubMed 16052441National Clinical Guideline Centre (UK). Alcohol Use Disorders: Diagnosis and Clinical Management of Alcohol-Related Physical Complications [Internet]. London: Royal College of Physicians (UK); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK65576/
PubMed 22876380Neyman KM, Gourin CG, Terris DJ. Alcohol withdrawal prophylaxis in patients undergoing surgical treatment of head and neck squamous cell carcinoma. Laryngoscope. 2005 May;115(5):786-90. doi: 10.1097/01.MLG.0000160085.98289.E8.
PubMed 15867640Allen NE, Beral V, Casabonne D, Kan SW, Reeves GK, Brown A, Green J; Million Women Study Collaborators. Moderate alcohol intake and cancer incidence in women. J Natl Cancer Inst. 2009 Mar 4;101(5):296-305. doi: 10.1093/jnci/djn514. Epub 2009 Feb 24.
PubMed 19244173Awissi DK, Lebrun G, Coursin DB, Riker RR, Skrobik Y. Alcohol withdrawal and delirium tremens in the critically ill: a systematic review and commentary. Intensive Care Med. 2013 Jan;39(1):16-30. doi: 10.1007/s00134-012-2758-y. Epub 2012 Nov 27.
PubMed 23184039Becker U, Deis A, Sorensen TI, Gronbaek M, Borch-Johnsen K, Muller CF, Schnohr P, Jensen G. Prediction of risk of liver disease by alcohol intake, sex, and age: a prospective population study. Hepatology. 1996 May;23(5):1025-9. doi: 10.1002/hep.510230513.
PubMed 8621128Delgado-Rodriguez M, Gomez-Ortega A, Mariscal-Ortiz M, Palma-Perez S, Sillero-Arenas M. Alcohol drinking as a predictor of intensive care and hospital mortality in general surgery: a prospective study. Addiction. 2003 May;98(5):611-6. doi: 10.1046/j.1360-0443.2003.00353.x.
PubMed 12751978Genther DJ, Gourin CG. The effect of alcohol abuse and alcohol withdrawal on short-term outcomes and cost of care after head and neck cancer surgery. Laryngoscope. 2012 Aug;122(8):1739-47. doi: 10.1002/lary.23348. Epub 2012 May 7.
PubMed 22566069
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02782156
- Acronym / sponsor ID
- EKNZ 2014-318
- Conditions
- Substance Withdrawal Syndrome
- Keywords
- Process Evaluation, alcohol withdrawal syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patient hospitalized with an ENT or jaw carcinoma
Key inclusion criteria (2 listed)
- Adult patient (18 years and older)
- Patient hospitalized with an ENT or jaw carcinoma with required hospitalization for 72 hours and beyond.
Key exclusion criteria (3 listed)
- non Swiss German speaking patient
- patient being deaf in both ears
- patients with known dementia in history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Process evaluationAdherence to screening and action algorithm | Other | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Background: PubMed 12947542Bleich S, Sperling W, Wiltfang J, Maler JM, Kornhuber J. [Excitatory neurotransmission in alcoholism]. Fortschr Neurol Psychiatr. 2003 Jul;71 Suppl 1:S36-44. doi: 10.1055/s-2003-40504. German.
- Background: PubMed 20870419Corfee 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.
- Background: PubMed 23159157Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.
- Background: PubMed 9307759Foy A, Kay J, Taylor A. The course of alcohol withdrawal in a general hospital. QJM. 1997 Apr;90(4):253-61. doi: 10.1093/qjmed/90.4.253.
- Background: PubMed 20642790Galvin R, Brathen G, Ivashynka A, Hillbom M, Tanasescu R, Leone MA; EFNS. EFNS guidelines for diagnosis, therapy and prevention of Wernicke encephalopathy. Eur J Neurol. 2010 Dec;17(12):1408-18. doi: 10.1111/j.1468-1331.2010.03153.x.
- Background: PubMed 17973172Kuo YR, Jeng SF, Lin KM, Hou SJ, Su CY, Chien CY, Hsueh KL, Huang EY. Microsurgical tissue transfers for head and neck reconstruction in patients with alcohol-induced mental disorder. Ann Surg Oncol. 2008 Jan;15(1):371-7. doi: 10.1245/s10434-007-9506-5. Epub 2007 Nov 1.
- Background: PubMed 15249349Mayo-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.
- Background: PubMed 16052441Nagel 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.
- Background: PubMed 22876380National Clinical Guideline Centre (UK). Alcohol Use Disorders: Diagnosis and Clinical Management of Alcohol-Related Physical Complications [Internet]. London: Royal College of Physicians (UK); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK65576/
- Background: PubMed 15867640Neyman KM, Gourin CG, Terris DJ. Alcohol withdrawal prophylaxis in patients undergoing surgical treatment of head and neck squamous cell carcinoma. Laryngoscope. 2005 May;115(5):786-90. doi: 10.1097/01.MLG.0000160085.98289.E8.
- Results publication: PubMed 19244173Allen NE, Beral V, Casabonne D, Kan SW, Reeves GK, Brown A, Green J; Million Women Study Collaborators. Moderate alcohol intake and cancer incidence in women. J Natl Cancer Inst. 2009 Mar 4;101(5):296-305. doi: 10.1093/jnci/djn514. Epub 2009 Feb 24.
- Results publication: PubMed 23184039Awissi DK, Lebrun G, Coursin DB, Riker RR, Skrobik Y. Alcohol withdrawal and delirium tremens in the critically ill: a systematic review and commentary. Intensive Care Med. 2013 Jan;39(1):16-30. doi: 10.1007/s00134-012-2758-y. Epub 2012 Nov 27.
Related trials for Substance Withdrawal Syndrome
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Not yet recruiting
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
Intoxication, Delirium Tremens (DTs)
RecruitingPhase 1
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
Opioid Use Disorder
Not yet recruitingPhase 2/3
Dexmedetomidine for Invasive Ventilation In the NEOnate
Invasive Ventilation, Infant Pain
Not yet recruitingPhase 4
Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use
E Cigarette Use, Cessation, Tobacco
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Hasemann, PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Withdrawal Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782156, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.