Trial Description
Title
Delirium and Stroke
Trial Acronym DELIUS
URL of the trial [---]*
Brief Summary in Lay Language
Background: Delirium among patients on stroke units is common and is associated with a higher complication rate, longer length of stay, higher mortality and a poorer clinical outcome.
Question: Does a standardized management of the delirium in patients with acute stroke on stroke units lead to a reduction in the severity of the delirium after a four-week introductory phase compared to a non-standardized treatment before?
Method: research project to improve the quality of delirium management with before / after comparison in 7 stroke units. Approximately 692 patients are included according to pre-determined rules. The effect of the study is mainly checked by the severity of a delirium, which is regularly assessed with a test.
Other results of interest include frequency and duration of delirium, degree of disability, length of stay on stroke unit, hospital days, mortality, sum of certain medications, nursing interventions and complications of a delirium for a period of 28 days. In addition, in various centers a) patients will be called after 90 days and asked about their state of health, b) the brain waves will be examined in some patients, c) the feasibility of the study will be evaluated, d) the knowledge and attitude of the employees will be examined; e) a prediction method for delirium will be developed; and f) the effect of the of continuous care will be evaluated.
Objectives: to estimate how well the introduction of an uniform delirium management can alleviate the severity of a delirium in stroke patients.
Background: Delirium in patients on stroke units is common and is associated with a higher complication rate, longer length of stay, higher mortality and a poorer clinical outcome.
Question: In patients with an acute stroke on stroke units, does a standardized delirium management after a four-week introductory phase in comparison to a non-standardized treatment result in a reduced severity of delirium?
Method: Multi-center, explorative quality improvement project for delirium
management with before / after comparison. A total of approximately 692 patients will be included on 7 stroke units in 6 centers before and after the implementation of a delirium management protocol. Included will be all patients aged at least 18 years who are admitted to the stroke unit with suspected stroke and who consent to their research for their data. Patients will be excluded a) who have been
treated in a hospital for> 24 hours before their admission and for whom a pre- Brief Summary in Scientific Language
disorder of a sopor or coma that makes it impossible to determine the delirium, c) total aphasia, d) with a high probability of death within 24 or 48 hours, e) who cannot be examined for delirium for other reasons. The primary outcome parameter is the severity of a delirium, defined as the highest value that is
assessed over the course by using the Nursing Delirium Screening Scale and a test for attention. Secondary outcome parameters are delirium incidence and duration, modified Rankin Scale, length of stay on stroke unit, hospital days, mortality, sum of anticholinergics, non-pharmacological interventions, and complications of a delirium for the duration of a follow-up of 28 days. In addition, in various centers a) patients are called after 90 days and asked about their state of health, b) the brain waves examined in some patients, c) the feasibility of the study examined, d) the knowledge and attitude of the employees examined; e) developed a
prediction method for delirium; and f) examined the effect of the continuity of care.
Objectives: To check the effect size to reduce the severity of delirium when carrying out standardized delirium management with nursing care and pharmacological interventions in patients with acute stroke.
Do you plan to share individual participant data with other researchers?
Yes
Description IPD sharing plan
After completion and publication, the anonymized data can be sent as an SPSS file on reasonable request.
Organizational Data
DRKS-ID: DRKS00021436
Date of Registration in DRKS: 2020/04/17
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: D 459/20 , Ethikkommission der Christian-Albrechts- Universität zu Kiel
Secondary IDs
ICD10: F05.0 - Delirium not superimposed on dementia, so described
ICD10: I63.0 - Cerebral infarction due to thrombosis of precerebral arteries
Health condition or Problem studied
Arm 1: It is a quality improvement study, strictly speaking without intervention, but with a before / after phase. Patients in the after-phase receive structured delirium management including a) evaluation of the causes, b) treatment of the causes, c) non-pharmacological interventions, d) in the case of stress, specific pharmacological interventions according to German guidelines
Arm 2: It is a quality improvement study, strictly speaking without intervention, but with a before / after phase. Patients in the before-phase receive the usual treatment for delirium at the discretion of the responsible staff.
Interventions/Observational Groups
Characteristics
Study Type: Interventional Study Type Non-Interventional: [---]*
Allocation: Non-randomized controlled trial Blinding: [---]*
Control: Active control (effective treament of control group), Historical Purpose: Treatment
Assignment: Other Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]*
Who is blinded: [---]*
The primary outcome parameter is the severity of the delirium. During the entire stay on the stroke unit, the parameter is assessed three times a day by nurses using the Nursing Delirium Screening Checklist (range 0-10 points, ≥4 = delirium, higher values indicate a greater severity of delirium) and a test for attention. A positive result will be validated by a specialist. The highest value during the stay will be counted.
Primary Outcome
Secondary Outcome
Delirium incidence and duration, score on the modified Rankin Scale, length of stay on stroke unit, hospital days, mortality, sum of anticholinergics, non- pharmacological interventions, complications of a delirium for the duration of a follow-up of 28 days.
Additionally in
Center Kiel: disability after 90 days,
Centers Kiel & Neumünster: correlation of the EEG with delirium, Centers Kiel & Flensburg: study performance
Centers Kiel, Flensburg, Schleswig, Neumünster: Knowledge and attitude of the staff
Center Berlin: Development of a prediction score for delirium Center Saarbrücken: Continuity of care.
DE Germany
Countries of recruitment
Locations of Recruitment
University Medical Center Stroke Unit, Klinik für Neurologie, Kiel Medical Center Stroke Unit, Klinik für Neurologie, Schleswig University Medical Center Stroke Unit I Charite, Berlin
Medical Center Diako, Klinik für Neurologie, Stroke Unit, Flensburg University Medical Center Stroke Unit, Klinik für Neurologie, Saarbrücken University Medical Center Stroke Unit II Charite, Berlin
Medical Center Friedrich Ebert Krankenhaus, Klinik für Neurologie, Stroke Unit, Neumünster
Recruitment
Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2020/08/12 Target Sample Size: 692
Monocenter/Multicenter trial: Multicenter trial National/International: National
Inclusion Criteria
Gender: Both, male and female Minimum Age: 18 Years
Maximum Age: no maximum age
Additional Inclusion Criteria All patients are included a) ≥ 18 years,
b) admission with suspected acute stroke on the stroke unit c) who give their consent to the research with their data.
All employees of the medical, nursing and therapeutic staff are included in personnel surveys.
Exclusion criteria
All patients are excluded
a) who have been treated in a hospital for >24 hours before their admission and for whom a pre-existing delirium cannot be excluded,
b) with impaired consciousness, which makes it impossible to determine the delirium
c) with a high probability of death within 24 or 48 hours,
d) which cannot be examined for delirium for other reasons (e.g. deaf, total aphasia).
In terms of personnel, all persons are excluded who a) work for education / studies, b) as temporary workers or pool employees on the stroke unit
Mr. Peter Nydahl
Universitätsklinikum Schleswig-Holstein, Pflegeforschung, Campus Kiel
Brunswiker Str. 10 24105 Kiel
Germany
Telephone: 043150013812 Fax: [---]*
E-mail: Peter.Nydahl at uksh.de Primary Sponsor
URL: http://www.uksh.de
Mr. Peter Nydahl
Universitätsklinikum Schleswig-Holstein, Pflegeforschung, Campus Kiel
Brunswiker Str. 10 24105 Kiel
Germany
Telephone: 043150013812 Fax: [---]*
E-mail: Peter.Nydahl at uksh.de Contact for Scientific Queries
URL: http://www.uksh.de
Mr. Peter Nydahl
Universitätsklinikum Schleswig-Holstein, Pflegeforschung, Campus Kiel
Brunswiker Str. 10 24105 Kiel
Germany
Telephone: 043150013812 Fax: [---]*
E-mail: Peter.Nydahl at uksh.de Contact for Public Queries
Addresses
Ms. Dr Manuela Bergjan
Geschäftsbereich Pflegedirektion - Pflegewissenschaft, Charité – Universitätsmedizin Berlin
Telephone: [---]*
Fax: [---]*
E-mail: Manuela.Bergjan at charite.de Collaborator, Other Address
URL: [---]*
Mr. Prof. Dr. Andreas Binder
Klinik für Neurologie, Klinikum Saarbrücken
Telephone: [---]*
Fax: [---]*
E-mail: abinder at klinikum-saarbruecken.de Collaborator, Other Address
URL: [---]*
Mr. Bernd Schöller
Stroke Unit Heliosklinikum Schleswig
Telephone: [---]*
Fax: [---]*
E-mail: bernd.seville at yahoo.de Collaborator, Other Address
URL: [---]*
Ms. BScN Uta Hansen
Diako, Klinik für Neurologie, Stroke Unit
Knuthstr. 1 24939 Flensburg Germany
Telephone: [---]*
Fax: [---]*
E-mail: hansenut at diako.de Collaborator, Other Address
URL: www.diako-krankenhaus.de
Mr. Prof. Dr. med. Hans-Christian Hansen Klinik für Neurologie
Friesenstraße 11 24534 Neumünster Germany
Collaborator, Other Address
Mr. Prof. Dr. med. Hans-Christian Hansen Klinik für Neurologie
Friesenstraße 11 24534 Neumünster Germany
Telephone: [---]*
Fax: [---]*
E-mail: hc.hansen at fek.de Collaborator, Other Address
URL: www.friedrich-ebert-krankenhaus.de
Institutional budget, no external funding (budget of sponsor/PI)
Brunswiker Str. 10
Universitätsklinikum Schleswig-Holstein, Pflegeforschung, Campus Kiel
24105 Kiel Germany
Mr. Peter Nydahl
Telephone: 043150013812 Fax: [---]*
E-mail: Peter.Nydahl at uksh.de URL: http://www.uksh.de
Sources of Monetary or Material Support
Status
Recruitment Status: Recruiting planned Study Closing (LPLV): [---]*
Trial Publications, Results and other documents
* This entry means the parameter is not applicable or has not been set.
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