DeltaScan Clinical Evaluation Program
Research type
Research Study
Full title
DeltaScan for the assessment of delirium in the intensive care and ward: a multicenter stepped wedge cluster randomized trial
IRAS ID
252242
Contact name
Daniel Davis
Contact email
Sponsor organisation
UMCU
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The purpose of this Clinical Evaluation Program is to evaluate the impact of the use of DeltaScan in routine hospital care situations compared to currently used delirium screening methods. the delirium detection rate, timeliness of detection and the lenght of stay are quantified. The study consists of two prospective multicenter stepped wedge cluster randomized trials in (at least) 4 ICU departments (trial 1) and (at least) 6 non-ICU departments (trial 2). Non-ICU departments are grouped under the name "General Wards" and will be either cardiothoracic surgery postoperative wards or geriatric traumatolgy postoperative wards.
During 12 months, patients presenting at the ICU of participating hospitals with an expected stay > 1 day (trial 1) and to a General Ward of participating hospitals with high risk of delirium (trial 2) will be included in the study. First, all hospitals will apply ‘usual care’ to all patients, i.e. standard delirium monitoring (e.g. the Confusion Assessment Method (CAM)-ICU in trial 1 or Delirium Observation Screening (DOS) or 4A-T in trial 2 or other currently used tools) in combination with a delirium treatment protocol and subsequent management without application of the DeltaScan for a period of 3 months. Then, during a 6 month period, each 2 months (trial 1) or each month (trial 2), starting at day 0, randomly allocated hospital departments will sequentially start to use DeltaScan for monitoring the patient with high risk of delirium (intervention period). During the last 3 months of the study all hospital departments will participate in the intervention period.
Primary endpoints: delirium detection rate (i.e. proportion of positive assessments according to the delirium detection tool), and duration of admission at ICU (trial 1) or General Ward (trial 2). Secondary endpoints: time interval between admission and the first delirium positive assessment, number of days with at least one positive delirium assessment, delirium incidence, hospital mortality, and direct medical costs of hospitalization.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0402
Date of REC Opinion
14 Dec 2018
REC opinion
Favourable Opinion