Item 1. Brief Name
Evidence-based, nurse-led individualized delirium intervention in ICU.
Item 2. Why: Rationale, Theory, or Goal of the Elements Essential to the Intervention
Step1: Needs assessment
Through literature review, three main needs were identified (1) a time-saving and easy-to-use assessment tool[12, 13]; (2) an informational hand-out of delirium risk factors[21], and an ICU delirium risk prediction model[22] which can dynamically assess patients’ risk levels in developing delirium[23]; (3) evidence-based interventions that can be easily tailored by the nurse.
Step2: Intervention development
(1) Flow chart of ICU delirium assessment tools
The PADIS guidelines recommend the use of CAM-ICU or ICDSC to recognize ICU delirium[24]. A flow chart of assessment tools procedures was designed based on the features of each tool. The patient’s risk for developing delirium is based on the nurse’s assessment of each item using the rules of each assessment tool.
(2) Formulation of risk factors assessment sheet
We performed a comprehensive search to identify the guidelines related to ICU delirium. ICU delirium is caused or exacerbated by the combination of multiple risk factors[25], three types of risk factors were summarized in our study, patient-related factors (e.g. hearing and visual impairment), disease-related factors (e.g. pain, infection), environmental or iatrogenic factors (e.g. physical restraints, mechanical ventilation).
(3) Translating evidence-based ABCDEF bundle intervention into practical applications
The PADIS Guidelines[26] have recommended to use a bundle approach, namely “ABCDEF bundle” which includes measures on managing pain, conducting spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs), maintaining light sedation, and encouraging early mobility, family participation and use of non-pharmacological interventions to prevent and manage ICU delirium. The ABCDEF bundle is targeted on eliminating various modifiable risk factors of ICU delirium, such as pain, mechanical ventilation, immobility, and can be used as either a preventive intervention to reduce the incidence of ICU delirium or as a management intervention once ICU delirium occurs. The appropriate subset of interventions from the ABCDEF bundle should be tailored to patients’ specific risk factors.
Step 3: Formulation of the library of IDI-ICU
We established an interdisciplinary team of clinical nurses, physicians, and researchers, to determine what modifications are necessary to streamline the delivery the protocol. This team kept touch online daily and meet weekly throughout the project, and discuss a set of change requests based on cognitive load theory and design requirements, including modifying document templates, creating new viewing fields, and revising algorithm between delirium risk factors and interventions. The modification requests are an iterative, ongoing input and cooperative process between clinical staff and the research team to optimize the delirium intervention. Finally, a set of delirium intervention to reduce the ICU delirium incidence were formulated (see Table S1).
Item 3. Materials: Physical and Informational Materials Used in the Intervention, Including Those Provided to Participants or Used in Intervention Delivery or in Training of Intervention Providers
The manual of IDI-ICU was developed to ensure that ICU nurses understand the use of these delirium intervention, which consists of three main parts (1) assessment tools, the rule to judge whether the patient having delirium were clearly made; (2) risk factors evaluation sheet, the definition/criteria of each factor has predefined; and (3) risk factor targeting interventions, detailed nursing interventions with duration or frequency were included in the instructions. These interventions are described as clearly as possible, so nurses can learn them with minimal training (Table S1).
Item 4. Procedures, Activities, and/or Processes Used in the Intervention
Intervention group
Nurses in the intervention group provide delirium intervention based on the AI-AntiDelirium. Firstly, an educational program is delivered by researchers, eligible nurses are trained on how to operate the AI-AntiDelirium. The AI-AntiDelirium consists of four main modules: assessment tools, risk factor assessment, nursing care plan and nursing checklist. Briefly introduction of the steps to use the AI-AntiDelirium: (1) logging into the system on a mobile phone; (2) diagnosing ICU delirium: nurses choose one instrument (CAM-ICU or ICDSC) and complete the items according to the prompts, the AI-AntiDelirium automatically presents whether the patient has delirium or not; (3) assessing risk factors: the AI-AntiDelirium automatically retrieves risk factors of ICU delirium from the hospital information system, nursing information system and laboratory test results. Risk factors that cannot be obtained from other systems are evaluated by the nurse. Additionally, the AI-AntiDelirium automatically calculates a predictive risk value for developing ICU delirium based on the prediction model[25]; (4) viewing nursing care plan: the AI-AntiDelirium can automatically tailor personalized ICU delirium prevention or management interventions based on the risk factors identified; (5) viewing nursing checklist: nurses view the nursing checklist which including frequency of the intervention and carry out the interventions for each patient and record reasons why patients did not receive these interventions.
Control group
Nurses in the control group provide delirium intervention based on the paper-version of assessment tools (CAM-ICU, ICDSC), delirium risk factors and ABCDEF bundle interventions. Prior to the study, an educational program related to ICU delirium is delivered by researchers to train nurses on how to use the paper-based materials. During the study, nurses use the paper-version of CAM-ICU or ICDSC to assess ICU delirium, use evaluation list to assess risk factors, and use the appropriate subset of interventions from the ABCDEF bundle targeted to patients’ specific risk factors.
Item 5. Description of the Expertise, Background, and Specific Training Given to Intervention Providers
ICU nurses are positioned best to provide early delirium detection and early management intervention for critically ill patients when necessary, because they are always at the patient's bedside and monitoring the changes in the patient's condition. The IDI-ICU has been used by ICU nurses who are qualified registered nurses, with a minimum of 1-year experience in intensive care.
ICU nurses in the intervention group attend a one-hour training session according to a standardized manual, that describes how to operate the AI-AntiDelirium, including logging on to the system, using the delirium assessment tools, recording risk factors, and providing individualized interventions. Additionally, the ICU nurses and the researchers are required to attend regular meetings to discuss and troubleshoot the use of the interventions. The purpose of these procedures is to ensure minimal deviation from the manual. Nurses in the control group provide ICU delirium related nursing care based on the paper-version of assessment tools, risk factors, and the ABCDEF bundle. Prior to the study, an educational program related to the use of a paper-based ICU delirium materials is delivered by researchers with the same content delivered to the intervention group.
Item 6. Mode of Delivery
The IDI-ICU are used individually with face-to-face, mainly delivered by ICU nurses; a few interventions are implemented by family members during visiting hours.
Item 7. Type(s) of Location(s) Where the Intervention Occurred, Including Any Necessary Infrastructure or Relevant Features
IDI-ICU were delivered in the ICU.
Item 8. Number of Times the Intervention Was Delivered and Over What Period of Time Including the Number of Sessions, Their Schedule, and Their Duration, Intensity or Dose
IDI-ICU is delivered 7 days a week, until the patient’s discharge. Nursing care activities varied with specific frequency, duration, intensity or dose. For example, assessment of delirium is recommended at least one time per shift. If the patients have the ability to exercises, nurses will guide the patient to do the active range-of-motion exercises, 10 times for each joint, three times a day. ICU nurses provide as much intervention as the patient could tolerate based on the patient’s condition. Some factors may result in lowered dose of the intervention including patients’ illness, patients’ family members, and staff shortages. The actual implementation of interventions for each patient was recorded on a separate report form.
Item 9. Tailoring of the Intervention
IDI-ICU is designed for adult patients with an expected ICU stay of at least 48 hours. On the first day of admission, the nurse assesses the patient’ s basic characteristics, vital signs, disease history, diagnosis, test results, medications, etc. Each day, different nursing interventions are provided for patients based on their daily assessment. In the manual, interventions for different delirium risk factors are tailored into detailed nursing interventions respectively (see Table S1).
Item 10. Modifications of the Intervention During the Study
Before the IDI-ICU trial, a pilot study was conducted to examine the feasibility of the intervention, and modifications were made according to providers’ feedback. No modifications were made on the current intervention protocol during the IDI-ICU trial.
Item 11. Planned Procedures for How Adherence or Fidelity Was Assessed, Describe How and by Whom, and if Any Strategies Were Used to Maintain or Improve Fidelity, Describe Them
The detail of the intervention providers’ training is presented in item 5. In this section, adherence to IDI-ICU by study nurses was described. The head nurse for each study units, received training of the intervention, serves the role of supervisor for the nurses’ fidelity to the manual. In addition, the principal investigator of this project acts as an observer during the implementation of the study in each center and do not provide any feedback to ICU nurses, because we record the authentic adherence without any interference.
11.1. Planned Procedures to Assess Feasibility in the Ongoing Trial.
The feasibility of IDI-ICU is assessed in a pilot study, therefore, no specific procedures are implemented to examine feasibility of the IDI-ICU in the large-scale clinical study.
Item 12. Actual Adherence or Fidelity
The fidelity of IDI-ICU protocol in the trial is measured by the intervention recording form, which is used in the pilot study to record frequency, duration, intensity or dose of intervention. These data are reported in an article with the clinical effect data and submitted to a peer-reviewed journal at the end of the study.
Patient and public involvement
No patient involved.