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| ID | Type | Description | Link |
|---|---|---|---|
| RFPR2324_29 | Other Grant/Funding Number | Imperial Health Charity | |
| 24/YH/0011 | Other Identifier | UK Health Research Authority (Research Ethics Committee) |
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STUDY SUMMARY
STUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit (ICU) at Hammersmith Hospital, Imperial College Healthcare NHS Trust (ICHT). This study is a mixed methods research design that includes the collection of data through qualitative interviews, quality-of-life questionnaires and patients' medical records.
AIMS
STUDY POPULATION 30 study participants (12 patients, 12 family members/friends and 6 ICU nurses)
ELIGIBILITY Study eligibility criteria are specific for each care group (patients, family members/friends and ICU nurses).
DURATION 12 months at Hammersmith Hospital, ICHT
DaCsi-ICU is a mixed methods research study including the collection of data from patient's medical notes, interviews and quality of life questionnaires following the study schedule of assessments. This study also involves the implementation of an auditory-visual sensory stimulation package in the cardiac ICU at ICHT to participants enrolled in the study.
Digital photos will be shown continuously at the patient's bedside (8am-8pm) after cardiac surgery and will always have reference to time and date. Additionally, videos will be played throughout the patient's stay in the ICU at least three times per day (timepoints: 9am, 2pm,7pm) and upon participant request. Videos will be also played when participants show signs of ICU delirium to reduce its incidence and improve overall health outcomes. Simultaneously, data from patients' medical records will be routinely collected by the research team (e.g., Confusion Assessment Method-ICU, Richmond Agitation Sedation Scale, etc.) to assess whether patients develop delirium during their stay in the ICU.
Interviews with patients and families/friends will be held on three different occasions. The first one will be on the same day as ICU discharge, the second interview will be on the day of hospital discharge and the third one will be carried out up to a month following hospital discharge during their clinical follow-up appointment. Where possible, family members/friends and patient interviews will be conducted together (dyadic interviewing), but the possibility of performing interviews separately will be given so that participants feel able to discuss opinions freely. Nurses' interviews will be held as a one-off and after they have provided direct care to participants who received the proposed intervention.
Each patient will be followed up daily on the wards and once at the monthly follow-up clinic after ICU discharge, where cognitive and emotional assessments will be performed to evaluate delirium outcomes. The research team will also collect relevant information from participants' medical notes if any complications post-ICU discharge arise during inpatient and follow-up stages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Arm | Experimental | 12 patients will be recruited pre-operatively and submitted to the study intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personal Pictures | Other | Digital photos will be shown continuously at the patient's bedside for 12 hours a day (between 8 am to 8 pm). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of implementing the study intervention | The investigators plan to implement a family-focused auditory-visual sensory stimulation intervention to reduce ICU delirium rates post-cardiac surgery. Feasibility will be assessed by exploring facilitator factors and challenges that may arise during the implementation of this intervention. These elements will be recorded on a study reflective log and further discussed within the study team. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Practicalities of introducing the study intervention | The investigators intend to explore the practical aspects of implementing an innovative non-pharmacological intervention in cardiac surgical ICU. The investigators also aim to collect nursing checklists, routinely liaise with the local clinical/research team and explore any additional internal approvals to implement the study in the ICU. | 12 months |
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INCLUSION CRITERIA
Patients
Family Members/Friends
Healthcare professionals
- Critical Care Nurses that have provided direct care to at least one patient who received the study intervention
EXCLUSION CRITERIA
Patients
Family Members/Friends
Healthcare professionals
WITHDRAWAL CRITERIA:
Participants
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Reguenga, BSN | Contact | 07585095566 | maria.reguenga@nhs.net | |
| Sanooj Soni, PhD | Contact | 07714329708 | sanooj.soni@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Maria Reguenga, BSN | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | Recruiting | London | W12 0HS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40273276 | Derived | De Azinheira Reguenga MJ, Lampridou S, Pattison N, Brett SJ, Soni S. The use of audio-visual aids to reduce delirium after cardiac surgery in intensive care units (DaCSi-ICU): A feasibility study protocol. PLoS One. 2025 Apr 24;20(4):e0320935. doi: 10.1371/journal.pone.0320935. eCollection 2025. |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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12-patient participants will be submitted to the study intervention.
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| Family Videos | Other | Family-recorded videos will be played three times at specific hours of the day - 9 am, 2 pm and 7 pm - throughout patient stay in the ICU |
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| Family Videos - Intervention as required | Other | The last video shown will be re-played upon patient request and/or if patients develop ICU delirium. |
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| Acceptability of implementing the study intervention | The investigators plan to conduct qualitative interviews with critical care staff, patients and family members/friends to explore their acceptance and experience of taking part in the study. | 12 months |
| Short-term delirium outcomes post-ICU discharge | The investigators intend to conduct an extra qualitative interview with patients and family members/friends up to a month after hospital discharge to explore any post-ICU delirium complications. Additionally, cognitive and emotional questionnaires (The Mini-Mental State Examination, General Anxiety Disorder-7 and Patient Health Questionnaire-9) will be performed at two different time points to further explore post-ICU delirium outcomes. | 12 months |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |