None listed
Conditions
Brief summary
This research study aims to develop, implement, and evaluate a novel delirium prevention and management intervention in an adult Intensive Care Unit. Background: Many adults admitted to the hospital experience acute delirium, one of the most common types of brain dysfunction in those admitted to intensive care. Delirium causes a significant psychological impact on patients and family members, caregivers and health professionals. There is a lack of evidence based drug free interventions for preventing and managing delirium. Intervention: The Family Members Voice Reorientation intervention FamVR, is a novel voice reorientation program that will record family members’ voices. The recorded voices can be played to the patient by clinical staff to provide orientation, reassurance, and comforting words to critically ill patients. Method: The researcher will conduct the study in two phases. The first phase will involve collaborating with relevant stakeholders comprising intensive care clinical experts and people with lived experience in the intensive care unit to develop the intervention. The second phase will involve implementing the FamVR as a pilot study in one adult intensive care unit and collecting statistical data about the FamVR. After implementing the FamVR, the researcher will evaluate the FamVR by exploring the experiences of ICU patients, families and clinicians. Significance: The proposed study is significant because it informs the integration of family members’ voices as a nonpharmacological intervention for delirium care. The intervention may enable the implementation of digital family presence to minimise the impacts of restrictions on physical presence imposed by units and the pandemic restrictions. The FamVR may optimise the reorientation and communication of intensive care patients by incorporating their first language into the content and strengthening the family-centred care approach. As this is a pilot study, it may inform a more extensive study using the same methods, which may, in turn, establish the utility of the FamVR.
Interventions
The Family Members Voice Reorientation intervention (FamVR) is a novel voice reorientation program that will record family members’ voices. The recorded voices can be played to the patient by clinical staff to provide orientation, reassurance, and comforting words to critically ill patients. The researcher will conduct the study in two phases. Phase One – Development of FamVR content: This phase comprises the development of the FamVR intervention content in collaboration with relevant stakeholders comprising ICU clinicians, patients and families. The FamVR program content will be stored on an iPad. The program will have four domains which comprise the ICU reorientation, ICU routine, ICU procedure and free category domains. The ICU reorientation domain will contain messages in family members' voices that family members or clinical staff can play to the patient during the early days of admission, during bed moves, in the wake of the day, during change of staff and at bedtime. The ICU routine domain will contain messages that can be played to the patient before routine care, such as washing, oral and eye care, bed lining change, and nursing and medical assessments. The ICU procedure domain can be played to the patient before invasive devices such as central venous lines, oxygen masks, suctioning, urinary catheter insertion, feeding tube insertion and lines for drugs. The free domain will contain messages that the family members choose in the context of everyday events, such as the news about their family, loved ones and events; the researcher and clinical staff will monitor his domain to ensure that appropriate messages are played to the patient. Phase Two – Pilot study implementation in one ICU: Phase Two will start approximately 3 weeks after Phase One. The researcher will consent and educate patients, family members and staff about the FamVR. Then the FamVR will be implemented in one adult ICU. During this time, the clinical staff and the researcher will use an agitation assessment scale to monitor the effect of the FamVR on patients. If patients show increased levels of agitation during the intervention, they will no longer receive FamVR for the duration of their ICU stay. The clinical staff are educated on using the agitation assessment scale because it is currently used in practice. However, the researcher who is an ICU clinician will provide further education about 2 weeks before implementing the intervention through a one-off 1-hour PowerPoint Presentation via Microsoft Teams which will be recorded for staff to replay in their own time. Also, the researcher will provide at least 3 face-to-face education sessions using pictures and the demonstration of the intervention on an iPad to reinforce the clinicians' knowledge and application of the assessment during this study. The family members will play the role of recording their voices in approximately 1 hour recording session; according to the scripts of the domain and the researcher will provide face-to-face education using pictures and iPad demonstration to the family members 3 days before implementing the intervention. The FamVR can be played to the patient in their absence daily as needed for each of the domains, the free category domain will be played at least twice a day. The FamVR will be administered to each patient participant from the time they are intubated in ICU to the time the breathing tube is removed. The researcher will collate information via an observational checklist that will record how long, when and how many times the FamVR was played. This phase will then evaluate the FamVR intervention by exploring the experiences of ICU staff, patients and families of the FamVR via individual interviews. Evaluation: The pilot study implementation of the FamVR intervention is anticipated to last for four months, with 30 participants consented and recruited in the study as guided by pilot studies. The researcher will evaluate the intervention by collecting data on the experiences of patients, family members and clinical staff of integrating the FamVR into the delirium care of their loved ones or patients. Data collection for the patients and family members will be one-to-one semi-structured interviews and recorded via Microsoft Teams. The interview will be recorded audio and visual and will last approximately 60 minutes. Patients can be interviewed as a family unit with the family members or separately if they prefer. The interview will take place in the participants' natural settings to minimise the risk of travelling to the study site and their natural settings will make them more at ease. For clinician participants, the researcher will conduct 3 focus groups with 8-12 participants in each focus group until no new information emerges (data saturation) from the focus group. If data saturation is not achieved, the researcher will undertake further focus groups until data saturation is achieved. The researcher will organise the focus groups to explore the experiences of the clinical staff of the FamVR intervention. The focus groups will comprise of doctors, nurses and physiotherapists. The focus group will be recorded via Microsoft Teams and will last for approximately 60 minutes
Sponsors
Study design
Eligibility
Inclusion criteria
The inclusion criteria includes adults aged 18 years and older. The stakeholder group: The ICU clinical expert will be a medical doctor (consultant or senior registrar doctor) and a senior nurse who has received formal critical care training and holds a clinical position in the ICU at the time of selection for the study. For the patients and families of a person who has survived a critical illness or a family member of someone who survived a critical illness. Those who consent to participate in the study. For Phase Two (Implementation and Evaluation): Patients and family members of a patient admitted to the ICU during the period the FamVR intervention is pilot implemented. Staff who currently holds a permanent clinical position in the ICU. A person who understands English. Those who voluntarily consent to participate in the study. Some patients may not have the capacity to consent in Phase 2 pilot implementation; in that case, an identified consultee will consent, and the consent will be reconfirmed directly from the patient when they regain the capacity to consent.
Exclusion criteria
Exclusion criteria will be patients and their family members who were palliated or receiving end-of-life care. Participants from the stakeholder group from phase one are excluded from being participants in Phase Two Evaluation. Participants who do not speak or understand English as they would not be able to participate in interviews.