Burden Survey on Delirium Care

JRCT ID: jRCT1070220061

Registered date:18/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Delirium
• Date of first enrollment: 09/11/2022
• Target sample size: 713
• Study type: Observational

Outcome(s)

Primary Outcome

Primary outcomes:
A validated questionnaire to determine burden of Japanese physician and nurses treating and caring for patients with delirium based on the following outcomes:
-Identification of behaviors of patients with delirium, or situations related to patients with delirium that physicians and nurses find most difficult to deal with
-Development of a burden scale to determine the level of burden of physicians and nurses, when treating or caring for delirium patients
-Validation of the new burden scale in terms of its comprehension, content validity, internal consistency (reliability), discriminant validity, sensitivity and known-group validity, and ceiling / floor effects
-Initial assessment of physician and nurse burden of treatment or care related to delirium patients, based on a newly developed burden scale

Secondary Outcome

Secondary outcomes:
-Associations between the burden on physicians and nurses treating or caring for patients with delirium, and their demographics.
-Associations between the burden on physicians and nurses treating or caring for patients with delirium, and their delirium-related experience and environment.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Physicians and nurses who meet the following criteria will be included in this study. Note that the participants for the expert interviews and cognitive debriefing in Phase 2 will not be eligible.
1.The number of beds in the facility where participants are mainly working is 20 or more.
2.Physicians and nurses who belong to one of the following departments
-Internal medicine departments
-Surgical departments
-Emergency departments
3.Frequency of care for patients with delirium should be at least 3 times per month
This criterion may be loosened, depending on the recruitment situation i.e., the percentage of screened candidates that meet the above criteria.

Exclude criteria

Physicians and nurses who do not meet the inclusion criteria will be excluded from this study (Note that the participants for the expert interviews and cognitive debriefing in Phase 2 will not be eligible). For example, the following will be excluded:
1.Physicians and nurses who are from the psychiatry department
2.Physicians and nurses who are full time health care professionals in the intensive care unit (ICU) departmentPhysicians and nurses who do not meet the inclusion criteria will be excluded from this study (Note that the participants for the expert interviews and cognitive debriefing in Phase 2 will not be eligible). For example, the following will be excluded:
1.Physicians and nurses who are from the psychiatry department
2.Physicians and nurses who are full time health care professionals in the intensive care unit (ICU) department

Related Information

• Primary Sponsor: Okuda Shoki