A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium

Hypoactive Delirium Clinical Trial

Official title:

A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837039
• Other study ID #: 2021-1177
• Secondary ID: NCI-2022-02412
• Status: Recruiting
• Start date: March 25, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Michael Tang, MD
• Phone: (832) 468-8895
• Email: mjtang[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To learn about your feelings as a caregiver about the level of discomfort of patients who have hypoactive delirium (loss of contact and response to reality) and who are at the end of life

Description:

Primary Objective: To assess the caregiver's perception of the level of discomfort of patients who have a hypoactive delirium and who are considered actively dying. The caregiver's perception will be based upon the Caregiver Survey of Patient Discomfort. Secondary Objective: To compare the perception of discomfort between the caregiver and bedside nurse. The caregiver's perception will be based upon the Caregiver Survey of Patient Discomfort, and the nurse's perception will be based upon the Healthcare Provider Survey of Patient Discomfort. Exploratory Objective: To assess associations between patient demographics and clinical characteristics as well as caregiver and nurse demographics on corresponding caregiver and nurse survey responses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria:

1. Patients with advanced cancer. Advanced cancer is defined as locally invasive, metastatic or recurrent cancer. Hematologic malignancies will also be included.

2. Patients who are admitted to the acute palliative care unit (APCU) at MD Anderson Cancer Center.

3. Patients who are unable to respond to questioning in the past 24 hours as determined by the attending physician, fellow physicians, or nursing staff of the APCU.

4. Patients who are considered to be actively dying, as defined as likely to die during the admission and not regain consciousness. The physical exam findings that will be utilized to help define those patients who are actively dying may include one but not limited to one of the following symptoms: pulseless of the radial artery, Cheyne-stokes breathing, peripheral cyanosis, apnea periods, respiration with mandibular movement, turbulent airway noise produced on inspiration and/or expiration due to airway secretions commonly known as the "death rattle", and loss of nasolabial folds.16,17 The presence of these signs will be based on the reporting of the attending physician, fellow physicians or nursing staff of the APCU.

5. Patients who have an unpaid adult caregiver at bedside age 18 years or older, who is willing and able to provide informed consent and who has been present at bedside for at least 3 hours a day.

Patient Exclusion Criteria:

1. Patients who had a hyperactive or mixed delirium in which they either had high level of arousal due to delirium or had mixed episodes of arousal and agitation with periods of unresponsiveness.

2. A family member or caregiver who cannot provide informed consent, or who cannot speak and read English.

Caregiver Inclusion Criteria:

1. Unpaid adult caregiver at bedside age 18 years or older, who is willing and able to provide informed consent, able to speak and read English, and who has been present at bedside for at least 3 hours a day.

Nursing Provider Inclusion Criteria:

1. Nursing providers in the acute palliative care unit who are providing direct patient care to eligible patients.

Related Conditions & MeSH terms

• Delirium
• Hypoactive Delirium
• Hypokinesia

Intervention

Behavioral:
• Healthcare Provider
Questionnaires
• Caregiver Perception
Questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Likert Scale Survey	Score Scales: (1-5); Strongly Disagree; Disagree; Neither Agree Nor Disagree; Agree; Strongly Agree	through study completion; an average of 1 year.

External Links

•   M D Anderson Cancer Center