Clinical trial NCT06161480: Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium
Official title: The Feasibility and Acceptability of Using Weighted Blankets to Prevent and/or Mitigate Delirium in Adult Critical Care Patients in Urban and Rural Settings.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study that will be conducted in a convenience sample of adult medicine ICU
Primary purpose: PREVENTION

Brief summary: The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.

Detailed description: To examine the feasibility and acceptability of weighted blankets as a single component, nonpharmacologic strategy to prevent and/or mitigate delirium in an adult medicine critical care patient population. To examine the feasibility and acceptability of videoconferencing (VCU Health Zoom), EHR screening, and VCU and VCU Health infrastructure (REDCap, OnCore) for rural participant recruitment and research participation, remote HealthCare provider protocol training and research engagement, and remote research monitoring and support for rural patient population. To collect preliminary descriptive data and examine trends related to the use of weighted blankets to prevent and/or mitigate delirium to inform future efficacy trials in an adult medicine critical care patient population (e.g., Agitation, Delirium, ICU length of stay, number ventilator days, sedation/opioid medication usage).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Requiring ICU level of care.
* Have a primary medical diagnosis.
* Proficient in English.

Exclusion Criteria:

* BMI less than 18.5.
* Significant deficit in cognitive functioning that is not expected to improve due to an end---stage disease stage or permanent injury (e.g., end-stage encephalopathy, traumatic or anoxic brain injury, dementia).
* Known pregnancy.
* Prisoners.
* Presence of skin injury (e.g., surgical wound, pressure injury, moisture injury) in an anatomical location where additional weight/pressure of blanket could prevent healing and /or lead to an expansion of the injury.
* Patients with skin injuries to areas easily left uncovered by the blanket (e.g., hands, feet) can be enrolled with additional communication to clinical team to leave areas uncovered to prevent additional injury.
* Paralysis effecting an area the weighted blanket will cover.
* Current neuromuscular blocking agent.
* Presence of recent/unhealed fractures on an area the blanket will cover (e.g., lower limb long bone, rib, pelvis, spine).
* History of claustrophobia reported by patient and/or their legally authorized representative (LAR).
* Fever of 37.5°C (99.5°F).
* Limited English proficiency.

Primary outcomes:
measure: Study Participants Experience Survey
timeFrame: Six months
measure: LAR Experience Survey
timeFrame: Six Months
measure: Nurse and Provider Experience Survey
timeFrame: Six Months
Secondary outcomes:
measure: Analysis of total ICU Length of Stay (Days)
timeFrame: Six Months.
measure: Analysis of total ICU Length of Stay on Study (Days)
timeFrame: Six Months
measure: Analysis of total Number of Ventilator Days (This admission)
timeFrame: Six Months
measure: Analysis of total number of Ventilator Days on Study
timeFrame: Six Months
measure: Daily Chart Review
timeFrame: Six Months
measure: Blanket Usage Log analysis
timeFrame: Six Months
measure: Confusion Assessment Method for the ICU (CAM-ICU) data analysis
timeFrame: Six Months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: VCU Health Systems
state: Virginia
Study officials:
References: