Feasibility and Acceptability of Using Weighted Blankets to Prevent and /or Mitigate Delirium

Study Overview
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Brief Summary
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The use of weighted blankets to avert or alleviate Delirium in Adult ICU patients.

Detailed Description
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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).

Official Title
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The Feasibility and Acceptability of Using Weighted Blankets to Prevent and/or Mitigate Delirium in Adult Critical Care Patients in Urban and Rural Settings.

Conditions
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Delirium

Intervention / Treatment
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* Device: Weighted Blanket


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study that will be conducted in a convenience sample of adult medicine ICU
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Weighted Blanket<br>To prevent and or mitigate delirium in adult ICU patients in urban and rural populations. | Device: Weighted Blanket<br>* Weighted Blanket is an occupational therapy modality which has been associated with significant increases in grounding, orientation to reality, soothing, and quality of life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Participants Experience Survey | Study Participants will be asked to complete a survey describing their experience with using the weighted blanket upon discharge from the ICU or if they stop using the weighted blanket, to determine if participants felt using the weighted blanket was beneficial to their overall health improvement. | Six months | 
| LAR Experience Survey | LAR will complete survey describing his/her perspective of the participant's use of the weighted blanket to improve family member's health outcome. LAR will complete survey after participant has been discharged from ICU or participant is no longer using the weighted blanket. | Six Months | 
| Nurse and Provider Experience Survey | The nurse and healthcare provider will complete surveys once their patient has completed the use of the weighted blanket describing whether they felt the weighted blanket improved the health outcome of their patients. | Six Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of total ICU Length of Stay (Days) | Study Team will collect data daily and conduct analysis of total ICU Length of Stay (Days). | Six Months. | 
| Analysis of total ICU Length of Stay on Study (Days) | Study Team will collect data daily and conduct analysis of total ICU Length of Stay on Study (Days) | Six Months | 
| Analysis of total Number of Ventilator Days (This admission) | Study Team will collect data daily and conduct analysis of total Number of Ventilator Days (This admission). | Six Months | 
| Analysis of total number of Ventilator Days on Study | Study Team will collect data daily and conduct analysis of total number of Ventilator Days on Study. | Six Months | 
| Daily Chart Review | Study Team will collect data daily and conduct analysis of the daily chart review data. | Six Months | 
| Blanket Usage Log analysis | Study Team will collect data daily and conduct analysis of the Blanket Usage Log. | Six Months | 
| Confusion Assessment Method for the ICU (CAM-ICU) data analysis | Study Team will collect data daily and conduct analysis of data from the CAM-ICU, a rating scale used be bedside clinicians to assess delirium for patients in the intensive care unit. The CAM-ICU-7 evaluates the presence of acute onset or fluctuating course (score of 0 or 1), inattention (score ranges from 0-2), altered level of consciousness (score ranges from 0-2, based on if RASS is anything other than alert and calm [zero]), and disorganized thinking (score ranges from 0-2). | Six Months |