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

Virginia Commonwealth University49 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Delirium

Interventions

Weighted BlanketDEVICE

Weighted Blanket is an occupational therapy modality which has been associated with significant increases in grounding, orientation to reality, soothing, and quality of life.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

VCU Health Systems

Richmond, Virginia, United States

Outcomes

Primary Outcomes

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. The full name is "Participant Weighted Blanket Satisfaction Survey." A likert scale (1-5) was used with 1 being less satisfied and 5 being higher satisfaction. There were 6 questions total. Total score was averaged.

Time frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days

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.

Time frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days

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. The full name is "Nurse \& Provider Weighted Blanket Experience Survey" A likert scale (1-5) was used with 1 being less satisfied and 5 being higher satisfaction. There were questions total. Total score was averaged.

Time frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days

Secondary Outcomes

Analysis of Total ICU Length of Stay (Days)

Study Team will collect data daily and conduct analysis of total ICU Length of Stay (Days).

Time frame: From participant enrollment until participant is downgraded from ICU level of care

Data from ClinicalTrials.gov

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