The Feasibility and Acceptability of Using Weighted Blankets to Prevent and/or Mitigate Delirium in Adult Critical Care Patients in Urban and Rural Settings.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Study Participants Experience Survey
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patient 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.
- •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.
Arms & Interventions
Weighted Blanket
To prevent and or mitigate delirium in adult ICU patients in urban and rural populations.
Intervention: Weighted Blanket (Device)
Outcomes
Primary Outcomes
Study Participants Experience Survey
Time Frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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.
LAR Experience Survey
Time Frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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.
Nurse and Provider Experience Survey
Time Frame: From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days
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.
Secondary Outcomes
- Analysis of Total ICU Length of Stay (Days)(From participant enrollment until participant is downgraded from ICU level of care)
- Analysis of Total ICU Length of Stay on Study (Days)(From participant enrollment until participant is downgraded from ICU level of care or until participant withdraws from study (whichever occurs first))
- Analysis of Total Number of Ventilator Days During Current ICU Admission(From current ICU admission date until participant is downgraded from ICU level of care, an average of 4 days. This measure includes any vent days prior to the participant being enrolled in the study)
- Analysis of Total Number of Ventilator Days on Study(From study enrollment date until participant is downgraded from ICU level of care, an average of 4 days. This measure only looks at vent days while enrolled and does NOT include vent days prior to enrollment)
- Richmond Agitation Sedation Scale (RASS)(From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days)
- Hours of Blanket Usage Per Day (24 Hours)(From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days)
- Confusion Assessment Method for the ICU (CAM-ICU)(From participant enrollment until participant is downgraded from ICU level of care, an average of 4 days)