Earplugs and Eye Masks for Reducing Delirium
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 2/10/2019 |
| Start Date: | August 6, 2018 |
| End Date: | December 8, 2018 |
Earplugs and Eye Masks Worn at Night to Reduce the Incidence of Delirium in General Medicine Inpatients
There has been some recent evidence to support the use of earplugs and eye masks to prevent
delirium, but the existing studies have been small, have not been thoroughly replicated, and
have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to
conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial
designed to assess the efficacy of earplugs and eye masks worn at night for prevention of
delirium in a population of general medicine inpatients over the age of 65. The primary
outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In
this pilot study, we will assess feasibility and will not perform any statistical
comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard
rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include
length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or
agitation. There are no physical risks and no cost to the subjects in this study.
delirium, but the existing studies have been small, have not been thoroughly replicated, and
have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to
conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial
designed to assess the efficacy of earplugs and eye masks worn at night for prevention of
delirium in a population of general medicine inpatients over the age of 65. The primary
outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In
this pilot study, we will assess feasibility and will not perform any statistical
comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard
rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include
length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or
agitation. There are no physical risks and no cost to the subjects in this study.
Inclusion Criteria:
- Admitted to General Medicine (units 8100 and 8300 only) from the Duke University
Hospital (DUH) Emergency Department
- Age >= 65
Exclusion Criteria:
- Admitted from outside hospitals, clinics (i.e., direct admissions), or transferred
from another department
- Admitted as "observation" (i.e., expected length of stay < 2 nights)
- Admitted > 24 hours prior to time of enrollment
- Non-English-speaking patients will be excluded because a language barrier would
introduce inaccuracy into the CAM measurement and for feasibility reasons (e.g.,
availability of translator services)
- Blind or deaf patients will be excluded because they are unlikely to benefit from the
intervention, but sensory-impaired patients will be included
- Patients lacking decision-making capacity for whom no Legally Authorized
Representative (LAR) is available
- Primary reason for admission "altered mental status", drug withdrawal, stroke, or
seizure
- Patients for whom a withdrawal pathway has been preemptively initiated based on their
substance use history (e.g., the alcohol withdrawal pathway order set or other as
needed ("PRN") orders for the indication of withdrawal)
- Delirium present at time of enrollment
- Glasgow Coma Scale (GCS) < 10 at time of enrollment
- Enrolled in this trial during a previous admission (i.e., we will not resample)
- Enrolled in a separate trial this admission
- Contraindication to using earplugs or an eye mask (e.g., facial trauma or other safety
concern)
- Significant fall risk per nursing assessment
We found this trial at
1
site
Click here to add this to my saved trials
