Earplugs and Eye Masks for Reducing Delirium

Duke University

Status

Completed

Conditions

Delirium

Hospital Acquired Condition

Treatments

Behavioral: Earplugs and eye masks

Study type

Interventional

Funder types

Other

Identifiers

NCT03471520

Pro00087770

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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