Clinical trial NCT03471520: Earplugs and Eye Masks for Reducing Delirium
Official title: Earplugs and Eye Masks Worn at Night to Reduce the Incidence of Delirium in General Medicine Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Hospital Acquired Condition
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of delirium
timeFrame: The first 5 days of patients' hospitalization
measure: Feasibility as measured by number of patients screened
timeFrame: 5 days
measure: Feasibility as measured by number of patients ineligible
timeFrame: 5 days
measure: Feasibility as measured by number of patients who decline to participate
timeFrame: 5 days
measure: Feasibility as measured by number of patients who dropped out of the study
timeFrame: 5 days
measure: Feasibility as measured by number of patients who wore the earplugs
timeFrame: 5 days
measure: Feasibility as measured by number of patients who wore the eye masks
timeFrame: 5 days
measure: Feasibility as measured by number of CAM assessment days
timeFrame: 5 days
measure: Feasibility as measured by number of patients who successfully completed the study
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Juliessa Pavon, MD
role: PRINCIPAL_INVESTIGATOR
References: