Inpatient Sleep Loss: Educating and Empowering Patients (ISLEEP)

The University of Chicago

Status: Completed

Conditions: Sleep

Treatments: Behavioral: Patient Empowerment; Other: Sleep Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT04151251

IRB19-0169

Details and patient eligibility

About

While many interventions have targeted hospital staff to improve sleep, few have been successful, and often suffer from limited adherence to staff protocols. Given preliminary data that suggests that empowered patients are more likely to obtain better sleep and have objectively lower noise levels in their rooms, it is plausible that partnering directly with patients can mitigate sleep loss and improve health outcomes. Patients will be randomized to receive the I-SLEEP education and empowerment program and test the effectiveness of this program on patient sleep and health outcome in the hospital and post-discharge. The aim of the project is to reduce environmental, healthcare-related, and patient-related factors that disrupt sleep of hospitalized patients by use of patient education and empowerment intervention.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Admitted to the general/hospitalist medicine departments
• Stayed at least one night in hospital since admission

Exclusion criteria

• Admitted >72 hours ago
• Patient has been diagnosed with a sleep disorder such as narcolepsy, insomnia, or sleep apnea
• Patient was transferred from ICU or outside hospital
• Patient under strict, droplet, or airborne isolation precautions
• Unable to ambulate
• Too confused or incoherent to provide consent
• Patient cannot speak English
• Pregnancy
• Residence in a nursing home or assisted living facility
• Patient was admitted in a hospital within two weeks of current admission

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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256 participants in 2 patient groups

Sleep Kit Alone

Active Comparator group

Description:

Patients who are not randomized into the I-SLEEP intervention will receive a sleep kit that includes an eye mask, earplugs, and headphones.They will still receive the usual standard of care provided by clinicians which includes measures to reduce unnecessary nighttime disruptions and limiting excessive noise within the hospital setting.

Treatment:

Other: Sleep Kit

Sleep Kit + Empowerment

Experimental group

Description:

A short video will be shown on iPads and a brochure will be given that both describe the importance of good sleep and how to facilitate it with good sleep hygiene. The video will show a few reasons why someone might not get optimal sleep while in a hospital, and offer advice to address this from a doctor. The brochure will be kept to no higher than a 6th grade reading level, considered optimal for health education materials. Text will be kept brief and to the point. To account for vision problems, we will use \>12-point font \& leave a large portion of each page empty. Visual Aids \& graphics will be employed when possible. All of this is given in addition to the usual standard of care provided by clinicians.

Treatment:

Other: Sleep Kit

Behavioral: Patient Empowerment