Inpatient Sleep Loss: Educating and Empowering Patients

Study Overview
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Brief Summary
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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.

Official Title
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Mentoring Patient-Oriented Research: Sleep & Health During & After Hospital Stay

Conditions
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Sleep

Intervention / Treatment
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* Behavioral: Patient Empowerment
* Other: Sleep Kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleep Kit Alone<br>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. | Other: Sleep Kit<br>* Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep<br>|
| Experimental: Sleep Kit + Empowerment<br>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. | Behavioral: Patient Empowerment<br>* Group to receive a 5 minute video about typical hospital sleep disruptions and what they can do to prevent them, as well as a brochure outlining the importance of sleep<br>Other: Sleep Kit<br>* Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karolinska Sleep Log - Sleep Times | A self-reported measure of time spent sleeping, time it took to fall asleep, etc. | Through stay in the hospital until discharge, usually 2-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Sleep Disruptions in the Hospital Setting | Administered to obtain a subjective view of typical disruptions to sleep such as bed comfort, room temperature, and pain. Items will also assess the disruptions that are caused by healthcare, such as vital signs, medication administration, and lab-work. This survey includes an item on how disruptive noise was to the patient's sleep, broken down into as many sources of hospital noise as possible. | Through stay in the hospital until discharge, usually 2-3 days | 
| Patients Who Report Talking to Clinicians About Their Healthcare | Measure of number of patients who advocate for their sleep by making lifestyle changes, including speaking to their clinicians to reduce nighttime disruptions | Through stay in the hospital until discharge, usually 2-3 days | 
| Number of nighttime disruptions to sleep | Measure of disruptions patients receive between 11 PM and 7 AM, determined by hospital hand sanitizer stations outside doors and electronic health record audits | Through stay in the hospital until discharge, usually 2-3 days | 
| Karolinska Sleep Log - Outcomes of Sleep | Subjective quality of sleep as determined by scales such as On a scale of 1 to 5, with 5 being the most, how refreshed did you feel upon waking up this morning? | Through stay in the hospital until discharge, usually 2-3 days | 
| Actigraphy - Objective Measure of Sleep Duration | Actiwatch Spectrum Pros used to determine sleep duration | During stay at the hospital, for a week after, and for a week three months after discharge | 
| Actigraphy - Objective Measure of Sleep Quality | Actiwatch Spectrum Pros used to determine sleep quality | During stay at the hospital, for a week after, and for a week three months after discharge |