Inpatient Sleep Loss: Educating and Empowering Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-08

Study Completion Date

2023-03-31

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.

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Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Trained research assistants will introduce the interventions to patients, leaving the outcomes assessor and investigator only able to see results. The care provider is not part of the study decision, as the study does not affect their healthcare.

Study Groups

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Sleep Kit Alone

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.

Group Type ACTIVE_COMPARATOR

Sleep Kit

Intervention Type OTHER

Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep

Sleep Kit + Empowerment

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.

Group Type EXPERIMENTAL

Patient Empowerment

Intervention Type BEHAVIORAL

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

Sleep Kit

Intervention Type OTHER

Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep

Interventions

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Patient Empowerment

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

Intervention Type BEHAVIORAL

Sleep Kit

Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes