Inpatient Sleep Loss: Educating and Empowering Patients

NCT04151251 | Completed DMC

• 1 other identifier: IRB19-0169
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Frequency of Sleep Disruptions in the Hospital Setting

  Through stay in the hospital until discharge, usually 2-3 days

• Patients Who Report Talking to Clinicians About Their Healthcare

  Through stay in the hospital until discharge, usually 2-3 days

• Number of nighttime disruptions to sleep

  Through stay in the hospital until discharge, usually 2-3 days

• Karolinska Sleep Log - Outcomes of Sleep

  Through stay in the hospital until discharge, usually 2-3 days

• Actigraphy - Objective Measure of Sleep Duration

  During stay at the hospital, for a week after, and for a week three months after discharge

Study Arms (2)

Sleep Kit Alone

ACTIVE COMPARATOR

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

Sleep Kit + Empowerment

EXPERIMENTAL

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; Other: Sleep Kit

Interventions

Patient Empowerment 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 + Empowerment

Sleep Kit 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; Sleep Kit Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (3)

• Arora VM, Machado N, Anderson SL, Desai N, Marsack W, Blossomgame S, Tuvilleja A, Ramos J, Francisco MA, LaFond C, Leung EK, Valencia A, Martin SK, Meltzer DO, Farnan JM, Balachandran J, Knutson KL, Mokhlesi B. Effectiveness of SIESTA on Objective and Subjective Metrics of Nighttime Hospital Sleep Disruptors. J Hosp Med. 2019 Jan;14(1):38-41. doi: 10.12788/jhm.3091.

  PMID: 30667409 BACKGROUND

• Adachi M, Staisiunas PG, Knutson KL, Beveridge C, Meltzer DO, Arora VM. Perceived control and sleep in hospitalized older adults: a sound hypothesis? J Hosp Med. 2013 Apr;8(4):184-90. doi: 10.1002/jhm.2027. Epub 2013 Mar 18.

  PMID: 23504939 BACKGROUND

• Mason NR, Orlov NM, Anderson S, Byron M, Mozer C, Arora VM. Piloting I-SLEEP: a patient-centered education and empowerment intervention to improve patients' in-hospital sleep. Pilot Feasibility Stud. 2021 Aug 19;7(1):161. doi: 10.1186/s40814-021-00895-z.

  PMID: 34412696 DERIVED

Study Officials

• Vineet Arora, MD, MAPP

  Medical Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 5, 2019
• Study Start: January 8, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

US (1)