Improving Sleep and the Patient Experience in the Emergency Department

NCT02488772 | Completed

• 1 other identifier: EMED-214-15
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background The emergency department is a chaotic place with high levels of noise and light 24 hours a day. Patients are often boarded overnight while they await tests or consultations scheduled for the morning. Sleep deprivation, high noise levels have been associated with negative patient experiences and outcomes in other clinical settings. Interventions to counter the effects of noise and light in the emergency department for patients staying overnight have not been investigated. Objective To determine if sleep and other aspects of the patient experience can be improved for patients boarded overnight in the Emergency Department with the use of a sleep mask and ear plugs. Methods A randomized control study will take place in the Emergency Department of Kingston General Hospital. Eligible patients will randomized to receive either sleep aids (sleep mask and ear plugs) or standard treatment (no sleep aids). The primary outcome will be sleep quality, assessed by Richards-Campbell Sleep Questionnaire. Secondary outcomes include patient satisfaction, hours of sleep, blood pressure, heart rate, new-onset delirium, patient's sense of feeling well-rested and patient overall sense of well-being. The primary analysis will be intention-to-treat comparing primary and secondary outcomes between the two groups in an unadjusted fashion. A secondary analysis will involve linear regression to explore the association between treatment group and Richards-Campbell Sleep Score, controlling for potential confounders. Importance Determining the feasibility and efficacy of sleep masks and earplugs for patients in the emergency department to improve sleep and the patient experience has never been done before. If found to be effective, this relatively low- cost intervention could be implemented in emergency departments across the country and around the world.

Conditions

Sleep Deprivation

Keywords

sleep quality; emergency department

Outcome Measures

Primary Outcomes (1)

• Sleep Quality

  Richards Campbell Sleep Questionnaire

  Measured following morning at approx. 0800h (up to 9hrs)

Secondary Outcomes (7)

• Delirium

  Measured following morning at approx. 0800h (up to 9hrs)

• Individual domains of Richards Campbell Sleep Questionnaire

  Measured following morning at approx. 0800h (up to 9hrs)

• Patient satisfaction

  Measured following morning at approx. 0800h (up to 9hrs)

• Perceived hours of sleep

  Measured following morning at approx. 0800h (up to 9hrs)

• Blood Pressure

  Measured following morning at approx. 0800h (up to 9hrs)

Other Outcomes (2)

• Nursing intervention tally

  Measured following morning at approx. 0800h from nursing records (up to 9hrs)

• Sedating medication use

  Measured following morning at approx. 0800h from nursing records (up to 9hrs)

Study Arms (2)

Treatment Group

EXPERIMENTAL

Patients allocated to treatment group will be supplied with sleep interventions (sleep mask and ear plugs), and standardized instructions of use.

Device: Sleep mask; Device: Ear Plugs

Control Group

ACTIVE COMPARATOR

Patients allocated to control group will be assessed for sleep quality, but not offered sleep mask and ear plugs. They will receive standard of care as decided by treating emergency physician.

Other: Standard of care

Interventions

Sleep mask DEVICE

Also known as: PharmaSystems, product PS970

Treatment Group

Standard of care OTHER

Standard of care as decided by treating emergency physician

Control Group

Ear Plugs DEVICE

Also known as: Stanley Low Pressure Foam Earplugs, product RST-63008

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Patients aged ≥18 years
• GCS 15
• At 2300h are deemed likely to board in the Emergency Department until 0700h the following morning, waiting for: Consultant assessments, investigations, transfers (including waiting for family members to drive them home in the morning)

You may not qualify if:

• Previously included in this study
• Engaged sleep research within the last month
• Legally blind or history of hearing impairment.
• Documented history of cognitive impairment
• Delirious at initial assessment
• Presenting complaint of head trauma
• Admitted to an inpatient service
• Poor English comprehension
• Prisoner

Sponsors & Collaborators

• Kingston Health Sciences Centre: lead

MeSH Terms

Conditions

Sleep Deprivation; Sleep Initiation and Maintenance Disorders; Emergencies

Interventions

Standard of Care; Ear Protective Devices

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Stuart Douglas, MD

  PGY3 - Emergency Medicine, Queen's University

  PRINCIPAL INVESTIGATOR

• Steven Brooks, MD, FRCP

  Emergency Physician, Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Stuart Douglas - PGY3 Emergency Medicine

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 2, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 2, 2020

Record last verified: 2020-08