WEsleep Trial: Improving Sleep in Hospitalized Patients
Study Details
Study Description
Brief Summary
In the WEsleep study, the investigators will perform a cluster randomized controlled trial. 3 surgical and 3 medical departments will be randomized to implement low-cost and simple interventions aimed at improving sleep in admitted patients. Another 3 surgical and 3 medical departments will be randomized to function as control groups. Subjective sleep quality and sleep-wake timing will be assessed in adult medical and surgical patients admitted into one of 12 participating wards, using questionnaires and a sleep diary.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Objectives
Primary objective Our primary objective is to investigate whether a set of low-cost and easily applicable interventions improves subjective sleep quality of hospitalized patients on the second night of admission as measured the Richards-campbells sleep questionnaire, comparing between intervention and control departments
Secondary objectives
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To investigate whether the WEsleep interventions improves subjective sleep quality for all night of admission (max. 7)
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To investigate whether the WEsleep interventions reduced the lowering of subjective sleep quality when compared to subjective sleep quality before admission (on a work-free day 30 days before admission, retrospectively assessed at inclusion)
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To investigate whether the disruption of the circadian timing system (as measured by the diurnal phase shift of midpoint of sleep) was smaller for patients in the intervention group on the first postoperative night for surgical patients and the second night of admission for medical patients
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To investigate whether the WEsleep interventions reduced night-to-night changes in sleep-wake timing (i.e. midpoint of sleep, on- and offset, duration, latency, inertia and daytime napping) for all nights of admission (max. 7)
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To investigate the association between the timing of food intake (i.e. first and last meal of the day and whether food was eaten after 21:00h) and sleep quality and timing
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To investigate the association between quality of recovery and sleep quality and sleep-wake timing
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To investigate 30-day mortality for patients admitted into intervention and control departments
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To investigate 30-day incidence of delirium for patients admitted into intervention and control departments
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For surgical patients: to investigate the 30-day incidence of surgical site infections
Study Procedure:
6 departments will be randomized (3 surgical, 3 medical) to receive the WEsleep-interventions, which will consist of: 1) Postponing morning nursing rounds to avoid waking patients early and daily assessment of sleep quality by the nurse during morning rounds; 2) Implementing sleep promoting interventions, including optimization of medication and iv fluid timing; 3) Education for health care professionals on sleep; 4) Implementing sleep rounds and change department infrastructure; including 'sleep menu' where patients can choose from earplugs, eye masks, and warm socks. Implement blackout curtains depending on baseline light intensity.
Implementation of the interventions will be evaluated on a regular basis throughout the length of the study to make sure that all interventions are provided to our patients as planned.
After implementing the interventions, 33 patients per participating department will be included, for a total of 396 patients (12 departments with 33 patients each). Before implementation, a baseline measurement will be conducted on all participating departments in a small number of patients (which is not part of the sample size).
Patients will be asked to complete two questionnaires daily:
Richards Campbell Sleep Questionnaire (RCSQ) on subjective sleep quality Consensus Sleep Diary (CSD) for day-to-day sleep wake timing during admission Furthermore, patients are asked at admission to complete the two questionnaires on sleep quality and sleep-wake timing on work- and work-free days (RCSQ and CSD) retrosoectively, i.e. for 30 days before admission. Patients will also complete a Quality of Recovery 15 (QoR-15) questionnaire twice (once at one day after surgery/first day of admission and once three days after surgery/third day of admission).
Informed consent will be obtained on the first or second day of admission into one of the participating wards. Patients will be followed until discharge or for a maximum of 7 nights of admission. Patient characteristics, as well as data on the admission will be extracted from the electronic medical record.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Surgical WEsleep Patients admitted into the 3 surgical departments/clusters where the WEsleep interventions are implemented. |
Other: WEsleep Interventions
1) Postponing morning nursing rounds to avoid waking patients early and daily assessment of sleep quality by the nurse during morning rounds; 2) Implementing sleep promoting interventions, including optimization of medication and iv fluid timing; 3) Education for health care professionals on sleep; 4) Implementing sleep rounds and change department infrastructure; including 'sleep menu' where patients can choose from earplugs, eye masks, and warm socks. Implement blackout curtains depending on baseline light intensity.
|
| Experimental: Medical WEsleep Patients admitted into the 3 non-surgical departments/clusters where the WEsleep interventions are implemented |
Other: WEsleep Interventions
1) Postponing morning nursing rounds to avoid waking patients early and daily assessment of sleep quality by the nurse during morning rounds; 2) Implementing sleep promoting interventions, including optimization of medication and iv fluid timing; 3) Education for health care professionals on sleep; 4) Implementing sleep rounds and change department infrastructure; including 'sleep menu' where patients can choose from earplugs, eye masks, and warm socks. Implement blackout curtains depending on baseline light intensity.
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| No Intervention: Surgical Standardcare Patients admitted into the 3 surgical departments/clusters where the WEsleep interventions are NOT implemented, and patients are receiving standardcare |
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| No Intervention: Medical Standardcare Patients admitted into the 3 non-surgical departments/clusters where the WEsleep interventions are NOT implemented, and patients are receiving standardcare |
Outcome Measures
Primary Outcome Measures
- Subjective Sleep Quality during admission [Second night of admission]
Subjective sleep quality will be assessed with the Richard Campbell Sleep Questionnaire (RCSQ). The RCSQ measures sleep quality on five questions using a visual analogue scale (VAS), ranging from 0 to 100, with higher scores indicating a better sleep quality. A sixth question was added to assess noise levels (as is quite customary), using a VAS-scale, ranging from 0-100, with a higher score indicating more noise
Secondary Outcome Measures
- Night-to night changes in subjective sleep quality [The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed]
Subjective sleep quality will be assessed with the RCSQ.
- Difference in subjective sleep quality between during admission and at home [Second night of admission vs. a work- and workfree day 30 days before admission]
Subjective sleep quality will be assessed with the RCSQ. For this outcome, we will assess the subjective sleep quality at home retrospectively at inclusion.
- Diurnal phase shift of sleep-wake timing [Second night of admission (for medical patients) or first postoperative night (for surgical patients) vs. a workfree day 30 days before admission]
The phase shift of sleep-wake timing will be assessed by comparing midpoint of sleep during admission with midpoint of sleep on a work-free day before admission, both measured with the Consensus Sleep Diary (CSD). For this outcome, we will assess sleep-wake timing at home retrospectively at inclusion.
- Night-to-night changes in sleep-wake timing [The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed]
The changes in sleep-wake timing (i.e. midpoint of sleep, sleep on- and offset time, sleep duration, sleep latency & inertia and daytime napping), as measured by the CSD.
- Timing of food intake and sleep quality/timing [The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed]
The association between food intake timing (i.e. first and last meal of the day and whether food was eaten after 21:00h), as measured by asking patients directly for the time of the first and last meal of the day and whether patients ate after 21:00h), and subjective sleep quality and sleep-wake timing (as measured by the RCSQ and CSD respectively).
- Quality of recovery and sleep quality/timing [First and third day after admission (for medical patients), first and third day after surgery (surgical patients)]
The association between quality of recovery, as measured by the Quality-of-Recovery 15 item questionnaire (QoR-15), and subjective sleep quality and sleep-wake timing (as measured by the RCSQ and CSD respectively). The QoR-15 will be completed twice by patients.
- 30 day mortality [30 days after admission]
30-day mortality, assessed by checking the medical record retrospectively 30 days after admission.
- 30-day incidence of delirium during admission [30 days after admission]
30-day incidence of the clinical diagnosis of delirium during hospitalization, as assessed by a physician during admission. Patients will be assessed for delirium at the request of nursing staff or if the score of the Delirium Observation Screening scale (DOS-score) is 3 or higher.
- 30-day incidence of surgical site infections (for surgical patients) [30 days after admission]
30-day incidence of surgical site infections, as assessed by physicians from the department where patient is admitted during hospitalization. If the patient obtained a surgical site infection after discharge, incidence was assessed in the outpatient clinic by a physician from the department where patient was admitted.
Eligibility Criteria
Criteria
Surgical: Patients admitted for elective surgery with planned overnight stay Medical:Patients admitted to the medical ward, with at least two expected nights of admission
Inclusion Criteria:
Surgical patients:
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Adult (18+) patients
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Undergoing elective non-cardiac surgery with planned (post-operative) overnight stay
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Willing and able to provide informed consent
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Able to read and write in Dutch
Medical patients:
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Adult (18+) patients medical admission with expected stay of at least two nights
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Willing and able to provide informed consent
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Able to read and write in Dutch
Exclusion Criteria:
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Surgical patients: ASA score of 4 or higher
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Admission on ICU-ward at any time during admission (both planned and unplanned, for both surgical and medical patients)
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Non-Dutch speaking
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Strict isolation (MRSA or aerogenic isolation)
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Pre-existing delirium or cognitive impairment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Amsterdam University Medical Centers | Amsterdam | Netherlands |
Sponsors and Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
- Principal Investigator: Jeroen j.hermanides@amsterdamumc.nl, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Principal Investigator: Dirk Jan Stenvers, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WEsleep Trial