A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit

Study Overview
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Brief Summary
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Hospitalized adult patients suffer from sleep deprivation, which has been associated with multiple negative consequences, both in short and in the long term. Many factors have been attributed to poor sleep quality, including excessive noise, inappropriate lighting, interactions with the healthcare team, administration of drugs, patients' symptoms, among others. There is scarce evidence reporting multicomponent interventions aimed at ensuring and improving sleep quality in hospitalized patients. The following before-after, randomized controlled trial will evaluate and determine the feasibility, acceptability and effectivity of a multicomponent intervention in improving sleep quality and reducing the consequences of poor sleep in a psychiatric intensive care unit (PICU). The intervention is comprised of changes in health personnel habits, improvements in the PICU environment, patient's psychoeducation and continuous sleep and activity monitoring through a validated wearable device.

Official Title
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A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit: A Before-After, Randomized, Controlled Trial

Conditions
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Dyssomnias

Intervention / Treatment
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* Behavioral: Sueña component 1: Sleep Hygiene Promotion
* Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening
* Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation
* Behavioral: Sueña component 4: Sleep Masks and Ear Plugs
* Other: Sueña component 5: Personalized Psychoeducation
* Device: Sueña component 6: Sleep Reports


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized in the last 72 hours. Capacity to consent Approval by treating physician Exclusion Criteria: Active psychosis Active eating disorder Delirium Major cognitive disorder

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Before-after design for the implementation of unit-wide intervention, with a later randomization for individualized interventions.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-intervention, control group<br>A basal measurement of primary and secondary outcomes of the target population, prior to the implementation the intervention. Estimated duration 3 months, n = 30. | |
| Experimental: Post-intervention, SUEÑA half bundle, active group 1<br>Post-intervention, environmental and behavioral modifications in patient care interventions. Implementation of components 1 through 4 of SUEÑA intervention in the entire PICU unit. All participants will be exposed to the intervention. Estimated duration: 3 months, n = 30. | Behavioral: Sueña component 1: Sleep Hygiene Promotion<br>* The nursery staff will be instructed to promote sleep hygiene. Nurse technicians will: inform patients of the efforts to ensure a healthy sleep environment, verify the minimization of light and noise after 23:00 PM, favour natural light after 07:00 AM, and foment patient's activities and participation in group therapy. Nurses will: reduce sleep interruptions to a minimum, to only perform actions (i.e. blood testing, clinical controls, medicine administration) deemed strictly necessary between 23:00 PM and 07:00 AM. A list of commonly used medications with their pharmacodynamic and pharmacokinetic properties tailored by a pharmaceutical chemist will be provided, to ensure optimal medication administration while protecting the guaranteed sleep hours, to be coordinated with the treating physician.<br>Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening<br>* Every night, nursery staff will include anxiety and pain screenings as part of vital signs assessments, using visual analog scales for each one. If any screening is altered, clinical actions will be performed to alleviate symptomatology if deemed necessary, using clinical judgement.<br>Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation<br>* The use of hypnotics will be standardized to be administered no later than at 22:00 PM; in the case of melatonin, its administration will be suggested at sundown, at 20:00 PM. Caffeinated drinks will be prohibited after 15:00 PM.<br>Behavioral: Sueña component 4: Sleep Masks and Ear Plugs<br>* Sleep masks and ear plugs will be available to all patients if they wish to use them. The nursery team will reinforce its use between 23:00 PM and 07:00 AM.<br>|
| Experimental: Post-intervention, randomization for SUEÑA half bundle plus, active group 2<br>Randomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment. Participants will be randomized to receive SUEÑA components 1 through 5 Estimated duration: 6 months, n = 30 | Behavioral: Sueña component 1: Sleep Hygiene Promotion<br>* The nursery staff will be instructed to promote sleep hygiene. Nurse technicians will: inform patients of the efforts to ensure a healthy sleep environment, verify the minimization of light and noise after 23:00 PM, favour natural light after 07:00 AM, and foment patient's activities and participation in group therapy. Nurses will: reduce sleep interruptions to a minimum, to only perform actions (i.e. blood testing, clinical controls, medicine administration) deemed strictly necessary between 23:00 PM and 07:00 AM. A list of commonly used medications with their pharmacodynamic and pharmacokinetic properties tailored by a pharmaceutical chemist will be provided, to ensure optimal medication administration while protecting the guaranteed sleep hours, to be coordinated with the treating physician.<br>Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening<br>* Every night, nursery staff will include anxiety and pain screenings as part of vital signs assessments, using visual analog scales for each one. If any screening is altered, clinical actions will be performed to alleviate symptomatology if deemed necessary, using clinical judgement.<br>Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation<br>* The use of hypnotics will be standardized to be administered no later than at 22:00 PM; in the case of melatonin, its administration will be suggested at sundown, at 20:00 PM. Caffeinated drinks will be prohibited after 15:00 PM.<br>Behavioral: Sueña component 4: Sleep Masks and Ear Plugs<br>* Sleep masks and ear plugs will be available to all patients if they wish to use them. The nursery team will reinforce its use between 23:00 PM and 07:00 AM.<br>Other: Sueña component 5: Personalized Psychoeducation<br>* Two individualized, nurse-led psychoeducation PowerPoint presentations on sleep hygiene will be presented to patients, supported by educational material aimed at the patient and their families.<br>|
| Experimental: Post-intervention, randomization for SUEÑA full bundle, active group 3<br>Randomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment and personalized psychoeducation. . Participants will be randomized to receive SUEÑA components 1 through 6. Estimated duration: 6 months, n = 30 | Behavioral: Sueña component 1: Sleep Hygiene Promotion<br>* The nursery staff will be instructed to promote sleep hygiene. Nurse technicians will: inform patients of the efforts to ensure a healthy sleep environment, verify the minimization of light and noise after 23:00 PM, favour natural light after 07:00 AM, and foment patient's activities and participation in group therapy. Nurses will: reduce sleep interruptions to a minimum, to only perform actions (i.e. blood testing, clinical controls, medicine administration) deemed strictly necessary between 23:00 PM and 07:00 AM. A list of commonly used medications with their pharmacodynamic and pharmacokinetic properties tailored by a pharmaceutical chemist will be provided, to ensure optimal medication administration while protecting the guaranteed sleep hours, to be coordinated with the treating physician.<br>Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening<br>* Every night, nursery staff will include anxiety and pain screenings as part of vital signs assessments, using visual analog scales for each one. If any screening is altered, clinical actions will be performed to alleviate symptomatology if deemed necessary, using clinical judgement.<br>Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation<br>* The use of hypnotics will be standardized to be administered no later than at 22:00 PM; in the case of melatonin, its administration will be suggested at sundown, at 20:00 PM. Caffeinated drinks will be prohibited after 15:00 PM.<br>Behavioral: Sueña component 4: Sleep Masks and Ear Plugs<br>* Sleep masks and ear plugs will be available to all patients if they wish to use them. The nursery team will reinforce its use between 23:00 PM and 07:00 AM.<br>Other: Sueña component 5: Personalized Psychoeducation<br>* Two individualized, nurse-led psychoeducation PowerPoint presentations on sleep hygiene will be presented to patients, supported by educational material aimed at the patient and their families.<br>Device: Sueña component 6: Sleep Reports<br>* Objective and subjective reports of sleep quality will be handed to attending psychiatrist, using data gathered with wearable devices (Fitbit Charge 4) and self-report questionnaires regarding perceived sleepiness and overall sleep. The psychiatrist in charge uses said information in the routine case management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Sleep Time | Measured in hours and minutes, using objective data obtained via Fitbit Charge 4 devices, and subjective data obtained directly from the patient using the Sleep Diary, a consensus tool for the self report of different standardized sleep variables. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Number and Total Duration of Nocturnal Awakenings | Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Mean Number and Total Duration of Naps During the Day | Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Average Time of Falling Sleep and Awakening | Measured in time of day in 24-hour notation, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Sleep Architecture | Measured in minutes of total duration for each sleep phase (awake, light sleep, deep sleep and REM) and as a relative value of the total sleep time, using objective data measured by Fitbit Charge 4 devices. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Sleep Onset Latency Mean Duration | Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered sleep phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in REM Onset Latency Mean Duration | Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered REM phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Wake After Sleep Onset Mean Duration | Measured in minutes of total time spent awake from the time of the first registered sleep phase to the time of the last registered awakening, using objective data measured by Fitbit Charge 4 devices. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Sleep Efficiency | Measured in percentage of total time spent sleeping at night, calculated as total sleep time divided by total time spent in bed, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Mean Heart Rate | Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices, considering the heart rate during the day and while in bed. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Mean Number of Steps | Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Mean Level of Sound | Measured in decibels, using objective data registered by a decibel meter placed in the participant's rooms. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Change in Mean Level of Light | Measured in lux, using objective data registered by a lux meter placed in the participant's rooms. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Changes in Sleep Quality Perception | Measured using the Richard Campbell Sleep Questionnaire (RCSQ), which considers 5 domains in Likert scales, and registers a mean score of all domains. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Changes in Daytime Sleepiness | Measured using the Epworth Sleepiness Scale (ESS), which considers 8 hypothetical situations and scores the likelihood of falling asleep from 0 to 3, and registers a total aggregated score (with a maximum total score of 24). | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Changes in Subjective Perception of Sleep-Disturbing Factors | Measured using complementary questions regarding the presence/absence of factors (either environmental, symptomatological, or other) and their identification using predefined options: excessive light, excessive noise, interactions with health personnel, pain, anxiety, or others. In case of selecting others, a text field will be available for its description. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Changes in Pharmacological Indications and Need of SOS Medication | Registered using extensive charts of common use medications during hospitalization, obtaining data registered in the participant's daily medical chart. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Changes in Systolic and Diastolic Blood Pressure | Measured in millimetres of mercury (mmHg), using morning data registered in the participant's daily medical chart. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. | 
| Level of Pain | Measured with a Visual Analog Scale for Pain (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation. | 
| Level of Anxiety | Measured with a Visual Analog Scale for Anxiety (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart. | From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation. | 
| Change in Mean Length of Stay | Measured in days, using data from the participant's medical record. | From day 1 of hospitalization until discharge | 
| Change in 30-day Readmission Rate | Measured as a proportion, using data from the participant's medical record and telephonic follow-up. | 30 days after the participant's discharge. | 
| Change in Participant Satisfaction Regarding Sleep During Hospitalization | Measurement of the subjective experience of the participant, using telephone surveys. | 7 days after the participant's discharge. | 
| Participant Satisfaction Regarding the Intervention | Measurement of the subjective experience of participants, using telephone surveys. | 7 days after the participant's discharge. | 
| Health Personnel Satisfaction and Agreeability Regarding the Intervention | Measurement of the subjective experience of treating physicians and nursery team, using web-based surveys. | Every 3 months through study completion, an average of 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Psychiatric Intensive Care Unit, Multicomponent Intervention, Wearable Activity Tracker, Behavioral Intervention, Psychoeducation, Environmental Interventions