Clinical trial NCT04995263: A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit
Official title: A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit: A Before-After, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyssomnias
Keywords: Sleep
Psychiatric Intensive Care Unit
Multicomponent Intervention
Wearable Activity Tracker
Behavioral Intervention
Psychoeducation
Environmental Interventions
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: UC CHRISTUS
First posted: 2021-08-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Before-after design for the implementation of unit-wide intervention, with a later randomization for individualized interventions.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Total Sleep Time
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary outcomes:
measure: Change in Mean Number and Total Duration of Nocturnal Awakenings
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Mean Number and Total Duration of Naps During the Day
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Average Time of Falling Sleep and Awakening
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Sleep Architecture
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Sleep Onset Latency Mean Duration
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in REM Onset Latency Mean Duration
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Wake After Sleep Onset Mean Duration
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Sleep Efficiency
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Mean Heart Rate
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Mean Number of Steps
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Mean Level of Sound
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Change in Mean Level of Light
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Changes in Sleep Quality Perception
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Changes in Daytime Sleepiness
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Changes in Subjective Perception of Sleep-Disturbing Factors
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Changes in Pharmacological Indications and Need of SOS Medication
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Changes in Systolic and Diastolic Blood Pressure
timeFrame: From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
measure: Level of Pain
timeFrame: 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.
measure: Level of Anxiety
timeFrame: 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.
measure: Change in Mean Length of Stay
timeFrame: From day 1 of hospitalization until discharge
measure: Change in 30-day Readmission Rate
timeFrame: 30 days after the participant's discharge.
measure: Change in Participant Satisfaction Regarding Sleep During Hospitalization
timeFrame: 7 days after the participant's discharge.
measure: Participant Satisfaction Regarding the Intervention
timeFrame: 7 days after the participant's discharge.
measure: Health Personnel Satisfaction and Agreeability Regarding the Intervention
timeFrame: Every 3 months through study completion, an average of 1.5 years
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Clínica San Carlos de Apoquindo UC
state: Región Metropolitana
Study officials:
affiliation: Pontifica Universidad Católica de Chile
name: Constanza Caneo Robles, MD
role: STUDY_DIRECTOR
affiliation: Pontifica Universidad Católica de Chile
name: Juan C Rodríguez, MD
role: STUDY_DIRECTOR
affiliation: Pontifica Universidad Católica de Chile
name: María Rodríguez Fernández, PhD
role: STUDY_CHAIR
affiliation: Pontifica Universidad Católica de Chile
name: Marcela Babul, MD
role: STUDY_CHAIR
References:
citation: Bano M, Chiaromanni F, Corrias M, Turco M, De Rui M, Amodio P, Merkel C, Gatta A, Mazzotta G, Costa R, Montagnese S. The influence of environmental factors on sleep quality in hospitalized medical patients. Front Neurol. 2014 Dec 11;5:267. doi: 10.3389/fneur.2014.00267. eCollection 2014.
citation: Bernhofer EI, Higgins PA, Daly BJ, Burant CJ, Hornick TR. Hospital lighting and its association with sleep, mood and pain in medical inpatients. J Adv Nurs. 2014 May;70(5):1164-73. doi: 10.1111/jan.12282. Epub 2013 Oct 27.
citation: Bourne RS, Mills GH. Sleep disruption in critically ill patients--pharmacological considerations. Anaesthesia. 2004 Apr;59(4):374-84. doi: 10.1111/j.1365-2044.2004.03664.x.
citation: Denkinger MD, Lindemann U, Nicolai S, Igl W, Jamour M, Nikolaus T. Assessing Physical Activity in Inpatient Rehabilitation: validity, practicality, and sensitivity to change in the physical activity in inpatient rehabilitation assessment. Arch Phys Med Rehabil. 2011 Dec;92(12):2012-7. doi: 10.1016/j.apmr.2011.06.032.
citation: Horne S, Hay K, Watson S, Anderson KN. An evaluation of sleep disturbance on in-patient psychiatric units in the UK. BJPsych Bull. 2018 Oct;42(5):193-197. doi: 10.1192/bjb.2018.42.
citation: Hu RF, Jiang XY, Chen J, Zeng Z, Chen XY, Li Y, Huining X, Evans DJ. Non-pharmacological interventions for sleep promotion in the intensive care unit. Cochrane Database Syst Rev. 2015 Oct 6;2015(10):CD008808. doi: 10.1002/14651858.CD008808.pub2.
citation: Kanji S, Mera A, Hutton B, Burry L, Rosenberg E, MacDonald E, Luks V. Pharmacological interventions to improve sleep in hospitalised adults: a systematic review. BMJ Open. 2016 Jul 29;6(7):e012108. doi: 10.1136/bmjopen-2016-012108.
citation: Lawrence G, Muza R. Assessing the sleeping habits of patients in a sleep disorder centre: a review of sleep diary accuracy. J Thorac Dis. 2018 Jan;10(Suppl 1):S177-S183. doi: 10.21037/jtd.2017.12.127.
citation: Milani RV, Bober RM, Lavie CJ, Wilt JK, Milani AR, White CJ. Reducing Hospital Toxicity: Impact on Patient Outcomes. Am J Med. 2018 Aug;131(8):961-966. doi: 10.1016/j.amjmed.2018.04.013. Epub 2018 May 3.
citation: Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013 Aug 7-13;27(49):35-42. doi: 10.7748/ns2013.08.27.49.35.e7649.
citation: Rodriguez JC, Dzierzewski JM, Alessi CA. Sleep problems in the elderly. Med Clin North Am. 2015 Mar;99(2):431-9. doi: 10.1016/j.mcna.2014.11.013. Epub 2014 Dec 30.
citation: Sandoval-Rincon M, Alcala-Lozano R, Herrera-Jimenez I, Jimenez-Genchi A. [Validation of the Epworth sleepiness scale in Mexican population]. Gac Med Mex. 2013 Jul-Aug;149(4):409-16. Spanish.
citation: Stewart NH, Arora VM. Sleep in Hospitalized Older Adults. Sleep Med Clin. 2018 Mar;13(1):127-135. doi: 10.1016/j.jsmc.2017.09.012. Epub 2017 Nov 10.
citation: Tamrat R, Huynh-Le MP, Goyal M. Non-pharmacologic interventions to improve the sleep of hospitalized patients: a systematic review. J Gen Intern Med. 2014 May;29(5):788-95. doi: 10.1007/s11606-013-2640-9. Epub 2013 Oct 10.
citation: Tembo AC, Parker V. Factors that impact on sleep in intensive care patients. Intensive Crit Care Nurs. 2009 Dec;25(6):314-22. doi: 10.1016/j.iccn.2009.07.002. Epub 2009 Oct 31.
citation: Tullmann DF, Dracup K. Creating a healing environment for elders. AACN Clin Issues. 2000 Feb;11(1):34-50; quiz 153-4. doi: 10.1097/00044067-200002000-00006.
citation: Wesselius HM, van den Ende ES, Alsma J, Ter Maaten JC, Schuit SCE, Stassen PM, de Vries OJ, Kaasjager KHAH, Haak HR, van Doormaal FF, Hoogerwerf JJ, Terwee CB, van de Ven PM, Bosch FH, van Someren EJW, Nanayakkara PWB; "Onderzoeks Consortium Acute Geneeskunde" Acute Medicine Research Consortium. Quality and Quantity of Sleep and Factors Associated With Sleep Disturbance in Hospitalized Patients. JAMA Intern Med. 2018 Sep 1;178(9):1201-1208. doi: 10.1001/jamainternmed.2018.2669.
citation: Novak C, Packer E, Paterson A, Roshi A, Locke R, Keown P, Watson S, Anderson KN. Feasibility and utility of enhanced sleep management on in-patient psychiatry wards. BJPsych Bull. 2020 Dec;44(6):255-260. doi: 10.1192/bjb.2020.30.