Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial (The ICU Visits Study)

Delirium Clinical Trial

Official title:

Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932358
• Other study ID #: ICU Visits
• Status: Completed
• Phase: N/A
• Start date: April 28, 2017
• Est. completion date: June 22, 2018

Study information

• Verified date: November 2018
• Source: Hospital Moinhos de Vento
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A cluster-randomized crossover trial involving adult ICU patients, family members, and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with visiting hours <4.5 h/day will be randomly assigned to either a restrictive family visitation model (RFVM) (visits according to local policies) or a flexible family visitation model (FFVM) (visitation during 12 consecutive hours per day) at a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days at day 7, any ICU-acquired infections, ICU length of stay, and all-cause hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of symptoms of burnout among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days at day 7, unplanned loss of invasive devices, and ICU-acquired pneumonia, urinary tract infection, or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1650
• Est. completion date: June 22, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For ICUs: medical-surgical ICUs of of public and philanthropic Brazilian hospitals with restricted visitation policies(<4.5 hours/day).

• For Patients: Age = 18 years, admission to the intensive care unit.

• For Patient's Family Members: nearest relative of the ICU patient recruited in the study and consent to participate in the study.

• For ICU Workers: ICU workers that assist patients in the ICU during the daytime for at least 20 hours per week and consent to participate in the study.

Exclusion Criteria:

• For ICUs: ICUs with structural or organizational impediments to extended visitation.

• For Patients: Subjects with coma (Richmond Agitation Sedation Scale -4 or -5) lasting > 96 hours from the moment of first evaluation for recruitment, or delirium at the baseline (positive Confusion Assessment Method for ICU) will be excluded. Individuals with cerebral death, aphasia, severe hearing deficit, a prediction of ICU length of stay < 48 hours, exclusively palliative treatment, or without a familiar member able to participate in extended ICU visits and those who are prisioners, unlikely to survive >24hs, re-admitted to the ICU after enrolment in the study will also be excluded.

• For Patient's Family Members: Another ICU patient's relative enrolled in the study; family members who don't speak Portuguese; Difficulty to answer the self-administered questionnaires (e.g.: illiteracy)

• For ICU Workers: ICU workers who have a prediction of withdrawal of ICU care activities >15 days during the study will be excluded.

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• Flexible Family Visitation Model (FFVM)
Visitation to ICU patients allowed during the period of 12 consecutive hours per day.
• Restrictive Family Visitation Model (RFVM)
Visitation to ICU patients allowed during intermittent periods according local ICU regulation.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Universidade Federal de Minas Gerais	Belo Horizonte	MG
Brazil	Hospital Tacchini	Bento Gonçalves	RS
Brazil	Hospital Universitário Alcides Carneiro	Campina Grande	PB
Brazil	Hospital do Caâncer de Cascavel (UOPECCAN)	Cascavel	PR
Brazil	Hospital Universitário do Oeste do Paraná (UNIOESTE)	Cascavel	PR
Brazil	Hospital São Camilo de Esteio	Esteio	RS
Brazil	Hospital Geral Clériston Andrade	Feira De Santana	BA
Brazil	Hospital INCARDIO	Feira De Santana	BA
Brazil	Hospital de Urgências de Goiânia	Goiânia	Goias
Brazil	Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa)	João
Brazil	Hospital Universitário Lauro Wanderley	João Pessoa	PB
Brazil	Hospital Dona Helena	Joinville	SC
Brazil	Fundação Hospital Adriano Jorge	Manaus	AM
Brazil	Hospital Montenegro	Montenegro
Brazil	Hospital Geral de Nova Iguaçú	Nova Iguaçú	RJ
Brazil	Hospital Deoclécio Marques de Lucena	Parnamirim	RN
Brazil	Hospital da Cidade de Passo Fundo	Passo Fundo	RS
Brazil	Hospital Universitário de Petrolina	Petrolina	PE
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS
Brazil	Hospital Dom Vicente Scherer	Porto Alegre	RS
Brazil	Hospital Mãe de Deus	Porto Alegre	RS
Brazil	Hospital Nossa Senhora da Conceiçaão	Porto Alegre	RS
Brazil	Hospital Santa Rita	Porto Alegre	RS
Brazil	Pavilhão Pereira Filho	Porto Alegre	RS
Brazil	Hospital Agamenom Magalhães	Recife	PE
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto	Ribeirão Preto	SP
Brazil	Hospital de Urgência e Emergência de Rio Branco	Rio Branco	AC
Brazil	Hospital Ana Nery	Santa Cruz Do Sul	RS
Brazil	Hospital Santa Cruz	Santa Cruz Do Sul	RS
Brazil	Hospital Regional do Baixo Amazonas	Santarém	PA
Brazil	Santa Casa de Misericórdia de São João Del Rei	São João Del Rei	MG
Brazil	Hospital do Coração (HCor)	São Paulo	SP
Brazil	Hospital Universitário da Universidade Federal do Piauí	Teresina	PI

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Rosa RG, Falavigna M, Robinson CC, da Silva DB, Kochhann R, de Moura RM, Santos MMS, Sganzerla D, Giordani NE, Eugênio C, Ribeiro T, Cavalcanti AB, Bozza F, Azevedo LCP, Machado FR, Salluh JIF, Pellegrini JAS, Moraes RB, Hochegger T, Amaral A, Teles JMM, da Luz LG, Barbosa MG, Birriel DC, Ferraz IL, Nobre V, Valentim HM, Corrêa E Castro L, Duarte PAD, Tregnago R, Barilli SLS, Brandão N, Giannini A, Teixeira C; ICU Visits Study Group Investigators and the BRICNet. Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units: a cluster-randomised, crossover trial (The ICU Visits Study). BMJ Open. 2018 Apr 13;8(4):e021193. doi: 10.1136/bmjopen-2017-021193. — View Citation

Sganzerla D, Teixeira C, Robinson CC, Kochhann R, Santos MMS, de Moura RM, Barbosa MG, da Silva DB, Ribeiro T, Eugênio C, Schneider D, Mariani D, Jeffman RW, Bozza F, Cavalcanti AB, Azevedo LCP, Machado FR, Salluh JI, Pellegrini JAS, Moraes RB, Damiani LP, da Silva NB, Falavigna M, Rosa RG. Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study). Trials. 2018 Nov 19;19(1):636. doi: 10.1186/s13063-018-3006-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Delirium among ICU patients	Incidence of delirium will be verified by trained intensive care professionals with the confusion assessment method for the ICU 2 times per day.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary	Daily hazard of delirium among ICU patients	The daily hazard of delirium will be analyzed using a joint survival model that accounts for the treatment effect on repeated daily indicator of delirium (Confusion Assessment Method for the ICU) within each patient and terminating event (death or discharge from the ICU).	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary	Antipsychotic use among ICU patients	Need of antipsychotic use during ICU stay	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary	Need of mechanical restraints among ICU patients	Need of mechanical restraints among ICU patients during ICU stay	During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Secondary	Coma-free days at day 7 among ICU patients	Days alive and free of coma (Richmond Agitation Sedation Scale -4 or -5) during ICU stay.	During the first 7 days following patient enrollment.
Secondary	Unplanned loss of invasive devices among ICU patients	Unplanned loss of venous catheter, tube feeding or urinary catheter	During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Secondary	Mechanical ventilation-free days at day 7 among ICU patients	Days alive and free of mechanical ventilation during ICU stay.	During the first 7 days following patient enrollment.
Secondary	Any ICU-acquired infection among ICU patients	Pneumonia or bloodstream infection or urinary tract infection acquired after 48 hours of ICU admission.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary	ICU-acquired pneumonia among ICU patients	Pneumonia acquired after 48 hours of ICU admission.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary	ICU-acquired bloodstream infection among ICU patients	Bloodstream infection acquired after 48 hours of ICU admission.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary	ICU-acquired urinary tract infection among ICU patients	Urinary tract infection acquired after 48 hours of ICU admission.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary	ICU length of stay among ICU patients	Length of ICU stay in days	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary	All-cause hospital mortality among ICU patients	rates of all-cause mortality during hospital stay	During hospital stay (from enrollment until hospital discharge, or death or a maximum of 30 days of follow-up)
Secondary	Symptoms of anxiety among family members	symptoms of anxiety among family members measured by the Hospital Anxiety and Depression scale	IOn the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Secondary	Symptoms of depression among family members	symptoms of depression among family members measured by the Hospital Anxiety and Depression scale	On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Secondary	Satisfaction among among family members	Rates of patient's families satisfaction measured by the critical care family needs inventory	On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Secondary	Prevalence of Burnout Syndrome among ICU professionals	Prevalence of Burnout Syndrome among ICU workers measured by the Maslach Burnout Inventory	It will be measured in two moments: within 15 days prior to the first ICU intervention and between the 15th and 30th days of the period in which no patient will be enrolled.
Secondary	Satisfaction with the current ICU visiting policy among ICU professionals	Satisfaction with the current ICU visiting policy among ICU professionals	It will be measured between the 15th and 30th days of the period in which no patient will be enrolled.
Secondary	Any adverse event related to ICU visitation	Any adverse event possible related to the ICU visitation model	During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)