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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexible Family Visitation Model (FFVM) | Active Comparator | In the FFVM, two or fewer family members will be allowed to visit the patient for up to 12 consecutive hours each day. In addition to family visitation, patients will be allowed to receive social visits in specific time intervals (according local ICU regulation). To have access to the FFVM, family members of ICU patients will have to attend a structured meeting at ICU in which they will receive orientations about the ICU environment, common ICU treatments, rehabilitation and basic infection control practices, multidisciplinary work at ICU and palliative treatment. Social visitors will not be required to attend the structured meeting. |
|
| Restrictive Family Visitation Model (RFVM) | Active Comparator | In the RFVM, patients will be allowed to receive restricted visits according routine ICU practices, but respecting the maximum limit of 4.5 hours of visitation per day. Visitors will not be required to attend the structured meeting. The length of ICU visits will be similar to those of social visits in the FFVM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexible Family Visitation Model (FFVM) | Other | Visitation to ICU patients allowed during the period of 12 consecutive hours per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Regis Rosa, MD, PhD | Hospital Moinhos de Vento | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Urgência e Emergência de Rio Branco | Rio Branco | Acre | Brazil | |||
| Fundação Hospital Adriano Jorge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29654049 | Background | Rosa RG, Falavigna M, Robinson CC, da Silva DB, Kochhann R, de Moura RM, Santos MMS, Sganzerla D, Giordani NE, Eugenio 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, Correa E Castro L, Duarte PAD, Tregnago R, Barilli SLS, Brandao 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. | |
| 30454019 |
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The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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The following interventions will be evaluated in the present study: restrictive family visitation model (intermittent visits according to local ICU regulation) and flexible family visitation model (12 consecutive hours per day). The unit of of concealed randomization is the ICU to minimize the risk of contamination, given that we intend to apply the intervention to the whole ICU multidisciplinary team. We will randomize ICUs to either an RFVM or to an FFVM as the initial intervention (T1). After enrollment of 25 ICU patients, there will be a 30-day period without recruitment to avoid contamination bias. After this period, each ICU will be assigned to an intervention contrary to that which initially receive (T2) until the enrollment of more 25 ICU patients.
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| Restrictive Family Visitation Model (RFVM) | Other | Visitation to ICU patients allowed during intermittent periods according local ICU regulation. |
|
| 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) |
| 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) |
| 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. |
| 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) |
| 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. |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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) |
| Manaus |
| Amazonas |
| Brazil |
| Hospital Geral Clériston Andrade | Feira de Santana | Estado de Bahia | Brazil |
| Hospital INCARDIO | Feira de Santana | Estado de Bahia | Brazil |
| Hospital de Urgências de Goiânia | Goiânia | Goiás | Brazil |
| Hospital das Clínicas da Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | Brazil |
| Santa Casa de Misericórdia de São João Del Rei | São João del Rei | Minas Gerais | Brazil |
| Hospital do Caâncer de Cascavel (UOPECCAN) | Cascavel | Paraná | Brazil |
| Hospital Universitário do Oeste do Paraná (UNIOESTE) | Cascavel | Paraná | Brazil |
| Hospital Universitário Alcides Carneiro | Campina Grande | Paraíba | Brazil |
| Hospital Universitário Lauro Wanderley | João Pessoa | Paraíba | Brazil |
| Hospital Regional do Baixo Amazonas | Santarém | Pará | Brazil |
| Hospital Universitário de Petrolina | Petrolina | Pernambuco | Brazil |
| Hospital Agamenom Magalhães | Recife | Pernambuco | Brazil |
| Hospital Universitário da Universidade Federal do Piauí | Teresina | Piauí | Brazil |
| Hospital Geral de Nova Iguaçú | Nova Iguaçu | Rio de Janeiro | Brazil |
| Hospital Deoclécio Marques de Lucena | Parnamirim | Rio Grande do Norte | Brazil |
| Hospital Tacchini | Bento Gonçalves | Rio Grande do Sul | Brazil |
| Hospital São Camilo de Esteio | Esteio | Rio Grande do Sul | Brazil |
| Hospital da Cidade de Passo Fundo | Passo Fundo | Rio Grande do Sul | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Dom Vicente Scherer | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Mãe de Deus | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Nossa Senhora da Conceiçaão | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Santa Rita | Porto Alegre | Rio Grande do Sul | Brazil |
| Pavilhão Pereira Filho | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Ana Nery | Santa Cruz do Sul | Rio Grande do Sul | Brazil |
| Hospital Santa Cruz | Santa Cruz do Sul | Rio Grande do Sul | Brazil |
| Hospital Dona Helena | Joinville | Santa Catarina | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto | São Paulo | Brazil |
| Hospital do Coração (HCor) | São Paulo | São Paulo | Brazil |
| Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa) | João Monlevade | Brazil |
| Hospital Montenegro | Montenegro | Brazil |
| Background |
| Sganzerla D, Teixeira C, Robinson CC, Kochhann R, Santos MMS, de Moura RM, Barbosa MG, da Silva DB, Ribeiro T, Eugenio 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. |
| 39172240 | Derived | de Souza JMB, Miozzo AP, da Rosa Minho Dos Santos R, Mocellin D, Rech GS, Trott G, Estivalete GPM, Sganzerla D, de Souza D, Rosa RG, Teixeira C. Long-term effects of flexible visitation in the intensive care unit on family members' mental health: 12-month results from a randomized clinical trial. Intensive Care Med. 2024 Oct;50(10):1614-1621. doi: 10.1007/s00134-024-07577-3. Epub 2024 Aug 22. |
| 33870915 | Derived | Rosa RG, Pellegrini JAS, Moraes RB, Prieb RGG, Sganzerla D, Schneider D, Robinson CC, Kochhann R, da Silva DB, Amaral A, Prestes RM, Medeiros GS, Falavigna M, Teixeira C. Mechanism of a Flexible ICU Visiting Policy for Anxiety Symptoms Among Family Members in Brazil: A Path Mediation Analysis in a Cluster-Randomized Clinical Trial. Crit Care Med. 2021 Sep 1;49(9):1504-1512. doi: 10.1097/CCM.0000000000005037. |
| 31310297 | Derived | Rosa RG, Falavigna M, da Silva DB, Sganzerla D, Santos MMS, Kochhann R, de Moura RM, Eugenio CS, Haack TDSR, Barbosa MG, Robinson CC, Schneider D, de Oliveira DM, Jeffman RW, Cavalcanti AB, Machado FR, Azevedo LCP, Salluh JIF, Pellegrini JAS, Moraes RB, Foernges RB, Torelly AP, Ayres LO, Duarte PAD, Lovato WJ, Sampaio PHS, de Oliveira Junior LC, Paranhos JLDR, Dantas ADS, de Brito PIPGG, Paulo EAP, Gallindo MAC, Pilau J, Valentim HM, Meira Teles JM, Nobre V, Birriel DC, Correa E Castro L, Specht AM, Medeiros GS, Tonietto TF, Mesquita EC, da Silva NB, Korte JE, Hammes LS, Giannini A, Bozza FA, Teixeira C; ICU Visits Study Group Investigators and the Brazilian Research in Intensive Care Network (BRICNet). Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit: The ICU Visits Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):216-228. doi: 10.1001/jama.2019.8766. |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003428 | Cross Infection |
| D002055 | Burnout, Professional |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D000073397 | Occupational Stress |
| D009784 | Occupational Diseases |
| D000077062 | Burnout, Psychological |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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