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)

Browse trials for

• Delirium 1,057

Keywords

• Intensive care units
• Delirium
• Cross infection
• Mortality
• Length of stay
• Burnout, Professional
• Depression
• Anxiety

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 1,650 is above the median of 120 across 599 interventional studies indexed under Delirium.

Lead sponsor

Hospital Moinhos de Vento is the lead sponsor of 34 studies on the registry; 6 are open to participants now.

Study arms

• Active comparator
  Flexible Family Visitation Model (FFVM)

  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.

  Other: Flexible Family Visitation Model (FFVM)

• Active comparator
  Restrictive Family Visitation Model (RFVM)

  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.

  Other: Restrictive Family Visitation Model (RFVM)

Interventions

• OtherFlexible Family Visitation Model (FFVM)

  Visitation to ICU patients allowed during the period of 12 consecutive hours per day.

• OtherRestrictive Family Visitation Model (RFVM)

  Visitation to ICU patients allowed during intermittent periods according local ICU regulation.

Primary outcomes

1. 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.

   Time frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

Secondary outcomes

1. 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).

   Time frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

2. Antipsychotic use among ICU patients

   Need of antipsychotic use during ICU stay

   Time frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

3. Need of mechanical restraints among ICU patients

   Need of mechanical restraints among ICU patients during ICU stay

   Time frame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)

4. 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.

   Time frame: During the first 7 days following patient enrollment.

5. Unplanned loss of invasive devices among ICU patients

   Unplanned loss of venous catheter, tube feeding or urinary catheter

   Time frame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)

6. Mechanical ventilation-free days at day 7 among ICU patients

   Days alive and free of mechanical ventilation during ICU stay.

   Time frame: During the first 7 days following patient enrollment.

7. Any ICU-acquired infection among ICU patients

   Pneumonia or bloodstream infection or urinary tract infection acquired after 48 hours of ICU admission.

   Time frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

8. ICU-acquired pneumonia among ICU patients

   Pneumonia acquired after 48 hours of ICU admission.

   Time frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

9. ICU-acquired bloodstream infection among ICU patients

   Bloodstream infection acquired after 48 hours of ICU admission.

   Time frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

10. ICU-acquired urinary tract infection among ICU patients

    Urinary tract infection acquired after 48 hours of ICU admission.

    Time frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

11. ICU length of stay among ICU patients

    Length of ICU stay in days

    Time frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

12. All-cause hospital mortality among ICU patients

    rates of all-cause mortality during hospital stay

    Time frame: During hospital stay (from enrollment until hospital discharge, or death or a maximum of 30 days of follow-up)

13. Symptoms of anxiety among family members

    symptoms of anxiety among family members measured by the Hospital Anxiety and Depression scale

    Time frame: IOn the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.

14. Symptoms of depression among family members

    symptoms of depression among family members measured by the Hospital Anxiety and Depression scale

    Time frame: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.

15. Satisfaction among among family members

    Rates of patient's families satisfaction measured by the critical care family needs inventory

    Time frame: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.

16. Prevalence of Burnout Syndrome among ICU professionals

    Prevalence of Burnout Syndrome among ICU workers measured by the Maslach Burnout Inventory

    Time frame: 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.

17. Satisfaction with the current ICU visiting policy among ICU professionals

    Satisfaction with the current ICU visiting policy among ICU professionals

    Time frame: It will be measured between the 15th and 30th days of the period in which no patient will be enrolled.

18. Any adverse event related to ICU visitation

    Any adverse event possible related to the ICU visitation model

    Time frame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)

Publications

• 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. PubMed 29654049 ↗
• 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. PubMed 30454019 ↗
• 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. PubMed 33870915 ↗
• 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. PubMed 31310297 ↗

Individual participant data

Plan to share: Undecided — The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.