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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)

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ClinicalTrials.gov Identifier: NCT02932358
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : November 23, 2018
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital Moinhos de Vento

Tracking Information
First Submitted Date  ICMJE October 11, 2016
First Posted Date  ICMJE October 13, 2016
Last Update Posted Date November 23, 2018
Actual Study Start Date  ICMJE April 28, 2017
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
Incidence of Delirium among ICU patients [ Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up) ]
Incidence of delirium will be verified by trained intensive care professionals with the confusion assessment method for the ICU 2 times per day.
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
Incidence of Delirium [ Time Frame: During ICU stay (from randomization until ICU discharge, or death or a maximum of 30 days of follow-up) ]
Incidence of delirium will be verified by trained intensive care physicians and nursers with the confusion assessment method for the ICU 3 times per day.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • Daily hazard of delirium among ICU patients [ Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    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).
  • Antipsychotic use among ICU patients [ Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Need of antipsychotic use during ICU stay
  • Need of mechanical restraints among ICU patients [ Time Frame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up) ]
    Need of mechanical restraints among ICU patients during ICU stay
  • Coma-free days at day 7 among ICU patients [ Time Frame: During the first 7 days following patient enrollment. ]
    Days alive and free of coma (Richmond Agitation Sedation Scale -4 or -5) during ICU stay.
  • Unplanned loss of invasive devices among ICU patients [ Time Frame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up) ]
    Unplanned loss of venous catheter, tube feeding or urinary catheter
  • Mechanical ventilation-free days at day 7 among ICU patients [ Time Frame: During the first 7 days following patient enrollment. ]
    Days alive and free of mechanical ventilation during ICU stay.
  • Any ICU-acquired infection among ICU patients [ Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Pneumonia or bloodstream infection or urinary tract infection acquired after 48 hours of ICU admission.
  • ICU-acquired pneumonia among ICU patients [ Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Pneumonia acquired after 48 hours of ICU admission.
  • ICU-acquired bloodstream infection among ICU patients [ Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Bloodstream infection acquired after 48 hours of ICU admission.
  • ICU-acquired urinary tract infection among ICU patients [ Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Urinary tract infection acquired after 48 hours of ICU admission.
  • ICU length of stay among ICU patients [ Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Length of ICU stay in days
  • All-cause hospital mortality among ICU patients [ Time Frame: During hospital stay (from enrollment until hospital discharge, or death or a maximum of 30 days of follow-up) ]
    rates of all-cause mortality during hospital stay
  • Symptoms of anxiety among family members [ Time Frame: IOn the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up. ]
    symptoms of anxiety among family members measured by the Hospital Anxiety and Depression scale
  • Symptoms of depression among family members [ Time Frame: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up. ]
    symptoms of depression among family members measured by the Hospital Anxiety and Depression scale
  • Satisfaction among among family members [ Time Frame: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up. ]
    Rates of patient's families satisfaction measured by the critical care family needs inventory
  • Prevalence of Burnout Syndrome among ICU professionals [ 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. ]
    Prevalence of Burnout Syndrome among ICU workers measured by the Maslach Burnout Inventory
  • 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. ]
    Satisfaction with the current ICU visiting policy among ICU professionals
  • Any adverse event related to ICU visitation [ Time Frame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up) ]
    Any adverse event possible related to the ICU visitation model
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
  • Delirium free-days [ Time Frame: During ICU stay (from randomization until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Days alive and free of delirium.
  • Antipsychotic use [ Time Frame: During ICU stay (from randomization until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Rates of antipsychotic use during ICU stay
  • Length of mechanical ventilation [ Time Frame: During ICU stay (from randomization until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Length of mechanical ventilation for those patients who require mechanical ventilation during ICU stay.
  • Any ICU-acquired infection [ Time Frame: During ICU stay (from randomization until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Pneumonia or bloodstream infection or urinary tract infection acquired after 72 hours of ICU admission.
  • ICU-acquired pneumonia [ Time Frame: During ICU stay (from randomization until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Pneumonia acquired after 72 hours of ICU admission.
  • ICU-acquired bloodstream infection [ Time Frame: During ICU stay (from randomization until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Bloodstream infection acquired after 72 hours of ICU admission.
  • ICU-acquired urinary tract infection [ Time Frame: During ICU stay (from randomization until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Urinary tract infection acquired after 72 hours of ICU admission.
  • ICU length of stay [ Time Frame: During ICU stay (from randomization until ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Length of ICU stay in days
  • All-cause hospital mortality [ Time Frame: During hospital stay (from randomization until hospital discharge, or death or a maximum of 30 days of follow-up) ]
    rates of all-cause mortality during hospital stay
  • Symptoms of anxiety among ICU visitors [ Time Frame: During patient ICU stay (from randomization until patient ICU discharge, or death or a maximum of 30 days of follow-up) ]
    symptoms of anxiety among ICU visitors measured by de Hospital Anxiety and Depression scale
  • Symptoms of depression among ICU visitors [ Time Frame: During patient ICU stay (from randomization until patient ICU discharge, or death or a maximum of 30 days of follow-up) ]
    symptoms of depression among ICU visitors measured by de Hospital Anxiety and Depression scale
  • Satisfaction among among ICU visitors [ Time Frame: During patient ICU stay (from randomization until patient ICU discharge, or death or a maximum of 30 days of follow-up) ]
    Rates of patient's families satisfaction measured by the critical care family needs inventory
  • Prevalence of Burnout Syndrome among ICU workers [ Time Frame: At the end of the first ICU intervention ]
    Prevalence of Burnout Syndrome among ICU workers measured by the Maslach Burnout Inventory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Delirium
Intervention  ICMJE
  • Other: Flexible Family Visitation Model (FFVM)
    Visitation to ICU patients allowed during the period of 12 consecutive hours per day.
  • Other: Restrictive Family Visitation Model (RFVM)
    Visitation to ICU patients allowed during intermittent periods according local ICU regulation.
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: Restrictive Family Visitation Model (RFVM)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2017)
1650
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2016)
1750
Actual Study Completion Date  ICMJE June 22, 2018
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02932358
Other Study ID Numbers  ICMJE ICU Visits
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Responsible Party Hospital Moinhos de Vento
Study Sponsor  ICMJE Hospital Moinhos de Vento
Collaborators  ICMJE Ministry of Health, Brazil
Investigators  ICMJE
Principal Investigator: Regis Rosa, MD, PhD Hospital Moinhos de Vento
PRS Account Hospital Moinhos de Vento
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP