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 |
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Recruitment Status :
Completed
First Posted : October 13, 2016
Last Update Posted : November 23, 2018
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Sponsor:
Hospital Moinhos de Vento
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital Moinhos de Vento
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Delirium | Other: Flexible Family Visitation Model (FFVM) Other: Restrictive Family Visitation Model (RFVM) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1650 participants |
| 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 |
| Official Title: | Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial |
| Actual Study Start Date : | April 28, 2017 |
| Actual Primary Completion Date : | June 22, 2018 |
| Actual Study Completion Date : | June 22, 2018 |
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| Arm | Intervention/treatment |
|---|---|
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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.
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Other: Flexible Family Visitation Model (FFVM)
Visitation to ICU patients allowed during the period of 12 consecutive hours per day. |
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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.
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Other: Restrictive Family Visitation Model (RFVM)
Visitation to ICU patients allowed during intermittent periods according local ICU regulation. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932358
Locations
Show 33 study locations
Sponsors and Collaborators
Hospital Moinhos de Vento
Ministry of Health, Brazil
Investigators
| Principal Investigator: | Regis Rosa, MD, PhD | Hospital Moinhos de Vento |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hospital Moinhos de Vento |
| ClinicalTrials.gov Identifier: | NCT02932358 |
| Other Study ID Numbers: |
ICU Visits |
| First Posted: | October 13, 2016 Key Record Dates |
| Last Update Posted: | November 23, 2018 |
| Last Verified: | November 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Hospital Moinhos de Vento:
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Intensive care units Delirium Cross infection Mortality |
Length of stay Burnout, Professional Depression Anxiety |
Additional relevant MeSH terms:
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Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |