[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656744":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":44,"studyPopulation":38,"armGroups":45,"interventions":57,"overallOfficials":67,"centralContacts":72,"locations":81,"responsibleParty":112,"collaborators":38,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":38,"enrollmentInfo":125,"targetDuration":38,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":136,"overallStatus":142,"whyStopped":38,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Family\u002Fsurrogate satisfaction with the ICU stay","Family or surrogate satisfaction is assessed using the Family Satisfaction with Care in the Intensive Care Unit 24R questionnaire (FS-ICU 24R), validated and culturally adapted for Brazil. Three summary scores are derived: Satisfaction with Care, Satisfaction with Decision Making, and Overall Satisfaction, each ranging from 0 to 100, with higher scores indicating greater satisfaction. The FS-ICU 24R is administered by a blinded assessor to all eligible family members or surrogates 15 days after ICU outcome (discharge or death), or 28 days after enrollment, whichever occurs first.\n\nThe Informed Consent Form (ICF) is collected from the family member or surrogate 48 hours after ICU admission. Questionnaire administration is classified as a research procedure; the panel itself (\"Come to Know me\") is implemented as part of routine clinical care during the intervention period and does not require separate consent.","15 days after ICU discharge or death, or Day 28 after enrollment, whichever occurs first",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Patient-perceived quality of communication in the ICU","Patient-perceived quality of communication is assessed using the Quality of Communication Questionnaire (QOC), translated into Portuguese and validated for cultural use in Brazil. The score is calculated as the mean of the 13 items (items 1-6 for the General Communication subscale, and items 7-13 for the End-of-Life Communication subscale), ranging from 0 to 10 each, with higher scores indicating better perceived quality of communication. The QOC is administered by a blinded assessor 15 days after ICU discharge, or 28 days after enrollment, whichever occurs first, and only in patients assessed as conscious and oriented at the time of administration.","15 days after ICU discharge, or Day 28 after enrollment, whichever occurs first.",{"measure":19,"description":20,"timeFrame":21},"ICU staff perception following first completion of the Patient-as-a-Person Characterization Panel","Staff perception is assessed using a structured questionnaire developed by the study team, administered via REDCap (version 14.5.21). The questionnaire evaluates perceived difficulty in completing the panel, barriers to its use in clinical practice, its potential contribution to patient care, and open comments. It is made available via QR code posted in the ICU or via a link sent by the research team, and is completed only once, upon the staff member's first use of the panel.","Day 1",{"measure":23,"description":24,"timeFrame":25},"Anxiety and depression in patients (where feasible) and family members\u002Fsurrogates","Symptoms of anxiety and depression are assessed using the Hospital Anxiety and Depression Scale (HADS), validated and adapted for the Brazilian population. The HADS is administered 3 months after ICU outcome (discharge or death) to ICU survivors and to family members or surrogates of both surviving and deceased patients.","3 months after ICU outcome (discharge or death)",[27,31],{"measure":28,"description":29,"timeFrame":30},"Bayesian analysis","A Bayesian re-analysis of the Family Satisfaction with Care in the Intensive Care Unit (FS-ICU 24R questionnarie) will be conducted as a sensitivity analysis.","15 days after ICU discharge or death, or Day 28 after enrollment, whichever occurs first.",{"measure":32,"description":33,"timeFrame":30},"Subgroup analyses of the primary outcome","The primary outcome will be evaluated in three pre-specified subgroups: (i) patient severity, as measured by the SAPS 3 score; (ii) ICU outcome (discharge vs. death); and (iii) presence or absence of terminal or advanced chronic illness. Subgroup effects will be assessed using an interaction term between the intervention and each subgroup of interest, within the same primary analysis model.",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":6,"observationalModel":38,"timePerspective":38,"maskingInfo":39},"RANDOMIZED","CROSSOVER","Prospective, open-label, multicenter, cluster-randomized trial conducted across 6 Intensive Care Units (ICUs), using a stepped-wedge design. All participating ICUs begin in the control phase and cross over to the intervention in a staggered, randomized sequence, one cluster every two months, with no transition period between phases, until all clusters have been exposed to the intervention. The design enables each ICU to serve as its own control, while also allowing comparisons between intervention and control periods across ICUs and assessment of temporal trends over time.",null,{"masking":40,"maskingDescription":41,"whoMasked":42},"SINGLE","The professional responsible for administering questionnaires used to assess the primary outcome (family satisfaction with the ICU stay, FS-ICU 24) and the secondary outcome measuring patient-perceived quality of communication (QOC Questionnaire) is blinded to each patient's condition (control vs. intervention) and to the details of their ICU stay.",[43],"OUTCOMES_ASSESSOR","Study design:\n\nStudy CONNECT is a prospective, open-label, multicenter clinical trial with cluster-level randomization, using a stepped-wedge design. The randomization unit is the Intensive Care Unit (cluster). All clusters begin in the control phase and cross over to the intervention in a staggered, randomly determined sequence, one cluster every two months, with no transition period between phases. The study runs for 14 months, comprising seven two-month periods (including a baseline period in which all Intensive Care Units (ICUs) remain in the control condition). Each cluster's allocation sequence is disclosed to researchers and staff one week before its respective phase transition. Blinding of patients, family members, and care staff is not feasible given the nature of the intervention; however, personnel responsible for administering outcome questionnaires are blinded to the period the patient was admitted to the ICU (i.e., control vs. intervention period) and to the details of each patient's ICU stay, to minimize information bias.\n\nSettings:\n\nThe trial is conducted in six ICUs across two hospitals in Brazil: four ICUs at Clinical Hospital of the University of São Paulo Medical School (HC-FMUSP), São Paulo, a public, academic, quaternary-care hospital; and two ICUs at Monte Klinikum Hospital, Fortaleza, a private, tertiary, non-academic hospital. This combination was selected to ensure diversity in hospital type, patient and family sociodemographic profiles, clinical case mix, and care team organization. All participating ICUs use closed (single-patient) rooms.\n\nIntervention:\n\nThe intervention is the \"Patient as a Person\" Characterization Panel (PCPP) named \"Come to Know me\", a structured bedside instrument inspired by the \"Get to Know Me\" poster developed at Massachusetts General Hospital. The PCPP comprises 19 fields completed collaboratively by the multidisciplinary care team (medicine, nursing, and physical therapy) together with the patient and family members, and may include photographs. The panel documents the patient's identity, personal preferences, biographical details, and what matters most to them outside the hospital, making this information visible and accessible to the entire care team. The panel is displayed near the patient's bedside in a location that preserves data privacy. Implementation is preceded by structured staff training delivered prior to each ICU's phase transition, supplemented by monthly retraining sessions and printed and online instructional materials throughout the intervention period.\n\nControl arm:\n\nIn the control phase, participating ICUs maintain standard care practices. No version of the PCPP or related training is introduced.\n\nEligibility:\n\nPatients are eligible if they are 18 years of age or older and have been admitted to a participating ICU for more than 48 hours. Their family members or legally designated representatives, also 18 years of age or older, are eligible as co-participants. Exclusion criteria are pregnancy, incarceration, and inability to communicate in Portuguese. Written informed consent is obtained from family members after 48 hours of ICU admission, and from patients once they are alert and oriented after 48 hours of ICU admission. In case patients are transferred between study ICUs or readmitted, they are assigned to the arm\u002Fperiod of their index ICU admission (intention-to-treat).\n\nOutcomes and data collection:\n\nThe primary outcome is family satisfaction with the ICU stay, assessed using the Family Satisfaction with Care in the Intensive Care Unit Questionnaire (FS-ICU 24R questionnaire), a validated instrument adapted for use in Brazil. Secondary outcomes include: patient-perceived quality of communication (Quality of Communication Questionnaire, QOC); ICU staff perceptions of the PCPP, assessed via a quantitative-qualitative questionnaire developed by the study team; and symptoms of anxiety and depression in patients (where feasible) and family members, assessed using the Hospital Anxiety and Depression Scale (HADS) at three months after ICU discharge. All questionnaires are administered in Brazilian Portuguese by a blinded assessor. Sociodemographic and clinical data, including age, sex, marital status, educational level, self-reported race\u002Fcolor, religion, admission diagnosis, ICU length of stay, ICU and hospital outcome, decisions regarding withholding or withdrawing life-sustaining treatment, and Simplified Acute Physiology Score 3 (SAPS 3) severity score, are collected via REDCap (version 14.5.21) for sample characterization.\n\nSample size:\n\nThe sample size was calculated using the steppedwedge command in Stata version 13.1, assuming a two-sided alpha of 5%, 80% power, a mean of 23 eligible patients per two-month period per ICU, a baseline mean FS-ICU 24R score of 75 points (SD 30), an expected absolute increase of 7.5 points (corresponding to a 10% relative increase, from 75 to 82.5 points), and a coefficient of variation (k) of 0.25. This yields an estimated total of 966 patients (6 ICUs × 7 periods × 23 patients per period). As is standard in stepped-wedge designs, study completion is determined by the elapsed time across the seven predefined periods, not by reaching a specific patient count.\n\nStatistical analysis:\n\nThe primary analysis follows the intention-to-treat principle, with two-sided tests and a 5% significance level. The primary outcome (FS-ICU 24R questionnaire), analyzed at the individual patient level, will be estimated using a generalized linear mixed model (GLMM), with intervention status, calendar time period, and pre-specified adjustment covariates (SAPS 3 score, clinical versus surgical profile, ICU region, and number of ICU beds) as fixed effects. The error distribution will be selected based on best fit to the data (Poisson, negative binomial, or alternative distributions). Random effects include a per-cluster intercept, capturing between-ICU variability, and, where warranted, an ICU-by-period interaction term, capturing intra-cluster temporal correlation. If a substantial proportion of primary outcome data are missing, multiple imputation by chained equations (MICE) will be applied under the missing-at-random (MAR) assumption. Pre-specified subgroup analyses will assess potential effect modification by patient severity (SAPS 3), ICU outcome (discharge versus death), and presence or absence of a terminal or advanced chronic illness, using the same GLMM with an intervention-by-subgroup interaction term. A statistical analysis plan (SAP) will be finalized and submitted for publication before database lock.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Intervention Period (Post-Crossover)","EXPERIMENTAL","A cluster (Intensive Care Unit) that has crossed over to the intervention period, according to its randomly allocated sequence, implements the Patient-as-a-Person Characterization Panel (PCPP) for all patients admitted from that point until study completion, with no reversion to standard care. Implementation is preceded by structured staff training and reinforced through monthly retraining sessions, supported by printed and online instructional materials.",[51],"Behavioral: Patient-as-a-Person Characterization Panel with Staff Training",{"label":53,"type":6,"description":54,"interventionNames":55},"Control Period (Pre-Crossover)","Until a cluster (Intensive Care Unit) reaches its designated crossover point according to the randomly allocated sequence, it provides standard ICU care. Patients admitted during this period are not exposed to the Patient-as-a-Person Characterization Panel. This condition applies only until the cluster's crossover, after which it transitions permanently to the intervention.",[56],"Other: Standard ICU Care",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":38},"BEHAVIORAL","Patient-as-a-Person Characterization Panel with Staff Training","The Patient-as-a-Person Characterization Panel (PCPP) \"Come to Know Me\" is a structured 19-item instrument completed collaboratively by the multidisciplinary care team (medicine, nursing, and physical therapy) together with the patient and\u002For family members, and may include photographs. The panel documents the patient's identity, personal preferences, and biographical details, making this information visible to all members of the care team. It is displayed within the patient's private Intensive Care Unit (ICU) room in a location that preserves data privacy, and is completed as part of routine clinical care. Prior to each cluster's crossover, all relevant staff receive structured training on panel use; monthly retraining sessions and printed and online instructional materials are provided throughout the intervention period. Patients in the intervention arm also receive standard ICU care as practiced at each participating unit.",[47],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":38},"Standard ICU Care","During the control period, each participating ICU maintains its routine standard of care without any study-related additions. The Patient-as-a-Person Characterization Panel is not used, and no related staff training is provided. Standard care practices vary by site and are not modified by the study.",[53],[68],{"name":69,"affiliation":70,"role":71},"Daniel N Forte, MD; PhD","University of São Paulo Medical School, São Paulo, Brazil","PRINCIPAL_INVESTIGATOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":38,"email":77},"Amanda P Botega, MD","CONTACT","+55 (35) 99155-4257","amandapbotega@gmail.com",{"name":69,"role":75,"phone":79,"phoneExt":38,"email":80},"+55 (11) 99914-5458","daniel.forte@hc.fm.usp.br",[82,100],{"facility":83,"status":38,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Monte Klinikum Hospital","Fortaleza","Ceará","60160-140","Brazil","BR",{"type":90,"coordinates":91},"Point",[92,93],-38.54306,-3.71722,{"lat":93,"lon":92},[96],{"name":97,"role":75,"phone":98,"phoneExt":38,"email":99},"Sabrina CC Ribeiro, MD; PhD","+5511996296717","sabrinaccr@gmail.com",{"facility":101,"status":38,"city":102,"state":102,"zip":103,"country":87,"countryCode":88,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Clinical Hospital of the University of São Paulo Medical School- Central Institute","São Paulo","05403-000",{"type":90,"coordinates":105},[106,107],-46.63611,-23.5475,{"lat":107,"lon":106},[110],{"name":74,"role":75,"phone":111,"phoneExt":38,"email":77},"+5535991554257",{"type":71,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Daniel Neves Forte","Principal Investigator and Clinical Professor","100656744","patient-characterization-panel-to-improve-satisfaction-with-the-intensive-care-unit-stay-connect-100656744",false,"NCT07830043","Patient Characterization Panel to Improve Satisfaction With the Intensive Care Unit Stay (CONNECT)","Effect of a \"Patient as a Person\" Characterization Panel on Family and Patient Satisfaction With the Intensive Care Unit (ICU) Stay: A Stepped-Wedge Cluster Randomized Trial (CONNECT)","CONNECT","Inclusion Criteria:\n\n* Patient admitted to a participating ICU for more than 48 hours.\n* Patient aged 18 years or older.\n* Patient's family member or legally designated surrogate aged 18 years or older, and identifiable at the time of enrollment.\n* Patient and\u002For family member\u002Fsurrogate able to speak and understand Portuguese.\n* Signature of the Informed Consent Form (ICF) by the family member or surrogate after 48 hours of ICU admission, and by the patient once conscious and oriented (also after 48 hours of ICU admission).\n\nExclusion Criteria:\n\n* ICU stay of 48 hours or less.\n* No identifiable family member or legally designated surrogate.\n* Patient or family member\u002Fsurrogate under 18 years of age.\n* Unable to speak or understand Portuguese.\n* Pregnant patient.\n* Patient deprived of liberty (incarcerated).\n* Refusal to sign the Informed Consent Form.","ALL","18 Years",{"count":126,"type":127},966,"ESTIMATED","INTERVENTIONAL",[130],"NA","Intensive care units (ICUs) present unique challenges to humanized, person-centered care. The severity of illness and the demands of complex technical management can displace attention from patients as individuals, making it harder to build meaningful connections with patients and their families.\n\nThis trial tests a simple, low-cost bedside intervention: a structured panel. The \"Patient as a Person\" panel, placed near each patient's bed. The care team, together with the patient and family, records personal information about who the patient is outside the hospital: how they prefer to be addressed, their interests, and what matters most to them. Physicians, nurses, and physical therapists receive training on how to incorporate this information into daily care interactions.\n\nThe study follows a stepped-wedge cluster randomized design across six ICUs in Brazil: four at Clinical Hospital of the University of São Paulo Medical School (São Paulo); and two at Monte Klinikum Hospital (Fortaleza). All ICUs begin with a control period of standard care. Every two months, one ICU transitions to the intervention, until all six units have adopted the panel. The total study duration is 14 months. Each ICU serves as its own control together with the comparison between ICUs for periods with and without the intervention. Questionnaire administrators are blinded to whether a given hospitalization occurred during the control or intervention phase.\n\nEligible participants are adult patients (≥18 years) admitted to a participating ICU for more than 48 hours, and their family members or legal representatives (≥18 years). Pregnant women, incarcerated individuals, and non-Portuguese speakers are excluded. Informed consent is obtained from family members after 48 hours of admission, and from patients once they are alert and oriented.\n\nThe primary outcome is family satisfaction with the ICU stay, assessed using the Family Satisfaction with Care in the Intensive Care Unit Questionnaire (FS-ICU 24R questionnaire), a validated intrument adapted for use in Brazil. Secondary outcomes include patient-reported quality of communication, ICU staff perceptions of the panel, and symptoms of anxiety and depression in family members at three months. Estimated enrollment is 966 patients.\n\nThe intervention involves no physical procedures. Data are coded and de-identified. Results will be published regardless of outcome.",[133,134,135],"Critical Illness","Family Satisfaction","Critical Care, Intensive Care",[137,138,139,140,141],"Critical Care","Humanization of Assistance","Patient-Centered Care","Clinical Trial","Family","NOT_YET_RECRUITING","2026-09-14",{"date":145,"type":146},"2026-09-21","ACTUAL",{"date":148,"type":127},"2026-10",{"date":150,"type":127},"2028-03",{"name":5,"class":6},2]