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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 966
- 试验地点
- 2
- 主要终点
- Family/surrogate satisfaction with the ICU stay
研究概览
简要总结
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.
This 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.
The 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.
Eligible 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.
The 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.
The intervention involves no physical procedures. Data are coded and de-identified. Results will be published regardless of outcome.
详细描述
Study design:
Study 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.
Settings:
The 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.
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to a participating ICU for more than 48 hours.
- •Patient aged 18 years or older.
- •Patient's family member or legally designated surrogate aged 18 years or older, and identifiable at the time of enrollment.
- •Patient and/or family member/surrogate able to speak and understand Portuguese.
- •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).
排除标准
- •ICU stay of 48 hours or less.
- •No identifiable family member or legally designated surrogate.
- •Patient or family member/surrogate under 18 years of age.
- •Unable to speak or understand Portuguese.
- •Pregnant patient.
- •Patient deprived of liberty (incarcerated).
- •Refusal to sign the Informed Consent Form.
研究组 & 干预措施
Intervention Period (Post-Crossover)
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.
干预措施: Patient-as-a-Person Characterization Panel with Staff Training (Behavioral)
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.
干预措施: Standard ICU Care (Other)
结局指标
主要结局
Family/surrogate satisfaction with the ICU stay
时间窗: 15 days after ICU discharge or death, or Day 28 after enrollment, whichever occurs first
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. The 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.
次要结局
- Patient-perceived quality of communication in the ICU(15 days after ICU discharge, or Day 28 after enrollment, whichever occurs first.)
- ICU staff perception following first completion of the Patient-as-a-Person Characterization Panel(Day 1)
- Anxiety and depression in patients (where feasible) and family members/surrogates(3 months after ICU outcome (discharge or death))
研究者
Daniel Neves Forte
Principal Investigator and Clinical Professor
University of Sao Paulo General Hospital