Quality of Life Clinical Trial
— FICUSOfficial title:
A Multi-center, Cluster Randomized Superiority Trial of a Guideline-based Family Support Intervention in Intensive Care Units
Verified date | May 2024 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Family members of critically ill patients face considerable uncertainty and distress during their close other's intensive care unit (ICU) stay, with about 20-60% of family members experiencing post-traumatic distress post-ICU. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation. Methods: To test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, the investigators will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. The trial will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 hours or longer. Families in the control arm will receive usual care. Families in the intervention arm, in addition to usual care, will receive a family support intervention consisting of specialist nurse support along the patient pathway at defined time-points, including follow-up care, and nurse-coordinated liaison and structured, interprofessional communication by the ICU team. The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members' mental health (well-being, psychological distress) measured at admission, discharge, and after three, six, and twelve months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference. Discussion: The FICUS trial will establish the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and whether an effective intervention could be scaled-up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being.
Status | Active, not recruiting |
Enrollment | 885 |
Est. completion date | December 31, 2025 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Potential participants are family members of critically ill persons admitted to a study ICU. A family member is defined as a close other from the patient's perspective, as noted in the clinical record or in advanced directives, or as indicated by the legally defined surrogate decision-maker. Inclusion criteria regarding patients (one or several): - Expected length of stay in ICU =48 hours, as predicted by the intaking ICU clinician (physician or nurse) at admission. - Life-threatening condition with a high risk of death or long-lasting functional impairment. - High risk of prolonged mechanical ventilation (>24 hours). Inclusion criteria regarding family members (all must apply): - Primary support person of the patient. - Able to complete family-reported outcome measures (questionnaires) in German language. - Age =18 years. - Signed informed consent form. Exclusion criteria regarding patients (one leads to exclusion): - Preexisting declined general consent. - ICU stay <24 hours. Exclusion criteria regarding family members (one leads to exclusion): - Prior inclusion in FICUS trial on another study ICU. - Cognitive inability to understand the study or complete the questionnaire as appraised by clinicians and / or study recruitment staff. - Inability to complete baseline data collection within the required timeframe after admission / study enrollment (Calvert et al., 2018). |
Country | Name | City | State |
---|---|---|---|
Switzerland | Cantonal Hospital Baden | Baden | |
Switzerland | Lindenhof-Hospital | Bern | |
Switzerland | University Hospital Bern - Inselspital | Bern | |
Switzerland | Cantonal Hospital Graubünden | Chur | |
Switzerland | Spital Thurgau AG, Cantonal Hospital Frauenfeld | Frauenfeld | |
Switzerland | Lucerne Cantonal Hospital | Lucerne | |
Switzerland | Solothurn Hospitals AG, Cantonal Hospital Olten | Olten | |
Switzerland | Cantonal Hospital St. Gallen | St. Gallen | |
Switzerland | Hospital Thun | Thun | |
Switzerland | Cantonal Hospital Winterthur | Winterthur | ZH |
Switzerland | Hirslanden Clinic Zurich | Zürich | |
Switzerland | University Hospital Zurich | Zürich |
Lead Sponsor | Collaborator |
---|---|
Rahel Naef | Swiss National Science Foundation |
Switzerland,
Naef R, Filipovic M, Jeitziner MM, von Felten S, Safford J, Riguzzi M, Rufer M. A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial). Trials. 2022 Jun 27;23(1):533. doi: 10.1186/s13063-022-06454-y. — View Citation
Oesch S, Verweij L, Clack L, Finch T, Riguzzi M, Naef R. Implementation of a multicomponent family support intervention in adult intensive care units: study protocol for an embedded mixed-methods multiple case study (FICUS implementation study). BMJ Open. 2023 Aug 8;13(8):e074142. doi: 10.1136/bmjopen-2023-074142. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Satisfaction with Care (Quality of Family Care) | Quality of family care in ICU is operationalized as family satisfaction with ICU care, and measured with the Family Satisfaction in ICU questionnaire (FS-ICU-24R, German version). The FS-ICU-24R is a well-established instrument that assesses satisfaction with care (16 items) and satisfaction with involvement in decision-making (ten items). Its scores range from 0-100 with 100 indicating maximal satisfaction. | Assessed no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU. | |
Secondary | Quality of Communication (Quality of Family Care) | The Questionnaire on the Quality of Physician-Patient Interaction (QQPPI, original German version) is used to assess quality of communication between the ICU staff and family members during consultation. The 14 items assess aspects such as relationship-building, information exchange, and shared decision-making. The mean score ranges from 1-5 with a higher score indicating higher quality. | Assessed no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU. | |
Secondary | Nurse Support (Quality of Family Care) | The Iceland Family Perceived Support Questionnaire (ICE-FPSQ, German version) is used to measure families' perception of support provided by nurses. The original English version has two subscales - emotional support (nine items) and cognitive support (five items). The ICE-FPSQ has been translated into German and is currently being validated prior to its use in the trial. A sum score is calculated for the total scale (range 14-70) and each subscale - emotional support (range 9-45) and cognitive support (range 5-25) - with higher scores indicating perception of better family support by nurses. | Assessed no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU. | |
Secondary | Family Functioning (Family Management) | The Family Assessment Device - General Functioning Scale (FAD-GF-12, German version) - is used to assess overall functioning of the family system by six positive and six negative items. The mean score ranges from 1-4 with a lower score reflecting better functioning. | Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU. | |
Secondary | Family Resilience (Family Management) | The Brief Resilience Scale (BRS, German version) measures the essence of resilience as the ability to bounce back from stress and is made up of three positive and three negative items. The items will be reformulated from "I" to "we" statements to assess the families' ability to bounce back from stress. The mean score ranges from 1-5 with a higher score indicating greater resilience. | Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU. | |
Secondary | Satisfaction with Life (Subjective Well-Being) | The Satisfaction with Life Scale (SWLS-5, German version) measures the global dimension of subjective well-being. The sum score ranges from 5-35 with a higher score indicating a higher degree of satisfaction. It can be treated as an ordinal variable with seven levels using established thresholds. | Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU. | |
Secondary | Well-Being (Subjective Well-Being) | The World Health Organization-5 Well-being Index (WHO-5, German version) measures subjective psychological well-being and is made up of five items tapping three major dimensions of positive affect as well as energy within the past two weeks. Its score ranges from 0-100, with a higher score indicating greater well-being, and has a threshold of 50 indicating depression. | Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU. | |
Secondary | Quality of Life (Subjective Well-Being) | An adapted version of the general Quality of Life a Visual Analog Scale (QoL-VAS) as used in the EuroQol EQ-5D questionnaire will be employed to measure general rather than health-related quality of life. The score ranges from 0-100 with a higher score representing higher quality of life. | Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU. | |
Secondary | Psychological Distress (Mental Health) | The Distress Thermometer (DT, German version) is a validated single-item screening instrument for distress in the past week originally (and still primarily) used among cancer patients with an established threshold for potential distress It ranges from 0-100 with a higher score indicating a higher level of distress. | Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU. | |
Secondary | Posttraumatic Stress (Mental Health) | The Impact of Events Scale-R (IES-R) measures the presence and severity of symptoms associated with a traumatic event during the past week, and has three subscales - intrusion, avoidance, and hyperarousal. The six-item brief version (IES-6) used in this study includes two items from each of the three subscales, and its simple sum score (range 0-24 with a higher score indicating higher impact) has been shown to be highly correlated to the IES-R in various populations. | Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU. | |
Secondary | Depression, Anxiety (Mental Health) | The Hospital Anxiety and Depression Scale (HADS, German version) is made up of 14 items with different response categories scored in two subscales - anxiety (HADS-A, seven items) and depression (HADS-D, seven items) - and has thresholds for mild depression or anxiety and caseness for depression or anxiety, respectively. The scores range from 0-21 with a higher score indicating worse symptoms. | Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU. |
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