Dataset Information

A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial).

ABSTRACT:

Background

Family members of critically ill patients face considerable uncertainty and distress during their close others' intensive care unit (ICU) stay. About 20-60% of family members experience adverse mental health outcomes post-ICU, such as symptoms of anxiety, depression, and posttraumatic stress. 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, we will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. It 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 h or longer. Families in the intervention arm will receive a family support intervention in addition to usual care. The intervention consists of specialist nurse support that is mapped to the patient pathway with follow-up care and includes psycho-educational and relationship-focused family interventions, and structured, interprofessional communication, and shared decision-making with families. Families in the control arm will receive usual care. 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 3, 6, and 12 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

This trial will examine 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 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.

Trial registration

ClinicalTrials.gov NCT05280691 . Prospectively registered on 20 February 2022.

SUBMITTER: Naef R

PROVIDER: S-EPMC9235279 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe Family in Intensive Care UnitS (FICUS) trial investigates the clinical effectiveness of a multicomponent, nurse-led interprofessional family support intervention (FSI) and explores its implementation in intensive care units (ICUs). The local context of each ICU strongly influences intervention performance in practice. To promote FSI uptake and to reduce variation in intervention delivery, we aimed to develop tailored implementation strategies.MethodsA mixed method contextual analysis guided by the Consolidated Framework for Implementation Research (CFIR) was performed from March to June 2022 on eight ICUs assigned to the intervention group. ICU key clinical partners were asked to complete a questionnaire on CFIR inner setting measures (i.e., organizational culture, resources, learning climate and leadership engagement) and the Organizational Readiness for Implementing Change (ORIC) scale prior to group interviews, which were held to discuss barriers and facilitators to FSI implementation. Descriptive analysis and pragmatic rapid thematic analysis were used. Then, tailored implementation strategies were developed for each ICU.ResultsIn total, 33 key clinical partners returned the questionnaire and 40 attended eight group interviews. Results showed a supportive environment, with CFIR inner setting and ORIC measures each rated above 3 (scale: 1 low-5 high value), with leadership engagement scoring highest (median 4.00, IQR 0.38). Interview data showed that the ICU teams were highly motivated and committed to implementing the FSI. They reported limited resources, new interprofessional information exchange, and role adoption of nurses as challenging.ConclusionWe found that important pre-conditions for FSI implementation, such as leadership support, a supportive team culture, and a good learning climate were present. Some aspects, such as available resources, interprofessional collaboration and family nurses' role adoption were of concern and needed attention. An initial set of implementation strategies were relevant to all ICUs, but some additions and adaptation to local needs were required. Multi-component interventions are challenging to implement within complex systems, such as ICUs. This pragmatic, theory-guided, mixed methods contextual analysis demonstrated high readiness and commitment to FSI implementation in the context of a clinical trial and enabled the specification of a tailored, multifaceted implementation strategy.

Project description:BackgroundThe implementation of complex interventions is considered challenging, particularly in multi-site clinical trials and dynamic clinical settings. This study protocol is part of the family intensive care units (FICUS) hybrid effectiveness-implementation study. It aims to understand the integration of a multicomponent family support intervention in the real-world context of adult intensive care units (ICUs). Specifically, the study will assess implementation processes and outcomes of the study intervention, including fidelity, and will enable explanation of the clinical effectiveness outcomes of the trial.Methods and analysisThis mixed-methods multiple case study is guided by two implementation theories, the Normalisation Process Theory and the Consolidated Framework for Implementation Research. Participants are key clinical partners and healthcare professionals of eight ICUs allocated to the intervention group of the FICUS trial in the German-speaking part of Switzerland. Data will be collected at four timepoints over the 18-month active implementation and delivery phase using qualitative (small group interviews, observation, focus group interviews) and quantitative data collection methods (surveys, logs). Descriptive statistics and parametric and non-parametric tests will be used according to data distribution to analyse within and between cluster differences, similarities and factors associated with fidelity and the level of integration over time. Qualitative data will be analysed using a pragmatic rapid analysis approach and content analysis.Ethics and disseminationEthics approval was obtained from the Cantonal Ethics Committee of Zurich BASEC ID 2021-02300 (8 February 2022). Study findings will provide insights into implementation and its contribution to intervention outcomes, enabling understanding of the usefulness of applied implementation strategies and highlighting main barriers that need to be addressed for scaling the intervention to other healthcare contexts. Findings will be disseminated in peer-reviewed journals and conferences.Protocol registration numberOpen science framework (OSF) https://osf.io/8t2ud Registered on 21 December 2022.

Project description:Individuals acting as surrogate decision makers for critically ill patients frequently struggle in this role and experience high levels of long-term psychological distress. Prior interventions designed to improve the sharing of information by the clinical team with surrogate decision makers have demonstrated little effect on surrogates' outcomes or clinical decisions. In this report, we describe the study protocol and corresponding intervention fidelity monitoring plan for a multicenter randomized clinical trial testing the impact of a multifaceted surrogate support intervention (Four Supports) on surrogates' psychological distress, the quality of decisions about goals of care, and healthcare use. We will randomize the surrogates of 300 incapacitated critically ill patients at high risk of death and/or severe long-term functional impairment to receive the Four Supports intervention or an education control. The Four Supports intervention adds to the intensive care unit (ICU) team a trained interventionist (family support specialist) who delivers four types of protocolized support-emotional support; communication support; decisional support; and, if indicated, anticipatory grief support-to surrogates through daily interactions during the ICU stay. The primary outcome is surrogates' symptoms of anxiety and depression at 6-month follow-up, measured with the Hospital Anxiety and Depression Scale. Prespecified secondary outcome measures are the Patient Perception of Patient Centeredness Scale (modified for use with surrogates) and Impact of Event Scale scores at 3- and 6-month follow-up, respectively, together with ICU and hospital lengths of stay and total hospital cost among decedents. The fidelity monitoring plan entails establishing and measuring adherence to the intervention using multiple measurement methods, including daily checklists and coding of audiorecorded encounters. This approach to intervention fidelity may benefit others designing and testing behavioral interventions in the ICU setting. Clinical trial registered with www.clinicaltrials.gov (NCT01982877).

Project description:BackgroundThe uptake of evidence-based therapies in the intensive care environment is suboptimal, particularly in limited-resource countries. Checklists, daily goal assessments, and clinician prompts may improve compliance with best practice processes of care and, in turn, improve clinical outcomes. However, the available evidence on the effectiveness of checklists is unreliable and inconclusive, and the mechanisms are poorly understood. We aim to evaluate whether the use of a multifaceted quality improvement intervention, including the use of a checklist and the definition of daily care goals during multidisciplinary daily rounds and clinician prompts, can improve the in-hospital mortality of patients admitted to intensive care units (ICUs). Our secondary objectives are to assess the effects of the study intervention on specific processes of care, clinical outcomes, and the safety culture and to determine which factors (the processes of care and/or safety culture) mediate the effect of the study intervention on mortality.Methods/designThis is a cluster randomized trial involving 118 ICUs in Brazil conducted in two phases. In the observational preparatory phase, we collect baseline data on processes of care and clinical outcomes from 60 consecutive patients with lengths of ICU stay longer than 48 h and apply the Safety Attitudes Questionnaire (SAQ) to 75% or more of the health care staff in each ICU. In the randomized phase, we assign ICUs to the experimental or control arm and repeat data collection. Experimental arm ICUs receive the multifaceted quality improvement intervention, including a checklist and definition of daily care goals during daily multidisciplinary rounds, clinician prompting, and feedback on rates of adherence to selected care processes. Control arm ICUs maintain usual care. The primary outcome is in-hospital mortality, truncated at 60 days. Secondary outcomes include the rates of adherence to appropriate care processes, rates of other clinical outcomes, and scores on the SAQ domains. Analysis follows the intention-to-treat principle, and the primary outcome is analyzed using mixed effects logistic regression.DiscussionThis is a large scale, pragmatic cluster-randomized trial evaluating whether a multifaceted quality improvement intervention, including checklists applied during the multidisciplinary daily rounds and clinician prompting, can improve the adoption of proven therapies and decrease the mortality of critically ill patients. If this study finds that the intervention reduces mortality, it may be widely adopted in intensive care units, even those in limited-resource settings.Trial registrationClinicalTrials.gov NCT01785966.

Project description:BACKGROUND:Every year, about 15 million of the world's infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [320/7] to 336/7 weeks) and late preterm (340/7 to 366/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. METHODS:We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. DISCUSSION:Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.

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Project description:Although experts advocate that physicians should express empathy to support family members faced with difficult end-of-life decisions for incapacitated patients, it is unknown whether and how this occurs in practice.To determine whether clinicians express empathy during deliberations with families about limiting life support, to develop a framework to understand these expressions of empathy, and to determine whether there is an association between more empathic statements by clinicians and family satisfaction with communication.Multi-center, prospective study of audiotaped physician-family conferences in intensive care units of four hospitals in 2000-2002.We audiotaped 51 clinician-family conferences that addressed end-of-life decisions. We coded the transcripts to identify empathic statements and used constant comparative methods to categorize the types of empathic statements. We used generalized estimating equations to determine the association between empathic statements and family satisfaction with communication.There was at least one empathic statement in 66% (34/51) of conferences with a mean of 1.6 +/- 1.6 empathic statements per conference (range 0-8). We identified three main types of empathic statements: statements about the difficulty of having a critically ill loved one (31% of conferences), statements about the difficulty of surrogate decision-making (43% of conferences), and statements about the difficulty of confronting death (27% of conferences). Only 30% of empathic statements were in response to an explicit expression of emotion by family members. There was a significant association between more empathic statements and higher family satisfaction with communication (p = 0.04).Physicians vary considerably in the extent to which they express empathy to surrogates during deliberations about life support, with no empathic statements in one-third of conferences. There is an association between more empathic statements and higher family satisfaction with communication.

Project description:BACKGROUND:Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants' care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits. METHODS:In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n =?5) or standard care (n =?5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2?months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge. RESULTS:We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96?days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55?days shorter (95% CI, -?4.44 to -?0.66) in the Alberta FICare™ group than standard care group, P =?.02. Secondary outcomes were not significantly different between groups. CONCLUSIONS:Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings. TRIAL REGISTRATION:ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.