A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study.
ABSTRACT: BACKGROUND:Delirium is very common in critically ill patients admitted to the intensive care unit (ICU) and results in negative long-term outcomes. Family members are also at risk of long-term complications, including depression and anxiety. Family members are frequently at the bedside and want to be engaged; they know the patient best and may notice subtle changes prior to the care team. By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care. METHODS:The primary aim of this study is to determine the effect of family-administered delirium prevention, detection, and management in critically ill patients on family member symptoms of depression and anxiety, compared to usual care. One-hundred and ninety-eight patient-family dyads will be recruited from four medical-surgical ICUs in Calgary, Canada. Dyads will be randomized 1:1 to the intervention or control group. The intervention consists of family-partnered delirium prevention, detection, and management, while the control group will receive usual care. Delirium, depression, and anxiety will be measured using validated tools, and participants will be followed for 1- and 3-months post-ICU discharge. All analyses will be intention-to-treat and adjusted for pre-identified covariates. Ethical approval has been granted by the University of Calgary Conjoint Health Research Ethics Board (REB19-1000) and the trial registered. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. DISCUSSION:Critically ill patients are frequently unable to participate in their own care, and partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families. TRIAL REGISTRATION:Registered September 23, 2019 on Clinicaltrials.gov NCT04099472.
Project description:The intensive care unit (ICU), where death is common and even survivors of an ICU stay face the risk of long-term morbidity and re-admissions to the ICU, represents an important setting for improving communication about palliative and end-of-life care. Communication about the goals of care in this setting should be a high priority since studies suggest that the current quality of ICU communication is often poor and is associated with psychological distress among family members of critically ill patients. This paper describes the development and evaluation of an intervention designed to improve the quality of care in the ICU by improving communication among the ICU team and with family members of critically ill patients. We developed a multi-faceted, interprofessional intervention based on self-efficacy theory. The intervention involves a "communication facilitator" - a nurse or social worker - trained to facilitate communication among the interprofessional ICU team and with the critically ill patient's family. The facilitators are trained using three specific content areas: a) evidence-based approaches to improving clinician-family communication in the ICU, b) attachment theory allowing clinicians to adapt communication to meet individual family member's communication needs, and c) mediation to facilitate identification and resolution of conflict including clinician-family, clinician-clinician, and intra-family conflict. The outcomes assessed in this randomized trial focus on psychological distress among family members including anxiety, depression, and post-traumatic stress disorder at 3 and 6 months after the ICU stay. This manuscript also reports some of the lessons that we have learned early in this study.
Project description:BACKGROUND: The practice of low vs. high sedation dosing strategy may impact the cognitive and mental health function in the intensive care unit (ICU). We aim to demonstrate that high sedation strategy will result in change of mental health function in ICU patients. METHODS: We performed a systemic search and meta-analysis of medical databases in MEDLINE (from 1966 to March 2013) and EMBASE (from 1980 to March 2013), as well as the Cochrane Library using the MESH terms "Intensive Care Unit," and "Mental Health, for assessing the impact of sedation on posttraumatic stress disorder (PTSD) or anxiety/depression and delirium in the mix ICU setting including cardiac surgery patients. A total of 1216 patients were included in the final analysis. RESULTS: We included 11 studies in the final analysis and concluded that high dose sedation strategy resulted in higher incidence of cognitive dysfunction with P value of 0.009. The result for subgroup of delirium showed P = 0.11 and PTSD/depression or anxiety of P = 0.001, Heterogeneity I2 was 64%. Overall analysis was statistically significant with a P value of 0.002. CONCLUSION: High sedation dosing strategy will negatively affect cognitive function in critically ill patients. Large randomized trials are needed to address cognitive dysfunction in subgroup of patients with delirium.
Project description:To engage the public to understand how to improve the care of critically ill patients.A qualitative content analysis of an open community forum (Café Scientifique).Public venue in Calgary, Alberta, Canada.Members of the general public including patients, families of patients, health care providers, and members of the community at large.A panel of researchers, decision-makers, and a family member led a Café Scientifique, an informal dialogue between the populace and experts, over three-hours to engage the public to understand how to improve the care of critically ill patients. Conventional qualitative content analysis was used to analyze the data. The inductive analysis occurred in three phases: coding, categorizing, and developing themes.Thirty-eight members of the public (former ICU patients, family members of patients, providers, community members) attended. Participants focused the discussion and provided concrete suggestions for improvement around communication (family as surrogate voice, timing of conversations, decision tools) and provider well-being and engagement, as opposed to medical interventions in critical care.Café participants believe patient and family centered care is important to ensure high-quality care in the ICU. A Café Scientifique is a valuable forum to engage the public to contribute to priority setting areas for research in critical care, as well as a platform to share lived experience. Research stakeholders including health care organizations, governments, and funding organizations should provide more opportunities for the public to engage in meaningful conversations about how to best improve healthcare.
Project description:BACKGROUND:Family-administered delirium detection tools may serve as valuable diagnostic adjuncts because family caregivers may be better able than providers to detect changes in patient cognition and behaviour from pre-illness levels of functioning. The aim of this pilot study was to assess the feasibility and acceptability of family-administered tools to detect delirium in critically ill patients. METHODS:In this single-centre pilot tool validation study conducted in August and September 2017, eligible family caregivers used the Family Confusion Assessment Method (FAM-CAM) and the Sour Seven questionnaire to detect delirium during the patient's intensive care unit (ICU) stay. We calculated descriptive statistics for all study variables. Patients and family caregivers were involved as research partners throughout the study. A patient-orient research approach was taken, engaging patients and family caregivers as full partners. RESULTS:Of 141 patients admitted to the ICU, 75 were eligible, of whom 53 were approached; 21 patients (40%), 23/38 family caregivers (60%) and 17/38 dyads (i.e., patient and family caregiver enrolled together) (45%) consented to participate. The most common reason for nonenrolment was refusal by the family, who commonly reported feeling overwhelmed. The completion rate for the FAM-CAM and Sour Seven questionnaire was 74% (17/23). Among 13 dyads, family caregivers detected delirium in 5 patients (38%) using the FAM-CAM, and delirium or possible delirium in 8 patients (62%) using the Sour Seven questionnaire, whereas trained research assistants detected delirium in 8 patients (62%) using the Confusion Assessment Method for the Intensive Care Unit 7 and the Richmond Agitation-Sedation Scale (? coefficient for agreement between the former and the FAM-CAM and Sour Seven questionnaire 0.62 and 0.85, respectively). INTERPRETATION:Administration of the FAM-CAM and Sour Seven questionnaire by family caregivers to detect delirium in the ICU is feasible and acceptable, although, as with most family engagement strategies, it was not desired by all. Results from this pilot study support a definitive study with a larger sample to enable calculation of inferential statistics, but additional recruitment strategies are necessary to improve the response rate. Trial registration: Clinicaltrials.gov, no. NCT03379129.
Project description:BACKGROUND:Delirium is a common condition in critically ill patients, affecting nearly half of all patients admitted to an intensive care unit (ICU). Family caregivers of critically ill patients can be partners in the early recognition, prevention and management of delirium provided they are aware of the signs/symptoms and appropriate non-pharmacological strategies that might be taken. Valid, reliable instruments that assess family caregiver knowledge are essential so that nurses can prepare family caregivers to be effective partners. The purpose of the current study was to (a) adapt an existing caregiver delirium knowledge questionnaire (CDKQ) for use by nurses to measure a family caregiver's delirium knowledge in the ICU; and (b) examine the psychometric properties and structure of the adapted Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ). METHODS:In this cross-sectional study, a multidisciplinary team developed the 21-item CIDKQ (possible score range: 0-21) and administered it to 158 family caregivers of critically ill patients. Descriptive statistics were examined for all variables. The CIDKQ was analyzed for face validity, content validity, reliability and internal consistency. RESULTS:The mean CIDKQ score was 14.1 (SD: 3.5, range?=?2 to 21). Path analysis revealed that a family caregiver's delirium knowledge in the actions and symptoms dimensions had a direct effect on knowledge of delirium risk factors. The CIDKQ was found to have face validity and reliability (Cronbach's ? = 0.79). CONCLUSIONS:The findings indicated good validity and reliability of the CIDKQ as a measure of ICU delirium knowledge in family caregivers of critically ill patients.
Project description:BACKGROUND:Cancer and its treatment can result in psychological distress in both adults with cancer and in their family caregivers. This psychological distress acts as a significant adverse factor in patient-caregiver dyads. The study purposes included: (i) to assess anxiety and depression in adults with cancer and their family caregivers, and examine the dyadic relationship of anxiety and depression in patient-caregiver dyads; (ii) to investigate factors that may modify these relationships; and (iii) to explore the impact of anxiety and depression on patient-caregiver dyad quality of life (QOL). METHODS:This was a secondary analysis of a cross-sectional study. Participants consisted of 641 patient-caregiver dyads. Participants completed a survey assessing adults with cancer-related, family caregiver-related, and family-related variables using a demographic/clinical information sheet. In addition, anxiety/depression and QOL were assessed by using the Chinese version of the Hospital Anxiety and Depression Scale and SF-12 respectively. Data were analyzed by using descriptive statistics, Pearson correlations, subgroup analysis, and the Actor-Partner Interdependence Model. RESULTS:Nearly one-third of participants had experienced anxiety and depression. Adults with cancer and family caregivers experienced a similar degree of anxiety and depression. Correlations (r) of anxiety and depression between patient-caregiver dyads ranged from 0.25 to 0.32. Various factors influencing the anxiety and depression relationship between patient-caregiver dyads were identified, including adults with cancer-related (e.g., age, gender, marital status, level of being informed about the disease, different types of cancer and treatment), family caregiver-related (e.g., being the spouse of a patient, duration in their role as a family caregiver, and amount of time spent on caregiving each day), and family-related (family relationship pre- and post-cancer, financial burden on the family due to cancer treatment) variables. To some extent, both actor and partner effects were identified for anxiety and depression on the QOL of patient-caregiver dyads. CONCLUSIONS:Study findings call attention to anxiety and depression, as well as related factors, in patient-caregiver dyads. The underlined essential components and focus of intervention, which will be developed to decrease psychological distress and improve QOL in patient-caregiver dyads, included individual characteristics of patient-caregiver dyads, family relationship, and anxiety and depression in their counterparts.
Project description:Importance:Physicians often rely on surrogate decision-makers (SDMs) to make important decisions on behalf of critically ill patients during times of incapacity. It is uncertain whether targeted interventions to improve surrogate decision-making in the intensive care unit (ICU) reduce nonbeneficial treatment and improve SDM comprehension, satisfaction, and psychological morbidity. Objective:To perform a systematic review and meta-analysis of randomized clinical trials (RCTs) to determine the association of such interventions with patient- and family-centered outcomes and resource use. Data Sources:A search was conducted of MEDLINE, Embase, and other relevant databases for potentially relevant studies from inception through May 30, 2018. Study Selection:Randomized clinical trials studying interventions that were targeted at SDMs or family members of critically ill adults in the ICU were included. Key search terms included surrogate or substitute decision-maker, critically ill, randomized controlled trials, and their respective related terms. Data Extraction and Synthesis:This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Two independent, blinded reviewers independently screened citations and extracted data. Random effects models with inverse variance weighting were used to pool outcomes data when possible and otherwise present findings qualitatively. Main Outcomes and Measures:Outcomes of interest were divided into 3 categories: (1) patient-related clinical outcomes (mortality, length of stay [LOS], duration of life-sustaining therapies), (2) SDM and family-related outcomes (comprehension, major change in goals of care, incident psychological comorbidities [posttraumatic stress disorder, anxiety, depression], and satisfaction with care), and (3) use of resources (cost of care and health care resource use). Results:Of 3735 studies screened, 13 RCTs were included, comprising a total of 10 453 patients. Interventions were categorized as health care professional led (n = 6), ethics consultation (n = 3), palliative care consultation (n = 2), and media (n = 1 pamphlet and 1 video). No association with mortality was observed (risk ratio, 1.03; 95% CI, 0.98-1.08; P = .22). Intensive care unit LOS was significantly shorter among patients who died (mean difference, -2.11 days; 95% CI, -4.16 to -0.07; P = .04), but not in the overall population (mean difference, -0.79 days; 95% CI, -2.33 to 0.76 days; P = .32). There was no consistent difference in SDM-related outcomes, including satisfaction with care or perceived quality of care (n = 6 studies) and incident psychological comorbidities (depression: ratio of means, -0.11; 95% CI, -0.29 to 0.08; P = .26; anxiety: ratio of means, -0.08; 95% CI, -0.25 to 0.08; P = .31; or posttraumatic stress disorder: ratio of means: -0.04; 95% CI, -0.21 to 0.13; P = .65). Among 6 trials reporting effects on health care resource use, only 1 nurse-led intervention observed a significant reduction in costs ($75 850 control vs $51 060 intervention; P = .04). Conclusions and Relevance:Systematic interventions aimed at improving surrogate decision-making for critically ill adults may reduce ICU LOS among patients who die in the ICU, without influencing overall mortality. Better understanding of the complex processes related to surrogate decision-making is needed.
Project description:Importance:The effects of intensive care unit (ICU) visiting hours remain uncertain. Objective:To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium. Design, Setting and Participants:Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018. Interventions:Flexible visitation (up to 12 hours per day) supported by family education (n?=?837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n?=?848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation. Main Outcomes and Measures:Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory). Results:Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P?<?.001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P?=?.44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P?=?.38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P?=?.36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P?<?.001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P?=?.003) were significantly better with flexible visitation. Conclusions and Relevance:Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium. Trial Registration:ClinicalTrials.gov Identifier: NCT02932358.
Project description:Providers have traditionally established priorities for quality improvement; however, patients and their family members have recently become involved in priority setting. Little is known about how to reconcile priorities of different stakeholder groups into a single prioritized list that is actionable for organizations.To describe the decision-making process for establishing consensus used by a diverse panel of stakeholders to reconcile two sets of quality improvement priorities (provider/decision maker priorities n=9; patient/family priorities n=19) into a single prioritized list.We employed a modified Delphi process with a diverse group of panellists to reconcile priorities for improving care of critically ill patients in the intensive care unit (ICU). Proceedings were audio-recorded, transcribed and analysed using qualitative content analysis to explore the decision-making process for establishing consensus.Nine panellists including three providers, three decision makers and three family members of previously critically ill patients.Panellists rated and revised 28 priorities over three rounds of review and reached consensus on the "Top 5" priorities for quality improvement: transition of patient care from ICU to hospital ward; family presence and effective communication; delirium screening and management; early mobilization; and transition of patient care between ICU providers. Four themes were identified as important for establishing consensus: storytelling (sharing personal experiences), amalgamating priorities (negotiating priority scope), considering evaluation criteria and having a priority champion.Our study demonstrates the feasibility of incorporating families of patients into a multistakeholder prioritization exercise. The approach described can be used to guide consensus building and reconcile priorities of diverse stakeholder groups.
Project description:This position statement provides clinical recommendations for the assessment of pain, level of sedation, iatrogenic withdrawal syndrome and delirium in critically ill infants and children. Admission to a neonatal or paediatric intensive care unit (NICU, PICU) exposes a child to a series of painful and stressful events. Accurate assessment of the presence of pain and non-pain-related distress (adequacy of sedation, iatrogenic withdrawal syndrome and delirium) is essential to good clinical management and to monitoring the effectiveness of interventions to relieve or prevent pain and distress in the individual patient.A multidisciplinary group of experts was recruited from the members of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). The group formulated clinical questions regarding assessment of pain and non-pain-related distress in critically ill and nonverbal children, and searched the PubMed/Medline, CINAHL and Embase databases for studies describing the psychometric properties of assessment instruments. Furthermore, level of evidence of selected studies was assigned and recommendations were formulated, and grade or recommendations were added on the basis of the level of evidence.An ESPNIC position statement was drafted which provides clinical recommendations on assessment of pain (n = 5), distress and/or level of sedation (n = 4), iatrogenic withdrawal syndrome (n = 3) and delirium (n = 3). These recommendations were based on the available evidence and consensus amongst the experts and other members of ESPNIC.This multidisciplinary ESPNIC position statement guides professionals in the assessment and reassessment of the effectiveness of treatment interventions for pain, distress, inadequate sedation, withdrawal syndrome and delirium.