Dataset Information

Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial.

ABSTRACT: As intensive care mortality is high, end of life is a subject of major concern for intensivists. In this context, relatives are particularly vulnerable and prone to post-ICU syndrome, in the form of high levels of anxiety, depression, post-traumatic stress, and complicated grief. Grieving families suffer from a feeling of abandonment and evoke the need to get back in touch with the team to ask questions and remove doubts, but very few actually do. Aiding families during the grieving process is an important aspect of palliative care. A condolence letter represents an opportunity to recognize the pain of the family member and the strong tie that linked the family member to the ICU team, and to offer additional information if necessary. The goal of the study is to measure the impact of the condolence letter on the experience of bereaved families after a death in the ICU. Our hypothesis is that a post-death follow-up in the form of a condolence letter sent by the ICU physician who was in charge of the patient may help to reduce the risks of presenting symptoms of anxiety/depression, post-traumatic stress, and complicated grief.This is a randomized, controlled, multicenter study. Research will compare two groups of bereaved family members: one group that does not receive a condolence letter (control) and one group that receives a condolence letter 15 days after the death (intervention). Each of the 22 participating centers will include 12 relatives. Participating relatives will be followed up by phone with a call at 1 month and one at 6 months to complete questionnaires, permitting evaluation of post-ICU burden. The main outcome is anxiety and depression measured at 1 month. Other outcomes include evaluation of quality of dying and death, post-traumatic stress, and complicated grief.This study will allow us to assess if sending a condolence letter can reduce the risks of presenting symptoms of anxiety and depression, complicated grief, and symptoms of post-traumatic stress disorder after the death of a loved one in the ICU.Clinicaltrials.gov NCT02325297 (23 December 2014).

SUBMITTER: Kentish-Barnes N

PROVIDER: S-EPMC4761130 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial.

Kentish-Barnes Nancy N Chevret Sylvie S Azoulay Elie E

Trials 20160220 1

<h4>Background</h4>As intensive care mortality is high, end of life is a subject of major concern for intensivists. In this context, relatives are particularly vulnerable and prone to post-ICU syndrome, in the form of high levels of anxiety, depression, post-traumatic stress, and complicated grief. Grieving families suffer from a feeling of abandonment and evoke the need to get back in touch with the team to ask questions and remove doubts, but very few actually do. Aiding families during the gr ...[more]

PMID: 26897630

Similar Datasets

Project description:BACKGROUND:Providing appropriate support and care for end-of-life patients and their relatives is a major concern and a daily responsibility for intensivists. Bereaved relatives of non-surviving patients in intensive care units (ICUs) often suffer from prolonged grief, posttraumatic stress disorder, anxiety, and depression. A physician-driven intervention, consisting of three meetings with the family, might reduce the post-ICU burden of bereaved family members 6?month after death. The patient's nurse is actively involved at each step. We hypothesize that this strategy will improve communication in the end-of-life setting and thus, should reduce the post-ICU burden for family members, specifically the development of prolonged grief 6?months after the death. METHODS/DESIGN:The COSMIC-EOL trial is a prospective, multicenter, cluster randomized controlled trial in which centers are allocated to two parallel arms: (1) intervention centers where relatives benefit from three-step physician-driven support during the dying and death process and (2) control centers where, during the dying and death process, relatives receive the standard of care practice. Each of the 36 participating centers will include 25 relatives of patients with a length of stay ?2?days. Participating relatives will be followed up by phone at 1, 3, and 6?months after the patient's death to complete questionnaires permitting evaluation of their post-ICU burden. The main outcome is prolonged grief measured 6?months after the death using the PG-13. Other outcomes include evaluation of quality of dying, quality of communication, anxiety, depression, and post-traumatic stress. The estimated duration of the study is 36?months. DISCUSSION:The results of the trial will provide information about the effectiveness of physician-driven support for relatives of patients dying in an ICU. The study is expected to demonstrate a decrease in the ICU burden for bereaved relatives who benefitted from this intervention. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02955992 . Registered on November 3rd 2016.

Project description:BACKGROUND:Discussing deceased organ donation can be difficult not only for families but for health professionals who initiate and manage the conversations. It is well recognised that the methods of communication and communication skills of health professionals are key influences on decisions made by families regarding organ donation. METHODS:This multicentre study is being performed in nine intensive care units with follow-up conducted by the Organ and Tissue Donation Service in New South Wales (NSW) Australia. The control condition is pre-intervention usual practice for at least six months before each site implements the intervention. The COMFORT intervention consists of six elements: family conversations regarding offers for organ donation to be led by a "designated requester"; family offers for donation are deferred to the designated requester; the offer of donation is separated from the end-of-life discussion that death is inevitable; it takes place within a structured family donation conversation using a "balanced" approach. Designated requesters may be intensivists, critical care nurses or social workers prepared by attending the three-day national "Family Donation Conversation" workshops, and the half-day NSW Simulation Program. The design is pre-post intervention to compare rates of family consent for organ donation six months before and under the intervention. Each ICU crosses from using the control to intervention condition after the site initiation visit. The primary endpoint is the consent rate for deceased organ donation calculated from 140 eligible next of kin families. Secondary endpoints are health professionals' adherence rates to core elements of the intervention; identification of predictors of family donation decision; and the proportion of families who regret their final donation decision at 90 days. DISCUSSION:The pragmatic design of this study may identify 'what works' in usual clinical settings when requesting organ donation in critical care areas, both in terms of changes in practice healthcare professionals are willing and able to adopt, and the effect this may have on desired outcomes. The findings of this study will be indicative of the potential benefits of the intervention and be relevant and transferrable to clinical settings in other states and countries. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000815763 (24 July 2013). ClinicalTrials.gov: NCT01922310 (14 August 2013) (retrospectively registered).

Project description:BackgroundPoint-of-care ultrasound (POCUS) is a tool in increasing use, but there is still a lack of basics for its routine use and evidence of its impact in intensive care.ObjectiveTo measure the impact of POCUS on resource utilization, diagnostic accuracy, and clinical management in medical-surgical intensive care units (ICUs).MethodsProspective, controlled study, in two polyvalent ICUs. The patients were randomly assigned to POCUS or control group.InterventionsPOCUS patients received systematic ultrasound examination of optic nerve, lung/pleura, heart, abdomen, and venous system, performed at the bedside by trained intensivists. Control patients were treated by critical care specialists who do not perform ultrasound in their clinical practice.ResultsWe included 80 patients, 40 per group. There were no significant differences in age, sex, APACHE II score, or admission diagnosis. POCUS group used fewer resources per patient in the first 5 days of hospitalization: chest radiography (2.6 ± 2.0 vs 4.1 ± 3.5, P = 0.01), additional ultrasound evaluations performed by a radiology specialist (0.6 ± 0.7 vs 1.1 ± 0.7, P = 0.002), and computed tomography studies (0.5 ± 0.6 vs 0.9 ± 0.7, P = 0.007). Time to perform any requested ultrasound evaluation after ICU admission was 2.1 ± 1.6 h versus 7.7 ± 6.7 h (P = 0.001). Systematic ultrasound evaluation led to better characterization of ICU admission diagnosis in 14 (35%) patients and change in clinical management in 24 (60%). POCUS group had lower fluid balance at 48 and 96 h after admission (P = 0.01) and spent less time mechanically ventilated (5.1 ± 5.7 days vs 8.8 ± 9.4, P = 0.03).ConclusionsSystematic application of POCUS may decrease utilization of conventional diagnostic imaging resources and time of mechanical ventilation, and facilitate meticulous intravenous fluid administration in critically ill patients during the first week of stay in the ICU. Trial registration ClinicalTrials.gov Identifier: NCT03608202.

Project description:BackgroundBurnout is an occupational syndrome that leads to mental health problems, job turnover, and patient safety events. Those caring for critically ill patients are especially susceptible due to high patient mortality, long hours, and regular encounters with trauma and ethical issues. Interventions to prevent burnout in this population are needed. Preliminary studies suggest debriefing sessions may reduce burnout. This study aims to assess whether participation in regular debriefing can prevent burnout in intensive care unit (ICU) clinicians.MethodsA randomized controlled trial will be conducted in two large academic medical centers. Two hundred ICU clinicians will be recruited with target enrollment of 100 physicians and 100 non-physicians (nurses, pharmacists, therapists). Participants must have worked in the ICU for the equivalent of at least 1 full time work week in the preceding 4 weeks. Enrolled subjects will be randomized to virtually attend biweekly debriefing sessions facilitated by a psychotherapist for 3 months or to a control arm without sessions. Our debriefs are modeled after Death Cafés, which are informal discussions focusing on death, dying, loss, grief, and illness. These sessions allow for reflection on distressing events and offer community and collaboration among hospital employees outside of work. The primary outcome is clinician burnout as measured by the Maslach Burnout Inventory (MBI) Score. Secondary outcomes include depression and anxiety, as measured by the Patient Health Questionnaire 8 (PHQ-8) and Generalized Anxiety Disorder 7-item scale (GAD-7), respectively. Questionnaires will be administered prior to the intervention, at 1 month, at 3 months, and at 6 months after enrollment. These values will be compared between groups temporally. Qualitative feedback will also be collected and analyzed.DiscussionWith ICU clinician burnout rates exceeding 50%, Death Café debriefing sessions may prove to be an effective tool to avert this debilitating syndrome. With COVID-19 limiting social interactions and overloading ICUs worldwide, the virtual administration of the Death Café for ICU clinicians provides an innovative strategy to potentially mitigate burnout in this vulnerable population.Trial registrationClinicalTrials.gov NCT04347811 . Registered on 15 April 2020.

Project description:Packed red blood cell (PRBC) transfusion is required in hematology patients treated with chemotherapy for acute leukemia, autologous (auto) or allogeneic (allo) hematopoietic stem cell transplantation (HSCT). In certain situations like septic shock, hip surgery, coronary disease or gastrointestinal hemorrhage, a restrictive transfusion strategy is associated with a reduction of infection and death. A transfusion strategy using a single PRBC unit has been retrospectively investigated and showed a safe reduction of PRBC consumption and costs. We therefore designed a study to prospectively demonstrate that the transfusion of a single PRBC unit is safe and not inferior to standard care.The 1versus2 trial is a randomized trial which will determine if a single-unit transfusion policy is not inferior to a double-unit transfusion policy. The primary endpoint is the incidence of severe complication (grade???3) defined as stroke, transient ischemic attack, acute coronary syndrome, heart failure, elevated troponin level, intensive care unit transfer, death, new pulmonary infiltrates, and transfusion-related infections during hospital stays. The secondary endpoint is the number of PRBC units transfused per patient per hospital stay. Two hundred and thirty patients will be randomized to receive a single unit or double unit every time the hemoglobin level is less than 8 g/dL. All patients admitted for induction remission chemotherapy, auto-HSCT or allo-HSCT in hematology intensive care units will be eligible for inclusion. Sample size calculation has determined that a patient population of 230 will be required to prove that the 1-unit PRBC strategy is non-inferior to the 2-unit PRBC strategy. Hemoglobin threshold for transfusion is below 8 g/dL. Estimated percentage of complication-free hospital stays is 93 %. In a non-inferiority hypothesis, the number of patients to include is 230 with a power of 90 % and an alpha risk of 5 %.14-128; Clinicaltrials.gov NCT02461264 (registered on 3 June 2015).

Project description:BackgroundHealthcare facility construction is increasing because of population demand and the need to replace ageing infrastructure. Research suggests that there may be a relationship between healthcare environment and patient care. To date, most evaluations of new healthcare facilities are derived from techniques used in other industries and focus on physical, financial and architectural performance. However, few studies have evaluated the impact of healthcare facility design on processes and outcomes of patient care.Study aimsThe primary objective of this study was to investigate the impact of relocation to a new intensive care unit (ICU) facility on clinical performance measures. This study also proposes to develop and test a framework for facility performance evaluation using accepted ICU design guidelines and Donabedian's model for healthcare quality.Methods and analysisWe will utilise a mixed-methods, observational, retrospective, controlled, before-and-after design to take advantage of the quasiexperimental conditions created with the construction of a new ICU facility in Calgary, Canada. For the qualitative substudy, we will conduct individual interviews with end-users to understand their impressions and experiences with the new environment and perform thematic analysis. For the quantitative substudy, we will compare process of care indicators and patient outcomes for the 12-month period before and after relocation to the new facility. Two other local ICU facilities that did not undergo structural change during the study period will serve as controls. We will triangulate qualitative and quantitative results utilising a novel framework.Ethics and disseminationThe results of this study will contribute in understanding the impact of new ICU facilities on clinical performance measures centred on patients, their families and healthcare providers. The framework will complement existing building performance evaluation techniques and help healthcare administrators plan new ICU facilities. The University of Calgary Research Ethics Board approved this study protocol.

Dataset Information

Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial.

Publications

Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets