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The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs.

ABSTRACT: Post-intensive care syndrome includes the multiple consequences of an intensive care unit (ICU) stay for patients and families. It has become a new challenge for intensivists. Prevention programs have been disappointing, except for ICU diaries, which report the patient's story in the ICU. However, the effectiveness of ICU diaries for patients and families is still controversial, as the interpretation of the results of previous studies was open to criticism hampering an expanded use of the diary. The primary objective of the study is to evaluate the post-traumatic stress syndrome in patients. The secondary objectives are to evaluate the post-traumatic stress syndrome in families, anxiety and depression symptoms in patients and families, and the recollected memories of patients. Endpoints will be evaluated 3 months after ICU discharge or death.A prospective, multicenter, randomized, assessor-blind comparative study of the effect of an ICU diary on patients and families. We will compare two groups: one group with an ICU diary written by staff and family and given to the patient at ICU discharge or to the family in case of death, and a control group without any ICU diary. Each of the 35 participating centers will include 20 patients having at least one family member who will likely visit the patient during their ICU stay. Patients must be ventilated within 48 h after ICU admission and not have any previous chronic neurologic or acute condition responsible for cognitive impairments that would hamper their participation in a phone interview. Three months after ICU discharge or death of the patient, a psychologist will contact the patient and family by phone. Post-traumatic stress syndrome will be evaluated using the Impact of Events Scale-Revised questionnaire, anxiety and depression symptoms using the Hospital Anxiety and Depression Scale questionnaire, both in patients and families, and memory recollection using the ICU Memory Tool Questionnaire in patients. The content of a randomized sample of diaries of each center will be analyzed using a grid. An interview of the patients in the intervention arm will be conducted 6 months after ICU discharge to analyze in depth how they use the diary.This study will provide new insights on the impact of ICU diaries on post-traumatic stress disorders in patients and families after an ICU stay.ClinicalTrial.gov, ID: NCT02519725 . Registered on 13 July 2015.

SUBMITTER: Garrouste-Orgeas M

PROVIDER: S-EPMC5688734 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs.

Garrouste-Orgeas Maïté M Flahault Cécile C Fasse Léonor L Ruckly Stéphane S Amdjar-Badidi Nora N Argaud Laurent L Badie Julio J Bazire Amélie A Bige Naike N Boulet Eric E Bouadma Lila L Bretonnière Cédric C Floccard Bernard B Gaffinel Alain A de Forceville Xavier X Grand Hubert H Halidfar Rebecca R Hamzaoui Olfa O Jourdain Mercé M Jost Paul-Henri PH Kipnis Eric E Large Audrey A Lautrette Alexandre A Lesieur Olivier O Maxime Virginie V Mercier Emmanuelle E Mira Jean Paul JP Monseau Yannick Y Parmentier-Decrucq Erika E Rigaud Jean-Philippe JP Rouget Antoine A Santoli François F Simon Georges G Tamion Fabienne F Thieulot-Rolin Nathalie N Thirion Marina M Valade Sandrine S Vinatier Isabelle I Vioulac Christel C Bailly Sebastien S Timsit Jean-François JF

Trials 20171115 1

<h4>Background</h4>Post-intensive care syndrome includes the multiple consequences of an intensive care unit (ICU) stay for patients and families. It has become a new challenge for intensivists. Prevention programs have been disappointing, except for ICU diaries, which report the patient's story in the ICU. However, the effectiveness of ICU diaries for patients and families is still controversial, as the interpretation of the results of previous studies was open to criticism hampering an expande ...[more]

PMID: 29141694

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Project description:Spinal muscular atrophy type 1 (SMA-1) is a severe neurodegenerative disorder, which in the absence of curative treatment, leads to death before 1 year of age in most cases. Caring for these short-lived and severely impaired infants requires palliative management. New drugs (nusinersen) have recently been developed that may modify SMA-1 natural history and thus raise ethical concerns about the appropriate level of care for patients. The national Hospital Clinical Research Program (PHRC) called "Assessment of clinical practices of palliative care in children with Spinal Muscular Atrophy Type 1 (SMA-1)" was a multicenter prospective study conducted in France between 2012 and 2016 to report palliative practices in SMA-1 in real life through prospective caregivers' reports about their infants' management. Thirty-nine patients were included in the prospective PHRC (17 centers). We also studied retrospective data regarding management of 43 other SMA-1 patients (18 centers) over the same period, including seven treated with nusinersen, in comparison with historical data from 222 patients previously published over two periods of 10 years (1989-2009). In the latest period studied, median age at diagnosis was 3 months [0.6-10.4]. Seventy-seven patients died at a median 6 months of age[1-27]: 32% at home and 8% in an intensive care unit. Eighty-five percent of patients received enteral nutrition, some through a gastrostomy (6%). Sixteen percent had a non-invasive ventilation (NIV). Seventy-seven percent received sedative treatment at the time of death. Over time, palliative management occurred more frequently at home with increased levels of technical supportive care (enteral nutrition, oxygenotherapy, and analgesic and sedative treatments). No statistical difference was found between the prospective and retrospective patients for the last period. However, significant differences were found between patients treated with nusinersen vs. those untreated. Our data confirm that palliative care is essential in management of SMA-1 patients and that parents are extensively involved in everyday patient care. Our data suggest that nusinersen treatment was accompanied by significantly more invasive supportive care, indicating that a re-examination of standard clinical practices should explicitly consider what treatment pathways are in infants' and caregivers' best interest. This study was registered on clinicaltrials.gov under the reference NCT01862042 (https://clinicaltrials.gov/ct2/show/study/NCT01862042?cond=SMA1&rank=8).

Project description:BackgroundThe Emergency unit of the hospital (Department) (ED) is the fastest and most common way for most French general practitioners (GPs) to respond to the complexity of managing older adults patients with multiple chronic diseases. In 2013, French regional health authorities proposed to set up telephone hotlines to promote interactions between GP clinics and hospitals. The main objective of our study was to analyze whether the hotlines and solutions proposed by the responding geriatrician reduced the number of hospital admissions, and more specifically the number of emergency room admissions.MethodsWe conducted a multicenter observational study from April 2018 to April 2020 at seven French investigative sites. A questionnaire was completed by all hotline physicians after each call.ResultsThe study population consisted of 4,137 individuals who met the inclusion and exclusion criteria. Of the 4,137 phone calls received by the participants, 64.2% (n = 2 657) were requests for advice, and 35.8% (n = 1,480) were requests for emergency hospitalization. Of the 1,480 phone calls for emergency hospitalization, 285 calls resulted in hospital admission in the emergency room (19.3%), and 658 calls in the geriatric short stay (44.5%). Of the 2,657 calls for advice/consultation/delayed hospitalization, 9.7% were also duplicated by emergency hospital admission.ConclusionThis study revealed the value of hotlines in guiding the care of older adults. The results showed the potential effectiveness of hotlines in preventing unnecessary hospital admissions or in identifying cases requiring hospital admission in the emergency room. Hotlines can help improve the care pathway for older adults and pave the way for future progress.Trial registrationRegistered under Clinical Trial Number NCT03959475. This study was approved and peer-reviewed by the Ethics Committee for the Protection of Persons of Sud Est V of Grenoble University Hospital Center (registered under 18-CETA-01 No.ID RCB 2018-A00609-46).

Dataset Information

The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs.

Publications

The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs.

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