Dataset Information

Design and rationale of a routine clinical care pathway and prospective cohort study in older patients needing intensive treatment.

ABSTRACT:

Background

Treatment decisions concerning older patients can be very challenging and individualised treatment plans are often required in this very heterogeneous group. In 2015 we have implemented a routine clinical care pathway for older patients in need of intensive treatment, including a comprehensive geriatric assessment (CGA) that was used to support clinical decision making. An ongoing prospective cohort study, the Triaging Elderly Needing Treatment (TENT) study, has also been initiated in 2016 for participants in this clinical care pathway, to study associations between geriatric characteristics and outcomes of treatment that are relevant to older patients. The aim of this paper is to describe the implementation and rationale of the routine clinical care pathway and design of the TENT study.

Methods

A routine clinical care pathway has been designed and implemented in multiple hospitals in the Netherlands. Patients aged ?70?years who are candidates for intensive treatments, such as chemotherapy, (chemo-)radiation therapy or major surgery, undergo frailty screening based on the Geriatric 8 (G-8) questionnaire and the Six-Item Cognitive Impairment Test (6CIT). If screening reveals potential frailty, a CGA is performed. All patients are invited to participate in the TENT study. Clinical data and blood samples for biomarker studies are collected at baseline. During follow-up, information about treatment complications, hospitalisations, functional decline, quality of life and mortality is collected. The primary outcome is the composite endpoint of functional decline or mortality at 1?year.

Discussion

Implementation of a routine clinical care pathway for older patients in need of intensive treatment provides the opportunity to study associations between determinants of frailty and outcomes of treatment. Results of the TENT study will support individualised treatment for future patients.

Trial registration

The study is retrospectively registered at the Netherlands Trial Register (NTR), trial number NL8107 . Date of registration: 22-10-2019.

SUBMITTER: van Holstein Y

PROVIDER: S-EPMC7791733 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Design and rationale of a routine clinical care pathway and prospective cohort study in older patients needing intensive treatment.

van Holstein Yara Y van Deudekom Floor J FJ Trompet Stella S Postmus Iris I Uit den Boogaard Anna A van der Elst Marjan J T MJT de Glas Nienke A NA van Heemst Diana D Labots Geert G Altena Mariëtte M Slingerland Marije M Liefers Gerrit Jan GJ van den Bos Frederiek F van der Bol Jessica M JM Blauw Gerard J GJ Portielje Johanneke E A JEA Mooijaart Simon P SP

BMC geriatrics 20210107 1

<h4>Background</h4>Treatment decisions concerning older patients can be very challenging and individualised treatment plans are often required in this very heterogeneous group. In 2015 we have implemented a routine clinical care pathway for older patients in need of intensive treatment, including a comprehensive geriatric assessment (CGA) that was used to support clinical decision making. An ongoing prospective cohort study, the Triaging Elderly Needing Treatment (TENT) study, has also been init ...[more]

PMID: 33413165

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Project description:IntroductionAs paediatric intensive care unit (PICU) mortality declines, there is growing recognition of the morbidity experienced by children surviving critical illness and their families. A comprehensive understanding of the adverse physical, cognitive, emotional and social sequelae common to PICU survivors is limited, however, and the trajectory of recovery and risk factors for morbidity remain unknown.Methods and analysisThe Post-Intensive Care Syndrome - paediatrics Longitudinal Cohort Study will evaluate child and family outcomes over 2 years following PICU discharge and identify child and clinical factors associated with impaired outcomes. We will enrol 750 children from 30 US PICUs during their first PICU hospitalisation, including 500 case participants experiencing ≥3 days of intensive care that include critical care therapies (eg, mechanical ventilation, vasoactive infusions) and 250 age-matched, sex-matched and medical complexity-matched control participants experiencing a single night in the PICU with no intensive care therapies. Children, parents and siblings will complete surveys about health-related quality of life, physical function, cognitive status, emotional health and peer and family relationships at multiple time points from baseline recall through 2 years post-PICU discharge. We will compare outcomes and recovery trajectories of case participants to control participants, identify risk factors associated with poor outcomes and determine the emotional and social health consequences of paediatric critical illness on parents and siblings.Ethics and disseminationThis study has received ethical approval from the University of Pennsylvania Institutional Review Board (protocol #843844). Our overall objective is to characterise the ongoing impact of paediatric critical illness to guide development of interventions that optimise outcomes among children surviving critical illness and their families. Findings will be presented at key disciplinary meetings and in peer-reviewed publications at fixed data points. Published manuscripts will be added to our public study website to ensure findings are available to families, clinicians and researchers.Trials registration numberNCT04967365.

Project description:ObjectivesThe prevalence and optimal management of clinically significant pleural effusion, confirmed by thoracic ultrasound, in the critically ill is unknown. This study aimed to determine: 1) the prevalence, characteristics, and outcomes of patients treated in intensive care with clinically significant effusion and 2) the comparative efficacy and safety of pleural drainage or expectant medical management.DesignA prospective multicenter cohort study.SettingICUs in four teaching hospitals in Western Australia.PatientsConsecutive patients with clinically significant pleural effusions (depth ≥ 2 cm on thoracic ultrasound with clinician-determined adverse effects on patient progress).InterventionsNone.Measurements and main resultsPrimary outcome was the change in Pao2:Fio2 (mm Hg) ratio from baseline to 24 hours. Changes in diagnosis and treatment based on pleural fluid analysis and pleural effusion related serious adverse events between those who underwent either drainage within 24 hours or expectant management were compared. Of the 7,342 patients screened, 226 patients (3.1%) with 300 pleural effusions were enrolled. Early drainage of pleural effusion occurred in 76 patients (34%) and significantly improved oxygenation (Pao2:Fio2 ratio 203 at baseline vs 263 at 24 hr, +29.6% increment; p < 0.01). This was not observed in the other 150 patients who had expectant management (Pao2:Fio2 ratio 250 at baseline vs 268 at 24 hr, +7.2% increment; p = 0.44). The improvement in oxygenation after early drainage remained unchanged after adjustment for a propensity score on the decision to initiate early drainage. Pleural effusion related serious adverse events were not different between the two groups (early drainage 10.5% vs no early drainage 16.0%; p = 0.32). Improvements in diagnosis were noted in 91 initial (nonrepetitive) drainages (76.5% out of 119); treatment strategy was optimized after 80 drainage episodes (59.7% out of 134).ConclusionsEarly drainage of clinically significant pleural effusion was associated with improved oxygenation and diagnostic accuracy without increased complications.

Dataset Information

Design and rationale of a routine clinical care pathway and prospective cohort study in older patients needing intensive treatment.

Background

Methods

Discussion

Trial registration

Publications

Design and rationale of a routine clinical care pathway and prospective cohort study in older patients needing intensive treatment.

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