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A feasibility study of a randomised controlled trial to examine the impact of the ABCDE bundle on quality of life in ICU survivors.

ABSTRACT: Background:Early rehabilitation has been found to prevent delirium and weakness that can hamper the recovery of intensive care unit (ICU) survivors. Integrated clinical practice guidelines for managing patient pain, agitation and delirium (PAD) have been developed. The Awakening and Breathing Coordination, Delirium monitoring/management, and Early exercise/mobility (ABCDE) bundle provides a strategy to implement PAD guidelines into everyday clinical practice. However, there is limited evidence on the effectiveness of the ABCDE bundle in the literature.The purpose of this study was to evaluate the feasibility of conducting a full-scale randomised controlled trial comparing the ABCDE bundle to standard care in an ICU. Trial feasibility was defined as the successful recruitment and retention of trial participants, adherence to the intervention, identification of barriers to the intervention, and the rigorous collection of outcome data. Methods:A prospective, single-centre, randomised controlled feasibility study was conducted. Thirty adult mechanically ventilated participants were recruited from an eight-bed ICU in south east Queensland, Australia, between April 2015 and December 2015. Participants were randomised to receive either the ABCDE bundle or standard routine management. The ABCDE bundle integrated prescribed awakening and breathing trials, delirium monitoring and management, and prescribed exercise and mobility regimes. Feasibility outcomes measured included recruitment and retention rates, intervention fidelity, and the feasibility of participant outcome data collection. Outcome measurement assessors were blinded to participant assignment. It was not possible to blind the research team or the participant to group assignment. Results:In total, 30 (81.1%) of 37 eligible participants consented and were randomised to the intervention group (n?=?15) or the control group (n?=?15). Of these, 23 (76.6%) participants successfully completed the 90-day post discharge assessment. A lengthy recruitment period of 8 months was related to overly stringent inclusion and exclusion criteria. Intervention adherence exceeded defined success rates with participation in awakening and breathing trials, delirium monitoring and exercise interventions performed on 80.2, 97.4 and 90.2% of ventilated days respectively. Outcome assessments were successfully and accurately performed at ICU and hospital discharge and 90-day post hospital discharge. Intervention participants were deemed to be delirious on 39.6% of mechanically ventilated days indicating a requirement for a scripted regime to prevent delirium. Conclusions:With minor adjustment of inclusion and exclusion criteria, the inclusion of delirium management protocols, and encouragement of family engagement and involvement, a large-scale definitive randomised controlled trial to test the impact of the ABCDEF bundle will be feasible. Trial registration:Australian New Zealand Clinical Trials Registry 12614000763640 Date registered 17/08/2014.

SUBMITTER: Sosnowski K

PROVIDER: S-EPMC5765639 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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A feasibility study of a randomised controlled trial to examine the impact of the ABCDE bundle on quality of life in ICU survivors.

Sosnowski Kellie K Mitchell Marion L ML White Hayden H Morrison Lynette L Sutton Joanne J Sharratt Jessica J Lin Frances F

Pilot and feasibility studies 20180111

<h4>Background</h4>Early rehabilitation has been found to prevent delirium and weakness that can hamper the recovery of intensive care unit (ICU) survivors. Integrated clinical practice guidelines for managing patient pain, agitation and delirium (PAD) have been developed. The Awakening and Breathing Coordination, Delirium monitoring/management, and Early exercise/mobility (ABCDE) bundle provides a strategy to implement PAD guidelines into everyday clinical practice. However, there is limited ev ...[more]

PMID: 29372070

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Project description:BackgroundICU survivors often suffer from prolonged physical and mental impairments resulting in the so called "Post-Intensive Care Syndrome" (PICS). The aftercare of former ICU patients affected by PICS in particular has not been addressed sufficiently in Germany so far. The aim of this study was to evaluate the feasibility of a pragmatic randomised trial (RCT) comparing an intensive care unit (ICU) follow-up clinic intervention to usual care.MethodsThis pilot study in a German university hospital evaluated the feasibility of a pragmatic RCT. Patients were assigned in a 1:1 ratio to an ICU follow-up clinic intervention or to usual care. The concept of this follow-up clinic was previously developed in a participatory process with patients, next of kin, health care professionals and researchers. We performed a process evaluation and determined acceptability, fidelity, completeness of measurement instruments and practicality as feasibility outcomes. The RCT's primary outcome (health-related quality of life) was assessed six months after ICU discharge by means of the physical component scale of the Short-Form-12 self-report questionnaire.ResultsThe pilot study was conducted from June 2020 to May 2021 with 21 and 20 participants in the intervention and control group. Principal findings related to feasibility were 85% consent rate (N = 48), 62% fidelity rate, 34% attrition rate (N = 41) and 77% completeness of outcome measurements. The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27). The majority of participants (85%) needed assistance with follow-up questionnaires (practicality). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. Six-month follow-up assessment was planned for all study participants and performed for 66% (N = 41) of the participants after 197 days (median).ConclusionThe participatory developed intervention of an ICU follow-up clinic and the pragmatic pilot RCT both seem to be feasible. We recommend to start a pragmatic RCT on the effectiveness of the ICU follow-up clinic.Trial registrationClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.

Project description:BACKGROUND:Although studies on the effectiveness of the use of ICU diaries on psychiatric disorders and quality of life have been published, the results still seem to be controversial. The study aimed to determine the effects of using an ICU diary on psychiatric disorders, sleep quality, and quality of life (QoL) in adult ICU survivors in China. METHODS:One hundred and twenty-six patients who underwent a scheduled cardiac surgery and were expected to stay ??24?h in ICU were randomized to two groups (63 in each group). The patients in the intervention group received the use of ICU diaries during the period of post-ICU follow-up, while the patients in the control group received usual care without ICU diaries. The primary outcome was significant PTSD symptoms (Chinese version of Impact of Event Scale-Revised, IES-R; total score ??35 was defined as significant PTSD symptoms) and its severity in patients 3?months post-ICU. The secondary outcomes included memories of the ICU at 1?month, QoL (Medical Outcomes Study 36-item Short-Form, SF-36), sleep quality (Pittsburgh Sleep Quality Index Questionnaire, PSQI), anxiety, and depression symptoms (Hospital Anxiety and Depression Scale, HADS) at 3?months. RESULTS:Eighty-five and 83 patients completed the follow-up interviews at 1?month and 3?months post-ICU, respectively. Significant PTSD symptoms were reported by 6 of 41 (14.63%) in the intervention group vs 9 of 42 (21.43%) in the control group (risk difference, -?9% [95% CI, -?2% to 21%], P =?0.10). There was no significant differences between groups in IES-R score, symptoms of intrusion, symptoms of avoidance, numbers of memories of feeling and delusional memories, SF-36 score and anxiety score (P >?0.05), while significant differences were found in symptom of hyperarousal score, numbers of factual memories and PSQI score (P <?0.05). No adverse effect was reported. CONCLUSIONS:Using an ICU diary is not useful for preventing PTSD symptoms and anxiety symptoms and preserving the quality of life of the patients at 3?months post-ICU, while it significantly improves the survivor's factual memory of ICU and sleep quality, and prevents the hyperarousal symptom. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR-IOR-16009109, registered on 28 August 2016.

Project description:IntroductionMortality amongst COPD patients treated on the ICU is high. Health-related quality of life (HRQL) after intensive care is a relevant concern for COPD patients, their families and providers of health care. Still, there are few HRQL studies after intensive care of this patient group. Our hypothesis was that HRQL of COPD patients treated on the ICU declines rapidly with time.MethodsFifty-one COPD patients (COPD-ICU group) with an ICU stay longer than 24 hours received a questionnaire at 6, 12 and 24 months after discharge from ICU. HRQL was measured using two generic instruments: the EuroQoL instrument (EQ-5D and EQ-VAS) and the Short Form 36 Health Survey (SF-36). The results were compared to HRQL of two reference groups from the general population; an age- and sex-adjusted reference population (Non-COPD reference) and a reference group with COPD (COPD reference).ResultsHRQL of the COPD-ICU group at 6 months after discharge from ICU was lower compared to the COPD reference group: Median EQ-5D was 0.66 vs. 0.73, P = 0.08 and median EQ-VAS was 50 vs.55, P < 0.05. There were no significant differences in the SF-36 dimensions between the COPD-ICU and COPD-reference groups, although the difference in physical functioning (PF) approached statistical significance (P = 0.059). Patients in the COPD-ICU group who were lost to follow-up after 6 months had low HRQL scores at 6 months. Scores for patients who died were generally lower compared to patients who failed to respond to the questionnaire. The PF and social functioning (SF) scores in those who died were significantly lower compared to patients with a complete follow up. HRQL of patients in the COPD-ICU group that survived a complete 24 months follow up was low but stable with no statistically significant decline from 6 to 24 months after ICU discharge. Their HRQL at 24 months was not significantly different from HRQL in the COPD reference group.ConclusionsHRQL in COPD survivors after intensive care was low but did not decline from 6 to 24 months after discharge from ICU. Furthermore, HRQL at 24 months was similar to patients with COPD who had not received ICU treatment.

Project description:BackgroundIntensive care unit (ICU) survivors often suffer from cognitive, physical and mental impairments, known as post-intensive care syndrome (PICS). ICU follow-up clinics may improve aftercare of these patients. There is a lack of evidence whether or which concept of an ICU follow-up clinic is effective. Within the PINA study, a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomised controlled trial (RCT), primarily to evaluate the feasibility and additionally the potential efficacy.Methods/designDesign: Pilot RCT with intervention and control (usual care) arms plus mixed-methods process evaluation.Participants100 ICU patients (50 per arm) of three ICUs in a university hospital (Regensburg, Germany), ≥ 18 years with an ICU stay of > 5 days, a sequential organ failure assessment (SOFA) score > 5 during the ICU stay and a life expectancy of more than 6 months.InterventionThe intervention will contain three components: information, consultation and networking. Information will be available in form of an intensive care guide for patients and next of kin at the ICU and phone support during follow-up. For consultation, patients will visit the ICU follow-up clinic at least once during the first 6 months after discharge from ICU. During these visits, patients will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The networking part (e.g. special referral letter from the ICU follow-up clinic) aims to provide a network of outpatient care providers for former ICU patients. Feasibility Outcomes: Qualitative and quantitative evaluation will be used to explore reasons for non-participation and the intervention´s acceptability to patients and caregivers. Efficacy Outcomes: Health-related quality of life (HRQOL) will be assessed as primary outcome by the physical component score (PCS) of the Short-Form 12 Questionnaire (SF-12). Secondary outcomes encompass further patient-reported outcomes. All outcomes are assessed at 6 months after discharge from ICU.DiscussionThe PINA study will determine feasibility and potential efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multi-centre RCT.Trial registrationClinicalTrials.gov , NCT04186468 . Submitted 2 December 2019.

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A feasibility study of a randomised controlled trial to examine the impact of the ABCDE bundle on quality of life in ICU survivors.

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A feasibility study of a randomised controlled trial to examine the impact of the ABCDE bundle on quality of life in ICU survivors.

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