BACKGROUND:Patients admitted to hospital with a terminal illness and uncertain recovery often receive inconsistent care and do not have the opportunity to die in their preferred place of death. Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to remedy this. It has not been evaluated in a randomised trial, but a definitive trial would face many hurdles. OBJECTIVE: To optimise the design of and determine the feasibility of a pragmatic, multicentre, cluster randomised controlled trial of the AMBER care bundle compared with best standard care. DESIGN: A feasibility cluster randomised controlled trial including semistructured interviews with patients and relatives, focus groups with health-care professionals, non-participant observations of multidisciplinary team meetings, a standard care survey, heat maps and case note reviews. Retrospective data were collected from the family or close friends of deceased patients via a bereavement survey. SETTING: Four general medical wards at district general hospitals in England. PARTICIPANTS: There were 65 participants (control, n = 36; intervention, n = 29). There were 24 interviews, four focus groups, 15 non-participant meeting observations, six case note reviews and three heat maps, and 15 of out 23 bereavement, standard care surveys were completed. INTERVENTION: The AMBER care bundle is implemented by a nurse facilitator. It includes the development and documentation of a medical plan, consideration of outcomes, resuscitation and escalation status and daily plan revisiting. The AMBER care bundle encourages staff, patients and families to talk openly about their preferences and priorities should the worst happen. MAIN OUTCOME MEASURES: Two 'candidate' primary outcomes were selected to be evaluated for a future definitive trial: Integrated Palliative care Outcome Scale patient/family anxiety and communication subscale and 'howRwe'. The secondary outcome measures were Integrated Palliative care Outcome Scale symptoms, Australian-modified Karnofsky Performance Status scale, EuroQol-5 Dimensions, five-level version, Client Service Receipt Inventory, recruitment rate, intervention fidelity and intervention acceptability. RESULTS: Data were collected for 65 patients. This trial was not powered to measure clinical effectiveness, but variance and changes observed in the Integrated Palliative care Outcome Scale subscale indicated that this measure would probably detect differences within a definitive trial. It was feasible to collect data on health, social and informal care service use and on quality of life at two time points. The AMBER care bundle was broadly acceptable to all stakeholders and was delivered as planned. The emphasis on 'clinical uncertainty' prompted health-care professional awareness of often-overlooked patients. Reviewing patients' AMBER care bundle status was integrated into routine practice. Refinements included simplifying the inclusion criteria and improving health-care professional communication training. Improvements to trial procedures included extending the time devoted to recruitment and simplifying consent procedures. There was also a recommendation to reduce data collected from patients and relatives to minimise burden. LIMITATIONS: The recruitment rate was lower than anticipated. The inclusion criteria for the trial were difficult to interpret. Information sheets and consent procedures were too detailed and lengthy for the target population. Health-care professionals' enthusiasm and specialty were not considered while picking trial wards. Participant recruitment took place later during hospital admission and the majority of participants were lost to follow-up because they had been discharged. Those who participated may have different characteristics from those who did not. CONCLUSIONS: This feasibility trial has demonstrated that an evaluation of the AMBER care bundle among an acutely unwell patient population, although technically possible, is not practical or feasible. The intervention requires optimisation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36040085. National Institute for Health Research (NIHR) Portfolio registration number 32682. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 55. See the NIHR Journals Library website for further project information.
RCT Entities:
BACKGROUND:Patients admitted to hospital with a terminal illness and uncertain recovery often receive inconsistent care and do not have the opportunity to die in their preferred place of death. Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to remedy this. It has not been evaluated in a randomised trial, but a definitive trial would face many hurdles. OBJECTIVE: To optimise the design of and determine the feasibility of a pragmatic, multicentre, cluster randomised controlled trial of the AMBER care bundle compared with best standard care. DESIGN: A feasibility cluster randomised controlled trial including semistructured interviews with patients and relatives, focus groups with health-care professionals, non-participant observations of multidisciplinary team meetings, a standard care survey, heat maps and case note reviews. Retrospective data were collected from the family or close friends of deceased patients via a bereavement survey. SETTING: Four general medical wards at district general hospitals in England. PARTICIPANTS: There were 65 participants (control, n = 36; intervention, n = 29). There were 24 interviews, four focus groups, 15 non-participant meeting observations, six case note reviews and three heat maps, and 15 of out 23 bereavement, standard care surveys were completed. INTERVENTION: The AMBER care bundle is implemented by a nurse facilitator. It includes the development and documentation of a medical plan, consideration of outcomes, resuscitation and escalation status and daily plan revisiting. The AMBER care bundle encourages staff, patients and families to talk openly about their preferences and priorities should the worst happen. MAIN OUTCOME MEASURES: Two 'candidate' primary outcomes were selected to be evaluated for a future definitive trial: Integrated Palliative care Outcome Scale patient/family anxiety and communication subscale and 'howRwe'. The secondary outcome measures were Integrated Palliative care Outcome Scale symptoms, Australian-modified Karnofsky Performance Status scale, EuroQol-5 Dimensions, five-level version, Client Service Receipt Inventory, recruitment rate, intervention fidelity and intervention acceptability. RESULTS: Data were collected for 65 patients. This trial was not powered to measure clinical effectiveness, but variance and changes observed in the Integrated Palliative care Outcome Scale subscale indicated that this measure would probably detect differences within a definitive trial. It was feasible to collect data on health, social and informal care service use and on quality of life at two time points. The AMBER care bundle was broadly acceptable to all stakeholders and was delivered as planned. The emphasis on 'clinical uncertainty' prompted health-care professional awareness of often-overlooked patients. Reviewing patients' AMBER care bundle status was integrated into routine practice. Refinements included simplifying the inclusion criteria and improving health-care professional communication training. Improvements to trial procedures included extending the time devoted to recruitment and simplifying consent procedures. There was also a recommendation to reduce data collected from patients and relatives to minimise burden. LIMITATIONS: The recruitment rate was lower than anticipated. The inclusion criteria for the trial were difficult to interpret. Information sheets and consent procedures were too detailed and lengthy for the target population. Health-care professionals' enthusiasm and specialty were not considered while picking trial wards. Participant recruitment took place later during hospital admission and the majority of participants were lost to follow-up because they had been discharged. Those who participated may have different characteristics from those who did not. CONCLUSIONS: This feasibility trial has demonstrated that an evaluation of the AMBER care bundle among an acutely unwell patient population, although technically possible, is not practical or feasible. The intervention requires optimisation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36040085. National Institute for Health Research (NIHR) Portfolio registration number 32682. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 55. See the NIHR Journals Library website for further project information.
Entities:
Keywords:
CLINICAL UNCERTAINTY; COMPLEX INTERVENTION; END OF LIFE CARE; FEASIBILITY CLUSTER RCT; MIXED METHODS; OUTCOMES; PALLIATIVE CARE
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