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Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: a feasibility study protocol.

ABSTRACT: Background:End-stage kidney disease is a life-changing illness. Many patients require haemodialysis, a treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; therefore, they may help address the impact of haemodialysis by improving these outcomes. However, there is a lack of evidence assessing their effectiveness in this population and few randomised controlled trials (RCTs) evaluating the effectiveness of complex arts-based interventions. Methods:The aims of this study are to establish the feasibility of a cluster RCT of an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis through a cluster randomised pilot study, explore the acceptability of the intervention with a process evaluation and explore the feasibility of an economic evaluation. The study will have three phases. The first phase consists of a cluster randomised pilot study to establish recruitment, participation and retention rates. This will involve the recruitment of 30 participants who will be randomly allocated through cluster randomisation according to shift pattern to experimental and control group. The second phase will be a qualitative process evaluation to establish the acceptability of the intervention within a clinical setting. This will involve semi-structured interviews with 13 patients and three focus groups with healthcare professionals. The third phase will be a feasibility economic evaluation to establish the best methods for data collection within a future cluster RCT. Discussion:Arts-based interventions have been shown to improve quality of life in healthcare settings, but there is a lack of evidence evaluating arts-based interventions for patients receiving haemodialysis. This study aims to assess the feasibility of a future cluster RCT assessing the impact of an arts-based intervention on the wellbeing and mental health of patients receiving haemodialysis and identify the key factors leading to successful implementation. The hope is this study will inform a trial that can influence future healthcare policy by providing robust evidence for arts-based interventions within the haemodialysis setting. Trial registration:The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.

SUBMITTER: Carswell C

PROVIDER: S-EPMC6320589 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: a feasibility study protocol.

Carswell Claire C Reid Joanne J Walsh Ian I McAneney Helen H Noble Helen H

Pilot and feasibility studies 20190105

<h4>Background</h4>End-stage kidney disease is a life-changing illness. Many patients require haemodialysis, a treatment that impacts profoundly on quality of life and mental health. Arts-based interventions have been used in other healthcare settings to improve mental health and quality of life; therefore, they may help address the impact of haemodialysis by improving these outcomes. However, there is a lack of evidence assessing their effectiveness in this population and few randomised control ...[more]

PMID: 30622728

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Project description:BackgroundHaemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysis.MethodsA parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation.ResultsOut of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n = 3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n = 11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation.ConclusionAn arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496 .

Project description:BackgroundPatients with end-stage kidney disease, receiving haemodialysis rely increasingly on informal carers to help manage their debilitating chronic disease. Informal carers may experience a negative impact on their quality of life exacting a toll on their physical, social and emotional well-being. Informal carers of patients with end-stage kidney disease receiving haemodialysis have significant unmet needs which may include physical and psychological issues, financial disadvantage and social isolation. Poor experiences of informal carers may also impact the experience of the patients for whom they care. The needs of this group of informal caregivers have been largely neglected, with little emphasis placed on supportive interventions that might assist and support them in their caring role. The aim of this study is therefore to explore the experiences and unmet needs of informal carers of people with end-stage kidney disease receiving haemodialysis and develop a psychosocial intervention to support them in their caring role.MethodsThis qualitative study will include a systematic review, semi-structured interviews with 30 informal carers and focus groups with renal health care professionals. Perceptions of care provision, caregiving experiences as well as contextual factors impacting the design and delivery of a psychosocial intervention for informal carers of patients with end-stage kidney disease, will be explored and will inform the development of a supportive intervention.DiscussionThe needs of informal carers of patients with end-stage kidney disease have been neglected with little emphasis placed on supportive interventions that might assist and support this group in their care giving role. This is in contrast to other chronic disease groups such as stroke, cancer and dementia. In these conditions well developed supportive interventions have significantly improved outcomes in regard to informal caregivers' preparedness, competence, positive emotions and psychological well-being in terms of informal care provision. Support interventions could potentially improve the quality of life of those informal carers who provide care to patients with end-stage kidney disease receiving haemodialysis.

Project description:ObjectiveThe updated 2019 National Kidney Foundation Kidney Disease Outcomes Quality Initiative vascular access guidelines recommend patient-centered, multi-disciplinary construction and regular update of an individualized end-stage kidney disease (ESKD) Life-Plan (LP) for each patient, a dramatic shift from previous recommendations and policy. The objective of this study was to examine barriers and facilitators to implementing the LP among key stakeholders.MethodsSemi-structured individual interviews were analyzed using inductive and deductive coding. Codes were mapped to relevant domains in the Consolidated Framework for Implementation Research (CFIR).ResultsWe interviewed 34 participants: 11 patients with end-stage kidney disease, 2 care partners, and 21 clinicians who care for patients with end-stage kidney disease. In both the clinician and the patient/care partner categories, saturation (where no new themes were identified) was reached at 8 participants. We identified significant barriers and facilitators to implementation of the ESKD LP across three CFIR domains: Innovation, Outer setting, and Inner setting. Regarding the Innovation domain, patients and care partners valued the concept of shared decision-making with their care team (CFIR construct: innovation design). However, both clinicians and patients had significant concerns about the complexity of decision-making around kidney substitutes and the ability of patients to digest the overwhelming amount of information needed to effectively participate in creating the LP (innovation complexity). Clinicians expressed concerns regarding the lack of existing evidence base which limits their ability to effectively counsel patients (innovation evidence base) and the implementation costs (innovation cost). Within the Outer Setting, both clinicians and patients were concerned about performance measurement pressure under the existing "Fistula First" policies and had concerns about reimbursement (financing). In the Inner Setting, clinicians and patients stressed the lack of available resources and access to knowledge and information.ConclusionGiven the complexity of decision-making around kidney substitutes and vascular access, our findings point to the need for implementation strategies, infrastructure development, and policy change to facilitate ESKD LP development.

Project description:BACKGROUND:Cognitive impairment is common in haemodialysis (HD) patients and is associated independently with depression and mortality. This association is poorly understood, and no intervention is proven to slow cognitive decline. There is evidence that cooler dialysis fluid (dialysate) may slow white matter changes in the brain, but no study has investigated the effect of cooler dialysate on cognition. This study addresses whether cooler dialysate can prevent the decline in cognition and improve quality of life (QOL) in HD patients. METHODS:This is a multi-site prospective randomised, double-blinded feasibility trial. SETTING:Four HD units in the UK. PARTICIPANTS AND INTERVENTIONS:Ninety HD patients randomised (1:1) to standard care (dialysate temperature 36.5 °C) or intervention (dialysate temperature 35?°C) for 12?months. PRIMARY OUTCOME MEASURE:Change in cognition using the Montreal Cognitive Assessment (MoCA). SECONDARY OUTCOME MEASURES:Recruitment and attrition rates, reasons for non-recruitment, frequency of intradialytic hypotension, depressive symptom scores, patient and carers burden, a detailed computerised cognitive test and QOL assessments. ANALYSIS:mixed method approach, utilising measurement of cognition, questionnaires, physiological measurements and semi-structured interviews. DISCUSSION:The results of this feasibility trial will inform the design of a future adequately powered substantive trial investigating the effect of dialysate cooling on prevention and/or slowing in cognitive decline in patients undergoing haemodialysis using a computerised battery of neuro-cognitive tests. The main hypothesis that would be tested in this future trial is that patients treated with regular conventional haemodialysis will have a lesser decline in cognitive function and a better quality of life over 1 year by using cooler dialysis fluid at 35?°C, versus a standard dialysis fluid temperature of 36.5?°C. This also should reflect in improvements in their abilities for activities of daily living and therefore reduce carers' burden. If successful, the treatment could be universally applied at no extra cost. TRIAL REGISTRATION:ClinicalTrials.gov NCT03645733 . Registered retrospectively on 24 August 2018.

Project description:BackgroundFrailty is a state of low physiological reserve and multi-systemic dysregulation that leads to susceptibility to external stressors; it is associated with adverse outcomes. North American data suggest that haemodialysis recipients are more likely to be frail than the general population, although data on UK cohorts are lacking. Furthermore, with a multitude of assessment tools, it is difficult for the clinician to ascertain which is most suitable for this population. The FITNESS Study aims to measure the prevalence and outcomes associated with frailty in a large UK haemodialysis cohort to determine the optimum frailty tool as defined by predictive value for mortality/hospitalisation and to conduct a feasibility study exploring a multi-disciplinary clinical intervention to improve frailty among haemodialysis recipients.Methods/designThe study will follow a cohort multiple randomised controlled trial design; the initial cohort study will identify participants to be invited into a subsequent open-label randomised controlled trial. Eligible patients will be identified and recruited from their usual haemodialysis session. They will be invited to complete tasks and questionnaires collecting data on sarcopenia, immunosenescence, mood, cognition, disability, and comorbidity. Fifty pre-frail participants with suitable English proficiency will be randomly selected from this cohort to participate in the randomised controlled trial phase of the study. Further stratified randomisation will occur to assign these 50 participants to active or passive groups. The active group will receive a psychologically supported, patient-centred, multi-disciplinary intervention into frailty, in what we believe to be a first within this patient group. The control group will receive usual haemodialysis standard of care. All participants will be followed up using electronic patient records for outcomes to include hospitalisation and mortality. Primary outcomes for this phase of the study will be feasibility and tolerability of the clinical intervention study.DiscussionThe study will collect data on multiple aspects of frailty allowing for a rich dataset for detailed analysis. We believe this will be the first study to explore a psychologically supported, patient-centred intervention in this patient group.Trial registrationClinicaltrials.gov, NCT03071107 . Registered on 6 March 2017.

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Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: a feasibility study protocol.

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Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: a feasibility study protocol.

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