Dataset Information

Hospital at Home care for older patients with cognitive impairment: a protocol for a randomised controlled feasibility trial.

ABSTRACT:

Introduction

An acute hospital admission is a stressful life event for older people, particularly for those with cognitive impairment. The hospitalisation is often complicated by hospital-associated geriatric syndromes, including delirium and functional loss, leading to functional decline and nursing home admission. Hospital at Home care aims to avoid hospitalisation-associated adverse outcomes in older patients with cognitive impairment by providing hospital care in the patient's own environment.

Methods and analysis

This randomised, non-blinded feasibility trial aims to assess the feasibility of conducting a randomised controlled trial in terms of the recruitment, use and acceptability of Hospital at Home care for older patients with cognitive impairment. The quality of care will be evaluated and the advantages and disadvantages of the Hospital at Home care programme compared with usual hospital care. Eligible patients will be randomised either to Hospital at Home care in their own environment or usual hospital care. The intervention consists of hospital level care provided at patients' homes, including visits from healthcare professionals, diagnostics (laboratory tests, blood cultures) and treatment. The control group will receive usual hospital care. Measurements will be conducted at baseline, during admission, at discharge and at 3 and 6?months after the baseline assessment.

Ethics and dissemination

Institutional ethics approval has been granted. The findings will be disseminated through public lectures, professional and scientific conferences, as well as peer-reviewed journal articles. The study findings will contribute to knowledge on the implementation of Hospital at Home care for older patients with cognitive disorders. The results will be used to inform and support strategies to deliver eligible care to older patients with cognitive impairment.

Trial registration number

e020313; Pre-results.

SUBMITTER: Pouw MA

PROVIDER: S-EPMC5875621 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Hospital at Home care for older patients with cognitive impairment: a protocol for a randomised controlled feasibility trial.

Pouw Maaike A MA Calf Agneta H AH van Munster Barbara C BC Ter Maaten Jan C JC Smidt Nynke N de Rooij Sophia E SE

BMJ open 20180327 3

<h4>Introduction</h4>An acute hospital admission is a stressful life event for older people, particularly for those with cognitive impairment. The hospitalisation is often complicated by hospital-associated geriatric syndromes, including delirium and functional loss, leading to functional decline and nursing home admission. Hospital at Home care aims to avoid hospitalisation-associated adverse outcomes in older patients with cognitive impairment by providing hospital care in the patient's own en ...[more]

PMID: 29593022

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Project description:IntroductionIn Germany, an efficient and feasible transition from hospital to home for older patients, ensuring continuous care across healthcare settings, has not yet been applied and evaluated. Based on the transitional care model (TCM), this study aims to reduce preventable readmissions of patients ?75 years of age with a transitional care intervention performed by geriatric-experienced care professionals. The study investigates whether the intervention ensures continuous care during transition and stabilises the care situation of patients at home.Methods and analysesRandomised controlled clinical trial, recruiting between 25 April 2018 and 31 December 2019 in one German hospital in the city of Regensburg. The intervention group is supported by care professionals in the transition process from hospital to home for up to 12 months. Based on TCM, the intervention includes an individual care plan according to a patient's symptoms, risks, needs and values. The plan is advanced in the domestic situation via personal visits and telephone contacts. All necessary care actions regarding, for example, mobility, residence adjustments, or nutrition, are initiated to be executed by ambulant care services, and are monitored, evaluated and adapted if necessary. In supervising the care plan, the care professionals do not administer active care services themselves but coordinate them. Patients and their caregivers are actively engaged in the care planning and execution. In contrast, the control group receives only usual discharge planning in the hospital and usual ambulatory care.The primary outcome is the all-cause readmission rate assessed using health insurance data within a follow-up of up to 12 months after hospital discharge. Secondary outcomes include care quality, mobility, nutritional and wound situation, and health-related quality of life. They are assessed at baseline, after 1 month, 3 months, 6?months, and at the end of study visit. Additionally, the economic efficiency of the intervention will be evaluated.Ethics and disseminationEthics approval for the trial was obtained from the Ethics Committee of the Friedrich-Alexander-Universität Erlangen-Nürnberg. Results will be published in peer-reviewed, open-access scientific journals and disseminated at national and international research conferences and through public presentations in the geriatric and healthcare community.Trial registrationClinicalTrials.gov identifier: NCT03513159.

Project description:BackgroundIn the healthcare system in Germany, different institutions and actors play specific roles in the discharge and transition of patients from hospitals into primary care (Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen, Wettbewerb an der Schnittstelle zwischen ambulanter und stationärer Gesundheitsversorgung, 2012). However, there are shortcomings in these intersectoral transitions. Especially in older people with cognitive impairment (PCI), discharge management often lacks coordination and cooperation between healthcare providers. This frequently results in higher rates of unscheduled readmission. The project intersec-CM is a randomised controlled trial (RCT) that aims to explore up to what extent an intersectoral care management (ICM) can improve this transition. This ICM is delivered by nurses with special training in care management. The objective of this paper is to describe a mixed-methods process evaluation of the intersectoral care management intervention and the factors that facilitate and inhibit its implementation.MethodsDifferent study designs for process evaluations from previous literature were collected and analysed according to the dimension implementation fidelity, satisfaction with the intervention, feasible transfer into routine care, optimum point of time, frequency and execution of the intervention, and context factors.ResultsThe actor-network theory was chosen as the theoretic framework for the process evaluation. Based on this theory, a mixed-methods design was developed to combine and integrate qualitative and quantitative evaluation methods. The qualitative part includes semi-structured interviews using topic guides (phase 1) and later in-depth interviews with narrative portions (phase 3), which will be analysed by using the qualitative content analysis according to Kuckartz. The quantitative survey (phase 2) is conducted with standardised questionnaires.DiscussionChallenges in data collection include the development of interview guidelines, which require different terminologies depending on every specific actor targeted in the intervention. Conducting the interviews, there is a risk of misunderstanding the older PCI by the interviewer and vice versa. However, the combination of qualitative and quantitative approaches as different techniques of process evaluation may help to capture, integrate and analyse data on different dimensions of the intervention.ConclusionsThe results of our process evaluation may serve as an implementation guideline for intersectoral care management in the German healthcare system. Furthermore, the approach to evaluate the process of a complex intervention in health care for older PCI may serve as a stimulus to broaden the evidence base also of other complex intervention studies to improve health care for this vulnerable group. The study was ethically approved by the Ethics Committee of the Ernst-Moritz-Arndt University of Greifswald. The study has been registered at the U.S. National Library of Medicine.Trial registrationClinicalTrials.gov NCT03359408 . Registered on 2 December 2017. The approximate date when recruitment to the process evaluation of the study will be completed is 31 May 2021.

Project description:IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers' health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers' health-related quality of life (HRQOL) after care recipients' hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient's discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30-45 min telephone support sessions over 6 months. The primary outcome is caregivers' HRQOL measured using the Assessment of Quality of Life-eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

Project description:IntroductionCommunity-dwelling older adults living with subjective cognitive decline or mild cognitive impairment may experience decreased efficiency in their overall functional performance. This decreased cognitive efficiency may result in anxiety, low mood, perceived stress and decreased emotional well-being and quality-of-life. These psychological symptoms may further exacerbate cognitive decline.Exploring non-pharmacological interventions such as mindfulness within primary care is vital in enabling individuals to develop strategies to manage cognitive impairment or psychological symptoms. Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated. The primary objective of this study is to explore the feasibility of conducting a randomised controlled trial of an occupational therapist-led MBSR programme within primary care.MethodsConvergent mixed-methods, randomised control feasibility trial with 40 participants from an interprofessional primary care team in Toronto, Ontario. Participants are randomised into the 8-week MBSR group or wait-list control will be compared at baseline, postintervention and 4weeks follow-up. The primary aim is to determine the feasibility of the intervention with this population and setting. The secondary aim is to examine perceived satisfaction with functional performance as measured by the Canadian Occupational Performance Measure. Secondary clinical outcomes include psychological symptoms.AnalysisInvestigators will analyse the quantitative and qualitative data strands separately. Descriptive statistics, focus group and interviews will then be merged and further analysed to best understand the feasibility and preliminary clinical outcomes from the study.Ethics and disseminationThe study is approved by Women's College Hospital (2017-0056-E), and Queen's University, Kingston, Ontario (6026418). The study will follow Standard Protocol Items: Recommendations for Interventional Trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.Trial registration numberNCT03867474; Pre-results.

Project description:ObjectiveTo develop and evaluate a best practice model of general hospital acute medical care for older people with cognitive impairment.DesignRandomised controlled trial, adapted to take account of constraints imposed by a busy acute medical admission system.SettingLarge acute general hospital in the United Kingdom.Participants600 patients aged over 65 admitted for acute medical care, identified as "confused" on admission.InterventionsParticipants were randomised to a specialist medical and mental health unit, designed to deliver best practice care for people with delirium or dementia, or to standard care (acute geriatric or general medical wards). Features of the specialist unit included joint staffing by medical and mental health professionals; enhanced staff training in delirium, dementia, and person centred dementia care; provision of organised purposeful activity; environmental modification to meet the needs of those with cognitive impairment; delirium prevention; and a proactive and inclusive approach to family carers.Main outcome measuresPrimary outcomenumber of days spent at home over the 90 days after randomisation.Secondary outcomesstructured non-participant observations to ascertain patients' experiences; satisfaction of family carers with hospital care. When possible, outcome assessment was blind to allocation.ResultsThere was no significant difference in days spent at home between the specialist unit and standard care groups (median 51 v 45 days, 95% confidence interval for difference -12 to 24; P=0.3). Median index hospital stay was 11 versus 11 days, mortality 22% versus 25% (-9% to 4%), readmission 32% versus 35% (-10% to 5%), and new admission to care home 20% versus 28% (-16% to 0) for the specialist unit and standard care groups, respectively. Patients returning home spent a median of 70.5 versus 71.0 days at home (-6.0 to 6.5). Patients on the specialist unit spent significantly more time with positive mood or engagement (79% v 68%, 2% to 20%; P=0.03) and experienced more staff interactions that met emotional and psychological needs (median 4 v 1 per observation; P<0.001). More family carers were satisfied with care (overall 91% v 83%, 2% to 15%; P=0.004), and severe dissatisfaction was reduced (5% v 10%, -10% to 0%; P=0.05).ConclusionsSpecialist care for people with delirium and dementia improved the experience of patients and satisfaction of carers, but there were no convincing benefits in health status or service use. Patients' experience and carers' satisfaction might be more appropriate measures of success for frail older people approaching the end of life.Trial registrationClinical Trials NCT01136148.

Project description:The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT).Adolescents aged 12-18 with low mood/depression, (scoring ?20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness.The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).ISRCTN31219579.

Dataset Information

Hospital at Home care for older patients with cognitive impairment: a protocol for a randomised controlled feasibility trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Hospital at Home care for older patients with cognitive impairment: a protocol for a randomised controlled feasibility trial.

Similar Datasets

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