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Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol.

ABSTRACT: INTRODUCTION:People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients' needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy. METHODS AND ANALYSIS:The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care--routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention. ETHICS AND DISSEMINATION:This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance. TRAIL REGISTRATION NUMBER:Clinical Trials.gov NCT02274701.

SUBMITTER: Snowden A

PROVIDER: S-EPMC4431131 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol.

Snowden Austyn A Young Jenny J White Craig C Murray Esther E Richard Claude C Lussier Marie-Therese MT MacArthur Ewan E Storey Dawn D Schipani Stefano S Wheatley Duncan D McMahon Jeremy J Ross Elaine E

BMJ open 20150511 5

<h4>Introduction</h4>People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients' needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and ( ...[more]

PMID: 25967990

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Project description:IntroductionUnmet needs in patients with cancer and their carers are common but poorly identified and addressed. The Needs Assessment Tool-Cancer (NAT-C) is a structured consultation guide to identify and triage patient and carer unmet needs. The NAT-C is validated, but its effectiveness in reducing unmet patient and carer needs in primary care is unknown.Methods and analysisCluster randomised controlled trial with internal pilot and embedded process evaluation to test the clinical and cost effectiveness of the NAT-C in primary care for people with active cancer in reducing unmet patient and carer need, compared with usual care. We will recruit 1080 patients with active cancer (and carers if relevant) from 54 general practices in England.Participating practices will be randomised 1:1 to either deliver an NAT-guided clinical consultation plus usual care or to usual care alone. Consenting participants with active cancer and their carers (if nominated) will be asked to complete study questionnaires at baseline, 1 and 3 months for all, 6 months except for those recruited outside of the last 3 months of recruitment, and attend an NAT-C appointment if allocated to an intervention practice. An internal pilot will assess: site and participant recruitment, intervention uptake and follow-up rates. The primary outcome, the proportion of patients with an unmet need on the Supportive Care Needs Survey Short Form 34 at 3 months postregistration, will be analysed using a multilevel logistic regression. Mixed-methods process evaluation informed by Normalisation Process Theory will use quantitative survey and interview data from clinicians and key stakeholders in cancer care to develop an implementation strategy for nationwide rollout of the NAT-C if the intervention is cost-effective.Ethics and disseminationEthical approval from London-Surrey REC (20/LO/0312). Results will be peer-reviewed, published and made available to research participants.Trial registration numberISRCTN15497400.

Project description:BACKGROUND:Despite evidence from clinical trials that intravenous (IV) thrombolysis is a cost-effective treatment for selected acute ischaemic stroke patients, there remain large variations in the rate of IV thrombolysis delivery between stroke services. This study is evaluating whether an enhanced care pathway delivered by paramedics (the Paramedic Acute Stroke Treatment Assessment (PASTA)) could increase the number of patients who receive IV thrombolysis treatment. METHODS:Study design: Cluster randomised trial with economic analysis and parallel process evaluation. SETTING:National Health Service ambulance services, emergency departments and hyper-acute stroke units within three geographical regions of England and Wales. Randomisation: Ambulance stations within each region are the units of randomisation. According to station allocation, paramedics based at a station deliver the PASTA pathway (intervention) or continue with standard stroke care (control). Study intervention: The PASTA pathway includes structured pre-hospital information collection, prompted pre-notification, structured handover of information in hospital and assistance with simple tasks during the initial hospital assessment. Study-trained intervention group paramedics deliver this pathway to adults within 4 h of suspected stroke onset. Study control: Standard stroke care according to national and local guidelines for the pre-hospital and hospital assessment of suspected stroke. PARTICIPANTS:Participants enrolled in the study are adults with confirmed stroke who were assessed by a study paramedic within 4 h of symptom onset. PRIMARY OUTCOME:Proportion of participants receiving IV thrombolysis. SAMPLE SIZE:1297 participants provide 90% power to detect a 10% difference in the proportion of patients receiving IV thrombolysis. DISCUSSION:The results from this trial will determine whether an enhanced care pathway delivered by paramedics can increase thrombolysis delivery rates. TRIAL REGISTRATION:ISRCTN registry, ISRCTN12418919 . Registered on 5 November 2015.

Project description:INTRODUCTION:Current guidelines recommend tailored interventions to optimise knee osteoarthritis (OA) management. However, models of care still have a 'one size fits all' approach, which is suboptimal as it ignores patient heterogeneity. This study aims to compare a stepped care strategy with standard care for overweight and obese persons with medial tibiofemoral OA. METHODS AND ANALYSIS:Participants will be randomised into two groups (85 each). The intervention will receive a diet and exercise programme for 18 weeks in the first step of the study. Disease remission will then be assessed using the Patient Acceptable Symptom State (PASS). PASS is defined as the highest level of symptom beyond which patients consider themselves well and takes into account pain intensity, patient's global assessment of disease activity and degree of functional impairment. In the second step, participants in remission will continue with diet and exercise. If remission is not achieved, participants will be assigned in a hierarchical order to cognitive behavioural therapy, knee brace or muscle strengthening for 12 weeks. The intervention will be decided based on their clinical presentation for symptoms of depression and varus malalignment. Participants without depression or varus malalignment will undertake a muscle strengthening programme. The control group will receive educational material related to OA management. Main inclusion criteria are age ?50 years, radiographic medial tibiofemoral OA, body mass index (BMI) ?28?kg/m2, knee pain ?40 (Visual Analogue Scale, 0-100), PASS (0-100) >32 for pain and global assessment, and 31 for functional impairment. Outcomes will be measured at 20-week and 32-week visits. The primary outcome is disease remission at 32 weeks. Other outcomes include functional mobility; patient-reported outcomes; BMI; waist-hip ratio; quadriceps strength; symptoms of depression, anxiety and stress; and knee range of motion. The analysis will be performed according to the intention-to-treat principle. ETHICS AND DISSEMINATION:The local ethics committee approved this protocol (HREC/14/HAWKE/381). Dissemination will occur through presentations at international conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12615000227594.

Project description:The potential of technology to aid integration of care delivery systems is being explored in a range of contexts across a variety of conditions in the United Kingdom. Prostate cancer is the most common cancer in UK men. With a 10-year survival rate of 84%, there is a need to explore innovative methods of care that are integrated between primary health care providers and specialist teams in order to address long-term consequences of the disease and its treatment as well as to provide continued monitoring for recurrence.Our aim was to test the feasibility of a randomized controlled trial to compare a model of prostate cancer continuing and follow-up care integration, underpinned by digital technology, with usual care in terms of clinical and cost-effectiveness, patient-reported outcomes, and experience.A first phase of the study has included development of an online adaptive prostate specific Holistic Needs Assessment system (HNA), training for primary care-based nurses, training of an IT peer supporter, and interviews with health care professionals and men with prostate cancer to explore views of their care, experience of technology, and views of the proposed intervention. In Phase 2, men in the intervention arm will complete the HNA at home to help identify and articulate concerns and share them with their health care professionals, in both primary and specialist care. Participants in the control arm will receive usual care. Outcomes including quality of life and well-being, prostate-specific concerns, and patient enablement will be measured 3 times over a 9-month period.Findings from phase 1 indicated strong support for the intervention among men, including those who had had little experience of digital technology. Men expressed a range of views on ways that the online system might be used within a clinical pathway. Health care professionals gave valuable feedback on how the output of the assessment might be presented to encourage engagement and uptake by clinical teams. Recruitment to the second phase of the study, the feasibility trial, commenced March 2017.To our knowledge, this study is the first in the United Kingdom to trial an online holistic needs assessment for men with prostate cancer, with data shared between patients and primary and secondary care providers. This study addresses recommendations in recent policy documents promoting the importance of data sharing and enhanced communication between care providers as a basis for care integration. We anticipate that this model of care will ultimately provide important benefits for both patients and the National Health Service.International Standard Randomized Controlled Trial Number (ISRCTN): 31380482; http://www.isrctn.com/ISRCTN31380482 (Archived by WebCite at http://www.webcitation.org/6s8I42u5N).

Project description:BackgroundThe prevalence of mental health problems in childhood and adolescence has increased significantly, not least due to the COVID-19 pandemic in Germany and other countries worldwide. Although holistic school interventions to promote mental health and prevent mental health problems are considered promising, there is currently uncertainty about their effectiveness due to evaluation studies with heterogeneous methodological quality. This paper presents the study protocol for the evaluation of the primary school module of MindMatters.MethodsAs part of a universal mental health intervention, the MindMatters primary school module 'Learning Together with Emotions' aims to promote social-emotional learning (SEL) in the classroom across five skill areas. In addition to classroom activities, the intervention includes a school development module to help primary schools create structures and processes to maintain and promote mental health. To evaluate the effectiveness of the intervention, a two-arm cluster-randomised controlled trial will be conducted, including schools implementing MindMatters over a 12-month period and a control group with no access to the intervention. Data will be collected before and 18 months after initiation of the intervention. Controlled for baseline conditions, multilevel regression analysis will be used to examine primary intervention outcomes at the pupil level (i.e. reductions in mental and behavioural problems). Further mediation and moderation analyses will examine whether proximal outcomes predict changes in mental health outcomes and whether school-level factors influence the effectiveness of the intervention.DiscussionThis study will contribute to strengthen the evidence base for holistic school (mental) health promotion interventions using a study design with high internal validity. Based on an intervention model, the results will not only provide insights into the relationship between proximal and distal outcomes, but will also allow conclusions to be drawn about how the implementation of the intervention affects its effectiveness. Finally, the findings also address the question of whether improved mental health has a positive effect on primary school pupils' academic performance.Trial registrationGerman Clinical Trials Register DRKS00023762. Registered on 5 January 2021.

Project description:BACKGROUND:Transfer of residential aged-care facility (RACF) residents to Emergency Departments (ED) is common, risky and expensive. RACF residents who present to ED are more likely to have hospital readmissions, longer stays and face major risks related to hospital acquired complications. Aged Care Emergency services (ACE) is a nurse led, protocol- guided, telephone RACF/ED outreach model that has been shown to be effective in reducing hospitalisation and length of hospital stay for RACF residents in the Hunter New England Local Health District, New South Wales (NSW). The Partnerships in Aged-Care Emergency services using Interactive Telehealth (PACE-IT) project enhances ACE by incorporating interactive video assessment and consultation. The PACE-IT project's primary aim is to assess whether augmentation of ACE services through the addition of protocol-guided interactive Visual Telehealth Consultation (VTC) for clinical decision-making, plus telephone follow-up, reduces RACF resident transfers to ED. METHODS:A stepped-wedge cluster randomised controlled trial will be conducted. The intervention will be delivered sequentially to 8 clusters; each cluster comprises one ED and two RACFs in NSW, Australia. The 16 RACFs in the study will be selected for order of implementation using a computer-generated randomisation sequence. A 2-step randomisation process will be undertaken, randomising the hospital EDs first and then randomising the RACFs aligned with each hospital. The PACE-IT intervention comprises: an initial phone call by RACFs to the ACE service in the ED; the ACE service in ED responds with a protocol-guided VTC, a management plan agreed between all participants; an automated consultation summary letter to the General Practitioner and the RACF; a post VTC 24?h follow-up phone call to the RACF. DISCUSSION:If shown to be effective, the intervention has the potential to improve the clinical care and quality of life for residents. Findings will provide high level evidence that will inform sustainable change and broad translation into practice across NSW. It will show how the change has been achieved and highlight success factors for scalability and sustainability. It will inform review of processes, the development of policy and guidelines that will integrate PACE-IT into existing service models in NSW. TRIAL REGISTRATION:The trial is registered with the Australian New Zealand Clinical Trials Registry (Trial ID ACTR N12619001692123 ) 02/12/2020.).

Project description:INTRODUCTION:It is unclear whether advance care planning (ACP) undertaken with patients living in the community can improve patient care and avoid unwanted interventions and hospital admissions. We have designed a randomised controlled trial (RCT) to examine if ACP undertaken with patients with advanced illnesses attending hospital outpatient clinics can reduce unplanned hospital admissions and improve patient and caregiver well-being. METHODS AND ANALYSIS:Pragmatic RCT involving patients from subspecialty outpatient clinics at five clinical sites in Sydney, Australia. Participants will be ≥18 years screened as potentially having palliative care needs and at risk of dying in 6-12 months. The patients will be randomised to intervention or control group. Intervention group will undertake ACP discussions facilitated by a trained health professional. The control group will receive written information on ACP, representing the current standard of care. The primary outcome is the number of unplanned hospital admissions at the 6-month follow-up. Secondary outcomes include: (i) patient's health-related quality-of-life and quality of chronic disease care; (ii) caregiver's health-related quality-of-life and caregiver burden and (iii) other health outcomes including ambulance usage, emergency department presentations, hospital admissions, resuscitation attempts, intensive care unit admissions, deaths, documentation of patient wishes in patient records and audit of ACP discussions and documents. The staff's self-reported attitudes and knowledge of ACP will also be measured. The data will be collected using self-report questionnaires, hospital records audit, audit of ACP documentation and data linkage analysis. Semistructured interviews and focus group discussions with patients, caregivers and healthcare professionals will explore the acceptability and feasibility of the intervention. ETHICS AND DISSEMINATION:Approved by South-East Sydney Local Health District Human Research Ethics Committee and NSW Population and Health Services Research Ethics Committee. Results will be disseminated via conference presentations, journal publications, seminars and invited talks. TRIAL REGISTRATION NUMBER:ACTRN12617000280303.

Project description:BackgroundWhile existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing.MethodsWe aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT.DiscussionWe will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample.Trial registrationISCRTN85278228, registered 27/03/2017.

Dataset Information

Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol.

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Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol.

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