scholarly journals Study protocol: delayed intervention randomised controlled trial within the Medical Research Council (MRC) Framework to assess the effectiveness of a new palliative care service

2006 ◽  
Vol 5 (1) ◽  
Author(s):  
Irene J Higginson ◽  
Bella Vivat ◽  
Eli Silber ◽  
Tariq Saleem ◽  
Rachel Burman ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Research Council ◽  
Medical Research Council ◽  
Care Service ◽  
Controlled Trial ◽  
Palliative Care Service ◽  
Mrc Framework ◽  
Randomised Controlled ◽  
Delayed Intervention

scholarly journals An Exploratory, Cluster Randomised Control Trial of the PAX Good Behaviour Game

2021 ◽  
Vol 9 (4) ◽  
pp. 47-59
Author(s):  
Joanne O’Keeffe ◽  
Allen Thurston ◽  
Frank Kee ◽  
Liam O'Hare ◽  
Katrina Lloyd
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Northern Ireland ◽  
Research Council ◽  
Medical Research Council ◽  
Controlled Trial ◽  
Self Regulation ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
Good Behaviour

This article presents the findings of an exploratory randomised controlled trial of the PAX Good Behaviour Game (PAX GBG) in Northern Ireland. The PAX GBG is an evidence‐based universal prevention programme designed to improve mental health by increasing self‐regulation, academic engagement, and decreasing disruptive behaviour in children. The study was designed in line with the Medical Research Council guidance on the development of complex interventions and is based on the Medical Research Council framework, more specifically within a Phase 2 exploratory trial. The study used a cluster randomised controlled trial design with a total of 15 schools (19 classes) randomised to intervention and control. This article reports specifically on the outcome of self‐regulation with 355 elementary school pupils in year 3 (age M = 7.40, SD = 0.30). Participating schools in the trial were located in areas of socio‐economic disadvantage. The teachers in the intervention group received training in the delivery of the PAX GBG and implemented the PAX GBG intervention for 12 weeks. A range of pre‐ and post‐test measures, including child reported behaviours, were undertaken. After the 12 weeks of implementation, this exploratory trial provided some evidence that the PAX GBG may help improve self‐regulation (d = .42) in participating pupils, while the findings suggest that it may offer a feasible mental health prevention and early intervention approach for Northern Ireland classrooms. However, a larger definitive trial would be needed to verify the findings in this study.

scholarly journals Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025692 ◽  
Author(s):  
Corita R Grudzen ◽  
Deborah J Shim ◽  
Abigail M Schmucker ◽  
Jeanne Cho ◽  
Keith S Goldfeld
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Randomised Controlled ◽  
End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

scholarly journals Effect of home-based specialised palliative care and dyadic psychological intervention on caregiver anxiety and depression: a randomised controlled trial

2018 ◽  
Vol 119 (11) ◽  
pp. 1307-1315 ◽  
Author(s):  
Annika von Heymann-Horan ◽  
Pernille Bidstrup ◽  
Mai-Britt Guldin ◽  
Per Sjøgren ◽  
Elisabeth Anne Wreford Andersen ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Home Based ◽  
Randomised Controlled ◽  
Caregiver Anxiety

35 Online randomised controlled trial to improve clinical estimates of survival (ORACLES): study design

2018 ◽  
Vol 8 (3) ◽  
pp. 373.1-373 ◽  
Author(s):  
Linda Oostendorp ◽  
Nicola White ◽  
Priscilla Harries ◽  
Sarah Yardley ◽  
Christopher Tomlinson ◽  
...  
Keyword(s):  
Palliative Care ◽  
Medical Students ◽  
Randomised Controlled Trial ◽  
Care Pathway ◽  
Low Cost ◽  
Controlled Trial ◽  
Online Training ◽  
List Type ◽  
More Care ◽  
Randomised Controlled

IntroductionClinicians often struggle to recognise whether palliative care patients are imminently dying.1 2 A previous study identified the factors that expert palliative care doctors (with demonstrated prognostic skills) had used to judge the probability of patients dying within 72 hours.Aim and methodsTo evaluate whether an online training resource can teach medical students to formulate survival estimates for palliative care patients that are more similar to experts’ estimates. In this online randomised controlled trial we will recruit 128 students in the penultimate/final year of medical school. Participants are asked to review three series of vignettes describing patients referred to palliative care and provide estimates (0%–100%) about the probability that patients will die within 72 hours. After the first series of vignettes students in the intervention arm are given access to the training resource showing how experts weighted the various symptoms/signs. Participants are asked to complete a second series of vignettes and then a third series after two weeks to assess if any effect has been maintained.ResultsStudents’ survival estimates will be correlated with experts’ estimates to determine the baseline level of agreement and any changes following the intervention. The primary outcome will be the survival estimates provided in the second series of vignettes. Secondary outcomes include the estimates provided at the follow-up the weighting of symptoms/signs and levels of discrimination and consistency.ConclusionThis study will provide evidence about whether a brief low-cost online training resource can influence how medical students make prognostic decisions in an experimental setting.References. Neuberger J. More care less pathway: A review of the liverpool care pathway.Department of Health2013. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/212450/Liverpool_Care_Pathway.pdf [Accessed: 30thMay 2018]. White N, Reid F, Harris A, Harries P, Stone P. A systematic review of predictions of survival in palliative care: How accurate are clinicians and who are the experts?PLoS One25 August 2016;11(8):e0161407. Available from: http://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0161407&type=printable [Accessed: 30th May 2018]

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