scholarly journals Community-based short-term integrated palliative and supportive care reduces symptom distress for older people with chronic noncancer conditions compared with usual care: a randomised controlled single-blind mixed method trial

Author(s):  
Catherine J. Evans ◽  
Anna E. Bone ◽  
Deokhee Yi ◽  
Wei Gao ◽  
Myfanwy Morgan ◽  
...  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.


2016 ◽  
Vol 45 (6) ◽  
pp. 863-873 ◽  
Author(s):  
Anna E. Bone ◽  
Myfanwy Morgan ◽  
Matthew Maddocks ◽  
Katherine E. Sleeman ◽  
Juliet Wright ◽  
...  

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e023969 ◽  
Author(s):  
Anne Wissendorff Ekdahl ◽  
Anna Axmon ◽  
Magnus Sandberg ◽  
Katarina Steen Carlsson

IntroductionComprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary diagnostic process used to determine the medical, psychological and functional capabilities of frail older people. The primary aim of our current study is to confirm whether CGA-based outpatient care is superior than usual care in terms of health-related outcomes, resource use and costs.Methods and analysisThe Geriatric Mobile Team trial is designed as a single-centre randomised, controlled, assessor-blinded (at baseline) trial. All participants will be identified via local healthcare registries with the following inclusion criteria: age ≥75 years, ≥3 different diagnoses and ≥3 visits to the emergency care unit (with or without admittance to hospital) during the past 18 months. Nursing home residency will be an exclusion criterion. Baseline assessments will be done before the 1:1 randomisation. Participants in the intervention group will, after an initial CGA, have access to care given by a geriatric team in addition to usual care. The control group receives usual care only. The primary outcome is the total number of inpatient days during the follow-up period. Assessments of the outcomes: mortality, quality of life, health care use, physical functional level, frailty, dependence and cognition will be performed 12 and 24 months after inclusion. Both descriptive and analytical statistics will be used, in order to compare groups and for analyses of outcomes over time including changes therein. The primary outcome will be analysed using analysis of variance, including in-transformed values if needed to achieve normal distribution of the residuals.Ethics and disseminationEthical approval has been obtained and the results will be disseminated in national and international journals and to health care leaders and stakeholders. Protocol amendments will be published in ClinicalTrials.gov as amendments to the initial registrationNCT02923843. In case of success, the study will promote the implementation of CGA in outpatient care settings and thereby contribute to an improved care of older people with multimorbidity through dissemination of the results through scientific articles, information to politicians and to the public.Trial registration numberNCT02923843; Pre-results.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e043663
Author(s):  
Kim de Nooijer ◽  
Lara Pivodic ◽  
Nele Van Den Noortgate ◽  
Peter Pype ◽  
Lieve Van den Block

IntroductionThere is limited evidence regarding the effectiveness of timely integration of short-term specialised palliative care services for older people in primary care. Using a Theory of Change approach, we developed such an intervention, the Frailty+ intervention. We present the protocol of a pilot randomised controlled trial (RCT) with a process evaluation that aims to assess the feasibility and preliminary effectiveness of the Frailty+ intervention.Methods and analysisWe will conduct a pilot RCT in Flanders, Belgium. Frail older people who are discharged to home from hospital will be identified and recruited. Seventy-six will be randomly assigned either to the control group (standard care) or the intervention group (Frailty+ intervention alongside standard care). Data will be collected from patients and family carers. At the core of the Frailty+ intervention is the provision of timely short-term specialised palliative care facilitated by a nurse from the specialised palliative home care service over a period of 8 weeks. We will assess feasibility in terms of recruitment, randomisation, acceptability of the intervention, retention in the programme and data completion. The primary outcome for assessing preliminary effectiveness is a mean score across five key symptoms that are amenable to change (ie, breathlessness, pain, anxiety, constipation, fatigue), measured at baseline and 8 weeks post-baseline. The process evaluation will be conducted in the intervention group only, with measurements at 8–11 weeks post-baseline to evaluate implementation, mechanisms of change and contextual factors.Ethics and disseminationThe study has been approved by the ethics committee of University Hospital Ghent. Results will be used to inform the design of a full-scale RCT and will be published in a peer-reviewed, open access journal.Trial registration numberISRCTN39282347; Pre-results.


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