Phase II randomized controlled trial (RCT) of medical intensive nutrition therapy (MINT) to improve chemotherapy (CT) tolerability in malnourished patients with solid tumor malignancies.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12090-12090
Author(s):  
Michael Shusterman ◽  
Gagandeep Brar ◽  
Kelsey Klute ◽  
Victoria Cooley ◽  
Alexandra Rosenstock ◽  
...  
Keyword(s):  
Usual Care ◽  
Phase Ii ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Nutrition Therapy ◽  
Predictive Tool ◽  
Nutritional Interventions ◽  
Median Proportion ◽  
Registered Dietician ◽  
The Impact

12090 Background: Malnutrition is an underrecognized predictor of inferior cancer related outcomes. Subjective global assessment (SGA), a brief validated survey for malnutrition, may predict increased CT toxicity. This phase II RCT was performed to validate SGA as a predictive tool for malnutrition and to evaluate the impact of MINT on CT associated toxicity. Methods: CT naive pts screened by SGA were assigned to well-nourished (SGA A) or malnourished (SGA B/C) cohorts. Both cohorts were followed for CT delivery, toxicity, quality of life (QOL) by FACT-G, biomarkers, radiology, and survival. SGA B/C pts, stratified by regimen/disease, were randomized 1:1 to MINT vs. usual care. The MINT cohort received weekly registered dietician counseling and symptom assessment over the 8-week study period. Percent standard and planned CT doses were calculated. Wilcoxon rank sum tests were used for differences between groups, log-rank tests for survival, and multivariable linear regression for adjusted comparisons. Results: 186 eligible pts were enrolled (94 SGA A, 92 SGA B/C). SGA A were younger (median age [range]; 63 [22, 89] vs. 70 [22, 91], p = 0.011) and more fit (ECOG 0-1; 96.8% vs. 72.8%, p < 0.001). Baseline QOL was higher for SGA A (median [range], 87 [34, 115]) vs SGA B/C (70 [31, 101], p < 0.001). SGA A was associated with higher CT delivery: median proportion of planned CT (1 [Q1 0.87, Q3 1] vs 0.94 [0.70, 1], p = 0.022) and standard CT (0.91 [0.72, 1] vs. 0.74 [0.57, 0.95] p < 0.001). Adjusted for age/ECOG, SGA A remained associated with > 80% of planned (OR 2.32, p = 0.05) and standard (OR 2.33, p = 0.04) CT. SGA B/C pts (n = 92) were randomized to MINT vs usual care: median nutrition encounters MINT 5.5 vs. usual care 0.5; we observed no differences in CT delivery: median proportion of planned CT (0.91 [0.69, 1] vs. 0.94 [0.74, 1], p = 0.84) and standard CT (0.75 [0.58, 0.96] vs 0.71 [0.52, 0.99], p = 0.59). SGA A was associated with a longer 12-month survival (77.8% [95% CI 69.6%, 86.9%]) vs. B/C (53.3% [42.8%, 66.4%], p < 0.0001; 12-month survival was similar for MINT (52.3% [38.1%, 71.9%]) vs usual care (54.4% [40.2%, 73.6%], p = 0.58). Conclusions: SGA is a validated tool to characterize malnutrition in pts receiving CT. Malnourished pts received significantly less CT, experienced worse baseline QOL, and had worse 12-month survival. Intensive medical nutrition therapy was not associated with differences in CT associated toxicity. Novel nutritional interventions are still needed to improve pt outcomes.

scholarly journals Rapid Multiplex Testing for Upper Respiratory Pathogens in the Emergency Department: A Randomized Controlled Trial

2019 ◽  
Author(s):  
Larissa May ◽  
Grant Tatro ◽  
Eduard Poltavskiy ◽  
Benjamin Mooso ◽  
Simson Hon ◽  
...  
Keyword(s):  
Emergency Department ◽  
Length Of Stay ◽  
Usual Care ◽  
Controlled Trial ◽  
Antibiotic Use ◽  
Respiratory Pathogens ◽  
Upper Respiratory Tract ◽  
Upper Respiratory ◽  
Tract Infections ◽  
The Impact

Abstract Background Acute upper respiratory tract infections are a common cause of Emergency Department (ED) visits and often result in unnecessary antibiotic treatment.  Methods We conducted a randomized clinical trial to evaluate the impact of a rapid, multi-pathogen respiratory panel (RP) test versus usual care (control). Patients were eligible if they were ≥12 months old, had symptoms of upper respiratory infection or influenza like illness, and were not on antibiotics. The primary outcome was antibiotic prescription; secondary outcomes included antiviral prescription, disposition, and length of stay (ClinicalTrials.gov# NCT02957136). Results Of 191 patients enrolled, 93 (49%) received RP testing; 98 (51%) received usual care. Fifty-three (57%) RP and 7 (7%) control patients had a virus detected and reported during the ED visit (p=0.0001). Twenty (22%) RP patients and 33 (34%) usual care patients received antibiotics during the ED visit (-12% [95% CI -25%, 0.4%]; p=0.06/0.08); 9 RP patients received antibiotics despite having a virus detected. The magnitude of antibiotic reduction was greater in children (-19%) versus adults (-9%; post-hoc analysis). There was no difference in antiviral use, length of stay, or disposition. Conclusions Rapid RP testing was associated with a trend towards decreased antibiotic use, suggesting a potential benefit from more rapid viral tests in the ED. Future studies should determine if specific groups are more likely to benefit from testing and evaluate relative cost and effectiveness of broad testing, focused testing, and a combined diagnostic and antimicrobial stewardship approach.

Effectiveness of an innovative and comprehensive eye care model for individuals in residential care facilities: results of the residential ocular care (ROC) multicentred randomised controlled trial

2020 ◽  
pp. bjophthalmol-2019-315620
Author(s):  
Ryan Eyn Kidd Man ◽  
Alfred Tau Liang Gan ◽  
Marios Constantinou ◽  
Eva K Fenwick ◽  
Edith Holloway ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Residential Care ◽  
Controlled Trial ◽  
Well Being ◽  
Vision Impairment ◽  
Residential Care Facilities ◽  
Care Facilities ◽  
Randomised Controlled ◽  
The Impact

BackgroundTo assess the clinical and patient-centred effectiveness of a novel residential ocular care (ROC) model in Australian individuals residing in residential care.MethodsIn this prospective, multicentred, randomised controlled trial conducted in 38 Australian aged-care facilities (2015–2017), 178 visually impaired individuals living in residential care facilities (mean age ±SD: 83.9±8.6 years; 65.7% women) were cluster randomised to ROC (n=95) or usual care (n=83) pathways. The ROC arm comprised a tailored and comprehensive within-site eye examination and care rehabilitation pathway, while usual care participants were given a referral to an external eyecare provider. Outcomes included presenting distance and near visual acuity (PNVA); Rasch-transformed Reading, Emotional and Mobility scores from the Impact of Vision Impairment questionnaire; quality of vision (QoV comprising Rasch-transformed Frequency, Severity and Bother domains) scores; Euroqol-5-Dimensions (raw scores); Cornell Scale for Depression (raw scores) and 6-month falls frequency, assessed at baseline and 6 months post intervention. Within-group and between-group comparisons were conducted using linear mixed models, adjusted for baseline differences in characteristics between the two arms.ResultsAt 6 months, intention-to-treat analyses showed significant between-group improvements in ROC residents compared with usual care for PNVA, Emotional and QoV scores (all p<0.05) These significant findings were retained in per-protocol analyses. No other between-group changes were observed.ConclusionOur ROC model was effective in improving near vision, emotional well-being and perceived burden of vision-related symptoms in residential care dwellers in Australia with vision impairment. Future studies to evaluate the cost effectiveness and implementation of ROC in Australia are warranted.

scholarly journals Feasibility & Efficacy of Deprescribing rounds in a Singapore rehabilitative hospital- a randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Andrew Peng Yong Wong ◽  
Tan Wan Ting ◽  
Ee Jia Ming Charissa ◽  
Tan Wee Boon ◽  
Kwan Yu Heng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Multidisciplinary Team ◽  
Controlled Trial ◽  
Total Daily Dose ◽  
Open Label ◽  
Rehabilitation Hospital ◽  
Link Type ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Deprescribing is effective and safe in reducing polypharmacy among the elderly. However, the impact of deprescribing rounds remain unclear in Asian settings. Hence, we conducted this study. Methods An open label randomised controlled trial was conducted on patients of 65 years and above, under rehabilitation or subacute care and with prespecified medications from a Singapore rehabilitation hospital. They were randomised using a computer generated sequence. The intervention consisted of weekly multidisciplinary team-led deprescribing rounds (using five steps of deprescribing) and usual care. The control had only usual care. The primary outcome is the percentage change in total daily dose (TDD) from baseline upon discharge, while the secondary outcomes are the total number of medicine, total daily cost and TDD up to day 28 postdischarge, overall side-effect rates, rounding time and the challenges. Efficacy outcomes were analysed using intention-to-treat while other outcomes were analysed as per protocol. Results 260 patients were randomised and 253 were analysed after excluding dropouts (female: 57.3%; median age: 76 years). Baseline characteristics were largely similar in both groups. The intervention arm (n = 126) experienced a greater reduction of TDD on discharge [Median (IQR): − 19.62% (− 34.38, 0.00%) versus 0.00% (− 12.00, 6.82%); p < 0.001], more constipation (OR: 3.75, 95% CI:1.75–8.06, p < 0.001) and laxative re-prescriptions (OR: 2.82, 95% CI:1.30–6.12, p = 0.009) though death and hospitalisation rates were similar. The median rounding time was 7.09 min per patient and challenges include the inconvenience in assembling the multidisciplinary team. Conclusion Deprescribing rounds can safely reduce TDD of medicine upon discharge compared to usual care in a Singaporean rehabilitation hospital. Trial registration This study is first registered at Clinicaltrials.gov (protocol number: NCT03713112) on 19/10/2018 and the protocol can be accessed on https://www.clinicaltrials.gov.

scholarly journals Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

2020 ◽  
Vol 6 (4) ◽  
pp. 00460-2020
Author(s):  
Michael G. Crooks ◽  
Jack Elkes ◽  
William Storrar ◽  
Kay Roy ◽  
Mal North ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Self Management ◽  
Open Label ◽  
Management Interventions ◽  
Randomised Controlled ◽  
The Impact

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.We explored the impact of myCOPD in patients with mild–moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, −1.27 (95% CI −4.47–1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09–1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46–5.85) in favour of myCOPD.The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

scholarly journals Cluster-randomised controlled trial of Stroke 1-2-0 education programme to reduce stroke prehospital delay in China: a study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e048064
Author(s):  
Yong Wang ◽  
Yang Liu ◽  
Renyu Liu ◽  
Jing Zhao
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Education Programme ◽  
Primary Objective ◽  
Prehospital Delay ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Impact

IntroductionStroke is the leading cause of death and disability in China. The median time of stroke pre-hospital delay is more than 15 hours, mainly due to the lack of awareness on stroke symptoms and calling emergency services. We developed Stroke 1-2-0 recognition tool in China, by adapting Face, Arm, Speech and Time. Our preliminary findings suggested that Stroke 1-2-0 can improve public’s knowledge of the stroke symptoms, but its impact on the prehospital delay is still unclear. Furthermore, these findings were mainly obtained from Shanghai, one of the largest metropolises in China. However, more than half of population in China lives in the rural area. Given the striking disparities in socioeconomic status and quality of stroke care across the nation, a multicentre trial is warranted.Methods and analysisStroke 1-2-0 education programme will adopt a multicentre, cluster-randomised controlled design. We aimed to recruit 32 communities from 16 counties across China. Each county includes two communities having more than 100 000 residents. The two communities sampled in the same county will be randomly assigned to receive either Stroke 1-2-0 education programme or usual care. The primary objective of this study is to evaluate the impact of Stroke 1-2-0 public education programme in reducing stroke prehospital delay among adults residing in the community, compared with the usual care. The intervention will be implemented for 1 year. The primary outcomes are the symptom onset to hospital arrival time (‘onset-to-door time’, ODT) and 3-hour hospital arriving rate. We will use an intention-to-treat approach. A linear mixed model will be used to control for potential cluster effects.Ethics and disseminationThis study is approved by the Shanghai Minhang District Central Hospital Institutional Review Board (Shanghai, China). The findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberChiCTR2000040782.

scholarly journals Advanced Practice Nurse Intervention Versus Usual Care For Hypertension Control: Study Protocol For An Open-Label Randomized Controlled Trial

2021 ◽  
Author(s):  
Juliette Vay-Demouy ◽  
Alexandre Vallée ◽  
Alexandre Cinaud ◽  
Hélène Lelong ◽  
Sandrine Kretz ◽  
...  
Keyword(s):  
Usual Care ◽  
Healthcare System ◽  
Controlled Trial ◽  
Medical Doctor ◽  
University Hospital ◽  
Control Group ◽  
Advanced Practice ◽  
Open Label ◽  
Cardiovascular Assessment ◽  
The Impact

Abstract Background: Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises. The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. Methods: The study is designed as prospective, open-label, controlled, randomized 1-to-1 and mono-centric at the Hôtel-Dieu University Hospital, Paris, France. The participants are all hypertensive and recruited during an ambulatory hospitalization (AH) for cardiovascular assessment in the context of the management of their hypertension. Patients are divided into two groups: a control group who keeps a traditional follow-up (AH then consultation with a medical doctor (MD) within approximately two to six months) and an interventional group who will see an APN between the AH and the MD consultation, within 1-3 months. Patients are followed up over six months. The main judgment criterion is BP control (BP < 135/85 mmHg in home BP measurement). The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control. Discussion: This innovative study is a first in France where APNs are at the dawn of their establishment in the healthcare system. It will provide an objective look at this new profession and the impact it can have on the overall management of hypertension. Trial registration: This trial was registered in ClinicalTrials.gov on June 24, 2020: protocol number NCT0448249.

The Impact of Integrated Multidisciplinary Palliative Care Program on Symptoms in Patients at the Palliative Care Ward—An Audit and a Protocol of Prospective Controlled Investigation

2017 ◽  
Vol 32 (3-4) ◽  
pp. 87-88 ◽  
Author(s):  
Andreas Jülich ◽  
Thomas Spreu ◽  
Britta Buchhold ◽  
Taras Usichenko
Keyword(s):  
Palliative Care ◽  
Controlled Trial ◽  
Symptom Control ◽  
Sample Size Calculation ◽  
Care Program ◽  
Symptom Assessment ◽  
University Hospital ◽  
Retrospective Audit ◽  
Edmonton Symptom Assessment Scale ◽  
The Impact

An integrated multidisciplinary palliative care (IMPC) program is a promising tool to improve symptom control in patients at the end of life. The aim was to study the feasibility of the IMPC program in patients at the palliative care (PC) ward. A retrospective audit, using the extended Edmonton Symptom Assessment Scale (ESAS), was conducted on the PC ward of the university hospital. Consecutive patients who were admitted for the IMPC program during 1 year were considered. One hundred forty-eight cases (93% with underlying cancer) were analyzed. The intensity of pain levels, nausea, vomiting, shortness of breath, and sleep disorders decreased at least by 50% ( P < .0001) during the 13 (median) days of IMPC. Integrated multidisciplinary PC program was associated with symptom improvements in patients at the PC ward. The information generated supports sample size calculation for a prospective controlled trial.

scholarly journals THE IMPACT OF “TELE-SAVVY” ON THE CAREGIVING EXPERIENCE OF DEMENTIA FAMILY CAREGIVERS: QUALITATIVE FINDINGS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S871-S871
Author(s):  
Fayron Epps ◽  
Elizabeth Maloch ◽  
Patricia Griffiths ◽  
Ken Hepburn
Keyword(s):  
Usual Care ◽  
Family Caregivers ◽  
Controlled Trial ◽  
Attention Control ◽  
Care Group ◽  
Healthy Living ◽  
Structured Interviews ◽  
Active Attention ◽  
Caregiver Interventions ◽  
The Impact

Abstract Tele-Savvy is a 3-arm randomized controlled trial (RCT) of a psychoeducation intervention that equips family caregivers of people living with dementia with the knowledge and skills they need to provide care to their person, while also caring for themselves. This RCT is currently underway, with cohorts rotating through over a period of 12 months. The purpose of this presentation is to describe the effectiveness of Tele-Savvy (active) versus Healthy Living Intervention (attention control) or usual care (wait-list) on the caregiving experience among dementia family caregivers. We conducted semi-structured interviews with 16 caregivers at the 6 month time point and after their initial participation in either the active, attention control, or usual care groups. Interviews elicited caregivers’ perceptions regarding the program’s influence on their caregiving experience. Caregivers who participated in Tele-Savvy reported positive experiences such as recognizing that their experience has become more pleasurable and happier. They also shared that the program expanded their knowledge and allowed them to become patient while implementing caregiving strategies learned. Majority of caregivers who participated in the Healthy Living program indicated that nothing changed related to their caregiving experience. Half of the caregivers in the usual care group, expressed frustration and unhappiness, while the others expressed no change in their caregiving experience. Results suggest that psychoeducation caregiver interventions are meaningful and can enact positive changes in their outlook on caregiving. Thus, results of this study may guide future policies and further development of caregiver programs and interventions.

scholarly journals Protocol for an economic analysis of the randomised controlled trial of Improving the Well-being of people with Opioid Treated CHronic pain: I-WOTCH Study

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037243
Author(s):  
Sheeja Manchira Krishnan ◽  
Vijay Singh Gc ◽  
Harbinder Kaur Sandhu ◽  
Martin Underwood ◽  
Sam Eldabe ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomised Controlled Trial ◽  
Economic Analysis ◽  
Usual Care ◽  
Controlled Trial ◽  
Well Being ◽  
Regression Equations ◽  
Randomised Controlled ◽  
The Impact

IntroductionOver the last two decades, the use of opioids for the treatment of chronic pain in England has steadily increased despite lack of evidence of both long-term effectiveness in pain relief and significant, well-documented physical and mental adverse events. Guidelines recommend tapering when harms outweigh benefits, but the addictive nature of opioids hinders simple dose-reduction strategies. Improving the Well-being of people with Opioid Treated CHronic pain (I-WOTCH) trial tests a multicomponent self-management intervention aimed to help patients with chronic non-malignant pain taper opioid doses. This paper outlines the methods to be used for the economic analysis of the I-WOTCH intervention compared with the best usual care.Methods and analysisEconomic evaluation alongside the I-WOTCH study, prospectively designed to identify, measure and value key healthcare resource use and outcomes arising from the treatment strategies being compared. A within-trial cost-consequences analysis and a model-based long-term cost-effectiveness analysis will be conducted from the National Health Service and Personal Social Service perspective in England. The former will quantify key parameters to populate a Markov model designed to estimate the long-term cost and quality-adjusted life years of the I-WOTCH intervention against best usual care. Regression equations will be used to estimate parameters such as transition probabilities, utilities, and costs associated with the model’s states and events. Probabilistic sensitivity analysis will be used to assess the impact of parameter uncertainty onto the predicted costs and health outcomes, and the resulting value for money assessment of the I-WOTCH intervention.Ethics and disseminationFull ethics approval was granted by Yorkshire & The Humber—South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). Current protocol: V.1.7, date 31 July 2019. Findings will be disseminated in peer-reviewed journals, scientific conferences, newsletters and websites.Trial registration numberInternational Standard Randomised Controlled Trial Number (49 470 934); Pre-result.

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