BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy.

BACKGROUND: Deep inspiration breath hold (DIBH) reduces radiotherapy cardiac dose for left-sided breast cancer patients. The primary aim of the BRAVEHeart (Breast Radiotherapy Audio Visual Enhancement for sparing the Heart) trial is to assess the accuracy and usability of a novel device, Breathe Well, for DIBH guidance for left-sided breast cancer patients. Breathe Well will be compared to an adapted widely available monitoring system, the Real-time Position Management system (RPM). METHODS: BRAVEHeart is a single institution prospective randomised trial of two DIBH devices. BRAVEHeart will assess the DIBH accuracy for Breathe Well and RPM during left-sided breast cancer radiotherapy. After informed consent has been obtained, 40 patients will be randomised into two equal groups, the experimental arm (Breathe Well) and the control arm (RPM with in-house modification of an added patient screen). The primary hypothesis of BRAVEHeart is that the accuracy of Breathe Well in maintaining the position of the chest during DIBH is superior to the RPM system. Accuracy will be measured by comparing chest wall motion extracted from images acquired of the treatment field during breast radiotherapy for patients treated using the Breathe Well system and those using the RPM system. DISCUSSION: The Breathe Well device uses a depth camera to monitor the chest surface while the RPM system monitors a block on the patient's abdomen. The hypothesis of this trial is that the chest surface is a better surrogate for the internal chest wall motion used as a measure of treatment accuracy. The Breathe Well device aims to deliver an easy-to-use implementation of surface monitoring. The findings from the study will help inform the technology choice for other centres performing DIBH. TRIAL REGISTRATION: ClinicalTrials.gov NCT02881203 . Registered on 26 August 2016.

Medication non-adherence in a cohort of chronically ill Australians: A case of missed opportunities.

BACKGROUND AND OBJECTIVES: This study investigated the effect of management - including home medicines reviews and chronic disease management plans funded through the Medicare Benefits Schedule - on self-reported medication non-adherence. METHOD: An observational cohort study including 244 individuals with an exacerbation of chronic illness enrolled into the Care Navigation randomised controlled trial of integrated care. Non-adherence was measured using the Morisky-Greene-Levine self-reported adherence tool. RESULTS: The cohort comprised an equal number of older men and women with, on average, three chronic diseases, receiving between five and 10 unique medications each month and visiting a general practitioner (GP) more than 50 times in the year prior to completing the questionnaire. Forty per cent reported non-adherence, which was greater in males (relative risk [RR]: 1.73; 95% confidence interval [CI]: 1.25, 2.54) and in patients reporting a recent fall (RR 1.40; 95% CI: 1.02, 1.89). GP-initiated chronic disease management programs did not influence adherence. DISCUSSION: Despite almost weekly contact with GPs, two in five patients were non-adherent. Better methods of encouraging adherence are needed.

Coordinated care versus standard care in hospital admissions of people with chronic illness: a randomised controlled trial.

OBJECTIVE: To determine whether Care Navigation (CN), a nurse-led hospital-based coordinated care intervention, reduced the use of hospital services and improved quality of life for patients with chronic illness. DESIGN: Randomised controlled trial; participants were allocated to CN or standard care. PARTICIPANTS AND SETTING: Patients with chronic illness presenting to the emergency department of Nepean Hospital, Sydney, New South Wales. High-risk status for an unplanned admission was defined as i) three or more unplanned hospital admissions in 12 months for patients aged ≥ 70 or at least one admission for cardiac or respiratory disease in patients aged 16-69 years; or ii) judged by a CN nurse to be high risk and likely to benefit. MAIN OUTCOME MEASURES: Numbers of re-presentations or readmissions, quality of life, time to re-presentation, readmission or death, length of stay, and access to hospital and community health services. RESULTS: 500 participants were randomised between May 2010 and February 2011; 359 by previous unplanned admission and 141 by clinical impression. The CN group received more community health services (rate ratio, 1.94; 95% CI, 1.35-2.81; P < 0.001) than participants receiving standard care; however, this did not result in statistically significant differences in number of re-presentations (rate ratio, 0.83; 95% CI, 0.68-1.01; P = 0.07), number of readmissions (rate ratio, 0.85; 95% CI, 0.70-1.04; P = 0.11), quality of life at 24 months (mean difference, 0; 95% CI, - 0.10 to 0.09, P = 0.93), or other measures. CONCLUSIONS: CN did not improve quality of life or reduce unplanned hospital presentations or admissions despite community health services almost doubling. Future service development should explore potential benefits of linking navigated intrahospital care to ongoing, proactive care planning and delivery in the community. TRIAL REGISTRATION: ACTRN12609000554268.

Demographic and clinical predictors of unplanned hospital utilisation among chronically ill patients: a prospective cohort study.

BACKGROUND: In urban Australia, patients with serious and continuing illnesses make frequent use of hospital emergency department (ED) services. However, the risk factors for hospital utilisation among the broad population of people with chronic illness are not well known. The aim of this study was to assess the predictors of hospital utilisation (either inpatient admissions or ED visits) in a cohort of 308 patients with chronic illness. METHODS: We studied patients with serious and continuing chronic illnesses presenting to an ED in a large periurban hospital in western Sydney, Australia, between 2010 and 2013. ED presentations and hospital admissions were observed over two years. Multivariate negative-binomial regression analyses were used to identify risk factors for the number of presentations to hospital. RESULTS: The main risk factors for hospital utilisation were having a live-in carer, and a history of hospital utilisation. Having a live-in carer was associated with an increase in number of ED presentations by 88% (RR 1.88; 95% CI 1.41-2.51), and of admissions by 116% (RR 2.16; 95% CI 1.61-2.92). Seventy-seven percent of hospital utilisation in the cohort was attributable to carer status. Each additional ED presentation that a person had in the 12 months prior to the study led to an increased risk of an ED presentation in the follow-up period by 6% (RR = 1.06, 95% CI = 1.03-1.08). Between 20% and 25% of variability in hospital utilisation in the cohort was attributable to the number of hospital admissions or ED presentations in the previous 12 months. CONCLUSIONS: Patients with a live-in carer and with a history of hospital utilisation are at high risk for future hospital use.

Implementation and effectiveness of 'care navigation', coordinated management for people with complex chronic illness: rationale and methods of a randomised controlled trial.

BACKGROUND: Chronic illness is a significant driver of the global burden of disease and associated health care costs. People living with severe chronic illness are heavy users of acute hospital services; better coordination of their care could potentially improve health outcomes while reducing hospital use. The Care Navigation trial will evaluate an in-hospital coordinated care intervention on health service use and quality of life in chronically ill patients. METHODS/DESIGN: A randomised controlled trial in 500 chronically ill patients presenting to the emergency department of a hospital in Western Sydney, Australia. Participants have three or more hospital admissions within a previous 12 month period and either aged ≥70 years; or aged ≥45 years and of Aboriginal or Torres Strait Islander descent; or aged ≥ 16 with a diagnosis of a respiratory or cardiology related illness. Patients are randomised to either the coordinated care program (Care Navigation), or to usual care. The Care Navigation program consists of dedicated nurses who conduct patient risk assessments, oversee patient nursing while in hospital, and guide development of a care plan for the management of chronic illness after being discharged from hospital. These nurses also book community appointments and liaise with general practitioners. The main outcome variables are the number of emergency department re-presentations and hospital readmissions, and quality of life during a 24 month follow-up. Secondary outcomes are length of hospital stay, mortality, time to first hospital re-admission, time to first emergency department re-presentation, patient satisfaction, adherence to prescribed medications, amount and type of in-hospital referrals made for consultations and diagnostic testing, and the number and type of community health referrals. A process evaluation and economic analysis will be conducted alongside the randomised trial. DISCUSSION: A trial of in-hospital care coordination may support recent evidence that engaging primary health services in care plans linked to multidisciplinary team support improves patient outcomes and reduces costs to the health system. This will inform local, national and international health policy. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12609000554268.

A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: trans Tasman Radiation Oncology Group (TROG) 04.01.

PURPOSE: A previous, unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine cream (sorbolene). The different appearances of these products precluded a blinded comparison. To test the acrylate terpolymer principle in a double-blinded manner required the use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC); the study was conducted by the Trans Tasman Radiation Oncology Group (TROG) as protocol 04.01. METHODS AND MATERIALS: A total of 333 patients were randomized; 1 patient was ineligible and 14 patients withdrew or had less than 7 weeks' observations, leaving 318 for analysis. The chest wall was divided into medial and lateral compartments, and patients were randomized to have MDBC applied daily to the medial or lateral compartment and sorbolene to the other compartment. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected to week 12 or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters. RESULTS: Rates of medial and lateral compartment Common Toxicity Criteria (CTC), version 3, greater than or equal to grade 3 skin reactions were 23% and 41%, but rates by skin care product were identical at 32%. There was no significant difference between MDBC and sorbolene in the primary endpoint of peak skin reactions or secondary endpoints of area-under-the-curve skin reaction scores. CONCLUSIONS: The MDBC did not reduce the peak skin reaction compared to sorbolene. It is possible that this is related to the difference in the formulation of the cream compared with the film formulation. Skin dosimetry verification and double blinding are essential for radiation skin care comparative studies.

Digital photography as source documentation of skin toxicity: an analysis from the Trans Tasman Radiation Oncology Group (TROG) 04.01 post-mastectomy radiation skin care trial.

INTRODUCTION: This study evaluated digital photographs as a method of providing auditable source documentation for radiotherapy-induced skin toxicity and the possibility therefore of centralised, blinded scoring for a multicentre randomised controlled trial. METHODS: Digital photograph sets from the first five patients from each of 12 participating centres were audited. Minimum camera specifications and photograph requirements were protocol specified. Three readers rated photographs for four key quality items. They also scored skin reactions according to National Cancer Institute Common Terminology Criteria (CTC) v3.0 acute skin score and also for the presence of any moist desquamation. RESULTS: Five hundred fifty-two images were available. Field of view was scored as inadequate in 1-10%, focus inadequate in 0.4-4%, lighting inadequate in 0.2-3% and dividing line marking inadequate for scoring of skin reactions within sectors in 18-23% of photographs by three readers. Reader pairwise inter-observer agreement was 83-88% for CTC acute skin scores, but the kappa value ranged from 0.58 to 0.73. The percentage of image sectors not scored by readers due to difficulty in assessing was 1-10%. Moist desquamation was scored by clinicians in 8 (medial)-13% (lateral) of patients compared with 3-5% and 5-11% by readers. CONCLUSION: Photo reader inter-observer agreement is only moderate. Photo readers tended to underscore the frequency of moist desquamation, but the trend by sector parallels the clinical scorers. Photographs are useful source documents for auditing and monitoring, but not a replacement for clinical scoring.