Communication between family carers and health professionals about end-of-life care for older people in the acute hospital setting: a qualitative study

This paper focuses on communication between hospital staff and family carers of patients dying on acute hospital wards, with an emphasis on the family carers’ perspective. The age at which people in the UK die is increasing and many continue to die in the acute hospital setting. Concerns have been expressed about poor quality end of life care in hospitals, in particular regarding communication between staff and relatives. This research aimed to understand the factors and processes which affect the quality of care provided to frail older people who are dying in hospital and their family carers

Evaluation of a Medical and Mental Health Unit compared with standard care for older people whose emergency admission to an acute general hospital is complicated by concurrent 'confusion': a controlled clinical trial. Acronym: TEAM: Trial of an Elderly Acute care Medical and mental health unit

Background: Patients with delirium and dementia admitted to general hospitals have poor outcomes, and their carers report poor experiences. We developed an acute geriatric medical ward into a specialist Medical and Mental Health Unit over an eighteen month period. Additional specialist mental health staff were employed, other staff were trained in the ‘person-centred’ dementia care approach, a programme of meaningful activity was devised, the environment adapted to the needs of people with cognitive impairment, and attention given to communication with family carers. We hypothesise that patients managed on this ward will have better outcomes than those receiving standard care, and that such care will be cost-effective. Methods/design: We will perform a controlled clinical trial comparing in-patient management on a specialist Medical and Mental Health Unit with standard care. Study participants are patients over the age of 65, admitted as an emergency to a single general hospital, and identified on the Acute Medical Admissions Unit as being ‘confused’. Sample size is 300 per group. The evaluation design has been adapted to accommodate pressures on bed management and patient flows. If beds are available on the specialist Unit, the clinical service allocates patients at random between the Unit and standard care on general or geriatric medical wards. Once admitted, randomised patients and their carers are invited to take part in a follow up study, and baseline data are collected. Quality of care and patient experience are assessed in a non-participant observer study. Outcomes are ascertained at a follow up home visit 90 days after randomisation, by a researcher blind to allocation. The primary outcome is days spent at home (for those admitted from home), or days spent in the same care home (if admitted from a care home). Secondary outcomes include mortality, institutionalisation, resource use, and scaled outcome measures, including quality of life, cognitive function, disability, behavioural and psychological symptoms, carer strain and carer satisfaction with hospital care. Analyses will comprise comparisons of process, outcomes and costs between the specialist unit and standard care treatment groups. Trial Registration number: ClinicalTrials.gov: NCT0113614

Randomised controlled trial of a supervised exercise rehabilitation program for colorectal cancer survivors immediately after chemotherapy: study protocol

Background Colorectal cancer (CRC) diagnosis and the ensuing treatments can have a substantial impact on the physical and psychological health of survivors. As the number of CRC survivors increases, so too does the need to develop viable rehabilitation programs to help these survivors return to good health as quickly as possible. Exercise has the potential to address many of the adverse effects of CRC treatment; however, to date, the role of exercise in the rehabilitation of cancer patients immediately after the completion of treatment has received limited research attention. This paper presents the design of a randomised controlled trial which will evaluate the feasibility and efficacy of a 12-week supervised aerobic exercise program (ImPACT Program) on the physiological and psychological markers of rehabilitation, in addition to biomarkers of standard haematological outcomes and the IGF axis. Methods/Design Forty CRC patients will be recruited through oncology clinics and randomised to an exercise group or a usual care control group. Baseline assessment will take place within 4 weeks of the patient completing adjuvant chemotherapy treatment. The exercise program for patients in the intervention group will commence a week after the baseline assessment. The program consists of three supervised moderate-intensity aerobic exercise sessions per week for 12 weeks. All participants will have assessments at baseline (0 wks), mid-intervention (6 wks), post-intervention (12 wks) and at a 6-week follow-up (18 wks). Outcome measures include cardio-respiratory fitness, biomarkers associated with health and survival, and indices of fatigue and quality of life. Process measures are participants' acceptability of, adherence to, and compliance with the exercise program, in addition to the safety of the program. Discussion The results of this study will provide valuable insight into the role of supervised exercise in improving life after CRC. Additionally, process analyses will inform the feasibility of implementing the program in a population of CRC patients immediately after completing chemotherapy

Skin reactions during radiotherapy for breast cancer: the use and impact of topical agents and dressings

Radiation skin reactions occur in the majority of cases of patients undergoing radiotherapy for breast cancer with varying degrees of severity. Guidelines for skin care and for the use of topical agents and dressings have developed over the years of practice but there is little empirical evidence on which to base a decision for best practice. This paper describes the incidence of radiation skin reactions in a sample of 126 women treated for breast cancer post-lumpectomy. The results show that by the end of whole breast irradiation between 4-8% of patients will have no reaction and less than 10% will have moist desquamation as measured by the RTOG acute scoring system. The majority of patients did not require application of a topical agent during the treatment period. Statistical analysis of relationships between the severity of radiation skin reaction and the use of topical agents found no support for additional healing or preventative benefit. However, these topical agents were found to promote comfort. The use of Fixomull(TM) as a protector and potential preventive measure for moist desquamation is described

Analysing sequential events in clinical trials

Background Data from clinical trials where the endpoint is a single survival time are readily analysed by standard methods, most commonly using a semi-parametric proportional hazards approach. However, when the outcome involves two sequential survival times, standard methods may not be applicable. Methods We consider methods appropriate for the analysis of survival data in clinical trials where there are two distinct, sequential and opposing survival endpoints and where inferences about the second event are of particular interest. Two motivating examples of randomized clinical trials with different designs provide important illustrations of the methodology in practice. Results Bivariate log-normal survival models are proposed as useful way of modeling such data. These models can be simply implemented in two stages, each of which is a univariate log-normal survival analysis. Different approaches to the analyses are described according to whether a second randomized treatment assignment is made at the time when the first event occurs and the second phase of the study commences. In the absence of a second randomization, the bivariate log-normal model adjusts for selection into the second phase of the study. Conclusions The investigation of ‘treatment sequences’ should, wherever possible, be handled by repeat randomization, which can then be followed by valid, unbiased analyses. However, in many clinical trial scenarios, this is simply not possible. In this case, the best approach is to consider the data as arising from an observational study, whilst controlling for all appropriate covariates. Limitations The approach we describe is appropriate for log-normally distributed data but could be generalised to handle other distributions, although the process of model fitting would be less straight-forward