An evidence-based approach to the use of telehealth in long-term health conditions: development of an intervention and evaluation through pragmatic randomised controlled trials in patients with depression or raised cardiovascular risk

Background: Health services internationally are exploring the potential of telehealth to support the management of the growing number of people with long-term conditions (LTCs). Aim: To develop, implement and evaluate new care programmes for patients with LTCs, focusing on two common LTCs as exemplars: depression or high cardiovascular disease (CVD) risk. Methods Development: We synthesised quantitative and qualitative evidence on the effectiveness of telehealth for LTCs, conducted a qualitative study based on interviews with patients and staff and undertook a postal survey to explore which patients are interested in different forms of telehealth. Based on these studies we developed a conceptual model [TElehealth in CHronic disease (TECH) model] as a framework for the development and evaluation of the Healthlines Service for patients with LTCs. Implementation: The Healthlines Service consisted of regular telephone calls to participants from health information advisors, supporting them to make behaviour change and to use tailored online resources. Advisors sought to optimise participants’ medication and to improve adherence. Evaluation: The Healthlines Service was evaluated with linked pragmatic randomised controlled trials comparing the Healthlines Service plus usual care with usual care alone, with nested process and economic evaluations. Participants were adults with depression or raised CVD risk recruited from 43 general practices in three areas of England. The primary outcome was response to treatment and the secondary outcomes included anxiety (depression trial), individual risk factors (CVD risk trial), self-management skills, medication adherence, perceptions of support, access to health care and satisfaction with treatment. Trial results Depression trial: In total, 609 participants were randomised and the retention rate was 86%. Response to treatment [Patient Health Questionnaire 9-items (PHQ-9) reduction of ≥ 5 points and score of < 10 after 4 months] was higher in the intervention group (27%, 68/255) than in the control group (19%, 50/270) [odds ratio 1.7, 95% confidence interval (CI) 1.1 to 2.5; p = 0.02]. Anxiety also improved. Intervention participants reported better access to health support, greater satisfaction with treatment and small improvements in self-management, but not improved medication adherence. CVD risk trial: In total, 641 participants were randomised and the retention rate was 91%. Response to treatment (maintenance of/reduction in QRISK®2 score after 12 months) was higher in the intervention group (50%, 148/295) than in the control group (43%, 124/291), which does not exclude a null effect (odds ratio 1.3, 95% CI 1.0 to 1.9; p = 0.08). The intervention was associated with small improvements in blood pressure and weight, but not smoking or cholesterol. Intervention participants were more likely to adhere to medication, reported better access to health support and greater satisfaction with treatment, but few improvements in self-management. The Healthlines Service was likely to be cost-effective for CVD risk, particularly if the benefits are sustained, but not for depression. The intervention was implemented largely as planned, although initial delays and later disruption to delivery because of the closure of NHS Direct may have adversely affected participant engagement. Conclusion: The Healthlines Service, designed using an evidence-based conceptual model, provided modest health benefits and participants valued the better access to care and extra support provided. This service was cost-effective for CVD risk but not depression. These findings of small benefits at extra cost are consistent with previous pragmatic research on the implementation of comprehensive telehealth programmes for LTCs

A randomised phase 2 trial of intensive induction chemotherapy (CBOP/BEP) and standard BEP in poor-prognosis germ cell tumours (MRC TE23, CRUK 05/014, ISRCTN 53643604).

Standard chemotherapy for poor-prognosis metastatic nonseminoma has remained bleomycin, etoposide, and cisplatin (BEP) for many years; more effective regimens are required

ProsCan for Men: Randomised controlled trial of a decision support intervention for men with localised prostate cancer

Background: Prostate cancer is the most common male cancer in the Western world but is highly heterogeneous in disease progression and outcomes. Consequently, the most substantial morbidity may actually arise from the adverse psychosocial impact of distress in decision-making and long term quality of life effects such as impotence. This paper presents the design of a randomised controlled trial of a decision support/psychosocial intervention for men newly diagnosed with localised prostate cancer. Methods/Design: 350 men per condition (700 men in total) have been recruited after diagnosis and before treatment through urology private practices and hospital outpatient clinics and randomised to 1) a tele-based nurse delivered five session decision support/psychosocial intervention or 2) a usual care control group. Two intervention sessions are delivered before treatment that address decision support, stress management and preparation for treatment. Three further sessions are provided three weeks, seven weeks and five months after treatment that focus on adjustment to cancer, problem solving and coping with treatment side effects. Participants are assessed at baseline (before treatment) and 2, 6, 12, 24 and 36 months post-treatment. Outcome measures include: cancer threat appraisal; decision-related distress and bother from treatment side effects; involvement in decision making; satisfaction with health care; heath care utilisation; use of health care resources; and a return to previous activities. Discussion: The study will provide recommendations about the efficacy of early decision support to facilitate adjustment after prostate cancer. As well the study will identify men diagnosed with localised prostate cancer at risk of poorer long term psychosocial adjustment

Cancer Carepartners: Improving patients' symptom management by engaging informal caregivers

<p>Abstract</p> <p>Background</p> <p>Previous studies have found that cancer patients undergoing chemotherapy can effectively manage their own symptoms when given tailored advice. This approach, however, may challenge patients with poor performance status and/or emotional distress. Our goal is to test an automated intervention that engages a friend or family member to support a patient through chemotherapy.</p> <p>Methods/Design</p> <p>We describe the design and rationale of a randomized, controlled trial to assess the efficacy of 10 weeks of web-based caregiver alerts and tailored advice for helping a patient manage symptoms related to chemotherapy. The study aims to test the primary hypothesis that patients whose caregivers receive alerts and tailored advice will report less frequent and less severe symptoms at 10 and 14 weeks when compared to patients in the control arm; similarly, they will report better physical function, fewer outpatient visits and hospitalizations related to symptoms, and greater adherence to chemotherapy. 300 patients with solid tumors undergoing chemotherapy at two Veteran Administration oncology clinics reporting any symptom at a severity of ≥4 and a willing informal caregiver will be assigned to either 10 weeks of automated telephonic symptom assessment (ATSA) alone, or 10 weeks of ATSA plus web-based notification of symptom severity and problem solving advice to their chosen caregiver. Patients and caregivers will be surveyed at intake, 10 weeks and 14 weeks. Both groups will receive standard oncology, hospice, and palliative care.</p> <p>Discussion</p> <p>Patients undergoing chemotherapy experience many symptoms that they may be able to manage with the support of an activated caregiver. This intervention uses readily available technology to improve patient caregiver communication about symptoms and caregiver knowledge of symptom management. If successful, it could substantially improve the quality of life of veterans and their families during the stresses of chemotherapy without substantially increasing the cost of care.</p> <p>Trial Registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT00983892">NCT00983892</a></p

The devil is in the details: trends in avoidable hospitalization rates by geography in British Columbia, 1990–2000

BACKGROUND: Researchers and policy makers have focussed on the development of indicators to help monitor the success of regionalization, primary care reform and other health sector restructuring initiatives. Certain indicators are useful in examining issues of equity in service provision, especially among older populations, regardless of where they live. AHRs are used as an indicator of primary care system efficiency and thus reveal information about access to general practitioners. The purpose of this paper is to examine trends in avoidable hospitalization rates (AHRs) during a period of time characterized by several waves of health sector restructuring and regionalization in British Columbia. AHRs are examined in relation to non-avoidable and total hospitalization rates as well as by urban and rural geography across the province. METHODS: Analyses draw on linked administrative health data from the province of British Columbia for 1990 through 2000 for the population aged 50 and over. Joinpoint regression analyses and t-tests are used to detect and describe trends in the data. RESULTS: Generally speaking, non-avoidable hospitalizations constitute the vast majority of hospitalizations in a given year (i.e. around 95%) with AHRs constituting the remaining 5% of hospitalizations. Comparing rural areas and urban areas reveals that standardized rates of avoidable, non-avoidable and total hospitalizations are consistently higher in rural areas. Joinpoint regression results show significantly decreasing trends overall; lines are parallel in the case of avoidable hospitalizations, and lines are diverging for non-avoidable and total hospitalizations, with the gap between rural and urban areas being wider at the end of the time interval than at the beginning. CONCLUSION: These data suggest that access to effective primary care in rural communities remains problematic in BC given that rural areas did not make any gains in AHRs relative to urban areas under recent health sector restructuring initiatives. It remains important to continue to monitor the discrepancy between them as a reflection of inequity in service provision. In addition, it is important to consider alternative explanations for the observed trends paying particular attention to the needs of rural and urban populations and the factors influencing local service provision

Rho-Regulatory Proteins in Breast Cancer Cell Motility and Invasion

The importance of the Rho-GTPases in cancer progression, particularly in the area of metastasis, is becoming increasingly evident. This review will provide an overview of the role of the Rho-regulatory proteins in breast cancer metastatis.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/44220/1/10549_2004_Article_5264599.pd