The association between comprehensive patient-centered care and health-related quality of life (HRQoL) for patients with chronic viral hepatitis-A pathway analysis.

BACKGROUND: Patient-centered care (PCC) is a crucial objective for enhancing healthcare in the 21st century. PCC has demonstrated effectiveness in caring for patients with chronic conditions. However, the process from PCC to patient outcomes has not been thoroughly studied, particularly for patients with chronic hepatitis. OBJECTIVE: To investigate the relationship between PCC and the outcomes of hepatitis patients and determine the key mediator in the connection between PCC and outcomes. METHODS: A cross-sectional study was conducted from October to December 2016 in four hospitals in northern Taiwan. Patients with chronic viral hepatitis were assessed for five PCC factors: autonomy support, goal setting, coordination of care, information/education/communication, and emotional support. Trust in the physician, patient adherence, and patient activation (PA) were selected as mediators, with health-related quality of life (HRQoL) as the patient outcome. Pathway analysis was applied to examine the correlation. RESULTS: In total, 496 chronic hepatitis patients were included in the study. The pathway analysis revealed that autonomy support (ß = 0.007, p = 0.011), information/education/communication (ß = 0.009, p = 0.017), and emotional support (ß = 0.001, p = 0.011) correlated with better HRQoL. The effects of PCC factors are fully mediated by trust in physicians, patient adherence, and PA. Among them, PA is the key factor in the process of PCC. CONCLUSION: For chronic viral hepatitis care, PCC should be introduced into clinical practice for better HRQoL, and PA is a key mediator.

Smoking Cessation and Quality of Life: Insights From Analysis of Longitudinal Australian Data, an Application for Economic Evaluations.

OBJECTIVES: A number of studies have shown an association between smoking habit and quality of life, but these have mainly involved cross-sectional data. This study takes advantage of longitudinal panel data to estimate the effect of the transition from "smoker" to "ex-smoker" status (smoking cessation) on health-related quality of life (HRQoL), measured by SF-36, in an Australian general population sample. METHODS: Panel data from 13 waves (2001-2013) of a nationally representative longitudinal survey of Household Income and Labour Dynamics of Australia (HILDA) were used; 1858 respondents (5% of total HILDA sample) who experienced only 1 cessation event in their HILDA life were selected. HRQoL trajectories elicited by SF-36 (0-100 scale, worst to best health) were modeled before and after cessation events using a piecewise (segmented) 2-way fixed-effect linear regression, adopted to capture within-person differences. This enabled measurement of changes of regression slopes and intercept while controlling time-invariant characteristics (eg, country of birth, gender) and time-varying changes in health status. RESULTS: Annual pre-post intervention improvements were estimated for the following dimensions: role physical 0.65 (95% CI 0.62-1.24), bodily pain 0.48 (95% CI 0.10-0.86), general health 0.55 (95% CI 0.2-0.9), and the physical component summary score 0.22 (95% CI 0.01-0.04). Immediate effects (discontinuity at the time of cessation) of smoking cessation existed for bodily pain -1.5 (95% CI -2.52 to -0.40) and general health 1.82 (95% CI 1.01-2.62). The effects for mental health domains were not significant. CONCLUSIONS: Adjusting for all unmeasured time-invariant confounders and controlling the effect of time, this study revealed the varied effects of smoking cessation on HRQoL; it has positive effect on physical and general health but nonsignificant effect on mental aspects. Preference-based utility measures based on SF-6D capture changes that can be measured in several of the domains of the SF-36.

Does public report card matter? A 10-year interrupted time series analysis on total knee replacement.

BACKGROUND: There is a lack of evidence that shows whether a report card can improve health outcomes in terms of infection rates or unscheduled readmission by using rigorous methods to evaluate its impact. METHODS: We used the National Health Insurance Administration's claims database from 1 January 2004 to 30 December 2013 and a time series analysis to evaluate the impact of the quality report card initiative on three negative outcomes of total knee replacement for each quarter of the year, including the rates of superficial infection of a knee replacement, deep infection of knee arthroplasty and unplanned readmissions for surgical site infection. RESULTS: These negative outcomes (original scale) do not show significant decreases in terms of superficial infection (-0.05‰, -0.63 to 0.53‰, P = 0.87), deep infection (-0.003‰, -0.19 to 0.18‰, P = 0.97) and unscheduled readmission (0.02‰, -0.21 to 0.25‰, P = 0.88). CONCLUSION: The total knee replacement public report card initiative did not improve the rate of infection and unscheduled readmission for surgical site infection. This report card in Taiwan should involve physicians' participation in the design and be tailored to be suitable for reading by patients in order to further enhance the chance of improvement in these negative outcomes.

The effect of a hepatitis pay-for-performance program on outcomes of patients undergoing antiviral therapy.

Background: To examine the effect of a participatory pay-for-performance (P4P) program in Taiwan on health outcomes for patients with severe hepatitis B or C. Methods: This study adopted 4-year panel data from the databases of the National Health Insurance Administration (NHIA) in Taiwan. Using the caliper matching method to match patients in the P4P (experimental) group with those in the potential comparison group on a one-to-one basis for the year 2010, we tracked patients up to the year 2013 and employed Cox proportional-hazards regression models to evaluate the effect on patient outcomes. Results: The P4P group did not have a lower risk (HR = 0.44, P = 0.05) of hospital admission for severe hepatitis patients (i.e. need antiviral therapy). The risk of developing liver cirrhosis was also lower, but the reduction was not statistically significant (HR = 0.92, P = 0.77). Conclusions: This study found that participatory-type P4P has not resulted in reduced hospital admission of hepatitis B or C patients who need antiviral therapy. The means by which the participatory P4P program could strengthen patient-centered care to achieve better patient health outcomes is discussed in detail.

Do Model-Based Studies in Chronic Obstructive Pulmonary Disease Measure Correct Values of Utility? A Meta-Analysis.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease that has considerable impact on utility-based health-related quality of life. Utility is a key input of many decision analytic models used for economic evaluations. OBJECTIVE: To systematically review COPD-related utilities and to compare these with alternative values used in decision models. METHODS: The literature review comprised studies that generated utilities for COPD-related stages based on EuroQol five-dimensional questionnaire surveys of patients and of decision models of COPD progression that have been used for economic evaluations. The utility values used in modeling studies and those from the meta-analysis of actual patient-level studies were compared and differences quantified. RESULTS: Twenty decision modeling studies that used utility value as an input parameter were found. Within the same span of publication period, 13 studies involving patient-level utility data were identified and included in the meta-analysis. The estimated mean utility values ranged from 0.806 (95% confidence interval [CI] 0.747-0.866) for stage I to 0.616 (95% CI 0.556-0.676) for stage IV. The utility scores for comparable stages in modeling studies were different (significant difference 0.045 [95% CI 0.041-0.052] for stage III). Modeling studies consistently used higher utility values than the average reported patient-level data. CONCLUSIONS: COPD decision analytic models are based on a limited range of utility values that are systematically different from average values estimated using a meta-analysis. A more systematic approach in the application of utility measures in economic evaluation is required to appropriately reflect current literature.

Health State Utility Value in Chronic Obstructive Pulmonary Disease (COPD); The Challenge of Heterogeneity: A Systematic Review and Meta-Analysis.

Chronic obstructive pulmonary disease (COPD) has a considerable impact on quality of life and well-being of patients. Health state utility value (HSUV) is a recognized measure for health economic appraisals and is extensively used as an indicator for decision-making studies. This study is a systematic review of literature aimed to estimate mean utility value in COPD using meta-analysis and explore degree of heterogeneity in the utility values across a variety of clinical and study characteristic. The literature review covers studies that used EQ-5D to estimate utility value for patient level research in COPD. Studies that reported utility values elicited by EQ-5D in COPD patients were selected for random-effect meta-analysis addressing inter-study heterogeneity and subgroup analyses. Thirty-two studies were included in the general utility meta-analysis. The estimated general utility value was 0.673 (95% CI 0.653 to 0.693). Meta-analyses of COPD stages utility values showed influence of airway obstruction on utility value. The utility values ranged from 0.820 (95% CI 0.767 to 0.872) for stage I to 0.624 (95% CI 0.571 to 0.677) for stage IV. There was substantial heterogeneity in utility values: I(2) = 97.7%. A more accurate measurement of utility values in COPD is needed to refine valid and generalizable scores of HSUV. Given the limited success of the factors studied to reduce heterogeneity, an approach needs to be developed how best to use mean utility values for COPD in health economic evaluation.

Measuring Preferences for a Diabetes Pay-for-Performance for Patient (P4P4P) Program using a Discrete Choice Experiment.

OBJECTIVE: To elicit a patient's willingness to participate in a diabetes pay-for-performance for patient (P4P4P) program using a discrete choice experiment method. METHODS: The survey was conducted in March 2013. Our sample was drawn from patients with diabetes at five hospitals in Taiwan (International Classification of Diseases, Ninth Revision, Clinical Modification code 250). The sample size was 838 patients. The discrete choice experiment questionnaire included the attributes monthly cash rewards, exercise time, diet control, and program duration. We estimated a bivariate probit model to derive willingness-to-accept levels after accounting for the characteristics (e.g., severity and comorbidity) of patients with diabetes. RESULTS: The preferred program was a 3-year program involving 30 minutes of exercise per day and flexible diet control. Offering an incentive of approximately US $67 in cash per month appears to increase the likelihood that patients with diabetes will participate in the preferred P4P4P program by approximately 50%. CONCLUSIONS: Patients with more disadvantageous characteristics (e.g., elderly, low income, greater comorbidity, and severity) could have less to gain from participating in the program and thus require a higher monetary incentive to compensate for the disutility caused by participating in the program's activities. Our result demonstrates that a modest financial incentive could increase the likelihood of program participation after accounting for the attributes of the P4P4P program and patients' characteristics.

Exploring health care providers' perceptions of the needs of stroke carers: informing development of an optimal health program.

BACKGROUND: Health care provider experiences of the carer have been researched, but little is written about how these can inform development of support programs. OBJECTIVES: This study aimed to (1) explore health care provider perceptions of stroke carer roles and support needs and (2) examine carer needs across the stroke care trajectory to assist with development of an Optimal Health Program (OHP) to support carers. This study is part of a staged program of research that will evaluate and refine the OHP. METHODS: Four dual-moderated semi-structured focus groups of stroke health care providers across acute, subacute, and community rehabilitation services were conducted. Facilitators used a semi-structured focus group schedule to guide discussion. Sessions were recorded, transcribed, and analyzed using thematic and content analysis. RESULTS: Three key themes emerged: transition, information, and impact of stroke. A number of subthemes highlighted the distinct roles of health care providers and carers. Specific elements of the OHP were identified as having the potential to advance support for carers across the stroke care trajectory. DISCUSSION: Findings support the integration of an OHP for carers within existing stroke care services in Australian public hospital and community settings. CONCLUSION: This study suggests how health care provider experiences could inform a self-management OHP to assist carers in navigating stroke services and to address their health-related concerns.

Close the gap for vision: The key is to invest on coordination.

OBJECTIVE: The study aims to estimate costs required for coordination and case management activities support access to treatment for the three most common eye conditions among Indigenous Australians, cataract, refractive error and diabetic retinopathy. DESIGN: Coordination activities were identified using in-depth interviews, focus groups and face-to-face consultations. Data were collected at 21 sites across Australia. The estimation of costs used salary data from relevant government websites and was organised by diagnosis and type of coordination activity. SETTING: Urban and remote regions of Australia. INTERVENTIONS: Needs-based provision support services to facilitate access to eye care for cataract, refractive error and diabetic retinopathy to Indigenous Australians. MAIN OUTCOME MEASURES: Cost (AUD$ in 2011) of equivalent full time (EFT) coordination staff. RESULTS: The annual coordination workforce required for the three eye conditions was 8.3 EFT staff per 10 000 Indigenous Australians. The annual cost of eye care coordination workforce is estimated to be AUD$21 337 012 in 2011. CONCLUSIONS: This innovative, 'activity-based' model identified the workforce required to support the provision of eye care for Indigenous Australians and estimated their costs. The findings are of clear value to government funders and other decision makers. The model can potentially be used to estimate staffing and associated costs for other Indigenous and non-Indigenous health needs.

Cost of close the gap for vision of Indigenous Australians: On estimating the extra resources required.

OBJECTIVE: To estimate the costs of the extra resources required to close the gap of vision between Indigenous and non-Indigenous Australians. DESIGN: Constructing comprehensive eye care pathways for Indigenous Australians with their related probabilities, to capture full eye care usage compared with current usage rate for cataract surgery, refractive error and diabetic retinopathy using the best available data. SETTING: Urban and remote regions of Australia. INTERVENTIONS: The provision of eye care for cataract surgery, refractive error and diabetic retinopathy. MAIN OUTCOME MEASURES: Estimated cost needed for full access, estimated current spending and estimated extra cost required to close the gaps of cataract surgery, refractive error and diabetic retinopathy for Indigenous Australians. RESULTS: Total cost needed for full coverage of all three major eye conditions is $45.5 million per year in 2011 Australian dollars. Current annual spending is $17.4 million. Additional yearly cost required to close the gap of vision is $28 million. This includes extra-capped funds of $3 million from the Commonwealth Government and $2 million from the State and Territory Governments. Additional coordination costs per year are $13.3 million. CONCLUSIONS: Although available data are limited, this study has produced the first estimates that are indicative of the need for planning and provide equity in eye care.

Factors Associated with the Patient/Client Use of Report Cards, Physician Rating Websites, Social Media, and Google for Hospital and Physician Selection: A Nationwide Survey.

OBJECTIVE: To explore the factors associated with the different uses of report cards, physician rating websites, social media, and Google, including awareness, physician finding, and decision-making based on reviews from the patient/client perspective. METHODS: We used computer-assisted telephone interviews to conduct a nationwide representative survey in Taiwan. RESULTS: The urbanization level of the area, income, and long-term health conditions were not associated with the three kinds of usage of the websites studied. Seeking health information was an important factor in the three kinds of website use. The employment industry was associated with awareness, and education level was associated with physician seeking and actions based on reviews. CONCLUSIONS: Different factors influenced the three kinds of usage: awareness, actual use (i.e., finding an appropriate physician), and decision-making based on reviews. Seeking health information is of primary importance regardless of how the websites are used. PRACTICAL IMPLICATIONS: Policy-makers should focus on educating individuals working outside the health care sector to increase awareness of these websites and to assist individuals with low levels of education in increasing their use of these websites.

Cost-utility analysis of telephone-based cognitive behavior therapy in chronic obstructive pulmonary disease (COPD) patients with anxiety and depression comorbidities: an application for willingness to accept concept.

BACKGROUND: This study evaluated the cost-utility of telephone-based cognitive behavioral therapy (TB-CBT) (experimental arm) in comparison with a placebo-befriending (control arm) program in COPD participants with mild to severe depression and/or anxiety. METHODS: The decision rule was based on willingness-to-pay if there is an increased unit of effectiveness (a quality-adjusted life year [QALY] gain) and an increase in cost, and willingness-to-accept (WTA) if there is a reduced unit of effectiveness (a QALY loss) and decrease in cost (a cost-saving). RESULTS: TB-CBT group was associated with a reduction in the incremental cost of AUS-$407.3 (p < 0.001, SE:34.1) plus a negative, nonsignificant incremental QALY gain of -0.008 (SE:0.011) per patient compared to control group. The point estimate of the mean incremental cost-utility ratio was AUS$50,284.0 cost saving per QALY sacrificed (the high value associated with small QALY value in the denominator). Ninety-five percent CI was AUS$13,426 cost sacrificed to AUS$32,018 cost gain (lower values associated with larger QALY values in the denominator). If the societal's minimum (flooring threshold) WTA is AUS$64,000 per QALY forgone, the probability of TB-CBT being cost-effective was 42% Conclusions: This study showed that TB-CBT can be recommended as a cost-saving and preventive approach over usual care plus befriending program.

The effects of a schizophrenia pay-for-performance program on patient outcomes in Taiwan.

OBJECTIVE: To examine the effects of a schizophrenia pay-for-performance (P4P) program on the health outcomes of patients in Taiwan. DATA SOURCES: Seven years (2007-2013) of data from the National Health Insurance Administration (NHIA) databases were examined. STUDY DESIGN: P4P patients included those who were treated at participating facilities and consecutively included in the regular group (classified by the NHIA). Non-P4P patients were treated at nonparticipating facilities and never included in the regular group. The caliper matching method and a generalized estimating equation were used to estimate difference-in-differences models (baseline year 2009) and examine the short- and long-term effects of the P4P program on adverse outcomes. PRINCIPAL FINDINGS: The schizophrenia P4P program was associated with decreases in unscheduled outpatient visits (OR: 0.69, P < 0.001) and compulsory admissions (incidence rate ratio: 0.33, P < 0.05). However, this program was not associated with decreases in other outcomes including emergency department visits for any disease, admissions to an acute psychiatric ward, and readmission within 6 months. CONCLUSIONS: Although the disease management component of the P4P program can be beneficial for compulsory admissions, more sophisticated activities, such as health promotion targeting disadvantaged patients, could be implemented to reduce the occurrence of complicated adverse outcomes.

Economic Evaluation of Midazolam-Droperidol Combination, Versus Droperidol or Olanzapine for the Management of Acute Agitation in the Emergency Department: A Within-Trial Analysis.

BACKGROUND: The combination of midazolam and droperidol has proven superior to droperidol or olanzapine monotherapy in the management of acute agitation in emergency departments (EDs). OBJECTIVE: This is the first economic analysis to evaluate the cost-benefit and cost effectiveness of the midazolam-droperidol combination compared with droperidol or olanzapine for the management of acute agitation in EDs. METHODS: This analysis used data derived from a randomised, controlled, double-blind clinical trial conducted in two metropolitan Australian EDs between October 2014 and August 2015. The economic evaluation was from the perspective of Australian public hospital EDs. The main outcomes included agitation management time and the agitation-free time gained. Sensitivity analyses were undertaken. RESULTS: The midazolam-droperidol combination was the least costly regimen (Australian dollars [AU$]46.25 per patient) compared with the droperidol and olanzapine groups (AU$92.18 and AU$110.45 per patient, respectively). The main cost driver for all groups was the cost of the labour required during the initial adequate sedation. The combination afforded an additional 10-13 min of mean agitation-free time gained, which can be translated to additional savings of AU$31.24-42.60 per patient compared with the droperidol and olanzapine groups. The benefit-cost ratio for the midazolam-droperidol combination was 12.2:1.0, or AU$122,000 in total benefit for every AU$10,000 spent on management of acute agitation. Sensitivity analyses over key variables indicated these results were robust. CONCLUSIONS: The midazolam-droperidol combination may be a cost-saving and dominant cost-effective regimen for the treatment of acute agitation in EDs as it is more effective and less costly than either droperidol or olanzapine monotherapy.

Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial.

BACKGROUND: Chronic kidney disease (CKD) and end-stage kidney disease (ESKD) are serious and growing health problems with enormous impact on psychological and social functioning. Despite high rates of comorbid depression and anxiety in these patient populations, and the adverse impact these have upon treatment adherence, quality of life, social connectedness and healthcare costs there has been little attention focused on the prevention or management of these problems. Thus, our aim was to evaluate the Dialysis Optimal Health Program (DOHP) that adopts a person-centred approach and engages collaborative therapy to educate and support those diagnosed with ESKD who are commencing dialysis. METHODS: The study design is a randomised controlled trial. Ninety-six adult patients initiating haemodialysis or peritoneal dialysis will be randomly allocated to either the intervention (DOHP) or usual care group. Participants receiving the intervention will receive nine (8 + 1 booster session) sequential sessions based on a structured information/workbook, psychosocial and educational supports and skills building. The primary outcome measures are depression and anxiety (assessed by the Hospital Anxiety and Depression Scale; HADS). Secondary outcomes include health-related quality of life (assessed by the Kidney Disease Quality of Life instrument; KDQOL), self-efficacy (assessed by General Self-Efficacy Scale) and clinical indices (e.g. albumin and haemoglobin levels). Cost-effectiveness analysis and process evaluation will also be performed to assess the economic value and efficacy of the DOHP. Primary and secondary measures will be collected at baseline and at 3-, 6-, and 12-month follow-up time points. DISCUSSION: We believe that this innovative trial will enhance knowledge of interventions aimed at supporting patients in the process of starting dialysis, and will broaden the focus from physical symptoms to include psychosocial factors such as depression, anxiety, self-efficacy, wellbeing and community support. The outcomes associated with this study are significant in terms of enhancing an at-risk population's psychosocial health and reducing treatment-related costs and associated pressures on the healthcare system. TRIAL REGISTRATION: ANZCTR no. 12615000810516 . Registered on 5 August 2015.

The Stroke and Carer Optimal Health Program (SCOHP) to enhance psychosocial health: study protocol for a randomized controlled trial.

BACKGROUND: Stroke is a leading cause of disability and distress, and often profoundly affects the quality of life of stroke survivors and their carers. With the support of carers, many stroke survivors are returning to live in the community despite the presence of disability and ongoing challenges. The sudden and catastrophic changes caused by stroke affects the mental, emotional and social health of both stroke survivors and carers. The aim of this study is to evaluate a Stroke and Carer Optimal Health Program (SCOHP) that adopts a person-centred approach and engages collaborative therapy to educate, support and improve the psychosocial health of stroke survivors and their carers. METHODS: This study is a prospective randomised controlled trial. It will include a total of 168 stroke survivors and carers randomly allocated into an intervention group (SCOHP) or a control group (usual care). Participants randomised to the intervention group will receive nine (8 + 1 booster) sessions guided by a structured workbook. The primary outcome measures for stroke survivors and carers will be health-related quality of life (AQoL-6D and EQ-5D) and self-efficacy (GSE). Secondary outcome measures will include: anxiety and depression (HADS); coping (Brief COPE); work and social adjustment (WSAS); carer strain (MCSI); carer satisfaction (CASI); and treatment evaluation (TEI-SF and CEQ). Process evaluation and a health economic cost analysis will also be conducted. DISCUSSION: We believe that this is an innovative intervention that engages the stroke survivor and carer and will be significant in improving the psychosocial health, increasing independence and reducing treatment-related costs in this vulnerable patient-carer dyad. In addition, we expect that the intervention will assist carers and stroke survivors to negotiate the complexity of health services across the trajectory of care and provide practical skills to improve self-management. TRIAL REGISTRATION: ACTRN12615001046594 . Registered on 7 October 2015.

Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial.

BACKGROUND: Rehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed extremities, promotes neurological improvement. The aim of this study is to compare the effects of a 12-week intensive activity-based therapy program for the whole body with a program of upper body exercise. METHODS/DESIGN: A multicenter, parallel group, assessor-blinded randomized controlled trial will be conducted. One hundred eighty-eight participants with spinal cord injury, who have completed their primary rehabilitation at least 6 months prior, will be recruited from five SCI units in Australia and New Zealand. Participants will be randomized to an experimental or control group. Experimental participants will receive a 12-week program of intensive exercise for the whole body, including locomotor training, trunk exercises and functional electrical stimulation-assisted cycling. Control participants will receive a 12-week intensive upper body exercise program. The primary outcome is the American Spinal Injuries Association (ASIA) Motor Score. Secondary outcomes include measurements of sensation, function, pain, psychological measures, quality of life and cost effectiveness. All outcomes will be measured at baseline, 12 weeks, 6 months and 12 months by blinded assessors. Recruitment commenced in January 2011. DISCUSSION: The results of this trial will determine the effectiveness of a 12-week program of intensive exercise for the whole body in improving neurological recovery after spinal cord injury. TRIAL REGISTRATION: NCT01236976 (10 November 2010), ACTRN12610000498099 (17 June 2010).

Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial.

BACKGROUND: Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation. METHODS/DESIGN: A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009. DISCUSSION: The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation. TRIAL REGISTRATION: NCT01086930 (12th March 2010)ACTRN12609000695202 (12th August 2009).