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Background: This paper presents a protocol for a randomised controlled trial of the Cardiac-Diabetes Transcare program which is a transitional care, multi-modal self-management program for patients with acute coronary syndrome comorbid with type 2 diabetes. Prior research has indicated people hospitalised with dual cardiac and diabetes diagnoses are at an elevated risk of hospital readmissions, morbidity and mortality. The primary aim of this study is to evaluate the effectiveness (and cost-effectiveness) of a Cardiac-Diabetes Transcare intervention program on 6-month readmission rate in comparison to usual care.Methods/design: A two-armed, randomised controlled trial with blinded outcome assessment will be conducted to evaluate the comparative effectiveness of two modes of care, including a Usual Care Group and a Cardiac-Diabetes Transcare Intervention (in addition to usual care) Group. The primary outcome is 6-month readmission rate, although a range of secondary outcomes will be collected (including self-efficacy) at baseline, 1, 3 and 6 month reassessments. The intervention group will receive in-hospital education tailored for people recovering from an acute coronary syndrome-related hospital admission who have comorbid diabetes, and they will also receive home visits and telephone follow-up by a trained Research Nurse to reinforce and facilitate disease-management-related behaviour change. Both groups will receive usual care interventions offered or referred from participating hospital facilities. A sample size of 432 participants from participating hospitals in the Australian states of Queensland and Victoria will be recruited for 90% power based on the most conservative scenarios modelled for sample size estimates.Discussion: The study outlined in this protocol will provide valuable insight into the effectiveness of a transitional care intervention targeted for people admitted to hospital with cardiac-related presentations commencing in the inpatient hospital setting and transition to the home environment. The purpose of theory-based intervention comprising face-to-face sessions and telephone follow up for patients with acute coronary syndrome and type 2 diabetes is to increase self-efficacy to enhance self-management behaviours and thus improve health outcomes and reduce hospital readmissions.Trial Registration: This study has been registered with the Australian New Zealand Clinical Trials Registry dated 16/12/2014: ACTRN12614001317684 . [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) are used by clinical quality registries to assess patients' perspectives of care outcomes and quality of life. PROMs can be assessed through a self-administered survey or by a third party. Use of mixed mode approaches where PROMs are completed using a single or combination of administration method is emerging. The aim of this study is to identify the most cost-effective efficient approach to collecting PROMs among three modes (telephone, postal service/mail and email) in a population-based clinical quality registry monitoring survivorship after a diagnosis of prostate cancer. This is important to assist the registry in achieving representative PROMs capture using the most cost-effective technique and in developing cost projections for national scale-up.Methods/design: This study will adopt an equivalence randomised controlled design. Participants are men diagnosed with and/or treated for prostate cancer (PCa) participating in PCOR-VIC and meet the criteria for 12-month follow-up. Participants will be individually randomized to three independent groups: telephone, mail/postal, or email to complete the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) survey. It is estimated each group will have 229 respondents. We will compare the proportion of completed surveys across the three groups. The economic evaluation will be undertaken from the perspective of the data collection centre and consider all operating costs (personnel, supplies, training, operation and maintenance). Cost data will be captured using an Activity Based Costs method. To estimate the most cost-effective approach, we will calculate incremental cost-effectiveness ratios. A cost projection model will be developed based on most cost-effective approach for nationwide scale-up of the PROMs tool for follow-up of PCa patients in Australia.Discussion: This study will identify the most cost-effective approach for collecting PROMs from men with PCa, and enable estimation of costs for national implementation of the PCa PROMs survey. The findings will be of interest to other registries embarking on PROMs data collection.Trial Registration: ACTRN12615001369516 (Registered on December 16, 2015). [ABSTRACT FROM AUTHOR]

Background: The Safety Attitudes Questionnaire (SAQ) is commonly used to assess staff perception of safety climate within their clinical environment. The psychometric properties of the SAQ have previously been explored with confirmatory factor analysis and found to have some issues with construct validity. This study aimed to extend the psychometric evaluations of the SAQ by using Rasch analysis.Methods: Assessment of internal construct validity included overall fit to the Rasch model (unidimensionality), response formats, targeting, differential item functioning (DIF) and person-separation index (PSI).Results: A total of 420 nurses completed the SAQ (response rate 60 %). Data showed overall fit to a Rasch model of expected item functioning for interval scale measurement. The questionnaire demonstrated unidimensionality confirming the appropriateness of summing the items in each domain. Score reliabilities were appropriate (internal consistency PSI 0.6-0.8). However, participants were not using the response options on the SAQ in a consistent manner. All domains demonstrated suboptimal targeting and showed compromised score precision towards higher levels of safety climate (substantial ceiling effects).Conclusion: There was general support for the reliability of the SAQ as a measure of safety climate although it may not be able to detect small but clinically important changes in safety climate within an organisation. Further refinement of the SAQ is warranted. This may involve changing the response options and including new items to improve the overall targeting of the scale.Trial Registration: This study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000332921 (21 March 2011). [ABSTRACT FROM AUTHOR]