A snapshot of consumer engagement in clinical trials in Australia: results of a national survey of clinical trial networks and research organisations.

BACKGROUND: Little is known about the extent, perceptions or experiences of consumers involved in clinical trials across Australia. The purpose of this National study was to better understand the activity and perceptions of clinical trial networks (CTNs), research co-ordinating centres and their consumers, around consumer involvement in clinical trials. METHODS: CTNs and research co-ordinating centres who were members of the Australian Clinical Trials Alliance (ACTA), and consumers involved in the activities of these organisations, were invited to participate in online surveys. Surveys were completed between April and September 2018. RESULTS: 80 respondents completed the surveys in full: 25 of 34 CTNs, 5 from 15 research co-ordinating centres, and included research investigators of 13 active trials, 10 completed trials. There were 27 consumer respondents. Consumers were involved in clinical trial activities across 19/25 (76%) of CTNs and 3/5 (60%) of research co-ordinating centres. Consumers were involved at all stages of the trial cycle. Despite this, only 8/30 (27%) of research organisations provided specific training to their employees or members on consumer involvement in research, and most did not have a specific policy or process relating to conducting consumer involvement in clinical trials. At the organisation level, barriers to consumer involvement in clinical trials included being unsure how to involve consumers effectively and systematically, difficulty in accessing consumers or lack of infrastructure and resources. At the consumer level, barriers included limited understanding of their roles, a lack of resources and training. Enablers included education, training and funding for both the research sector and for consumers. Almost all consumer respondents (25/27; 92%) would recommend the consumer role to other potential consumers, stating it was a valuable experience that led to knowledge exchange and learning about the research process. CONCLUSIONS: Over the last few years, consumer involvement in clinical trials has increased in Australia, but the scope of involvement varies across different research organisations, and therapeutic areas. Consumer involvement in clinical trials is valued by most that do it, however, there are opportunities to further foster and strengthen ongoing partnerships, for example by providing practical advice for researchers on how to best engage and involve consumers.

Consumer involvement in clinical research (including clinical trials) is considered best practice in Australia, yet it is not yet standard practice. Before doing this research, we did not know the involvement, perceptions and experiences of researchers and consumers within research networks or organisations. Surveys were used to ask Australian Clinical Trials Alliance (ACTA) member organisations including their consumers, about how consumers are being involved in clinical trials. The surveys found that consumers are involved across many clinical trials conducted in Australia, and that their input is valued by researchers and research organisations. Sometimes researchers were uncertain on how to best involve consumers in the different aspects of clinical trials so their contribution was effective and added value. Consumers also expressed at times they were uncertain as to what was expected of them, and in some instances training would have been useful to help them engage more effectively. Support and training also needs to be more appropriate for people from different populations, ethnic backgrounds and cultures, including First Nations peoples. All agreed more resources, training and funding would be needed to support consumer involvement in clinical trials.

Engaging consumers in health research: a narrative review.

Objective Consumer and community engagement (CCE) in research is increasingly valued in a contemporary healthcare environment that seeks to genuinely partner with consumers and the wider community. Although there is widespread agreement at research governance levels as to the benefits of CCE in research, there is little available research-based guidance as to how best to proceed with CCE organisationally and how to manage and overcome barriers. The aim of this narrative review was to draw together the available research, review findings and relevant governance-related material and to discuss these in light of a case series among research-engaged consumers in order to chart a practical way forward. Methods A narrative literature review about CCE in research was conducted. Following this, a case series among seven consumers who had been engaged as partners in health research was conducted. Finally, the lived experience of these consumers was explored against the findings of the narrative review. Results In all, 121 papers were identified and reviewed, 37 of which were used to inform the content of this paper. The most important benefits of CCE to both consumers and healthcare researchers were related to improvements in trust between consumer and researchers, and the increased relevance and ethics of research agendas ultimately pursued. Barriers to CCE were found to be pragmatic, attitudinal and organisational. Enabling factors that capitalise on the benefits and help address the barriers to meaningful CCE are outlined and discussed in light of a case series conducted among research-engaged consumers in Australia and internationally. Conclusion Best practice standards, organisational commitments and resources are needed to improve the status quo in Australia and to provide health research end-users with research outcomes that better align with their priorities and needs. What is known about the topic? Consumer and community engagement (CCE) in research is increasing in prevalence and is likely to be beneficial to both consumers and healthcare providers and researchers. What does this paper add? Following review of the available research findings and governance statements about CCE, enabling strategies are presented in light of a case series among Sydney-based research-engaged consumers. What are the implications for practitioners? Barriers to consumer and community engagement can be overcome if well understood and tackled organisationally. The potential benefits of shifting to a fully consumer- or community-engaged healthcare research environment are multifactorial and represent a paradigm shift in favour of evidence-based patient and family-centred care.

Testing the implementation of an electronic process-of-care checklist for use during morning medical rounds in a tertiary intensive care unit: a prospective before-after study.

BACKGROUND: To improve the delivery of important care processes in the ICU, morning ward round checklists have been implemented in a number of intensive care units (ICUs) internationally. Good quality evidence supporting their use as clinical support tools is lacking. With increased use of technology in clinical settings, integration of such tools into current work practices can be a challenge and requires evaluation. Having completed preliminary work revealing variations in practice and evidence supporting the construct validity of a process-of-care checklist, the need to develop, test and further validate an e(lectronic)-checklist in an ICU was identified. METHODS: A prospective, before-after study was conducted in a 19-bed general ICU within a tertiary hospital. Data collection occurred during baseline and intervention periods for 6 weeks each, with education and training conducted over a 4-week period prior to intervention. The e-checklist was used at baseline by ICU research nurses conducting post-ward round audits. During intervention, senior medical staff completed the e-checklist after patient assessments during the morning ward rounds, and research staff conducted post-ward round audits for validity testing (via concordance measurement). To examine changes in compliance over time, checklist-level data were analysed using generalised estimating equations that factored in confounding variables, and statistical process control charts were used to evaluate unit-level data. Established measures of concordance were used to evaluate e-checklist validity. RESULTS: Compliance with each care component improved significantly over time; the largest improvement was for pain management (42% increase; adjusted odds ratio = 23, p < 0.001), followed by glucose management (22% increase, p < 0.001) and head-of-bed elevation (19% increase, p < 0.001), both with odds ratios greater than 10. Most detected omissions were corrected by the following day. Control charts illustrated reduced variability in care compliance over time. There was good concordance between physician and auditor e-checklist responses; seven out of nine cares had kappa values above 0.8. CONCLUSION: Improvements in the delivery of essential daily care processes were evidenced after the introduction of an e-checklist to the morning ward rounds in an ICU. High levels of agreement between physician and independent audit responses lend support to the validity of the e-checklist.

Optimal occupancy in the ICU: a literature review.

INTRODUCTION: In intensive care, occupancy is a commonly used measure. There is inconsistency however in its measurement and optimal occupancy targets need to be defined. The objectives of this literature review were to explore how occupancy is measured, reported, and interpreted and investigate optimal occupancy levels for ICUs. METHOD: A literature search was performed using the Medline, Embase and CINAHL databases and citation tracking identified additional relevant articles. Articles published since 1997, written in English and focused on the adult ICU setting were included. As a result, 16 articles were selected for this review. RESULTS: Although it was apparent there was no commonly accepted or used method for calculating ICU occupancy, methods described as more accurate enumerate actual patient hours in the ICU, use operational (and preferably fully staffed) beds as the denominator, and are calculated daily. Issues pertaining to the utility, interpretation, and reporting of ICU occupancy measures were identified and there were indications that optimal ICU occupancy rates were around 70-75%. It was evident however that setting a uniform target figure for all ICUs would be problematic as there are a range of factors both at the unit and the hospital level that impact occupancy figures and optimal occupancy levels. IMPLICATIONS: This literature review informed the recommendation of a proposed method for calculating ICU occupancy which provides a realistic measure of occupied bed hours as a percentage of available beds. Despite the importance of gaining an understanding of ICU occupancy at the local and broader health system levels, there are a number of unknown factors that require further research. Appropriate occupancy targets, impact of unavailable beds, and the intrinsic and extrinsic factors on occupancy measurement are a few examples of where more information is required to adequately inform ICU monitoring, planning and evaluation activities.

Developing content for a process-of-care checklist for use in intensive care units: a dual-method approach to establishing construct validity.

BACKGROUND: In the intensive care unit (ICU), checklists can be used to support the delivery of quality and consistent clinical care. While studies have reported important benefits for clinical checklists in this context, lack of formal validity testing in the literature prompted the study aim; to develop relevant 'process-of-care' checklist statements, using rigorously applied and reported methods that were clear, concise and reflective of the current evidence base. These statements will be sufficiently instructive for use by physicians during ICU clinical rounds. METHODS: A dual-method approach was utilized; semi-structured interviews with local clinicians; and rounds of surveys to an expert Delphi panel. The interviews helped determine checklist item inclusion/exclusion prior to the first round Delphi survey. The panel for the modified-Delphi technique consisted of local intensivists and a state-wide ICU quality committee. Minimum standards for consensus agreement were set prior to the distribution of questionnaires, and rounds of surveys continued until consensus was achieved. RESULTS: A number of important issues such as overlap with other initiatives were identified in interviews with clinicians and integrated into the Delphi questionnaire, but no additional checklist items were suggested, demonstrating adequate checklist coverage sourced from the literature. These items were verified by local clinicians as being relevant to ICU and important elements of care that required checking during ward rounds. Two rounds of Delphi surveys were required to reach consensus on nine checklist statements: nutrition, pain management, sedation, deep vein thrombosis and stress ulcer prevention, head-of-bed elevation, blood glucose levels, readiness to extubate, and medications. CONCLUSIONS: Statements were developed as the most clear, concise, evidence-informed and instructive statements for use during clinical rounds in an ICU. Initial evidence in support of the checklist's construct validity was established prior to further prospective evaluation in the same ICU.

CNE article: safety culture in Australian intensive care units: establishing a baseline for quality improvement.

BACKGROUND: Workplace safety culture is a crucial ingredient in patients' outcomes and is increasingly being explored as a guide for quality improvement efforts. OBJECTIVES: To establish a baseline understanding of the safety culture in Australian intensive care units. METHODS: In a nationwide study of physicians and nurses in 10 Australian intensive care units, the Safety Attitudes Questionnaire intensive care unit version was used to measure safety culture. Descriptive statistics were used to summarize the mean scores for the 6 subscales of the questionnaire, and generalized-estimation-equations models were used to test the hypotheses that safety culture differed between physicians and nurses and between nurse leaders and bedside nurses. RESULTS: A total of 672 responses (50.6% response rate) were received: 513 (76.3%) from nurses, 89 (13.2%) from physicians, and 70 (10.4%) from respondents who did not specify their professional group. Ratings were highest for teamwork climate and lowest for perceptions of hospital management and working conditions. Four subscales, job satisfaction, teamwork climate, safety climate, and working conditions, were rated significantly higher by physicians than by nurses. Two subscales, working conditions and perceptions of hospital management, were rated significantly lower by nurse leaders than by bedside nurses. CONCLUSIONS: Measuring the baseline safety culture of an intensive care unit allows leaders to implement targeted strategies to improve specific dimensions of safety culture. These strategies ultimately may improve the working conditions of staff and the care that patients receive.

Quality and safety in intensive care-A means to an end is critical.

BACKGROUND: To achieve improvement in healthcare quality and safety, all four domains (outcome, process, structure and culture) must be considered in conjunction with the best available clinical evidence to improve patient care and reduce harm. A range of improvement initiatives have targeted processes of care in recognition of: (1) complexities of patient care and (2) evidence that a large portion of adverse events are preventable, occur during ongoing care, and result in poorer patient outcomes. PURPOSE: The aims of this paper are to: (1) outline national and international quality and safety initiatives; (2) identify evidence-based processes of care applicable to the general adult ICU patient population; (3) summarise the literature on relevant quality improvement strategies. METHODS: An integrative literature review was conducted by: (1) database search of Ovid Medline, CINAHL, EMBASE and Cochrane for articles published between 1996 and October 2009; (2) identification of additional studies from articles obtained; (3) purposive internet search identifying relevant quality and safety initiatives. FINDINGS: Quality improvement initiatives across the globe were identified, with ensuing focus on how the development, implementation and evaluation of evidence-based processes of care can lead to improvements in the delivery and outcomes of intensive care practice. Variation in practice and methodological limitations of existing studies were also noted, highlighting the need for innovative approaches to improving processes in the ICU. CONCLUSION: This integrative review has outlined potential for achieving practice improvements in intensive care and highlighted the need for further evaluative research to improve patient care at the bedside.

Preliminary insights into data collection processes in New South Wales intensive care units.

OBJECTIVE: To investigate the resources and infrastructure available for collecting intensive care unit data in New South Wales for submission to the Australian and New Zealand Intensive Care Society (ANZICS) Adult Patient Database (APD). DESIGN: Descriptive cross-sectional survey, part of an annual survey of ICU resources. SETTING: All 42 adult ICUs in public hospitals in NSW, March-April 2006. PARTICIPANTS: Nurse unit managers of ICUs. RESULTS: There was variability in who was responsible for data collection and data entry, and who oversaw the data collection process. The time dedicated to these functions also varied greatly and depended on available resources, which were often reported as insufficient. At least 55% of ICUs experienced delays in entering data into a database. Although 65% reported conducting quality checks on data, 30% could not report the frequency of checks; another 30% did not use checks to improve data quality. CONCLUSIONS: It appears that NSW ICUs are generally not adequately resourced or organised for collecting data, which could significantly affect the quality of data submitted to the ANZICS APD. Further investigation of data quality is warranted, and a follow-up survey of ICU directors is planned. Until the issue of data quality is adequately addressed, outcomes measurement based on these data should be treated with caution.