How digital health translational research is prioritised: a qualitative stakeholder-driven approach to decision support evaluation.

OBJECTIVES: Digital health is now routinely being applied in clinical care, and with a variety of clinician-facing systems available, healthcare organisations are increasingly required to make decisions about technology implementation and evaluation. However, few studies have examined how digital health research is prioritised, particularly research focused on clinician-facing decision support systems. This study aimed to identify criteria for prioritising digital health research, examine how these differ from criteria for prioritising traditional health research and determine priority decision support use cases for a collaborative implementation research programme. METHODS: Drawing on an interpretive listening model for priority setting and a stakeholder-driven approach, our prioritisation process involved stakeholder identification, eliciting decision support use case priorities from stakeholders, generating initial use case priorities and finalising preferred use cases based on consultations. In this qualitative study, online focus group session(s) were held with stakeholders, audiorecorded, transcribed and analysed thematically. RESULTS: Fifteen participants attended the online priority setting sessions. Criteria for prioritising digital health research fell into three themes, namely: public health benefit, health system-level factors and research process and feasibility. We identified criteria unique to digital health research as the availability of suitable governance frameworks, candidate technology's alignment with other technologies in use,and the possibility of data-driven insights from health technology data. The final selected use cases were remote monitoring of patients with pulmonary conditions, sepsis detection and automated breast screening. CONCLUSION: The criteria for determining digital health research priority areas are more nuanced than that of traditional health condition focused research and can neither be viewed solely through a clinical lens nor technological lens. As digital health research relies heavily on health technology implementation, digital health prioritisation criteria comprised enablers of successful technology implementation. Our prioritisation process could be applied to other settings and collaborative projects where research institutions partner with healthcare delivery organisations.

Qualitative study of international key informants' perspectives on the current and future state of healthcare quality measurement and feedback.

OBJECTIVES: The aim of this study is to explore the current and future state of quality measurement and feedback and identify factors influencing measurement feedback systems, including the barriers and enablers to their effective design, implementation, use and translation into quality improvement. DESIGN: This qualitative study used semistructured interviews with key informants. A deductive framework analysis was conducted to code transcripts to the Theoretical Domains Framework (TDF). An inductive analysis was used to produce subthemes and belief statements within each TDF domain. SETTING: All interviews were conducted by videoconference and audio-recorded. PARTICIPANTS: Key informants were purposively sampled experts in quality measurement and feedback, including clinical (n=5), government (n=5), research (n=4) and health service leaders (n=3) from Australia (n=7), the USA (n=4), the UK (n=2), Canada (n=2) and Sweden (n=2). RESULTS: A total of 17 key informants participated in the study. The interview length ranged from 48 to 66 min. 12 theoretical domains populated by 38 subthemes were identified as relevant to measurement feedback systems. The most populous domains included environmental context and resources, memory, attention and decision-making, and social influences. The most populous subthemes included 'quality improvement culture', 'financial and human resource support' and 'patient-centred measurement'. There were minimal conflicting beliefs outside of 'data quality and completeness'. Conflicting beliefs in these subthemes were predominantly between government and clinical leaders. CONCLUSIONS: Multiple factors were found to influence measurement feedback systems and future considerations are presented within this manuscript. The barriers and enablers that impact these systems are complex. While there are some clear modifiable factors in the design of measurement and feedback processes, influential factors described by key informants were largely socioenvironmental. Evidence-based design and implementation, coupled with a deeper understanding of the implementation context, may lead to enhanced quality measurement feedback systems and ultimately improved care delivery and patient outcomes.

Implementation of a novel stratified PAthway of CarE for common musculoskeletal (MSK) conditions in primary care: protocol for a multicentre pragmatic randomised controlled trial (the PACE MSK trial).

INTRODUCTION: Musculoskeletal (MSK) conditions constitute the highest burden of disease globally, with healthcare services often utilised inappropriately and overburdened. The aim of this trial is to evaluate the effectiveness of a novel clinical PAthway of CarE programme (PACE programme), where care is provided based on people's risk of poor outcome. METHODS AND ANALYSIS: Multicentre randomised controlled trial. 716 people with MSK conditions (low back pain, neck pain or knee osteoarthritis) will be recruited in primary care. They will be stratified for risk of a poor outcome (low risk/high risk) using the Short Form Örebro Musculoskeletal Pain Screening Questionnaire (SF-ÖMSPQ) then randomised to usual care (n=358) or the PACE programme (n=358). Participants at low risk in the PACE programme will receive up to 3 sessions of guideline based care from their primary healthcare professional (HCP) supported by a custom designed website (mypainhub.com). Those at high risk will be referred to an allied health MSK specialist who will conduct a comprehensive patient-centred assessment then liaise with the primary HCP to determine further care. Primary outcome (SF 12-item PCS) and secondary outcomes (eg, pain self-efficacy, psychological health) will be collected at baseline, 3, 6 and 12 months. Cost-effectiveness will be measured as cost per quality-adjusted life-year gained. Health economic analysis will include direct and indirect costs. Analyses will be conducted on an intention-to-treat basis. Primary and secondary outcomes will be analysed independently, using generalised linear models. Qualitative and mixed-methods studies embedded within the trial will evaluate patient experience, health professional practice and interprofessional collaboration. ETHICS AND DISSEMINATION: Ethics approval has been received from the following Human Research Ethics Committees: The University of Sydney (2018/926), The University of Queensland (2019000700/2018/926), University of Melbourne (1954239), Curtin University (HRE2019-0263) and Northern Sydney Local Health District (2019/ETH03632). Dissemination of findings will occur via peer-reviewed publications, conference presentations and social media. TRIAL REGISTRATION NUMBER: ACTRN12619000871145.

Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals.

INTRODUCTION: In multisite intervention trials, implementation success often varies widely across settings. Process evaluations are crucial to interpreting trial outcomes and understanding contextual factors and causal chains necessary for successful implementation. Lynch syndrome is a hereditary cancer predisposition conferring an increased risk of colorectal, endometrial and other cancer types. Despite systematic screening protocols to identify Lynch syndrome, the condition remains largely underdiagnosed. The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks. To enhance widespread implementation of optimal Lynch syndrome identification, there is a need to understand not only what works, but also why, in what contexts, and at what costs. Here we describe an in-depth investigation of factors influencing successful implementation of procedures evaluated in the HaSP trial. METHODS AND ANALYSIS: A mixed-methods, theory-driven process evaluation will be undertaken in parallel to the HaSP trial. Data will include: interviews of Implementation Leads and Lynch syndrome stakeholders, pre-post implementation questionnaires, audio analysis of meetings and focus groups, observation of multidisciplinary team meetings, fidelity checklists and project log analysis. Results will be triangulated and coded, drawing on the Theoretical Domains Framework, Consolidated Framework for Implementation Research and Proctor's implementation outcomes. ETHICS AND DISSEMINATION: Use of a theory-based process evaluation will enhance interpretation and generalisability of HaSP trial findings, and contribute to the implementation research field by furthering understanding of the conditions necessary for implementation success. Ethical approval has been granted and results will be disseminated via publications in peer-reviewed journals and conference presentations. At trial completion, key findings will be fed back to sites to enable refinement of intervention strategies, both in the context of Lynch syndrome and for the possible generalisability of intervention components in other genetic and broader clinical specialties. HASP TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (Identifier: ACTRN12618001072202). Registered 27 June 2018. http://www.ANZCTR.org.au/ACTRN12618001072202.aspx.

Implementation of a lung cancer multidisciplinary team standardised template for reporting to general practitioners: a mixed-method study.

OBJECTIVES: Few interventions have been designed that provide standardised information to primary care clinicians about the diagnostic and treatment recommendations resulting from cancer multidisciplinary team (MDT) (tumour board) meetings. This study aimed to develop, implement and evaluate a standardised template for lung cancer MDTs to provide clinical information and treatment recommendations to general practitioners (GPs). Specific objectives were to (1) evaluate template feasibility (acceptability, appropriateness and timeliness) with GPs and (2) document processes of preimplementation, implementation and evaluation within the MDT setting. DESIGN: A mixed-method study design using structured interviews with GPs and qualitative documentation of project logs about implementation processes. SETTING: Two hospitals in Central Sydney, New South Wales, Australia. PARTICIPANTS: 61 GPs evaluated the template. Two lung cancer MDTs, consisting of 33 clinicians, and eight researchers participated in template development and implementation strategy. RESULTS: The MDT-reporting template appears to be a feasible way of providing clinical information to GPs following patient presentation at a lung cancer MDT meeting. Ninety-five per cent of GPs strongly agreed or agreed that the standardised template provided useful and relevant information, that it was received in a timely manner (90%) and that the information was easy to interpret and communicate to the patient (84%). Implementation process data show that the investment made in the preimplementation stage to integrate the template into standard work practices was a critical factor in successful implementation. CONCLUSIONS: This study demonstrates that it is feasible to provide lung cancer MDT treatment recommendations to GPs through implementation of a standardised template. A simple intervention, such as a standardised template, can help to address quality gaps and ensure that timely information is communicated between tertiary and primary care healthcare providers.

Using an Objective Structured Clinical Examination to test adherence to Joint Commission National Patient Safety Goal--associated behaviors.

BACKGROUND: A study was conducted at a tertiary care academic medical center to assess a simulation-based, single-station Objective Structured Clinical Examination (OSCE) designed to evaluate intern trainees' familiarity with and adherence to behaviors associated with Joint Commission National Patient Safety Goals and The Joint Commission Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. METHOD: Subjects were interns, from all disciplines, completing basic skills training during intern orientation. The OSCE scenario was designed to assess 13 behaviors associated with four National Patient Safety Goals (1, 2, 3, and 7) from 2009 and 2010 and the Universal Protocol. Sessions were digitally recorded and independently reviewed by two observers, who scored behaviors using a standardized score sheet. Behaviors were assigned point values and tabulated for all trainees. Kappa coefficient was calculated to assess interrater reliability. RESULTS: One-hundred eleven (74.5%) of 149 interns completed the station. The average time to completion was 6.9 minutes (standard deviation [SD] 1.8; range, 3.5-12.6). Interns scored an average of 9.5 points (SD, 4.7; range, 2-20; mode, 8) of 26. The interrater reliability for the two reviewers was 0.9. Interns most frequently requested chlorhexidine to sterilize the patient's skin (98.2% of interns demonstrated); identifying an unlabeled medication vial as inappropriate for use was the most frequently missed item (8.1% of interns demonstrated). CONCLUSIONS: Behaviors related to tenets of patient safety and quality care can be assessed using a simple to design and execute OSCE. Using simulation to test behaviors associated with the National Patient Safety Goals may be a desirable adjunct to traditional simple knowledge-based tests.

Impact of online education on intern behaviour around joint commission national patient safety goals: a randomised trial.

PURPOSE: To compare the effectiveness of two types of online learning methodologies for improving the patient-safety behaviours mandated in the Joint Commission National Patient Safety Goals (NPSG). METHODS: This randomised controlled trial was conducted in 2010 at Massachusetts General Hospital and Brigham and Women's Hospital (BWH) in Boston USA. Incoming interns were randomised to either receive an online Spaced Education (SE) programme consisting of cases and questions that reinforce over time, or a programme consisting of an online slide show followed by a quiz (SQ). The outcome measures included NPSG-knowledge improvement, NPSG-compliant behaviours in a simulation scenario, self-reported confidence in safety and quality, programme acceptability and programme relevance. RESULTS: Both online learning programmes improved knowledge retention. On four out of seven survey items measuring satisfaction and self-reported confidence, the proportion of SE interns responding positively was significantly higher (p<0.05) than the fraction of SQ interns. SE interns demonstrated a mean 4.79 (36.6%) NPSG-compliant behaviours (out of 13 total), while SQ interns completed a mean 4.17 (32.0%) (p=0.09). Among those in surgical fields, SE interns demonstrated a mean 5.67 (43.6%) NPSG-compliant behaviours, while SQ interns completed a mean 2.33 (17.9%) (p=0.015). Focus group data indicates that SE was more contextually relevant than SQ, and significantly more engaging. CONCLUSION: While both online methodologies improved knowledge surrounding the NPSG, SE was more contextually relevant to trainees and was engaging. SE impacted more significantly on both self-reported confidence and the behaviour of surgical residents in a simulated scenario.