Melbourne School of Health Sciences Collected Works - Research Publications
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ItemImproving treatment of patients with psychosis in low-and-middle-income countries in Southeast Europe: Results from a hybrid effectiveness-implementation, pragmatic, cluster-randomized clinical trial (IMPULSE)(CAMBRIDGE UNIV PRESS, 2022-08-10)BACKGROUND: In Southeast Europe (SEE) standard treatment of patients with psychosis is largely based on pharmacotherapy with psychosocial interventions rarely available. DIALOG+ is a digital psychosocial intervention designed to make routine care therapeutically effective. This trial simultaneously examined effectiveness of DIALOG+ versus standard care on clinical and social outcomes (Aim 1) and explored intervention fidelity (Aim 2). METHODS: A hybrid type II effectiveness-implementation, cluster-randomized trial was conducted in five SEE countries: Bosnia and Herzegovina, Kosovo*, Montenegro, North Macedonia, and Serbia. The intervention was offered to patients six times across 12 months instead of routine care. The outcomes were subjective quality of life (primary), clinical symptoms, satisfaction with services, and economic costs. Intervention fidelity was operationalized as adherence to the protocol in terms of frequency, duration, content, and coverage. Data were analyzed using multilevel regression. RESULTS: A total of 81 clinicians and 468 patients with psychosis were randomized to DIALOG+ or standard care. The intervention was delivered with high fidelity. The average number of delivered sessions was 5.5 (SD = 2.3) across 12 months. Patients in the intervention arm had better quality of life (MANSA) at 6 months (p = 0.03). No difference was found for other outcomes at 6 months. Due to disruptions caused by the COVID-19 pandemic, 12-month data were not interpretable. CONCLUSIONS: DIALOG+ improved subjective quality of life of individuals with psychosis at 6 months (after four sessions), albeit with small effect size. The intervention has the potential to contribute to holistic care of patients with psychosis.
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ItemDementia Risk Reduction in Primary Care: A Scoping Review of Clinical Guidelines Using a Behavioral Specificity Framework(IOS PRESS, 2022)BACKGROUND: Primary care practitioners are being called upon to work with their patients to reduce dementia risk. However, it is unclear who should do what with whom, when, and under what circumstances. OBJECTIVE: This scoping review aimed to identify clinical guidelines for dementia risk reduction (DRR) in primary care settings, synthesize the guidelines into actionable behaviors, and appraise the guidelines for specificity. METHODS: Terms related to "dementia", "guidelines", and "risk reduction" were entered into two academic databases and two web search engines. Guidelines were included if they referred specifically to clinical practices for healthcare professionals for primary prevention of dementia. Included guidelines were analyzed using a directed content analysis method, underpinned by the Action-Actor-Context-Target-Time framework for specifying behavior. RESULTS: Eighteen guidelines were included in the analysis. Together, the guidelines recommended six distinct clusters of actions for DRR. These were to 1) invite patients to discuss DRR, 2) identify patients with risk factors for dementia, 3) discuss DRR, 4) manage dementia risk factors, 5) signpost to additional support, and 6) follow up. Guidelines recommended various actors, contexts, targets, and times for performing these actions. Together, guidelines lacked specificity and were at times contradictory. CONCLUSION: Currently available guidelines allow various approaches to promoting DRR in primary care. Primary care teams are advised to draw on the results of the review to decide which actions to undertake and the locally appropriate actors, contexts, targets, and times for these actions. Documenting these decisions in more specific, local guidelines for promoting DRR should facilitate implementation.
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ItemExploring patient acceptability of a short-stay care pathway in hospital post arthroplasty: A theory-informed qualitative study(WILEY, 2022-08)INTRODUCTION: Arthroplasty is an effective, yet costly, surgical procedure for end-stage osteoarthritis. Shorter stays in hospital are being piloted in Australia. In some countries, short stay is established practice, associated with improving perioperative care and enhanced recovery after surgery practices. Exploring the acceptability to patients of a short stay care pathway in hospital postarthroplasty is important for informing health policy, adoption and potential scalability of this model of care. METHODS: Consecutive patients at one site, at least 3 months post total joint arthroplasty, were invited to participate in theory-informed semi-structured qualitative interviews. The Theoretical Framework of Acceptability (TFA) informed development of the interview guide. Interview data were analysed using the Framework Method. RESULTS: Eighteen patients were invited. Fifteen consented to be contacted and were interviewed. Short-stay post arthroplasty was highly acceptable to patients who had the supports necessary to recover safely at home. Key findings were as follows: flexibility of short-stay care pathway was essential and valued; prior beliefs and expectations informed acceptability; and the absence of out-of-pocket expenses had an incentivizing effect, but was not the primary reason for patients choosing this care pathway. Further themes analysed within the TFA constructs highlighted nuances of acceptability relating to this model of care. CONCLUSIONS: A short stay in hospital post arthroplasty appeared to be acceptable to patients who had experienced this care pathway. Our thematic findings identified aspects of the short-stay care pathway that enhanced acceptability and some aspects that limited acceptability. These findings can inform refinement of the short-stay care pathway. PATIENT OR PUBLIC CONTRIBUTION: Patients/people with lived experience were not involved in the study design or conduct of this preliminary work; as this short-stay model of care was recently introduced, only a small group of patients was eligible to participate in this study. This study is the first step towards understanding the experiences of patients about a short-stay model of care post arthroplasty. The findings will help inform future patient and public involvement in expanding the programme.
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ItemA randomised fractional factorial screening experiment to predict effective features of audit and feedback(BMC, 2022-05-26)BACKGROUND: Audit and feedback aims to improve patient care by comparing healthcare performance against explicit standards. It is used to monitor and improve patient care, including through National Clinical Audit (NCA) programmes in the UK. Variability in effectiveness of audit and feedback is attributed to intervention design; separate randomised trials to address multiple questions about how to optimise effectiveness would be inefficient. We evaluated different feedback modifications to identify leading candidates for further "real-world" evaluation. METHODS: Using an online fractional factorial screening experiment, we randomised recipients of feedback from five UK NCAs to different combinations of six feedback modifications applied within an audit report excerpt: use effective comparators, provide multimodal feedback, recommend specific actions, provide optional detail, incorporate the patient voice, and minimise cognitive load. Outcomes, assessed immediately after exposure to the online modifications, included intention to enact audit standards (primary outcome, ranked on a scale of -3 to +3, tailored to the NCA), comprehension, user experience, and engagement. RESULTS: We randomised 1241 participants (clinicians, managers, and audit staff) between April and October 2019. Inappropriate repeated participant completion occurred; we conservatively excluded participant entries during the relevant period, leaving a primary analysis population of 638 (51.4%) participants. None of the six feedback modifications had an independent effect on intention across the five NCAs. We observed both synergistic and antagonistic effects across outcomes when modifications were combined; the specific NCA and whether recipients had a clinical role had dominant influences on outcome, and there was an antagonistic interaction between multimodal feedback and optional detail. Among clinical participants, predicted intention ranged from 1.22 (95% confidence interval 0.72, 1.72) for the least effective combination in which multimodal feedback, optional detail, and reduced cognitive load were applied within the audit report, up to 2.40 (95% CI 1.88, 2.93) for the most effective combination including multimodal feedback, specific actions, patient voice, and reduced cognitive load. CONCLUSION: Potentially important synergistic and antagonistic effects were identified across combinations of feedback modifications, audit programmes, and recipients, suggesting that feedback designers must explicitly consider how different features of feedback may interact to achieve (or undermine) the desired effects. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN41584028.
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ItemNo Preview AvailableBlood transfusion in haematology: A qualitative exploration of patients' and healthcare professionals' perceptions(WILEY, 2022-11)OBJECTIVES: Repeated blood transfusions are indicated for the management of patients with cancer or blood disorders. Patients' perceptions about transfusions may be associated with decision-making and coping, which has been under-explored in the haematology context. This study therefore aimed to explore haematology transfusion patients' and HCPs' perceptions of blood transfusion, drawing on theory and previously identified themes of transfusion perceptions. DESIGN: Semi-structured interview study with 14 adult blood transfusion patients and 14 HCPs (consultants, registrars, nurses) at two UK haematology units. METHODS: Patient- and HCP-tailored topic guides were developed based on themes of blood transfusion perceptions identified in a systematic review: 'Health benefits', 'Safety/risk', 'Negative emotions', 'Alternatives' 'Decision making' and 'Necessity'. Transcripts were analysed using deductive and thematic analysis. Patient and HCP themes were compared using triangulation methods. Conceptual models (one for patients, one for HCPs) specific to haematology portraying the association between themes were developed. RESULTS: Findings for patients and HCPs converged with transfusion reported as beneficial for patients, who were largely involved in the decision-making. Both groups also reported concerns about transfusion, including iron-overload, allergic reactions and challenges to deliver transfusions in time-pressurized services. Themes in the conceptual models included patient 'Burden' of receiving repeated transfusions and 'Supportive relationships', reflective of patients' positive interactions with other patients and HCPs in the haematology unit. CONCLUSION: Despite the challenges for patients receiving repeated transfusions, convergent perceptions suggest a shared understanding of patients' transfusion experiences. Identified challenges could inform ways to improve transfusion services and patients' experiences.
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ItemNo Preview AvailableEnhanced feedback interventions to promote evidence-based blood transfusion guidance and reduce unnecessary use of blood components: the AFFINITIE research programme including two cluster factorial RCTs(National Institute for Health and Care Research, 2022)
Background
Blood transfusion is a common but costly treatment. Repeated national audits in the UK suggest that up to one-fifth of transfusions are unnecessary when judged against recommendations for good clinical practice. Audit and feedback seeks to improve patient care and outcomes by comparing clinical care against explicit standards. It is widely used internationally in quality improvement. Audit and feedback generally has modest but variable effects on patient care. A considerable scope exists to improve the impact that audit and feedback has, particularly through head-to-head trials comparing different ways of delivering feedback.Objectives
The AFFINITIE (Development & Evaluation of Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE) programme aimed to design and evaluate enhanced feedback interventions, within a national blood transfusion audit programme, to promote evidence-based guidance and reduce the unnecessary use of blood components. We developed, piloted and refined two feedback interventions, ‘enhanced content’ and ‘enhanced follow-on’ (workstream 1), evaluated the effectiveness and cost-effectiveness of the two feedback interventions compared with standard feedback practice (workstream 2), examined intervention fidelity and contextual influences (workstream 3) and developed general implementation recommendations and tools for other audit and feedback programmes (workstream 4).Design
Interviews, observations and documentary analysis in four purposively sampled hospitals explored contemporary practice and opportunities for strengthening feedback. We developed two interventions: ‘enhanced content’, to improve the clarity and utility of feedback reports, and ‘enhanced follow-on’, to help hospital staff with action-planning (workstream 1). We conducted two linked 2 × 2 factorial cross-sectional cluster-randomised trials within transfusion audits for major surgery and haematological oncology, respectively (workstream 2). We randomised hospital clusters (the organisational level at which hospital transfusion teams operate) to enhanced or standard content or enhanced or standard follow-on. Outcome assessment was masked to assignment. Decision-analytic modelling evaluated the costs, benefits and cost-effectiveness of the feedback interventions in both trials from the perspective of the NHS. A parallel process evaluation used semistructured interviews, documentary analyses and web analytics to assess the fidelity of delivery, receipt and enactment and to identify contextual influences (workstream 3). We explored ways of improving the impact of national audits with their representatives (workstream 4).Setting and participants
All NHS hospital trusts and health boards participating in the National Comparative Audit of Blood Transfusions were invited to take part. Among 189 hospital trusts and health boards screened, 152 hospital clusters participated in the surgical audit. Among 187 hospital trusts and health boards screened, 141 hospital clusters participated in the haematology audit.Interventions
‘Enhanced content’ aimed to ensure that the content and format of feedback reports were consistent with behaviour change theory and evidence. ‘Enhanced follow-on’ comprised a web-based toolkit and telephone support to facilitate local dissemination, planning and response to feedback.Main outcome measures
Proportions of acceptable transfusions, based on existing evidence and guidance and algorithmically derived from national audit data.Data sources
Trial primary outcomes were derived from manually collected, patient-level audit data. Secondary outcomes included routinely collected data for blood transfusion.Results
With regard to the transfusions in the major surgery audit, 135 (89%) hospital clusters participated from 152 invited. We randomised 69 and 66 clusters to enhanced and standard content, respectively, and 68 and 67 clusters to enhanced and standard follow-on, respectively. We analysed a total of 2222 patient outcomes at 12 months in 54 and 58 (enhanced and standard content, respectively) and 54 and 58 (enhanced and standard follow-on, respectively) hospital clusters. With regard to the haematology audit, 134 hospital clusters (95%) participated from 141 invited. We randomised 66 and 68 clusters to enhanced and standard content, respectively, and 67 clusters to both enhanced and standard follow-on. We analysed a total of 3859 patient outcomes at 12 months in 61 and 61 (enhanced and standard content, respectively) and 63 and 59 (enhanced and standard follow-on) hospital clusters. We found no effect of either of the enhanced feedback interventions in either trial across all outcomes. Incremental enhanced intervention costs ranged from £18 to £248 per site. The enhanced feedback interventions were dominated by the standard intervention in cost-effectiveness analyses. The interventions were delivered as designed and intended, but subsequent local engagement was low. Although the enhancements were generally acceptable, doubts about the credibility of the blood transfusion audits undermined the case for change.Limitations
Limitations included the number of participating clusters; loss to follow-up of trial clusters, reducing statistical power and validity; incomplete audit and cost data contributing to outcome measures; participant self-selection; reporting; missing data related to additional staff activity generated in response to receiving feedback; and recall biases in the process evaluation interviews.Conclusions
The enhanced feedback interventions were acceptable to recipients but were more costly and no more effective than standard feedback in reducing unnecessary use of blood components, and, therefore, should not be recommended on economic grounds.Future work
We have demonstrated the feasibility of embedding ambitious large-scale rigorous research within national audit programmes. Further head-to-head comparisons of different feedback interventions are needed in these programmes to identify cost-effective ways of increasing the impact of the interventions.Trial registration
This trial is registered as ISRCTN15490813.Funding
This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 2. See the NIHR Journals Library website for further project information. -
ItemNo Preview AvailablePatient-Facing Mobile Apps to Support Physiotherapy Care: Protocol for a Systematic Review of Apps Within App Stores(JMIR PUBLICATIONS, INC, 2021-12)BACKGROUND: Care delivered by physiotherapists aims to facilitate engagement in positive health behaviors by patients (eg, adherence to exercise). However, research suggests that behavioral interventions are frequently omitted from care. Hence, better understanding of strategies that can be used by physiotherapists to support patients to engage in positive behaviors is important and likely to optimize outcomes. Digital health interventions delivered via mobile apps are garnering attention for their ability to support behavior change. They have potential to incorporate numerous behavior change techniques (BCTs) to support goals of physiotherapy care, including but not limited to self-monitoring, goal setting, and prompts/alerts. Despite their potential to support physiotherapy care, much is still unknown about what apps are available to consumers, the BCTs they use, their quality, and their potential to change behaviors. OBJECTIVE: The primary aim of this study is to systematically review the mobile apps available in app stores that are intended for use by patients to support physiotherapy care, including the BCTs within these apps. The secondary aims are to evaluate the quality and behavior change potential of these apps. METHODS: A systematic review of mobile apps in app stores will be undertaken. This will be guided by recommendations for systematic reviews in line with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement but adapted to suit our app store search, consistent with similar systematic reviews of apps published in the Journal of Medical Internet Research. Apple Store and Google Play will be searched with a two-step search strategy, using terms relevant to physiotherapy, physiotherapists, and common physiotherapy care. Key eligibility criteria will include apps that are intended for use by patients and are self-contained or stand-alone without the need of additional wearable devices or other add-ons. Included apps will be coded for BCTs and rated for quality using the Mobile Application Rating Scale (MARS) and for potential to change behavior using the App Behavior Change Scale (ABACUS). RESULTS: App store search and screening are expected to be completed in 2021. Data extraction and quality appraisal are expected to commence by November 2021. The study results are expected to be published in a subsequent paper in 2022. CONCLUSIONS: Knowledge gained from this review will support clinical practice and inform research by providing a greater understanding of the quality of currently available mobile apps and their potential to support patient behavior change goals of physiotherapy care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/29047.
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ItemWhy trials lose participants: A multitrial investigation of participants perspectives using the theoretical domains framework(ELSEVIER SCIENCE INC, 2021-09)OBJECTIVES: To use the Theoretical Domains Framework (TDF) to identify barriers and enablers to participant retention in trials requiring questionnaire return and/or attendance at follow-up clinics. STUDY DESIGN AND SETTING: We invited participants (n = 607) from five pragmatic effectiveness trials, who missed at least one follow-up time point (by not returning a questionnaire and/or not attending a clinic visit), to take part in semistructured telephone interviews. The TDF informed both data collection and analysis. To establish what barriers and enablers most likely influence the target behavior the domain relevance threshold was set at >75% of participants mentioning the domain. RESULTS: Sixteen participants (out of 25 showing interest) were interviewed. Overall, seven theoretical domains were identified as both barriers and enablers to the target behaviors of attending clinic appointments and returning postal questionnaires. Barriers frequently reported in relation to both target behaviours stemmed from participants' knowledge, beliefs about their capabilities and the consequences of performing (or not performing) the behavior. Two domains were identified as salient for questionnaire return only: goals; and memory, attention and decision-making. Emotion was identified as relevant for clinic attendance only. CONCLUSION: This is the first study informed by behavioural science to explore trial participants' accounts of trial retention. Findings will serve as a guiding framework when designing trials to limit barriers and enhance enablers of retention within clinical trials.
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ItemOptimizing responsiveness to feedback about antibiotic prescribing in primary care: protocol for two interrelated randomized implementation trials with embedded process evaluations.(Springer Science and Business Media LLC, 2022-02-14)BACKGROUND: Audit and feedback (A&F) that shows how health professionals compare to those of their peers, can be an effective intervention to reduce unnecessary antibiotic prescribing among family physicians. However, the most impactful design approach to A&F to achieve this aim is uncertain. We will test three design modifications of antibiotic A&F that could be readily scaled and sustained if shown to be effective: (1) inclusion of case-mix-adjusted peer comparator versus a crude comparator, (2) emphasizing harms, rather than lack of benefits, and (3) providing a viral prescription pad. METHODS: We will conduct two interrelated pragmatic randomized trials in January 2021. One trial will include family physicians in Ontario who have signed up to receive their MyPractice: Primary Care report from Ontario Health ("OH Trial"). These physicians will be cluster-randomized by practice, 1:1 to intervention or control. The intervention group will also receive a Viral Prescription Pad mailed to their office as well as added emphasis in their report on use of the pad. Ontario family physicians who have not signed up to receive their MyPractice: Primary Care report will be included in the other trial administered by Public Health Ontario ("PHO Trial"). These physicians will be allocated 4:1 to intervention or control. The intervention group will be further randomized by two factors: case-mix adjusted versus unadjusted comparator and emphasis or not on harms of antibiotics. Physicians in the intervention arm of this trial will receive one of four versions of a personalized antibiotic A&F letter from PHO. For both trials, the primary outcome is the antibiotic prescribing rate per 1000 patient visits, measured at 6 months post-randomization, the primary analysis will use Poisson regression and we will follow the intention to treat principle. A mixed-methods process evaluation will use surveys and interviews with family physicians to explore potential mechanisms underlying the observed effects, exploring targeted constructs including intention, self-efficacy, outcome expectancies, descriptive norms, and goal prioritization. DISCUSSION: This protocol describes the rationale and methodology of two interrelated pragmatic trials testing variations of theory-informed components of an audit and feedback intervention to determine how to optimize A&F interventions for antibiotic prescribing in primary care. TRIAL REGISTRATION: NCT04594200, NCT05044052. CIHR Grant ID: 398514.
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ItemDevelopment of a theory-informed questionnaire to assess the acceptability of healthcare interventions(BMC, 2022-03-01)BACKGROUND: The theoretical framework of acceptability (TFA) was developed in response to recommendations that acceptability should be assessed in the design, evaluation and implementation phases of healthcare interventions. The TFA consists of seven component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy) that can help to identify characteristics of interventions that may be improved. The aim of this study was to develop a generic TFA questionnaire that can be adapted to assess acceptability of any healthcare intervention. METHODS: Two intervention-specific acceptability questionnaires based on the TFA were developed using a 5-step pre-validation method for developing patient-reported outcome instruments: 1) item generation; 2) item de-duplication; 3) item reduction and creation; 4) assessment of discriminant content validity against a pre-specified framework (TFA); 5) feedback from key stakeholders. Next, a generic TFA-based questionnaire was developed and applied to assess prospective and retrospective acceptability of the COVID-19 vaccine. A think-aloud method was employed with two samples: 10 participants who self-reported intention to have the COVID-19 vaccine, and 10 participants who self-reported receiving a first dose of the vaccine. RESULTS: 1) The item pool contained 138 items, identified from primary papers included in an overview of reviews. 2) There were no duplicate items. 3) 107 items were discarded; 35 new items were created to maximise coverage of the seven TFA constructs. 4) 33 items met criteria for discriminant content validity and were reduced to two intervention-specific acceptability questionnaires, each with eight items. 5) Feedback from key stakeholders resulted in refinement of item wording, which was then adapted to develop a generic TFA-based questionnaire. For prospective and retrospective versions of the questionnaire, no participants identified problems with understanding and answering items reflecting four TFA constructs: affective attitude, burden, perceived effectiveness, opportunity costs. Some participants encountered problems with items reflecting three constructs: ethicality, intervention coherence, self-efficacy. CONCLUSIONS: A generic questionnaire for assessing intervention acceptability from the perspectives of intervention recipients was developed using methods for creating participant-reported outcome measures, informed by theory, previous research, and stakeholder input. The questionnaire provides researchers with an adaptable tool to measure acceptability across a range of healthcare interventions.