Feasibility and acceptability of patient- and clinician-level antithrombotic stewardship interventions to reduce gastrointestinal bleeding risk in patients using warfarin (Anticoagulation with Enhanced Gastrointestinal Safety): a factorial randomized controlled pilot trial.

Background: Overuse of antiplatelet therapy and underuse of gastroprotection contribute to preventable bleeding in patients taking anticoagulants. Objectives: (1) Determine the feasibility of a factorial trial testing patient activation and clinician outreach to reduce gastrointestinal (GI) bleeding risk in patients prescribed warfarin-antiplatelet therapy without proton pump inhibitor gastroprotection and (2) assess intervention acceptability. Methods: Pragmatic 2 × 2 factorial cluster-randomized controlled pilot comparing (1) a patient activation booklet vs usual care and (2) clinician notification vs clinician notification plus nurse facilitation was performed. The primary feasibility outcome was percentage of patients completing a structured telephone assessment after 5 weeks. Exploratory outcomes, including effectiveness, were evaluated using chart review, surveys, and semistructured interviews. Results: Among 47 eligible patients, 35/47 (74.5%; 95% CI, 58.6%-85.7%) met the feasibility outcome. In the subset confirmed to be high risk for upper GI bleeding, 11/29 (37.9%; 95% CI, 16.9%-64.7%) made a medication change, without differences between intervention arms. In interviews, few patients reported reviewing the activation booklet; barriers included underestimating GI bleeding risk, misunderstanding the booklet's purpose, and receiving excessive health communication materials. Clinicians responded to notification messages for 24/47 patients (51.1%; 95% CI, 26.4%-75.4%), which was lower for surgeons than nonsurgeons (22.7% vs 76.0%). Medical specialists but not surgeons viewed clinician notification as acceptable. Conclusion: The proposed trial design and outcome ascertainment strategy were feasible, but the patient activation intervention is unlikely to be effective as designed. While clinician notification appears promising, it may not be acceptable to surgeons, findings which support further refinement and testing of a clinician notification intervention.

Development of a multicomponent implementation strategy to reduce upper gastrointestinal bleeding risk in patients using warfarin and antiplatelet therapy, and protocol for a pragmatic multilevel randomized factorial pilot implementation trial.

BACKGROUND: The concomitant use of anticoagulant and antiplatelet medications increases the risk of upper gastrointestinal (GI) bleeding. Two underused evidence-based practices (EBPs) can reduce the risk: de-prescribe unnecessary antiplatelet therapy or initiate a proton pump inhibitor. We describe the development of a multicomponent intervention to increase use of these EBPs in patients treated with warfarin and followed by an anticoagulation monitoring service (AMS), and the design of a pilot pragmatic implementation trial. METHODS: A participatory planning group iteratively used Implementation Mapping and the Multiphase Optimization Strategy to develop implementation strategies and plan the trial. Informed by qualitative interviews with patients and clinicians, we drew on several implementation science theories, as well as self-determination theory, to design interventions. For patients, we developed an activation guide to help patients discuss the EBPs with their clinicians. For clinicians, we developed two electronic health record (EHR)-based interventions: (1) clinician notification (CN) consists of a templated message that identifies a patient as high risk, summarizes the EBPs, and links to a guidance statement on appropriate use of antiplatelet therapy. (2) Clinician notification with nurse facilitation (CN+NF) consists of a similar notification message but includes additional measures by nursing staff to support appropriate and timely decision-making: the nurse performs a chart review to identify any history of vascular disease, embeds indication-specific guidance on antiplatelet therapy in the message, and offers to assist with medication order entry and patient education. We will conduct a pilot factorial cluster- and individual-level randomized controlled trial with a primary objective of evaluating feasibility. Twelve clinicians will be randomized to receive either CN or CN+NF for all their patients managed by the AMS while 50 patients will be individually randomized to receive either the activation guide or usual care. We will explore implementation outcomes using patient and clinician interviews along with EHR review. DISCUSSION: This pilot study will prepare us to conduct a larger optimization study to identify the most potent and resource conscious multicomponent implementation strategy to help AMSs increase the use of best practices for upper GI bleeding risk reduction. TRIAL REGISTRATION: ClinicalTrials.gov NCT05085405 . Registered on October 19, 2021-retrospectively registered.

Evaluation of Mobile Health Applications: Is Regulatory Policy Up to the Challenge?

OBJECTIVES: The aim of this study is to determine whether the approach used in Australia to regulate mobile medical applications (MMA) is consistent with international standards and is suitable to address the unique challenges of these technologies. METHODS: The policies of members of the International Medical Device Regulator's Forum (IMDRF) were analyzed, to determine whether these regulatory bodies address IMDRF recommendations for the clinical evaluation of software as a medical device (SaMD). Case-studies of varying types of regulated MMAs in Australia and the United States were also reviewed to determine how well the guidance in the IMDRF's SaMD: Clinical Evaluation (2017) document was operationalized. RESULTS: All included jurisdictions evaluated the effectiveness of MMAs and addressed the majority of the key sub-categories recommended in the IMDRF guidance document. However, safety principles concerning information security (cybersecurity) and potential dangers of misinformation (risk-classification) were generally not addressed in either the case-studies or in the policy documents of international regulatory bodies. Australia's approach was consistent with MMA regulation conducted internationally. None of the approaches used by global regulatory bodies adequately addressed the risk of misinformation from apps and the potential for adverse clinical consequences. CONCLUSIONS: The risks posed by MMAs are mainly through the information they provide and how this is used in clinical decision-making. Policy in Australia and elsewhere should be adjusted to follow the IMDRF risk-classification criteria to address potential harms from misinformation. Australian regulatory information should also be updated so the harm posed by cybersecurity and connectivity can be comprehensively evaluated.

Food consumption habits in two states of Australia, as measured by a Food Frequency Questionnaire.

BACKGROUND: Obesity is an important public health problem in Australia, and monitoring the nutritional intake of the population is an important endeavour. One way to assess food habits is via Food Frequency Questionnaires (FFQ). This pilot study used a routine telephone risk factor surveillance survey to recruit participants in South Australia (SA) and Western Australia (WA) to a postal survey investigating food consumption habits, using a FFQ. Respondents were also asked specific additional questions about their fruit and vegetable consumption and also about their height and weight so that comparisons could be made between the data collected in the risk factor surveillance system and the postal survey. FINDINGS: In total, 1275 respondents (65% of eligible telephone respondents) completed the postal survey. The results of the FFQ were very similar for WA and SA. Western Australians consumed statistically significantly more serves of vegetables than South Australians (t = 2.69 df = 1245 p <= 0.01), and females consumed statistically significantly more serves of both fruit and vegetables than males (t = 4.51 df = 1249 p <= 0.01 and t = 4.83 df = 1249 p <= 0.01 respectively). Less than 10% of respondents met the daily guidelines for vegetable consumption. Over half of respondents were overweight or obese. CONCLUSIONS: Although a wide variety of foods were consumed, guidelines for fruit and vegetable consumption were not being met and overweight and obesity continue to be issues in this population.

Using risk factor surveillance as a basis for mixed-methodology research: an example from Australia using food intake and anthropometric measures.

OBJECTIVES: Risk factor surveillance is an integral part of public health, and can provide a ready-made sample for further research. This study assessed the utility of mixed-methodology research using telephone and postal surveys. METHODS: Adult respondents to telephone surveys in South Australia and Western Australia were recruited to a postal survey about food consumption, in particular, relating to fruit and vegetables. Responses to the two surveys were compared. RESULTS: Around 60% of eligible telephone survey respondents participated in the postal survey. There was fair to poor agreement between the results from the two methods for serves of fruit and vegetables consumed. There was excellent agreement between the two methods for self-reported height and weight. CONCLUSIONS: The telephone survey was a useful way to recruit people to the postal survey; this could be due to the high level of trust gained through the telephone interview, or social desirability bias. It is difficult to ascertain why different results on fruit and vegetable intake were obtained, but it may be associated with understanding of the parameters of a 'serve', recall bias or the time taken to calculate an answer.

Evidence-based practice in rural and remote clinical practice: where is the evidence?

OBJECTIVE: To critically review the evidence regarding barriers to implementing research findings in rural and remote settings, and the ways those barriers have been addressed. DESIGN: A systematic review that included searching several electronic databases, Internet sites and reference lists of relevant articles, assessment of methodological quality of the studies, and data extraction and analysis where possible. Eligibility for the review was not limited by study design. SETTINGS/PARTICIPANTS: Studies that reported on: (1) barriers to the implementation of evidence by health professionals in rural and remote areas, or (2) interventions for implementing evidence-based practice or an element of evidence-based practice in rural and remote areas. RESULTS: There were no experimental data available on the implementation of research findings in rural and remote clinical settings. The small amounts of empirical research undertaken (surveys) showed that some of the problems experienced by general practitioners were exacerbated by rural and remote location, particularly with relation to isolation, lack of time and locum cover, and poor information technology infrastructure. CONCLUSION: There is a paucity of empirical literature on implementing evidence-based practice in rural and remote settings. This is in contrast to the large amount of literature available on implementing evidence in other clinical settings. A clear finding from the literature was that getting evidence into practice needs to be context-specific and yet very little research has been conducted into the rural and remote context. Research is needed into how evidence can be implemented in contextually specific ways in rural and remote areas.