Data-Driven Interventions for an Emergency Preparedness System: A National Experience in Australia.

Natural disasters and health emergencies disproportionally affect vulnerable populations causing disruptions to usual care and increasing chronic disease burden. Data and digital technologies are important tools to identify and mitigate indirect effects of emergencies. In this paper, we describe the methods used in the development of a series of digital emergency preparedness interventions to mitigate the direct and indirect consequences of the COVID-19 pandemic in the veteran community in Australia. The case studies demonstrate the use of data for surveillance, patient phenotyping, data-driven decision support and stakeholder communication in primary care. The intervention successfully increased appropriate healthcare use by vulnerable individuals and could be expanded to other populations.

Opportunities for clinical decision support targeting medication safety in remote primary care management of chronic kidney disease: A qualitative study in Northern Australia.

INTRODUCTION: This study aimed to identify opportunities for clinical decision support targeting medication safety in remote primary care, by investigating the relationship between clinical workflows, health system priorities, cognitive tasks, and reasoning processes in the context of medicines used in people with chronic kidney disease (CKD). METHODS: This qualitative study involved one-on-one, semistructured interviews. The participants were healthcare professionals employed in a clinical or managerial capacity with clinical work experience in a remote health setting for at least 1 year. RESULTS: Twenty-five clinicians were interviewed. Of these, four were rural medical practitioners, nine were remote area nurses, eight were Aboriginal health practitioners, and four were pharmacists. Four major themes were identified from the interviews: (1) the need for a clinical decision support system to support a sustainable remote health workforce, as clinicians were "constantly stretched" and problems may "fall through the cracks"; (2) reliance on digital health technologies, as medical staff are often not physically available and clinicians-on-duty usually "flick an email and give a call so that I can actually talk it through to our GP"; (3) knowledge gaps, as "it takes a lot of mental space" to know each patient's renal function and their medication history, and clinicians believe "mistakes can be made"; and (4) multiple risk factors impacting CKD management, including clinical, social and behavioural determinants. CONCLUSIONS: The high prevalence of CKD and reliance on digital health systems in remote primary health settings can make a clinical decision support system valuable for supporting clinicians who may not have extensive experience in managing medicines for people with CKD.

Exploring the role of a facilitator in supporting family carers when embedding the iSupport for Dementia programme in care services: A qualitative study.

AIMS: To explore stakeholders' perceptions of a facilitator's role in supporting carers when embedding iSupport for Dementia psychoeducation program, in care services. METHODS: A qualitative descriptive study design was applied. Data were collected from workshops and interviews with carers of people living with dementia (PLWD)and with health and social care professionals from two tertiary hospitals and two community aged care organisations across three Australian states between October 2021 and March 2022. A thematic analysis was used to analyse data. The COREQ guideline was followed to report our findings. RESULTS: A total of 30 family carers and 45 health and social care professionals participated in the study. Three main themes and seven subthemes were identified from the data. We described the main themes as (1) the facilitator's role at the time of dementia diagnosis, (2) the facilitator's role throughout the everyday dementia care journey and (3) the facilitator's role during transition moments. CONCLUSIONS: Caring for family members with dementia is demanding and stressful for carers. Embedding a facilitator-enabled iSupport for Dementia program in hospital and community aged care settings has the potential to mitigate sources of stress associated with care recipient factors, carer factors and care service factors, and improve the health and well-being of carers and those for whom they care. RELEVANCE TO CLINICAL PRACTICE: Our findings will inform the establishment of iSupport facilitators appointed by dementia care providers in hospital and community care settings and help determine their roles and responsibilities in delivering the iSupport program. Our findings relate to nurse-led and coordinated dementia care in hospital and community aged care settings. PATIENT OR PUBLIC CONTRIBUTION: This study was co-designed with stakeholders from two aged care organisations and two tertiary hospitals. The study participants were staff employed by these organisations and carers of PLWD who were service users.

Reducing opioid use for chronic non-cancer pain in primary care using an evidence-based, theory-informed, multistrategic, multistakeholder approach: a single-arm time series with segmented regression.

BACKGROUND: Many countries have high opioid use among people with chronic non-cancer pain. Knowledge about effective interventions that could be implemented at scale is limited. We designed a national intervention that included audit and feedback, deprescribing guidance, information on catastrophising assessment, pain neuroscience education and a cognitive tool for use by patients with their healthcare providers. METHOD: We used a single-arm time series with segmented regression to assess rates of people using opioids before (January 2015 to September 2017), at the time of (October 2017) and after the intervention (November 2017 to August 2019). We used a cohort with historical comparison group and log binomial regression to examine the rate of psychologist claims in opioid users not using psychologist services prior to the intervention. RESULTS: 13 968 patients using opioids, 8568 general practitioners, 8370 pharmacies and accredited pharmacists and 689 psychologists were targeted. The estimated difference in opioid use was -0.51 persons per 1000 persons per month (95% CI -0.69, -0.34; p<0.001) as a result of the intervention, equating to 25 387 (95% CI 24 676, 26 131) patient-months of opioid use avoided during the 22-month follow-up. The targeted group had a significantly higher rate of incident patient psychologist claims compared with the historical comparison group (rate ratio: 1.37, 95% CI 1.16, 1.63; p<0.001), equating to an additional 690 (95% CI 289, 1167) patient-months of psychologist treatment during the 22-month follow-up. CONCLUSIONS: Our intervention addressed the cognitive, affective and sensory factors that contribute to pain and consequent opioid use, demonstrating it could be implemented at scale and was associated with a reduction in opioid use and increasing utilisation of psychologist services.

Prevalence and Preventability of Adverse Medicine Events in a Sample of Australian Aged-Care Residents: A Secondary Analysis of Data from the ReMInDAR Trial.

BACKGROUND: Aged care residents are vulnerable to the harmful effects of medicines; however, data on the prevalence and preventability of adverse medicine events in aged care residents are scarce. AIM: To determine the prevalence and preventability of adverse medicine events in Australian aged care residents. METHODS: A secondary analysis of data from the Reducing Medicine-Induced Deterioration and Adverse Reactions (ReMInDAR) trial was conducted. Potential adverse medicine events were identified and independently screened by two research pharmacists to produce a short-list of potential adverse medicine events. An expert clinical panel reviewed each potential adverse medicine to determine the likelihood that the event was medicine related (based on the Naranjo Probability Scale criteria). The clinical panel assessed preventability of medicine-related events using Schumock-Thornton criteria. RESULTS: There were 583 adverse events due to medicines, involving 154 residents (62% of the 248 study participants). There was a median of three medication-related adverse events (interquartile range [IQR] 1-5) per resident over the 12-month follow-up period. The most common medication-related adverse events were falls (56%), bleeding (18%) and bruising (9%). There were 482 (83%) medication-related adverse events that were preventable, most commonly falls (66% of preventable adverse medicine events), bleeding (12%) and dizziness (8%). Of the 248 residents, 133 (54% of the cohort) had at least one preventable adverse medicine event, with a median of 2 (IQR 1-4) preventable adverse medicine events per resident. CONCLUSION: In total, 62% of aged care residents in our study had an adverse medicine event and 54% had a preventable adverse medicine event in a 12-month period.

Precision public-health intervention for care coordination: a real-world study.

BACKGROUND: Health emergencies disproportionally affect vulnerable populations. Digital tools can help primary care providers find, and reach, the right patients. AIM: To evaluate whether digital interventions delivered directly to GPs' clinical software were more effective at promoting primary care appointments during the COVID-19 pandemic than interventions delivered by post. DESIGN AND SETTING: Real-world, non-randomised, interventional study involving GP practices in all Australian states. METHOD: Intervention material was developed to promote care coordination for vulnerable older veterans during the COVID-19 pandemic, and sent to GPs either digitally to the clinical practice software system or in the post. The intervention material included patient-specific information sent to GPs to support care coordination, and education material sent via post to veterans identified in the administrative claims database. To evaluate the impact of intervention delivery modalities on outcomes, the time to first appointment with the primary GP was measured; a Cox proportional hazards model was used, adjusting for differences and accounting for pre-intervention appointment numbers. RESULTS: The intervention took place in April 2020, during the first weeks of COVID-19 social distancing restrictions in Australia. GPs received digital messaging for 51 052 veterans and postal messaging for 26 859 veterans. The digital group was associated with earlier appointments (adjusted hazard ratio 1.38 [1.34 to 1.41]). CONCLUSION: Data-driven digital solutions can promote care coordination at scale during national emergencies, opening up new perspectives for precision public-health initiatives.

Wrist accelerometer temporal analysis as a prognostic tool for aged care residents: A sub-study of the ReMInDAR trial.

BACKGROUND: Objective measures for screening, prioritizing, and planning care for frail individuals are essential for appropriate aged care provision. This study evaluates metrics derived from actigraphy measures (captured by wrist accelerometer) as a digital biomarker to identify frail individuals at risk of adverse outcomes, including death, hospitalization, and cognitive decline. METHODS: This was a secondary study using data from a randomized controlled trial assessing the effectiveness of an ongoing pharmacist service in residential aged care facilities. Three metrics are studied and compared: the Frailty Index, the daily time spent in light time activity, and the temporal correlation of the actigraphy signal, measured by detrended fluctuation analysis. The association between actigraphy-derived metrics at baseline and adverse events within 12 months (death, cognitive decline, and hospitalizations) was assessed using logistic regression. RESULTS: Actigraphy records were available for 213 participants living in aged-care, median age of 85 years. Individuals with higher temporal correlation (activity is less random) were at lower risk of death (Standardized OR: 0.49; 95% CI 0.34, 0.7, p < 0.001) and hospitalization (Standardized OR: 0.57; 95% CI 0.42, 0.77, p < 0.001) in 12 months, but there was no difference in cognitive decline (Standardized OR: 1; 95% CI 0.74, 1.35, p = 0.98). The predictive model that included temporal correlation had an area under the curve of 0.70 (CI 0.60-0.80) for death and 0.64 (CI 0.54-0.72) for hospitalization. CONCLUSION: Temporal correlation of the actigraphy signal from aged care residents was strongly associated with death and hospitalization, but not cognitive decline. Digital biomarkers may have a place as an objective, accurate, and low-cost patient metric to support risk stratification and clinical planning.

Frailty trajectory over one year among residential aged care (nursing home) residents.

Objectives: Large population-based studies examining frailty trajectory found a linear increase in frailty over time. The pattern in which frailty changes over time for an individual person is less well-described. We examined the frailty trajectory of older adults living in aged-care in Australia. Materials and methods: This secondary study used data from a randomised controlled trial involving 39 aged-care facilities in Australia. The trial intervention was an on-going pharmacist-led intervention occurring every 8 weeks over 12 months aimed at preventing medicine-induced deterioration and adverse reactions. Frailty was assessed using the Frailty Index. Participants were categorised as non-frail, pre-frail and frail. Individual frailty trajectory over 12 months was visualised using the alluvial plot. Case notes were examined to explore reasons for any rapid transitions in frailty status. Results: A total of 248 participants was included. At baseline, 40.3% were non-frail and 59.7% were pre-frail. The proportion of participants who were non-frail and pre-frail decreased over time; 15.7% were frail at 6 months and 23.4% were frail at 12 months. Overall, twenty different combinations of frailty transitions were identified over 12 months. Retrospective analysis of case notes suggest that death or transition from non-frail to frail was often preceded by hospitalisation, falls, medication change or clinically significant deterioration in grip strength or cognition. Conclusion: The degree of frailty increased over time, but there were variations in the individual trajectories. Regular monitoring of events that precede changes in frailty status is needed to identify strategies to prevent further deterioration in residents' conditions.

Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial).

OBJECTIVE: To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions. DESIGN AND SETTING: Multicenter, open-label parallel randomised controlled trial involving 39 Australian aged-care facilities. PARTICIPANTS: Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine. INTERVENTION: Pharmacist-led intervention using validated tools to detect signs and symptoms of medicine-induced deterioration which occurred every 8 weeks over 12 months. COMPARATOR: Usual care (Residential Medication Management Review) provided by accredited pharmacists. OUTCOMES: Primary outcome was change in Frailty Index at 12 months. Secondary outcomes included changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life. RESULTS: 248 persons (median age 87 years) completed the study; 120 in the interventionand, 128 in control arms. In total 575 pharmacist, sessions were undertaken in the intervention arm. There was no statistically significant difference for change in frailty between groups (mean difference: 0.009, 95% CI: -0.028, 0.009, P = 0.320). A significant difference for cognition was observed, with a mean difference of 1.36 point change at 12 months (95% CI: 0.01, 2.72, P = 0.048). Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups. Point estimates favoured the intervention arm at 12 months for frailty, 24-hour movement behaviour and grip strength. CONCLUSIONS: The use of validated tools by pharmacists to detect signs of medicine-induced deterioration is a model of practice that requires further research, with promising results from this trial, particularly with regards to improved cognition.

Implementation and Evaluation of a Digitally Enabled Precision Public Health Intervention to Reduce Inappropriate Gabapentinoid Prescription: Cluster Randomized Controlled Trial.

BACKGROUND: Digital technologies can enable rapid targeted delivery of audit and feedback interventions at scale. Few studies have evaluated how mode of delivery affects clinical professional behavior change and none have assessed the feasibility of such an initiative at a national scale. OBJECTIVE: The aim of this study was to develop and evaluate the effect of audit and feedback by digital versus postal (letter) mode of delivery on primary care physician behavior. METHODS: This study was developed as part of the Veterans' Medicines Advice and Therapeutics Education Services (MATES) program, an intervention funded by the Australian Government Department of Veterans' Affairs that provides targeted education and patient-specific audit with feedback to Australian general practitioners, as well as educational material to veterans and other health professionals. We performed a cluster randomized controlled trial of a multifaceted intervention to reduce inappropriate gabapentinoid prescription, comparing digital and postal mode of delivery. All veteran patients targeted also received an educational intervention (postal delivery). Efficacy was measured using a linear mixed-effects model as the average number of gabapentinoid prescriptions standardized by defined daily dose (individual level), and number of veterans visiting a psychologist in the 6 and 12 months following the intervention. RESULTS: The trial involved 2552 general practitioners in Australia and took place in March 2020. Both intervention groups had a significant reduction in total gabapentinoid prescription by the end of the study period (digital: mean reduction of 11.2%, P=.004; postal: mean reduction of 11.2%, P=.001). We found no difference between digital and postal mode of delivery in reduction of gabapentinoid prescriptions at 12 months (digital: -0.058, postal: -0.058, P=.98). Digital delivery increased initiations to psychologists at 12 months (digital: 3.8%, postal: 2.0%, P=.02). CONCLUSIONS: Our digitally delivered professional behavior change intervention was feasible, had comparable effectiveness to the postal intervention with regard to changes in medicine use, and had increased effectiveness with regard to referrals to a psychologist. Given the logistical benefits of digital delivery in nationwide programs, the results encourage exploration of this mode in future interventions.

Empowering Dementia Carers With an iSupport Virtual Assistant (e-DiVA) in Asia-Pacific Regional Countries: Protocol for a Pilot Multisite Randomized Controlled Trial.

BACKGROUND: Dementia is a global public health priority with an estimated prevalence of 150 million by 2050, nearly two-thirds of whom will live in the Asia-Pacific region. Dementia creates significant care needs for people with the disease, their families, and carers. iSupport is a self-help platform developed by the World Health Organization (WHO) to provide education, skills training, and support to dementia carers. It has been adapted in some contexts (Australia, India, the Netherlands, and Portugal). Carers using the existing adapted versions have identified the need to have a more user-friendly version that enables them to identify solutions for immediate problems quickly in real time. The iSupport virtual assistant (iSupport VA) is being developed to address this gap and will be evaluated in a randomized controlled trial (RCT). OBJECTIVE: This paper reports the protocol of a pilot RCT evaluating the iSupport VA. METHODS: Seven versions of iSupport VA will be evaluated in Australia, Indonesia, New Zealand, and Vietnam in a pilot RCT. Feasibility, acceptability, intention to use, and preliminary impact on carer-perceived stress of the iSupport VA intervention will be assessed. RESULTS: This study was funded by the e-ASIA Joint Research Program in November 2020. From January to July 2023, we will enroll 140 dementia carers (20 carers per iSupport VA version) for the pilot RCT. The study has been approved by the Human Research Committee, University of South Australia, Australia (203455). CONCLUSIONS: This protocol outlines how a technologically enhanced version of the WHO iSupport program-the iSupport VA-will be evaluated. The findings from this intervention study will provide evidence on the feasibility and acceptability of the iSupport VA intervention, which will be the basis for conducting a full RCT to assess the effectiveness of the iSupport VA. The study will be an important reference for countries planning to adapt and enhance the WHO iSupport program using digital health solutions. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621001452886; https://tinyurl.com/afum5tjz. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/33572.

Influence of Baseline User Characteristics and Early Use Patterns (24-Hour) on Long-Term Adherence and Effectiveness of a Web-Based Weight Loss Randomized Controlled Trial: Latent Profile Analysis.

BACKGROUND: Low adherence to real-world online weight loss interventions reduces long-term efficacy. Baseline characteristics and use patterns are determinants of long-term adherence, but we lack cohesive models to guide how to adapt interventions to users' needs. We also lack information whether very early use patterns (24 hours) help describe users and predict interventions they would benefit from. OBJECTIVE: We aim to understand the impact of users' baseline characteristics and early (initial 24 hours) use patterns of a web platform for weight loss on user adherence and weight loss in the long term (24 weeks). METHODS: We analyzed data from the POEmaS randomized controlled trial, a study that compared the effectiveness of a weight loss platform with or without coaching and a control approach. Data included baseline behavior and use logs from the initial 24 hours after platform access. Latent profile analysis (LPA) was used to identify classes, and Kruskal-Wallis was used to test whether class membership was associated with long-term (24 weeks) adherence and weight loss. RESULTS: Among 828 participants assigned to intervention arms, 3 classes were identified through LPA: class 1 (better baseline health habits and high 24-hour platform use); class 2 (better than average health habits, but low 24-hour platform use); class 3 (worse baseline health habits and low 24-hour platform use). Class membership was associated with long-term adherence (P<.001), and class 3 members had the lowest adherence. Weight loss was not associated with class membership (P=.49), regardless of the intervention arm (platform only or platform + coach). However, class 2 users assigned to platform + coach lost more weight than those assigned to platform only (P=.02). CONCLUSIONS: Baseline questionnaires and use data from the first 24 hours after log-in allowed distinguishing classes, which were associated with long-term adherence. This suggests that this classification might be a useful guide to improve adherence and assign interventions to individual users. TRIAL REGISTRATION: ClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-018-5882-y.

Personalized Web-Based Weight Loss Behavior Change Program With and Without Dietitian Online Coaching for Adults With Overweight and Obesity: Randomized Controlled Trial.

BACKGROUND: The effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear. OBJECTIVE: We aimed to compare the effectiveness of a web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention in promoting weight loss in community-based adults with overweight or obesity. METHODS: This pragmatic, 3-group, parallel-arm, randomized trial recruited students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m2, and were not pregnant. Participants were allocated to one of 3 groups: platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos). Self-reported weight at 24 weeks was the primary outcome. Changes in dietary and physical activity habits within 24 weeks were secondary outcomes. RESULTS: Among the 1298 participants, 375 (28.89%) were lost to follow-up. In the intention-to-treat analysis, the platform-only and platform plus coaching groups had greater mean weight loss than the waiting-list group at 24 weeks (-1.08 kg, 95% CI -1.41 to -0.75 vs -1.57 kg, 95% CI -1.92 to -1.22 vs -0.66 kg, 95% CI -0.98 to -0.34, respectively). The platform-only and platform plus coaching groups, compared with the waiting list group, had a greater increase in the consumption of vegetables (3%, 95% CI 1% to 6% vs 5%, 95% CI 2% to 8% vs -3%, 95% CI -5% to 0%) and fruits (9%, 95% CI 6% to 12% vs 6%, 95% CI 2% to 9% vs 2%, 95% CI 0% to 6%) and a larger reduction in ultraprocessed food intake (-18%, 95% CI -23% to -13% vs -25%, 95% CI -30% to -20% vs -12%, 95% CI -16% to -8%). Changes in physical activity did not differ across the groups. Engagement was higher in the platform plus coaching group than in the platform-only group (7.6 vs 5.2 completed sessions; P=.007). Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04). CONCLUSIONS: The web-based behavior change programs with computer- and human-delivered personalized feedback led to greater, albeit small-magnitude, weight loss within 24 weeks. Improvement in multiple dietary habits, but not physical activity, were also greater in the personalized programs compared with the nonpersonalized one. The human-delivered personalized feedback by the online dietitian coach increased user engagement with the program and was associated with a significantly higher chance of clinically meaningful weight loss. TRIAL REGISTRATION: ClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10.1186/s12889-018-5882-y.

Determinants of usefulness in professional behaviour change interventions: observational study of a 15-year national program.

OBJECTIVE: Educational, and audit and feedback interventions are effective in promoting health professional behaviour change and evidence adoption. However, we lack evidence to pinpoint which particular features make them most effective. Our objective is to identify determinants of quality in professional behaviour change interventions, as perceived by participants. DESIGN: We performed a comparative observational study using data from the Veterans' Medicines Advice and Therapeutics Education Services program, a nation-wide Australian Government Department of Veterans' Affairs funded program that provides medicines advice and promotes physician adoption of best practices by use of a multifaceted intervention (educational material and a feedback document containing individual patient information). SETTING: Primary care practices providing care to Australian veterans. PARTICIPANTS: General practitioners (GPs) targeted by 51 distinct behaviour change interventions, implemented between November 2004 and June 2018. PRIMARY AND SECONDARY OUTCOME MEASURES: We extracted features related to presentation (number of images, tables and characters), content (polarity and subjectivity using sentiment analysis, number of external links and medicine mentions) and the use of five behaviour change techniques (prompt/cues, goal setting, discrepancy between current behaviour and goal, information about health consequences, feedback on behaviour). The main outcome was perceived usefulness, extracted from postintervention survey. RESULTS: On average, each intervention was delivered to 9667 GPs. Prompt and goal setting strategies in the audit and feedback were independently correlated to perceived usefulness (p=0.030 and p=0.005, respectively). The number of distinct behaviour change techniques in the audit and feedback was correlated with improved usefulness (Pearson's coefficient 0.45 (0.19, 0.65), p=0.001). No presentation or content features in the educational material were correlated with perceived usefulness. CONCLUSIONS: The finding provides additional evidence encouraging the use of behaviour change techniques, in particular prompt and goal setting, in audit and feedback interventions.

Reducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome.

INTRODUCTION: Many medicines have adverse effects which are difficult to detect and frequently go unrecognised. Pharmacist monitoring of changes in signs and symptoms of these adverse effects, which we describe as medicine-induced deterioration, may reduce the risk of developing frailty. The aim of this trial is to determine the effectiveness of a 12-month pharmacist service compared with usual care in reducing medicine-induced deterioration, frailty and adverse reactions in older people living in aged-care facilities in Australia. METHODS AND ANALYSIS: The reducing medicine-induced deterioration and adverse reactions trial is a multicentre, open-label randomised controlled trial. Participants will be recruited from 39 facilities in South Australia and Tasmania. Residents will be included if they are using four or more medicines at the time of recruitment, or taking more than one medicine with anticholinergic or sedative properties. The intervention group will receive a pharmacist assessment which occurs every 8 weeks. The pharmacists will liaise with the participants' general practitioners when medicine-induced deterioration is evident or adverse events are considered serious. The primary outcome is a reduction in medicine-induced deterioration from baseline to 6 and 12 months, as measured by change in frailty index. The secondary outcomes are changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use. The statistical analysis will use mixed-models adjusted for baseline to account for repeated outcome measures. A health economic evaluation will be conducted following trial completion using data collected during the trial. ETHICS AND DISSEMINATION: Ethics approvals have been obtained from the Human Research Ethics Committee of University of South Australia (ID:0000036440) and University of Tasmania (ID:H0017022). A copy of the final report will be provided to the Australian Government Department of Health. TRIAL REGISTRATION NUMBER: Australian and New Zealand Trials Registry ACTRN12618000766213.

Accuracy of Self-Reported Weight Collected Through a Web-Based Platform in a Weight Loss Trial: Validation Study of the POEmaS Clinical Trial.

Self-reported anthropometric data in web-based weight loss interventions may be inaccurate. We studied the agreement between online self-reported and measured weight in the course of the POEmaS randomized controlled trial. Measured weight was not different from reported one (-0.4 kg; 95%CI -0.93 to 0.12). 95.6% of the cases were within the limits of agreement (Bland-Altman method). Self-reported weight collected online was accurate, which suggests that interventions and outcomes assessment can rely on these data.

Exploring the User Engagement Scale Short Form as a Determinant of Adherence in Digital Health Interventions.

Adherence determines the impact of digital health interventions. Standard tools provide a measure for user experience and predict adherence. We evaluated the User Engagement Scale Short Form (UES-SF) during the POEmaS project, a randomized clinical trial of an online weight loss platform. We received answers from 178 participants (13.7% of the cohort) and correlated the UES-SF scores with the number of sessions attended. Our findings suggest the UES-SF is an accurate evaluation of user experience, but only one domain (reward) was associated with long-term use.

Web-Based Digital Health Interventions for Weight Loss and Lifestyle Habit Changes in Overweight and Obese Adults: Systematic Review and Meta-Analysis.

BACKGROUND: Obesity is a highly prevalent condition with important health implications. Face-to-face interventions to treat obesity demand a large number of human resources and time, generating a great burden to individuals and health system. In this context, the internet is an attractive tool for delivering weight loss programs due to anonymity, 24-hour-accessibility, scalability, and reachability associated with Web-based programs. OBJECTIVE: We aimed to investigate the effectiveness of Web-based digital health interventions, excluding hybrid interventions and non-Web-based technologies such as text messaging, short message service, in comparison to nontechnology active or inactive (wait list) interventions on weight loss and lifestyle habit changes in individuals with overweight and obesity. METHODS: We searched PubMed or Medline, SciELO, Lilacs, PsychNet, and Web of Science up to July 2018, as well as references of previous reviews for randomized trials that compared Web-based digital health interventions to offline interventions. Anthropometric changes such as weight, body mass index (BMI), waist, and body fat and lifestyle habit changes in adults with overweight and obesity were the outcomes of interest. Random effects meta-analysis and meta-regression were performed for mean differences (MDs) in weight. We rated the risk of bias for each study and the quality of evidence across studies using the Grades of Recommendation, Assessment, Development, and Evaluation approach. RESULTS: Among the 4071 articles retrieved, 11 were included. Weight (MD -0.77 kg, 95% CI -2.16 to 0.62; 1497 participants; moderate certainty evidence) and BMI (MD -0.12 kg/m2; 95% CI -0.64 to 0.41; 1244 participants; moderate certainty evidence) changes were not different between Web-based and offline interventions. Compared to offline interventions, digital interventions led to a greater short-term (<6 months follow-up) weight loss (MD -2.13 kg, 95% CI -2.71 to -1.55; 393 participants; high certainty evidence), but not in the long-term (MD -0.17 kg, 95% CI -2.10 to 1.76; 1104 participants; moderate certainty evidence). Meta-analysis was not possible for lifestyle habit changes. High risk of attrition bias was identified in 5 studies. For weight and BMI outcomes, the certainty of evidence was moderate mainly due to high heterogeneity, which was mainly attributable to control group differences across studies (R2=79%). CONCLUSIONS: Web-based digital interventions led to greater short-term but not long-term weight loss than offline interventions in overweight and obese adults. Heterogeneity was high across studies, and high attrition rates suggested that engagement is a major issue in Web-based interventions.

Using the Behaviour Change Wheel for Designing an Online Platform for Healthy Weight Loss - "POEmaS".

INTRODUCTION: Behaviour change is a key point in weight management. Digital health interventions are attractive tools to deliver behaviour interventions for weight loss, due to the potential to reach a large number of people. We aimed to report how the Behaviour Change Wheel (BCW) was used to develop and implement a web platform to promote weight loss in Brazilian adults with overweight and obesity. Moreover, we aimed to describe the first 12 weeks of usage of the platform in a randomized controlled trial. METHODS: The BCW framework was used to define intake of fruit/vegetables, ultra-processed products and sweetened beverages, leisure physical activity and sitting time as target behaviours. The BCW components of behaviour-capability, opportunity and motivation were used to make a behaviour diagnosis of the population and BCW second layer oriented the selection of information, goal setting, self-monitoring, feedback, social support and incentives as behaviour techniques. Using these behaviour techniques, a 24-week behaviour intervention delivered by seven different platform functionalities was developed. The platform was tested in a three-arm parallel (basic platform versus enhanced platform versus minimal intervention control group) randomized controlled trial from September 2017 to April 2018. In the present analysis, we classified the platform functionalities according to the BCW behaviour component (capability, opportunity and behaviour) and used descriptive statistics and Spearman correlations to report functionalities usage according to the BCW behaviour component over the first 12 weeks of the trial. The study was approved by the Ethics Committee of the Federal University of Minas Gerais, Brazil and was registered under NCT 03435445. RESULTS: Over the first 12 weeks of the RCT, the 809 participants (619, 76.5% women; mean age 33.7 years, SD 10.3; mean BMI 29.9 kg/m2, SD 4.3) were enrolled for use of the basic and enhance versions of the platform. Capability-driven functionalities were accessed by 455 (56.2%) users with median access of 1 (IQR 1-6) times, whereas opportunity-driven platform functionalities were accessed by 592 participants with 8 (IQR 1-27) median access times and motivation-driven functionalities were accessed by 560 (69.2%) participants with 13 (IQR 1-30) median times of access. Spearman correlations between the use of capability and opportunity functionalities, capability and motivation functionalities and opportunity and motivation functionalities were 0.74 (95% CI 0.70-0.77), 0.74 (95% CI 0.70-0.78), 0.89 (95% CI 0.87-0.91), respectively. DISCUSSION: BCW provided a systematic approach to planning, designing and implementing a complex weight loss intervention based on behaviour change. Moreover, it promoted a clear understanding of the relation between platform functionalities and behaviour determinants. The low use of the capability-driven functionalities might have been related to lack of accuracy in the behaviour diagnosis, as well as to implementation issues. The high correlation between the functionalities use suggests that the BCW approach did not determine the platform usage profile. CONCLUSION: The BCW provided a framework for an evidence-based intervention on weight loss delivered by a web platform. Using the framework led to a clear understanding of the behaviour determinants and their relation to the platform features.