General Practice and Primary Care - Research Publications
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ItemProtocol for a randomised controlled trial of a healthy relationship tool for men who use intimate partner violence (BETTER MAN)(BMC, 2023-12-02)BACKGROUND: Intimate partner violence (IPV) is common globally, but there is a lack of research on how to intervene early with men who might be using IPV. Building on evidence supporting the benefits of online interventions for women victim/survivors, this study aims to test whether a healthy relationship website (BETTER MAN) is effective at improving men's help seeking, their recognition of behaviours as IPV and their readiness to change their behaviours. METHODS/DESIGN: In this two-group, pragmatic randomised controlled trial, men aged 18-50 years residing in Australia who have been in an adult intimate relationship (female, male or non-binary partner) in the past 12 months are eligible. Men who report being worried about their behaviour or have had others express concerns about their behaviour towards a partner in the past 12 months will be randomised with a 1:1 allocation ratio to receive the BETTER MAN website or a comparator website (basic healthy relationships information). The BETTER MAN intervention includes self-directed, interactive reflection activities spread across three modules: Better Relationships, Better Values and Better Communication, with a final "action plan" of strategies and resources. Using an intention to treat approach, the primary analysis will estimate between-group difference in the proportion of men who report undertaking help-seeking behaviours for relationship issues in the last 6 months, at 6 months post-baseline. Analysis of secondary outcomes will estimate between-group differences in: (i) mean score of awareness of behaviours in relationships as abusive immediately post-use of website; (ii) mean score on readiness to change immediately post-use of website and 3 months after baseline; and (iii) cost-effectiveness. DISCUSSION: This trial will evaluate the effectiveness of an online healthy relationship tool for men who may use IPV. BETTER MAN could be incorporated into practice in community and health settings, providing an evidence-informed website to assist men to seek help to promote healthy relationships and reduce use of IPV. TRIAL REGISTRATION: ACTRN12622000786796 with the Australian New Zealand Clinical Trials Registry: 2 June 2022. Version: 1 (28 September 2023).
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ItemNo Preview AvailableSMARTERscreen protocol: A three-arm cluster randomised controlled trial of patient SMS messaging in general practice to increase participation in the Australian National Bowel Cancer Screening Program.(Research Square Platform LLC, 2023-10-16)Abstract Background: Australia persistently has one of the highest rates of colorectal cancer (CRC) in the world. Australia’s National Bowel Cancer Screening Program (NBCSP) sends a biennial Faecal Immunochemical Test (FIT) – the ‘NBCSP kit’ - to everyone eligible for the Program between 50-74 years old, however participation in the program is low, especially in the 50- to 60-year-old age group. Our previous efficacy trial (‘SMARTscreen’) demonstrated an absolute increase in uptake of 16.5% (95% confidence interval:2.02-30.9%) for people sent an SMS with motivational and instructional videos, from their general practice prior to receiving their NBCSP kit, compared to those receiving usual care. Building on the strengths of the SMARTscreen trial and addressing limitations, the ‘SMARTERscreen’ trial will test the effect on participation in the NBCSP of sending either an SMS only or an SMS with online video material to general practice patients due to receive their NBCSP compared to ‘usual care’. Methods: SMARTERscreen is a three-arm stratified cluster randomised controlled trial involving 63 general practices in two states in Australia. Eligible patients who are aged 49-60 years and due to receive their NBCSP kit within next two weeks during the intervention period. General practices will be equally randomised to three trial arms (21:21:21, average 260 patients/practice). The two interventions include: i) an SMS with an encouraging message from their general practice, or ii) the same SMS with web-links to additional motivational and instructional videos. The control arm will receive ‘usual care’. Using the intention-to-treat approach, primary analysis will estimate the three pair-wise between-arm differences in the proportion of eligible patients who participate in the NBCSP within 6-months of when their kit is sent, utilising screening data from the Australian National Cancer Screening Register (NCSR). Patient intervention adherence to the interventions will also be evaluated. Findings will be incorporated into the Policy1-Bowel microsimulation model to estimate the long-term health benefits and cost-effectiveness of the interventions. Discussion: SMARTERscreen will provide high-level evidence determining whether an SMS or an SMS with web-based material sent to general practice patients prior to receiving their NBCSP kit increases participation in bowel cancer screening. Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12623000036617, 13th January 2023. Trial URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385119&isClinicalTrial=False
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ItemNo Preview AvailableThe Colorectal cancer RISk Prediction (CRISP) trial: a randomised controlled trial of a decision support tool for risk-stratified colorectal cancer screening(ROYAL COLL GENERAL PRACTITIONERS, 2023-08)BACKGROUND: A risk-stratified approach to colorectal cancer (CRC) screening could result in a more acceptable balance of benefits and harms, and be more cost-effective. AIM: To determine the effect of a consultation in general practice using a computerised risk assessment and decision support tool (Colorectal cancer RISk Prediction, CRISP) on risk-appropriate CRC screening. DESIGN AND SETTING: Randomised controlled trial in 10 general practices in Melbourne, Australia, from May 2017 to May 2018. METHOD: Participants were recruited from a consecutive sample of patients aged 50-74 years attending their GP. Intervention consultations included CRC risk assessment using the CRISP tool and discussion of CRC screening recommendations. Control group consultations focused on lifestyle CRC risk factors. The primary outcome was risk-appropriate CRC screening at 12 months. RESULTS: A total of 734 participants (65.1% of eligible patients) were randomised (369 intervention, 365 control); the primary outcome was determined for 722 (362 intervention, 360 control). There was a 6.5% absolute increase (95% confidence interval [CI] = -0.28 to 13.2) in risk-appropriate screening in the intervention compared with the control group (71.5% versus 65.0%; odds ratio [OR] 1.36, 95% CI = 0.99 to 1.86, P = 0.057). In those due CRC screening during follow-up, there was a 20.3% (95% CI = 10.3 to 30.4) increase (intervention 59.8% versus control 38.9%; OR 2.31, 95% CI = 1.51 to 3.53, P<0.001) principally by increasing faecal occult blood testing in those at average risk. CONCLUSION: A risk assessment and decision support tool increases risk-appropriate CRC screening in those due screening. The CRISP intervention could commence in people in their fifth decade to ensure people start CRC screening at the optimal age with the most cost-effective test.
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ItemNo Preview AvailableSMARTERscreen protocol: a three-arm cluster randomised controlled trial of patient SMS messaging in general practice to increase participation in the Australian National Bowel Cancer Screening Program(BMC, 2023-11-13)BACKGROUND: Australia persistently has one of the highest rates of colorectal cancer (CRC) in the world. Australia's National Bowel Cancer Screening Program (NBCSP) sends a biennial Faecal Immunochemical Test (FIT)-the 'NBCSP kit'-to everyone eligible for the programme between 50 and 74 years old; however, participation in the programme is low, especially in the 50- to 60-year-old age group. Our previous efficacy trial ('SMARTscreen') demonstrated an absolute increase in uptake of 16.5% (95% confidence interval = 2.02-30.9%) for people sent an SMS with motivational and instructional videos, from their general practice prior to receiving their NBCSP kit, compared to those receiving usual care. Building on the strengths of the SMARTscreen trial and addressing limitations, the 'SMARTERscreen' trial will test the effect on participation in the NBCSP of sending either an SMS only or an SMS with online video material to general practice patients due to receive their NBCSP compared to 'usual care'. METHODS: SMARTERscreen is a three-arm stratified cluster randomised controlled trial involving 63 general practices in two states in Australia. Eligible patients are patients who are aged 49-60 years and due to receive their NBCSP kit within the next 2 weeks during the intervention period. General practices will be equally randomised to three trial arms (21:21:21, estimated average 260 patients/practice). The two interventions include (i) an SMS with an encouraging message from their general practice or (ii) the same SMS with weblinks to additional motivational and instructional videos. The control arm will receive 'usual care'. Using the intention-to-treat approach, primary analysis will estimate the three pair-wise between-arm differences in the proportion of eligible patients who participate in the NBCSP within 6 months of when their kit is sent, utilising screening data from the Australian National Cancer Screening Register (NCSR). Patient intervention adherence to the interventions will also be evaluated. Findings will be incorporated into the Policy1-Bowel microsimulation model to estimate the long-term health benefits and cost-effectiveness of the interventions. DISCUSSION: SMARTERscreen will provide high-level evidence determining whether an SMS or an SMS with web-based material sent to general practice patients prior to receiving their NBCSP kit increases participation in bowel cancer screening. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12623000036617. Registered on 13 January 2023. Trial URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385119&isClinicalTrial=False.
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ItemNo Preview AvailableWill a fee-for-service payment for a young people's health assessment in general practice increase the detection of health risk behaviours and health conditions? Protocol for a cluster randomised controlled trial (RAd Health Trial)(BMJ PUBLISHING GROUP, 2023-08)INTRODUCTION: Adolescence is a period of major transition in physical, cognitive, social and emotional development, and the peak time for the onset of mental health conditions, substance use disorders and sexual and reproductive health risks. Prevention and treatment during this time can improve health and well-being now and into the future. However, despite clinical guidelines recommending annual preventive health assessments for young people, health professionals cite lack of consultation time and adequate funding as key barriers. This trial aims to determine whether a specific fee-for-service ('rebate payment') for a young person's health assessment, is effective and cost-effective at increasing the detection and management of health risk behaviours and conditions among young people. METHODS AND ANALYSIS: This cluster randomised controlled trial will be conducted in Australian general practice. 42 general practices (clusters) will be randomly allocated 1:1 to either an intervention arm where general practitioners receive a rebate payment for each annual health assessment undertaken for 14-24-year-olds during a 2 year study period, or a control arm (no rebate). The rebate amount will be based on the Medical Benefits Schedule (Australia's list of health professional services subsidised by the Australian Government) currently available for similar age-based assessments. Our primary outcome will be the annual rate of risk behaviours and health conditions recorded in the patient electronic health record (eg, alcohol/drug use, sexual activity and mental health issues). Secondary outcomes include the annual rate of patient management activities related to health risks and conditions identified (eg, contraception prescribed, sexually transmitted infection tests ordered). A process evaluation will assess acceptability, adoption, fidelity and sustainability of the rebate; an economic evaluation will assess its cost-effectiveness. Analyses will be intention-to-treat. ETHICS AND DISSEMINATION: Ethics approval has been obtained from University of Melbourne Human and Research Ethics Committee (2022-23435-29990-3). Findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12622000114741.
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ItemChanges in mental health across the COVID-19 pandemic for local and international university students in Australia: a cohort study(SPRINGERNATURE, 2023-02-28)PURPOSE: Previous research has indicated that university students experienced substantial mental health issues during the global COVID-19 pandemic, but few studies have considered changes relative to pre-pandemic levels across population groups. Hence, the aim of this study was to compare changes in mental health and associated stressors across the pandemic for international and local university students studying in Australia. METHODS: In a cohort of 4407 university students, we assessed depression (Patient Health Questionnaire 2), anxiety (Generalized Anxiety Disorder-2), social support (Medical Outcomes Study-Social Support Survey), inability to afford food, fear of partner, and experiences of discrimination, both pre-pandemic (April-May 2019) and during the pandemic (September-October 2020). Change in prevalence between local and international students were estimated with logistic regression, adjusting for baseline factors. RESULTS: Compared to local students, international students experienced an increase in probable major depression (odds ratio (OR) 1.43, 95% Confidence Interval (CI) 1.23, 1.66), low social support (OR 2.63, 95% CI 2.23, 3.11), inability to afford food (OR 5.21, 95% CI 3.97, 6.83) race-based discrimination (OR 2.21, 95% CI 1.82, 2.68) and fear of partner (OR 3.46, 95% CI 2.26, 5.13). Interaction analyses indicated that these issues were more likely to be experienced by students living outside their country of origin, inclusive of international students based in Australia (depression p value interaction term 0.02). CONCLUSION: The pandemic had a substantial negative impact on international students, particularly those living outside of their country of origin during the pandemic. The inequalities exacerbated by the pandemic were present prior to the pandemic and are likely to continue post-pandemic without action. Interventions to build the supports for international students need to be urgently explored.
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ItemDeveloping and internally validating a prediction model for total knee replacement surgery in patients with osteoarthritis.(Elsevier BV, 2022-09)OBJECTIVE: The objective of this study was to develop and internally validate a clinical algorithm for use in general practice that predicts the probability of total knee replacement (TKR) surgery within the next five years for patients with osteoarthritis. The purpose of the model is to encourage early uptake of first-line treatment strategies in patients likely to undergo TKR and to provide a cohort for the development and testing of novel interventions that prevent or delay the progression to TKR. METHOD: Electronic health records (EHRs) from 201,462 patients with osteoarthritis aged 45 years and over from 483 general practices across Australia were linked with records from the Australian Orthopaedic Association National Joint Replacement Registry and the National Death Index. A Fine and Gray competing risk prediction model was developed using these data to predict the risk of TKR within the next five years. RESULTS: During a follow-up time of 5 years, 15,979 (7.9%) patients underwent TKR and 13,873 (6.9%) died. Predictors included in the final algorithm were age, previous knee replacement, knee surgery (other than TKR), prescribing of osteoarthritis medication in the 12 months prior, comorbidity count and diagnosis of a mental health condition. Optimism corrected model discrimination was 0.67 (95% CI: 0.66 to 0.67) and model calibration acceptable. CONCLUSION: The model has the potential to reduce some of the economic burden associated with TKR in Australia. External validation and further optimisation of the algorithm will be carried out prior to implementation within Australian general practice EHR systems.
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ItemTowards a health promoting university: descriptive findings on health, wellbeing and academic performance amongst university students in Australia(BMC, 2022-12-27)BACKGROUND: Universities are increasingly recognised as institutions where health and wellbeing can be promoted to maximise academic outcomes, career transitions, and lifelong positive health behaviours. There is concern about the mental health of university students and other factors which affect academic outcomes particularly for subgroups such as international students. There are few cohort studies of the breadth of issues that can impact on mental health and academic outcomes for both local and international students. We conducted a baseline prevalence survey of students at a large Australian university covering health, academic, and social determinants of wellbeing. The purpose was to inform the university's new student health and wellbeing framework with a view to follow-up to determine predictors of mental ill-health and academic outcomes in the subsequent year. In this paper we present the baseline prevalence data and report on selected mental health and health care access issues for local and international students. METHODS: The entire university population as of April 2019 of over 56,375 students aged 18 or above were invited to complete the online survey. Questions explored eight domains: demographic characteristics, general health and wellbeing, mental health, risk taking behaviours, psychosocial stressors, learning and academic factors, social and cultural environment, and awareness of and access to health and wellbeing services. Records of academic results were also accessed and matched with survey data for a large subset of students providing consent. RESULTS: Fourteen thousand eight hundred eighty (26.4%) students commenced our survey and were representative of the entire student population on demographic characteristics. Three quarters were aged between 18 to 25 years and one third were international students. Eighty-five percent consented to access of their academic records. Similar proportions of local and international students experienced symptoms of a depression or anxiety disorder, however international students were less aware of and less likely to access available health services both inside and external to the university. We also reported on the prevalence of: general lifestyle factors (diet, exercise, amount of daily sleep); risk-taking behaviours (including alcohol, tobacco and other drug use; unprotected sexual activity); psychosocial stressors (financial, intimate partner violence, discrimination, academic stressors, acculturative stress); subjects failed; resilience; social supports; social media use; and health services accessed online. CONCLUSIONS: This rigorous and comprehensive examination of the health status of local and international students in an Australian university student population establishes the prevalence of mental health issues and other psychosocial determinants of health and wellbeing, along with academic performance. This study will inform a university-wide student wellbeing framework to guide health and wellbeing promotion and is a baseline for a 12-month follow-up of the cohort in 2020 during the COVID-19 pandemic.
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ItemThe SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care(BMC, 2022-09-27)BACKGROUND: Polygenic risk scores (PRSs) can predict the risk of colorectal cancer (CRC) and target screening more precisely than current guidelines using age and family history alone. Primary care, as a far-reaching point of healthcare and routine provider of cancer screening and risk information, may be an ideal location for their widespread implementation. METHODS: This trial aims to determine whether the SCRIPT intervention results in more risk-appropriate CRC screening after 12 months in individuals attending general practice, compared with standard cancer risk reduction information. The SCRIPT intervention consists of a CRC PRS, tailored risk-specific screening recommendations and a risk report for participants and their GP, delivered in general practice. Patients aged between 45 and 70 inclusive, attending their GP, will be approached for participation. For those over 50, only those overdue for CRC screening will be eligible to participate. Two hundred and seventy-four participants will be randomised to the intervention or control arms, stratified by general practice, using a computer-generated allocation sequence. The primary outcome is risk-appropriate CRC screening after 12 months. For those in the intervention arm, risk-appropriate screening is defined using PRS-derived risk; for those in the control arm, it is defined using family history and national screening guidelines. Timing, type and results of the previous screening are considered in both arms. Objective health service data will capture screening behaviour. Secondary outcomes include cancer-specific worry, risk perception, predictors of CRC screening behaviour, screening intentions and health service use at 1, 6 and 12 months post-intervention delivery. DISCUSSION: This trial aims to determine whether a PRS-derived personalised CRC risk estimate delivered in primary care increases risk-appropriate CRC screening. A future population risk-stratified CRC screening programme could incorporate risk assessment within primary care while encouraging adherence to targeted screening recommendations. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12621000092897p. Registered on 1 February 2021.
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ItemEconomic evaluation of a Decision Support Tool to guide intensity of mental health care in general practice: the Link-me pragmatic randomised controlled trial(BMC, 2022-09-16)BACKGROUND: This paper reports on the cost-effectiveness evaluation of Link-me - a digitally supported, systematic approach to triaging care for depression and anxiety in primary care that uses a patient-completed Decision Support Tool (DST). METHODS: The economic evaluation was conducted alongside a parallel, stratified individually randomised controlled trial (RCT) comparing prognosis-matched care to usual care at six- and 12-month follow-up. Twenty-three general practices in three Australian Primary Health Networks recruited 1,671 adults (aged 18 - 75 years), predicted by the DST to have minimal/mild or severe depressive or anxiety symptoms in three months. The minimal/mild prognostic group was referred to low intensity services. Participants screened in the severe prognostic group were offered high intensity care navigation, a model of care coordination. The outcome measures included in this evaluation were health sector costs (including development and delivery of the DST, care navigation and other healthcare services used) and societal costs (health sector costs plus lost productivity), psychological distress [Kessler Psychological Distress Scale (K10)] and quality adjusted life years (QALYs) derived from the EuroQol 5-dimension quality of life questionnaire with Australian general population preference weights applied. Costs were valued in 2018-19 Australian dollars (A$). RESULTS: Across all participants, the health sector incremental cost-effectiveness ratio (ICER) of Link-me per point decrease in K10 at six months was estimated at $1,082 (95% CI $391 to $6,204) increasing to $2,371 (95% CI $191 to Dominated) at 12 months. From a societal perspective, the ICER was estimated at $1,257/K10 point decrease (95% CI Dominant to Dominated) at six months, decreasing to $1,217 (95% CI Dominant to Dominated) at 12 months. No significant differences in QALYs were detected between trial arms and the intervention was dominated (less effective, more costly) based on the cost/QALY ICER. CONCLUSIONS: The Link-me approach to stepped mental health care would not be considered cost-effective utilising a cost/QALY outcome metric commonly adopted by health technology assessment agencies. Rather, Link-me showed a trend toward cost-effectiveness by providing improvement in mental health symptoms, measured by the K10, at an additional cost. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ANZCTRN 12617001333303.
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