Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19.

BackgroundMany non-COVID-19 trials were disrupted in 2020 and either struggled to recruit participants or stopped recruiting altogether. In December 2019, just before the pandemic, we were awarded a grant to conduct a randomised controlled trial, the Should I Take Aspirin? (SITA) trial, in Victoria, the Australian state most heavily affected by COVID-19 during 2020.Main bodyWe originally modelled the SITA trial recruitment method on previous trials where participants were approached and recruited in general practice waiting rooms. COVID-19 changed the way general practices worked, with a significant increase in telehealth consultations and restrictions on in person waiting room attendance. This prompted us to adapt our recruitment methods to this new environment to reduce potential risk to participants and staff, whilst minimising any recruitment bias. We designed a novel teletrial model, which involved calling participants prior to their general practitioner appointments to check their eligibility. We delivered the trial both virtually and face-to-face with similar overall recruitment rates to our previous studies.ConclusionWe developed an effective teletrial model which allowed us to complete recruitment at a high rate. The teletrial model is now being used in our other primary care trials as we continue to face the impacts of the COVID-19 pandemic

Clinicians' opinions on recommending aspirin to prevent colorectal cancer to Australians aged 50-70 years: a qualitative study.

OBJECTIVES: Australian guidelines recommend all adults aged 50-70 years old without existing contraindications consider taking low-dose aspirin (100-300 mg per day) for at least 2.5 years to reduce their risk of developing colorectal cancer. We aimed to explore clinicians' practices, knowledge, opinions, and barriers and facilitators to the implementation of these new guidelines. METHODS: Semistructured interviews were conducted with clinicians to whom the new guidelines may be applicable (Familial Cancer Clinic staff (geneticists, oncologists and genetic counsellors), gastroenterologists, pharmacists and general practitioners (GPs)). The Consolidated Framework for Implementation Research (CFIR) underpinned the development of the interview guide. Coding was inductive and themes were developed through consensus between the authors. Emerging themes were mapped onto the CFIR domains: characteristics of the intervention, outer setting, inner setting, individual characteristics and process. RESULTS: Sixty-four interviews were completed between March and October 2019. Aspirin was viewed as a safe and cheap option for cancer prevention. GPs were considered by all clinicians as the most important health professionals for implementation of the guidelines. Cancer Council Australia, as a trusted organisation, was an important facilitator to guideline adoption. Uncertainty about aspirin dosage and perceived strength of the evidence, precise wording of the recommendation, previous changes to guidelines about aspirin and conflicting findings from trials in older populations were barriers to implementation. CONCLUSION: Widespread adoption of these new guidelines could be an important strategy to reduce the incidence of bowel cancer, but this will require more active implementation strategies focused on primary care and the wider community. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12620001003965)

An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: a study protocol for the SITA (Should I Take Aspirin?) trial.

BACKGROUND: Australian guidelines recommend that all people aged 50-70 years old actively consider taking daily low-dose aspirin (100-300 mg per day) for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC). Despite the change of national CRC prevention guidelines, there has been no active implementation of the guidelines into clinical practice. We aim to test the efficacy of a health consultation and decision aid, using a novel expected frequency tree (EFT) to present the benefits and harms of low dose aspirin prior to a general practice consultation with patients aged 50-70 years, on informed decision-making and uptake of aspirin. METHODS: Approximately five to seven general practices in Victoria, Australia, will be recruited to participate. Patients 50-70 years old, attending an appointment with their general practitioner (GP) for any reason, will be invited to participate in the trial. Two hundred fifty-eight eligible participants will be randomly allocated 1:1 to intervention or active control arms using a computer-generated allocation sequence stratified by general practice, sex, and mode of trial delivery (face-to-face or teletrial). There are two co-primary outcomes: informed decision-making at 1-month post randomisation, measured by the Multi-dimensional Measure of Informed Choice (MMIC), and self-reported daily use of aspirin at 6 months. Secondary outcomes include decisional conflict at 1-month and other behavioural changes to reduce CRC risk at both time points. DISCUSSION: This trial will test the efficacy of novel methods for implementing national guidelines to support informed decision-making about taking aspirin in 50-70-year-olds to reduce the risk of CRC and other chronic diseases. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001003965 . Registered on 10 October 2020

The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening: study protocol for a randomised controlled trial.

BACKGROUND: Australia and New Zealand have the highest incidence rates of colorectal cancer worldwide. In Australia there is significant unwarranted variation in colorectal cancer screening due to low uptake of the immunochemical faecal occult blood test, poor identification of individuals at increased risk of colorectal cancer, and over-referral of individuals at average risk for colonoscopy. Our pre-trial research has developed a novel Colorectal cancer RISk Prediction (CRISP) tool, which could be used to implement precision screening in primary care. This paper describes the protocol for a phase II multi-site individually randomised controlled trial of the CRISP tool in primary care. METHODS: This trial aims to test whether a standardised consultation using the CRISP tool in general practice (the CRISP intervention) increases risk-appropriate colorectal cancer screening compared to control participants who receive standardised information on cancer prevention. Patients between 50 and 74 years old, attending an appointment with their general practitioner for any reason, will be invited into the trial. A total of 732 participants will be randomised to intervention or control arms using a computer-generated allocation sequence stratified by general practice. The primary outcome (risk-appropriate screening at 12 months) will be measured using baseline data for colorectal cancer risk and objective health service data to measure screening behaviour. Secondary outcomes will include participant cancer risk perception, anxiety, cancer worry, screening intentions and health service utilisation measured at 1, 6 and 12 months post randomisation. DISCUSSION: This trial tests a systematic approach to implementing risk-stratified colorectal cancer screening in primary care, based on an individual's absolute risk, using a state-of-the-art risk assessment tool. Trial results will be reported in 2020. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry, ACTRN12616001573448p . Registered on 14 November 2016

Clinicians’ opinions on recommending aspirin to prevent colorectal cancer to Australians aged 50–70 years: a qualitative study

Objectives Australian guidelines recommend all adults aged 50–70 years old without existing contraindications consider taking low-dose aspirin (100–300 mg per day) for at least 2.5 years to reduce their risk of developing colorectal cancer. We aimed to explore clinicians’ practices, knowledge, opinions, and barriers and facilitators to the implementation of these new guidelines.Methods Semistructured interviews were conducted with clinicians to whom the new guidelines may be applicable (Familial Cancer Clinic staff (geneticists, oncologists and genetic counsellors), gastroenterologists, pharmacists and general practitioners (GPs)). The Consolidated Framework for Implementation Research (CFIR) underpinned the development of the interview guide. Coding was inductive and themes were developed through consensus between the authors. Emerging themes were mapped onto the CFIR domains: characteristics of the intervention, outer setting, inner setting, individual characteristics and process.Results Sixty-four interviews were completed between March and October 2019. Aspirin was viewed as a safe and cheap option for cancer prevention. GPs were considered by all clinicians as the most important health professionals for implementation of the guidelines. Cancer Council Australia, as a trusted organisation, was an important facilitator to guideline adoption. Uncertainty about aspirin dosage and perceived strength of the evidence, precise wording of the recommendation, previous changes to guidelines about aspirin and conflicting findings from trials in older populations were barriers to implementation.Conclusion Widespread adoption of these new guidelines could be an important strategy to reduce the incidence of bowel cancer, but this will require more active implementation strategies focused on primary care and the wider community.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12620001003965)

Exploring a novel method for optimising the implementation of a colorectal cancer risk prediction tool into primary care: a qualitative study.

BACKGROUND: We developed a colorectal cancer risk prediction tool ('CRISP') to provide individualised risk-based advice for colorectal cancer screening. Using known environmental, behavioural, and familial risk factors, CRISP was designed to facilitate tailored screening advice to patients aged 50 to 74 years in general practice. In parallel to a randomised controlled trial of the CRISP tool, we developed and evaluated an evidence-based implementation strategy. METHODS: Qualitative methods were used to explore the implementation of CRISP in general practice. Using one general practice in regional Victoria, Australia, as a 'laboratory', we tested ways to embed CRISP into routine clinical practice. General practitioners, nurses, and operations manager co-designed the implementation methods with researchers, focussing on existing practice processes that would be sustainable. Researchers interviewed the staff regularly to assess the successfulness of the strategies employed, and implementation methods were adapted throughout the study period in response to feedback from qualitative interviews. The Consolidated Framework for Implementation Research (CFIR) underpinned the development of the interview guide and intervention strategy. Coding was inductive and themes were developed through consensus between the authors. Emerging themes were mapped onto the CFIR domains and a fidelity checklist was developed to ensure CRISP was being used as intended. RESULTS: Between December 2016 and September 2019, 1 interviews were conducted, both face-to-face and via videoconferencing (Zoom). All interviews were transcribed verbatim and coded. Themes were mapped onto the following CFIR domains: (1) 'characteristics of the intervention': CRISP was valued but time consuming; (2) 'inner setting': the practice was open to changing systems; 3. 'outer setting': CRISP helped facilitate screening; (4) 'individual characteristics': the practice staff were adaptable and able to facilitate adoption of new clinical processes; and (5) 'processes': fidelity checking, and education was important. CONCLUSIONS: These results describe a novel method for exploring implementation strategies for a colorectal cancer risk prediction tool in the context of a parallel RCT testing clinical efficacy. The study identified successful and unsuccessful implementation strategies using an adaptive methodology over time. This method emphasised the importance of co-design input to make an intervention like CRISP sustainable for use in other practices and with other risk tools

The SYMPTOM-upper gastrointestinal study: A mixed methods study exploring symptom appraisal and help-seeking in Australian upper gastrointestinal cancer patients.

OBJECTIVE: There is limited evidence on the development of pancreatic and oesophagogastric cancer, how patients decide to seek help and the factors impacting help-seeking. Our study, the first in Australia, aimed to explore symptom appraisal and diagnostic pathways in these patients. A secondary aim was to examine the potential to recruit cancer patients through a cancer quality registry. METHODS: Patients diagnosed with pancreatic or oesophagogastric cancer were recruited through Monash University's Upper-Gastrointestinal Cancer Registry. Data collected through general practitioners (GP) and patient questionnaires included symptoms and their onset, whereas patient interviews focused on the patient's decision-making in seeking help from healthcare pracitioners. Data collection and analysis was informed by the Aarhus statement. Coding was inductive, and themes were mapped onto the Model of Pathways to Treatment. RESULTS: Between November 2018 and March 2020, 27 patient questionnaires and 13 phone interviews were completed. Prior to diagnosis, patients lacked awareness of pancreatic and oesophagogastric cancer symptoms, leading to the normalisation, dismissal and misattribution of the symptoms. Patients initially self-managed symptoms, but worsening of symptoms and jaundice triggered help-seeking. Competing priorities, beliefs about illnesses and difficulties accessing healthcare delayed help-seeking. CONCLUSION: Increased awareness of insidious pancreatic and oesophagogastric cancer symptoms in patients and general practitioners may prompt more urgent investigations and lead to earlier diagnosis

Implementing the aspirin guidelines into clinical care (I-MAGIC Project)

In 2017, Cancer Council Australia updated their guidelines for the prevention of colorectal cancer (CRC) to recommend that all people aged 50–70 who are at average risk of CRC actively consider taking aspirin to reduce their risk. Interviews were conducted with a range of health professionals whom the new guidelines may apply, including gastroenterologists, geneticists, genetic counsellors, pharmacists and general practitioners. Interviews explored their current practice, knowledge and opinions toward recommending aspirin to people at average risk of CRC and potential barriers and facilitators to implementing the guidelines. An expected frequency tree showing the potential harms and benefits of aspirin was also developed to facilitate discussion of the risks and benefits of aspirin with patients. Interviews were coded using thematic analysis and themes were mapped onto the Consolidated Framework for Implementation Research

[In Press] Designing a decision aid for cancer prevention : a qualitative study

Objectives: Australian guidelines recommend people aged 50–70 years old consider taking low-dose aspirin to reduce their risk of colorectal cancer. The aim was to design sex-specific decision aids (DAs) with clinician and consumer input, including expected frequency trees (EFTs) to communicate the risks and benefits of taking aspirin. Methods: Semi-structured interviews were conducted with clinicians. Focus groups were conducted with consumers. The interview schedules covered ease of comprehension, design, potential effects on decision-making, and approaches to implementation of the DAs. Thematic analysis was employed; independent coding by 2 researchers was inductive. Themes were developed through consensus between authors. Results: Sixty-four clinicians were interviewed over 6 months in 2019. Twelve consumers aged 50–70 years participated in two focus groups in February and March 2020. The clinicians agreed that the EFTs would be helpful to facilitate a discussion with patients but suggested including an additional estimate of the effects of aspirin on all-cause mortality. The consumers felt favourable about the DAs and suggested changes to the design and wording to ease comprehension. Conclusion: DAs were designed to communicate the risks and benefits of low-dose aspirin for disease prevention. The DAs are currently being trialled in general practice to determine their impact on informed decision-making and aspirin uptake

Maintenance of physical activity and sedentary behavior change, and physical activity and sedentary behavior change after an abridged intervention: secondary outcomes from the ACTIVATE Trial

Background: This brief report examines the maintenance of moderate to vigorous physical activity (MVPA) and sedentary behavior changes approximately 12\ua0weeks after the delivery of the ACTIVATE Trial primary intervention (use of the Garmin Vivofit 2 activity tracker coupled with a behavioral feedback and goal-setting session and 5 telephone-delivered health coaching sessions). We also examine the efficacy of an abridged intervention (use of the Garmin Vivofit 2 only) in the waitlist control group. Methods: A pre-post design was employed to examine the secondary aims of the ACTIVATE Trial (n\ua0=\ua080; mean age\ua0=\ua062\ua0years). MVPA and sedentary behavior were measured using Actigraph and activPAL accelerometers after delivery of the primary intervention (T2), and again 12\ua0weeks later (T3). Linear mixed models with random effects were used to examine within-group changes in MVPA and sitting time variables. Results: After the 12-week follow-up period, women in the primary intervention group had maintained their higher levels of MVPA (change from T2 to T3\ua0=\ua014\ua0min/wk; 95% CI\ua0=\ua0−18 to 46; P\ua0=.37). However, their sitting time increased slightly, by 7\ua0min/d (95% CI\ua0=\ua0−20 to 34; P\ua0=.58), but it did not return to its preintervention level. After receiving the Garmin Vivofit 2, the waitlist control group increased their MVPA by 33\ua0min/wk (95% CI\ua0=\ua03-64; P\ua0=.03) and reduced their sitting time by 38\ua0min/d (95% CI\ua0=\ua0−69 to −7; P\ua0=.02) over the same 12-week period. Conclusion: The secondary outcomes from the ACTIVATE Trial suggest that wearable technology may generate sustainable changes in MVPA and sitting time. Wearable technology alone may be sufficient to change behavior, at least in the short term