None listed
Conditions
Brief summary
This is a multisite, pragmatic cluster randomised trial. We will compare the (1) Ageing Well Tool that incorporates a personalised report (provided to GPs and patients) that outlines the presence/absence of personalised risk factors coupled with clinical treatment recommendations and management plans, to (2) a treatment-as-usual with a self-help control condition. N = 384 patients (n = 192 for each condition) will be enrolled in the study. We expect the The Ageing Well Tool will result in significantly greater reductions in the number of risk factors present from baseline to 12-month screening compared to the control condition. The Ageing Well Tool will also result in increased healthcare costs and improved health outcomes based on activities undertaken by participants to change dementia risk factors, significantly reduced cognitive decline on neuropsychological measures, and older adult and GP satisfaction with the Ageing Well Tool treatment condition will be high with few significant barriers, at 12-month measurement.
Interventions
Practice Enrolment (Cluster) Following HREC approval, primary care practices will be recruited to the study. Primary care practices will be sent information about the study through usual primary care communication channels. In addition, the researchers will inform GP practices about the study at professional talks or workshops, or by handing out information flyers to GP practices. They may also be recruited via information on social media platforms associated with Macquarie University (e.g. Lifespan Health & Wellbeing Research Centre, Centre for Ageing, Cognition & Wellbeing, Centre for Emotional Health, School of Psychology, MQ Health) and the Sydney North Primary Health Network, and GP professional networks. All GPs within a practice will have the option to volunteer to participate in the study, and each will be individually consented to be involved in the study. Interventions Patients will receive one of two interventions: 1) Ageing Well Tool or 2) Control Condition. Patients will spend 30 minutes completing the survey on a tablet at the practice (e.g., in the waiting room) at each timepoint (baseline, 6 months post-baseline, 12 months post-baseline) before their consultation with their GP. GPs will access the tool on a tablet at their practice. After patients fill out self-report measures (e.g., depression, social isolation), GPs will enter medical data on the tablet (e.g., cholesterol, hypertension). In the Ageing Well Tool Condition following completion of the Risk Screening Survey, GPs will receive the personalised risk profile report for that patient on the tablet indicating patients’ risk factors that are present/absent and some evidence-based recommendations for risks that are present. For example, recommendations for a referral to a clinical psychologist or to an evidence-based treatment program will be provided to GPs to consider for the presence of anxiety and depressive symptomology. GPs will provide feedback to the patient on their results and, using patient-centred approaches and joint decision making, will plan the appropriate interventions, and provide them with a copy of the planned actions. At the next measurement 6 months later, the GP will receive a list of the previous recommendations they provided and will ask patients if they followed recommendations, recording this information in the Ageing Well Tool. Following the 6 month and 12 month follow up risk screening, GPs and their patients will receive updated information on their current risk profile. Training GPs will receive a 30-minute training session (on premises or via videoconferencing) on how to use the tool from a postdoctoral researcher or research officer/assistant within one week prior to commencing the intervention at the GP practice (or as close to that timeframe as is practical for general practitioners). There will also be a summary of training materials on a website. Acceptability and Feasibility of Ageing Well Tool (Mixed Methods approach) To evaluate the acceptability and feasibility of the Ageing Well Tool, a research assistant will gather feedback on the screening and feedback process via an acceptability and feasibility measure comprising semi-structured qualitative focus group questions conducted with primary care staff and patients (separately), as described below. Audio will be transcribed verbatim by a MQ-approved transcription service (e.g., Digital Transcripts). Transcripts will be checked against audio files for accuracy. All data will be deleted from the transcription service once the transcription process is completed. Primary care staff GPs, practice manager(s), practice nurse(s) and other staff involved in patient care related to the Ageing Well Tool will be invited to provide feedback on the Ageing Well Tool via focus groups to assess their overall liking of the Ageing Well Tool, liking of aspects of the tool, how beneficial it is, barriers, potential solutions, and GP-observed patient compliance with the co-created treatment plan over 12 months. A sample of GPs and practice staff will be recruited from different locations and demographics to ensure focus group members are representative of the total sample. Patients A sample of patients will be invited to provide feedback on the Ageing Well Tool via focus groups to assess their overall liking of the Ageing Well Tool, liking of aspects of the tool, how beneficial it is, barriers, potential solutions, and patient self-report of compliance with the co-created treatment plan over 12 months. A sample of patients will be recruited from different locations and demographics to ensure focus group members are representative of the total sample. In addition, all patients in the Ageing Well Tool condition will be asked to complete a 3-question mixed methods measure of acceptability and feasibility of the Ageing Well Tool following their 12-month assessment consultation. Procedure: After HREC clearance, GP practices and practice staff will be recruited into the trial, and practices randomised via clusters into one of the two treatment conditions. GPs and practice staff will identify and recruit eligible participants into the trial and book them into an appointment to complete the risk screening survey. Participants will be contacted by the study RA to complete the cognitive screener (6 item), check study criteria, book the appointment for the cognitive testing and reconfirm participant consent. Participants will complete the neuropsychological tests in a dedicated 30 min session with the RA. For participants in practices allocated to the Ageing Well Tool, a personalised risk profile report will be presented to their GP who will then go through the results with the patient in a consultation and determine any treatment recommendations using the personalised Ageing Well Tool report. All patients will recomplete the risk screening survey at 6- and 12-months post-baseline, and recomplete the cognitive testing at 12-months only (not at 6 months). Patients in the Ageing Well Tool condition will be invited to complete short acceptability and feasibility feedback on the Ageing Well Tool. A subgroup of consumers, practice nurses and GPs will be invited to participate in focus groups to understand acceptability, feasibility, barriers, and future improvements to the Ageing Well Tool. The Zoom/Teams focus groups will be audio recorded and transcribed. Following the 12-month risk survey, patients and their GPs in the control condition will receive a copy of the patient’s personalised risk profile and evidence-based treatment recommendations.
Sponsors
Study design
Eligibility
Inclusion criteria
• The patient must be aged between 60 and 70 years of age (inclusive). • Patient has a life expectancy of 5+ years from baseline assessment. • Normal cognition based on 6-item screener. • Patient of a General Practitioner in a practice who has signed up to the study. • Lives independently in the community. • Able to read and write in English at a sufficient level to enable informed written consent to be provided and capable of reading and responding to study questionnaires and resources).
Exclusion criteria
• Patients who are <60 years of age or 71 years and older. • Patients with a life expectancy of <5 years. • Patients who have a significant medical condition that will prevent them from being able to actively engage in the study over the next 12 months. • Patients with a dementia (based on medical record indicating existing dementia or based on score below threshold on the 6-item screener) • Living in a residential aged care facility. • Unable to read and write in English at a sufficient level. • GP is not part of the trial.