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Future Health Today: A cluster randomised controlled trial of quality improvement activities in general practice

Future Health Today: A pragmatic 12-month cluster randomised controlled trial of quality improvement activities in general practice for patients with chronic kidney disease or high risk of undiagnosed cancer

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000993998
Acronym
N/A
Enrollment
15373
Registered
2020-10-02
Start date
2020-11-18
Completion date
2022-04-30
Last updated
2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine if a new software (called Future Health Today) can be used by general practices to optimise diagnosis of cancers and management of chronic kidney disease. Who is it for? You may be eligible for this study if you are over the age of 18, have either chronic kidney disease or are considered at high risk for an undiagnosed cancer, and attend one of the practices enrolled in this study. Study details General practices will be randomly assigned to one of two trial arms. One arm will receive the software and educational activities focusing on prevention of cardiovascular conditions in those with chronic kidney disease and the other will receive software and educational activities focusing on identification of patients with potential undiagnosed cancer. Both clinics will receive modules regarding quality improvement. Participants who are patients of the general practice involved in this study will attend their general practice as per usual. Data will then be collected from practices 12 months after enrolment to determine if there have been changes in management of patients and whether this has had an impact on diagnosis of cancers and management of chronic kidney disease. This research will help to understand the role of technology and education activities in facilitating quality improvement in general practice.

Interventions

Future Health Today (FHT) trial is testing a quality improvement (QI) program in order to reduce cardiovascular disease (CVD) risk in people with chronic kidney disease (CKD) and to facilitate earlier diagnosis of cancer in general practice. The intervention consists of: 1. Technology platform consisting of audit, point of care clinical decision support, and QI templates. Practices will generate a baseline cohort of patients using the audit tool at the beginning of the trial. The progress of the

Future Health Today (FHT) trial is testing a quality improvement (QI) program in order to reduce cardiovascular disease (CVD) risk in people with chronic kidney disease (CKD) and to facilitate earlier diagnosis of cancer in general practice. The intervention consists of: 1. Technology platform consisting of audit, point of care clinical decision support, and QI templates. Practices will generate a baseline cohort of patients using the audit tool at the beginning of the trial. The progress of the cohort will be automatically updated using the Future Health Today platform over the trial duration. Practices will be encouraged to review their progress and complete a minimum of three reviews of audit data as part of an accredited Royal Australian College of General Practitioners (RACGP) quality improvement activity. These can be carried out at any time during the trial, but we will recommend that they are conducted at least once every four months over the 12-month trial period. The point of care tool will automatically deploy when the electronic medical record of an eligible patient is opened and will provide a prompt regarding guideline-concordant care. The QI template has been developed specifically for this study, and aligns to RACGP requirements. 2. ECHO (Extension for Community Healthcare Outcomes) education activities. ECHO sessions are delivered using the zoom videoconference platform. The 60-minute sessions consist of (1) Introductions of participants (2) Delivery of a short didactic lecture (approximately 10 minutes in duration), followed by question and answer session (3) Presentation of a clinical case by a participant followed by feedback from participants and an expert panel. Each arm will receive 3 ECHO sessions based on their allocation (see below). The ECHO activities will be facilitated and presented by GPs and relevant disease specialists e.g. nephrologists, urologists, oncologists, gastroenterologists etc.) depending on trial arm. These activities will be offered in month 1, 3 and 6. Both arms will be invited to three QI sessions. The QI sessions will include topics on RACGP requirements for QI activities, building a team to lead QI and QI frameworks; these will be tailored based on participant requirements consistent with the ECHO model. These sessions will be held in months 2, 7 and 10. 3. QI toolkit, phone and zoom support to develop practice-specific QI programs will be provided by practice liaison staff who have been trained in QI methodology at the University of Melbourne. Support offered to practices will vary depending on the practice-specific needs identified through communication between practice champions and practice liaison staff at the University of Melbourne (both prompted by practice liaison staff and as requested by the practice). Practices will be able to request additional QI support from Primary Health Networks. The QI toolkit consists of an introduction to QI, a framework that can be used for QI activities and links to web-based resources that can assist practices with QI activities. Arm 1: Arm 1 will have access to the chronic kidney disease (CKD) FHT module. The focus will be on increasing appropriate use of Angiotensin Converting Enzyme inhibitor or angiotensin receptor blocker and/or statin medications which are known to slow the progression of CKD and reduce cardiovascular disease (CVD) risk respectively in people with CKD. General practices in Arm 1 will be offered three ECHOs on chronic kidney disease (Cardiovascular risk assessment, controversies in cardiovascular disease management in people with chronic kidney disease, management of hypertension in people with chronic kidney disease; these will be tailored based on participant requirements consistent with the ECHO model) and three on quality improvement. Arm 2: Arm 2 will have access to the cancer FHT module. The focus will be on identifying people at risk of undiagnosed cancer based on abnormal pathology results, and recalling them for appropriate assessment and investigation. General practices in Arm 2 will be offered three ECHOs on identification and management of people at increased risk of undiagnosed cancer (prostate cancer screening, high platelet count and cancer, anaemia and cancer; these will be tailored based on participant requirements consistent with the ECHO model), and three on quality improvement. A process evaluation will be conducted. Participation in ECHO activities, usage of FHT platform, interaction with practice participants will be recorded. QI templates which summarise the activities undertaken by practices will be collected. Brief surveys after each ECHO module will be completed.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

General practices: • Contributing data, or willing to contribute data, to Data for Decisions program • See at least 35 adults aged 18 years or older per day, have at least 2,500 active adult patients (attended at least three times in the last two years) recorded in their EMR*, have at least 50 patients that fit cohort definitions for people with CKD not on optimal medications and abnormal test results and additional clinical features placing them at risk of an undiagnosed cancer • Employ a practice nurse • Utilise EMR (Best Practice, Medical Director or ZedMed software) for recording of clinical consultations, prescription of medications and ordering and receiving pathology results • Use Windows 10 as the practice computer operating system and can identify a single workstation on which GRHANITE (the data extraction tool required to extract data for Patron) and FHT can be installed. The workstation must be i5/i7 and 16GB RAM or upgradable to 16GB and cannot be the practice management system server. • Have Edge, Chrome or Firefox installed on all computers CKD module: Age 18-80 years old Recorded diagnosis or pathology results consistent with chronic kidney disease in electronic medical record Not prescribed ACE inhibitor or angiotensin receptor blocker and/or statin when indicated according to Kidney Health Australia, RACGP Red Book and National Vascular Disease Prevention Alliance Guidelines Cancer module: • Raised platelet count: o Age 40 to 80 years o Most recent Platelet count greater than 400 x 10^9/L • Anaemia: o Age 50 to 80 years o Patients with anaemia markers, defined as Haemoglobin less than 130g/L in men and less than 115g/L in women or MCV less than 80fl or MHC less than 27pg or ferritin less than 30µg/L • Altered PSA: o Male Aged 40 to less than 50 years of age and PSA greater than 2.0 ng/ml; o Male Aged 50 to 80 years and PSA greater than 3.0 ng/ml *Note regarding number of active patients: COVID-19 is having a significant impact on patient attendance at general practice. As such, the number of active patients per clinic may reduce. The impact of this on general practices will be monitored and the inclusion criteria broadened to patients marked as attending the practice (i.e. not marked as deceased or moved to another practice) if required.

Exclusion criteria

General practices: • Previous participation in FHT pilot and optimisation projects • Practice is intending to change to another medical software supplier during the trial period • Practice is using a cloud based EMR system that does not have GRHANITE (data extraction tool) installed CKD module: Recorded history of renal transplant Recorded history of chronic dialysis Cancer module: • Lung, colorectal, gastro-oesophageal, ovarian or endometrial cancer diagnosis in the previous 5 years • Prostate cancer

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026