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Trial registered on ANZCTR


Registration number
ACTRN12620000993998
Ethics application status
Approved
Date submitted
2/07/2020
Date registered
2/10/2020
Date last updated
2/10/2020
Date data sharing statement initially provided
2/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Future Health Today: A cluster randomised controlled trial of quality improvement activities in general practice
Scientific title
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
Secondary ID [1] 301681 0
None
Universal Trial Number (UTN)
U1111-1254-1693
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 318123 0
Cancer- gastric 318126 0
Prostate cancer 318469 0
Oesophageal cancer 318470 0
Colorectal cancer 318471 0
Endometrial cancer 318472 0
Lung cancer 318473 0
Ovarian cancer 318474 0
Condition category
Condition code
Renal and Urogenital 316146 316146 0 0
Kidney disease
Cancer 316147 316147 0 0
Prostate
Cancer 316148 316148 0 0
Oesophageal (gullet)
Cancer 316149 316149 0 0
Stomach
Cancer 316150 316150 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 316151 316151 0 0
Womb (Uterine or endometrial cancer)
Cancer 316152 316152 0 0
Lung - Small cell
Cancer 316153 316153 0 0
Lung - Non small cell
Cancer 316154 316154 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317990 0
Other interventions
Comparator / control treatment
The active control for Arm 1 will be patients attending practices in Arm 2, and vice versa. Usual care will be provided to patients in the control arms. For the purposes of this trial, usual care is defined as general practice staff having the freedom to treat control patients according to their own insight and practice.
Control group
Active

Outcomes
Primary outcome [1] 324332 0
Proportion of eligible patients with a diagnosis of CKD that are receiving ACE inhibitors or Angiotensin receptor blockers and/or statins consistent with Kidney Health Australia, RACGP Red Book and National Vascular Disease Prevention Alliance Guidelines. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [1] 324332 0
12 months post-baseline
Primary outcome [2] 324333 0
Proportion of eligible patients at risk of undiagnosed prostate, oesophageal, gastric, colorectal, endometrial, lung or ovarian cancer that have been assessed and investigated according to NICE, Cancer Council Australia, Victorian Government Department of Health and Human Services, Prostate Cancer Foundation of Australia guidelines. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [2] 324333 0
12 months post-baseline
Secondary outcome [1] 384358 0
Proportion of patients with a diagnosis of CKD that are prescribed an angiotensin converting enzyme inhibitor or angiotensin receptor blocker consistent with Kidney Health Australia, RACGP Red Book and National Vascular Disease Prevention Alliance guidelines. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [1] 384358 0
12 months post-baseline
Secondary outcome [2] 384359 0
Proportion of patients with a diagnosis of CKD that are prescribed statin medication consistent with National Vascular Disease Prevention Alliance guidelines and ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [2] 384359 0
12 months post-baseline
Secondary outcome [3] 384360 0
Mean systolic blood pressure (mmHg). This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [3] 384360 0
12 months post-baseline
Secondary outcome [4] 384361 0
Mean total cholesterol (mmol/L ). This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [4] 384361 0
12 months post-baseline
Secondary outcome [5] 384362 0
Mean urine albumin:creatinine ratio (ACR). This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [5] 384362 0
12 months post-baseline
Secondary outcome [6] 384363 0
Mean estimated glomerular filtration rate. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [6] 384363 0
12 months post-baseline
Secondary outcome [7] 384364 0
Cardiovascular risk: Proportion of people at low/moderate/high CVD risk as per National Vascular Disease Prevention Alliance guidelines. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [7] 384364 0
12 months post-baseline
Secondary outcome [8] 384365 0
Proportion of patients with markers of anaemia (defined as Haemoglobin <130g/L in men and <115g/L in women) or MCV <80fl or MHC <27pg or ferritin<30µg/L)
that have been assessed for upper and lower GI symptoms and/or haematuria who have had at least one of the following investigations ordered: coeliac disease serology (defined as any of the following tests: Tissue transglutaminase antibodies; tTG IgA; tTG IgG; Anti-tTG; Gliadin antibodies; Endomyseal antibodies; Endomysium Ab; Gluten-sensitive enteropathy tests), faecal occult blood test, transvaginal ultrasound. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [8] 384365 0
12 months post-baseline
Secondary outcome [9] 384366 0
Proportion of patients with markers of anaemia (defined as Haemoglobin <130g/L in men and <115g/L in women) or MCV <80fl or MHC <27pg or ferritin<30µg/L) that have been prescribed oral supplements and/or had an iron infusion in the general practice clinic. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [9] 384366 0
12 months post-baseline
Secondary outcome [10] 384367 0
Proportion of patients with raised platelet count assessed for symptoms defined in Victorian Department of Health, NICE, and Cancer Council guidelines as indicative of prostate, oesophageal, gastric, colorectal, endometrial, lung or ovarian cancer that have been followed up with one or more of the following: chest x-ray, faecal occult blood test, transvaginal ultrasound and CA-125. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [10] 384367 0
12 months post-baseline
Secondary outcome [11] 384368 0
Proportion of patients with one raised prostate-specific antigen (PSA) that have been followed up with a second PSA and/or free-to-total PSA percentage as per Cancer Council Australia guidelines. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [11] 384368 0
12 months post-baseline
Secondary outcome [12] 384369 0
Proportion of patients with a diagnosis of prostate, oesophageal, gastric, colorectal, endometrial, lung or ovarian cancer. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [12] 384369 0
12 months post-baseline
Secondary outcome [13] 384370 0
Mean number of general practice encounters per patient. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [13] 384370 0
12 months post-baseline
Secondary outcome [14] 385250 0
Proportion of patients with ACR <3.5mg/mmol (women) and <2.5mg/mmol (men). This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [14] 385250 0
12 months post-baseline
Secondary outcome [15] 385252 0
Mean LDL cholesterol (mmol/L ). This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [15] 385252 0
12 months post-baseline
Secondary outcome [16] 385253 0
Mean HDL cholesterol (mmol/L ). This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [16] 385253 0
12 months post-baseline
Secondary outcome [17] 385254 0
Mean triglycerides (mmol/L ). This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset.
Timepoint [17] 385254 0
12 months post-baseline

Eligibility
Key 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:
Recorded diagnosis of 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 years or older
o Most recent Platelet count greater than 400 x 10^9/L

• Anaemia:
o Age 50 years or older
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 years or older 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.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General practices:
• Previous participation in EMAP CKD, CD IMPACT or 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Practices will be recruited by VicREN Department of General Practice staff.
Allocation concealment is ensured because random allocation of practices to the study arms will occur after all practices are recruited and baseline measures collected. Statisticians and data managers will be blinded to allocation of clusters.
Practices will be informed of their allocation by clinical liaison staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
General practices will be allocated in a 1:1 ratio to the two study arms using covariate-constrained randomisation to balance practices between the two arms on the following factors: general practice size, practice location’s geographic remoteness of the practice (Modified Monash Model) and SEIFA index (index of relative social disadvantage), participation in a formalised quality improvement program (yes, no) and patient level information at the cluster level: mean age, percentage male. If not all practices are recruited prior to December 2020, a minimisation approach will instead be used.

The senior statistician will generate the allocation sequence by randomly selecting at random a sequence from all the possible random allocation sequences of assigning the clusters to the two study arms with acceptable balance across all the factors above.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Forty practices (20 in arm) will be recruited. We determined the minimum number of patients required for each study using a two-sided 5% significance test, intra-cluster correlation coefficient of 0.03 to allow for the clustering effect, and coefficient of variation of 0.64 to account for variable cluster sizes. We expect that each practice will have variable number of active patients for each sub-study. We have also allowed for the potential loss of six practices by 12 months (e.g. practice closure, practice withdrawals). Minimally important absolute differences were informed from published CKD and cancer intervention trials.

Descriptive statistics will be used to summarise general practice, clinician and patient characteristics in both the study arms. For each study, marginal logistic model using Generalised Estimating Equations with robust standard errors to adjust for correlation of outcomes within general practice will be used to estimate the intervention effect for primary and secondary binary outcomes. In secondary analyses, pre-specified baseline variables strongly associated with the outcome will also be adjusted in the regression analysis. Estimates of the intervention effect will be reported as odds ratios with 95% confidence intervals and p-values. Mixed effects linear regression will be used to determine predictors for continuous outcomes. Analyses will use an intention-to-treat approach. Strategies will be taken to minimise the missing data. A blinded assessment of the data and reasons for loss to follow-up will inform how to handle missing data in the analysis and sensitivity analyses will be conducted to assess the robustness of the missing data assumption.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306116 0
Charities/Societies/Foundations
Name [1] 306116 0
Paul Ramsay Foundation
Address [1] 306116 0
243 Liverpool Street
Darlinghurst NSW 2010
Australia
Country [1] 306116 0
Australia
Funding source category [2] 306117 0
Charities/Societies/Foundations
Name [2] 306117 0
Cancer Research UK
Address [2] 306117 0
2 Redman Place
London
E20 1JQ
Country [2] 306117 0
United Kingdom
Funding source category [3] 306118 0
Government body
Name [3] 306118 0
NHMRC
Address [3] 306118 0
16 Marcus Clarke St,
Canberra ACT 2601
Country [3] 306118 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Department of General Practice
University of Melbourne
780 Elizabeth St
Melbourne Vic 3010
Country
Australia
Secondary sponsor category [1] 306587 0
None
Name [1] 306587 0
Address [1] 306587 0
Country [1] 306587 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306335 0
Medicine and Dentistry Human Ethics Sub-Committee, University of Melbourne
Ethics committee address [1] 306335 0
Alan Gilbert Building, Level 5, The University of Melbourne, 161 Barry Street, Victoria 3010 Australia
Ethics committee country [1] 306335 0
Australia
Date submitted for ethics approval [1] 306335 0
Approval date [1] 306335 0
23/06/2020
Ethics approval number [1] 306335 0
2056564

Summary
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.
Trial website
https://futurehealthtoday.com.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103534 0
A/Prof Jo-Anne Manski-Nankervis
Address 103534 0
Department of General Practice, University of Melbourne
780 Elizabeth St
Melbourne Vic 3010
Country 103534 0
Australia
Phone 103534 0
+61 3 90358019
Fax 103534 0
Email 103534 0
jomn@unimelb.edu.au
Contact person for public queries
Name 103535 0
A/Prof Jo-Anne Manski-Nankervis
Address 103535 0
Department of General Practice, University of Melbourne
780 Elizabeth St
Melbourne Vic 3010
Country 103535 0
Australia
Phone 103535 0
+61 3 90358019
Fax 103535 0
Email 103535 0
jomn@unimelb.edu.au
Contact person for scientific queries
Name 103536 0
A/Prof Jo-Anne Manski-Nankervis
Address 103536 0
Department of General Practice, University of Melbourne
780 Elizabeth St
Melbourne Vic 3010
Country 103536 0
Australia
Phone 103536 0
+61 3 90358019
Fax 103536 0
Email 103536 0
jomn@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data extracted from general practice electronic medical records and stored in the Patron general practice data repository at the University of Melbourne will be used in this study. Data sharing from this repository is not permitted. Researchers can apply for access to this data repository more broadly - information is available here: https://medicine.unimelb.edu.au/school-structure/general-practice/engagement/data-for-decisions
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8389 0
Study protocol
Citation [1] 8389 0
Link [1] 8389 0
Email [1] 8389 0
Other [1] 8389 0
The study protocol will be made available via publication (planned)
Attachment [1] 8389 0
Type [2] 8390 0
Informed consent form
Citation [2] 8390 0
Link [2] 8390 0
Email [2] 8390 0
jomn@unimelb.edu.au
Other [2] 8390 0
Attachment [2] 8390 0
Type [3] 8391 0
Statistical analysis plan
Citation [3] 8391 0
Link [3] 8391 0
Email [3] 8391 0
Other [3] 8391 0
The statistical analysis plan will be made available via publication (planned)
Attachment [3] 8391 0
Type [4] 8392 0
Ethical approval
Citation [4] 8392 0
Link [4] 8392 0
Email [4] 8392 0
Other [4] 8392 0
Summary results
No Results