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Trial registered on ANZCTR


Registration number
ACTRN12619000508178p
Ethics application status
Submitted, not yet approved
Date submitted
12/03/2019
Date registered
28/03/2019
Date last updated
28/03/2019
Date data sharing statement initially provided
28/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A cluster randomised controlled trial of a MedicineInsight educational quality improvement program to improve the diagnosis and treatment of chronic hepatitis C in Australian general practice - the EQUIP-HEPC trial
Scientific title
A cluster randomised controlled trial of a MedicineInsight educational quality improvement program to improve the diagnosis and treatment of chronic hepatitis C in Australian general practice - the EQUIP-HEPC trial
Secondary ID [1] 297704 0
MedicineInsight Protocol Number 2018-040
Universal Trial Number (UTN)
U1111-1229-9722
Trial acronym
EQUIP-HEPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic hepatitis C (CHC) 312009 0
Condition category
Condition code
Infection 310575 310575 0 0
Other infectious diseases
Oral and Gastrointestinal 310576 310576 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NPS MedicineWise has developed an educational intervention to be delivered to general practices to support GPs in the diagnosis and management of CHC. The 150 practices that are randomised to the intervention arm will be offered the intervention as described below:

The one-off educational intervention will be delivered at each practice by trained clinical service specialists (CSS) from NPS MedicineWise. The majority of CSS are pharmacists. The intervention involves a 1-hour facilitated discussion among the health professionals at the practice, led by one of the CSS. The intervention supports GPs to take an active role in identification, diagnosis and management of people with CHC including treatment or referral as appropriate. The intervention aims to raise awareness, provide education and increase confidence in management of CHC, as well as facilitating links between GPs and specialists who can provide approval for treatment and support GPs while they increase their experience in CHC management.
The materials used during the intervention include:
1. A one-off personalised MedicineInsight practice ‘audit and feedback’ report that includes data specific to their practice and which benchmarks this information against the average of all MedicineInsight practices. This MedicineInsight practice report describes the management of patients with possible or confirmed CHC who visited their practice in the last two years, against the average of all MedicineInsight practices.
2. An accompaying patient case study developed by NPS MedicineWise.
3. Educational materials and guidelines developed by ASHM.
4. An action sheet completed by the CSS during the visit.
5. Encrypted patient lists from MedicineInsight identified as requiring follow-up at the practice.
6. An online audit tool will be made available following the practice visit, to support practice staff to initiate care of patients identified by MedicineInsight as requiring follow-up.
7. The NPS MedicineWise CSS will be trained to deliver the intervention in a systematic way at each practice by following the NPS MedicineWise "Topic Discussion Guide"
Intervention code [1] 313936 0
Other interventions
Comparator / control treatment
MedicineInsight practices allocated to the control arm will continue usual practice without being offered the educational intervention from NPS MedicineWise. As with the intervention arm, practices participating in any Quality Improvement activities for the management of CHC will continue participation as usual.
Control group
Active

Outcomes
Primary outcome [1] 319429 0
The number of patients with a new prescription for a direct acting antiviral (DAA) therapy for chronic hepatitis C in the 6 months after the index date, as recorded in the MedicineInsight dataset.
Timepoint [1] 319429 0
Six months after the date the practice receives the educational intervention (intervention arm)
Six months after the date of randomisation (control arm)
Secondary outcome [1] 368124 0
The proportion of patients with untreated CHC who visit the practice and initiate a DAA in the 6 months after the index date, as recorded in the MedicineInsight dataset
Timepoint [1] 368124 0
Six months after the date the practice receives the educational intervention (intervention arm)
Six months after the date of randomisation (control arm)
Secondary outcome [2] 368125 0
The number of patients with untreated CHC who visit the practice in the 6 months after the index date, as recorded in the MedicineInsight dataset.
Timepoint [2] 368125 0
Six months after the date the practice receives the educational intervention (intervention arm)
Six months after the date of randomisation (control arm)
Secondary outcome [3] 368126 0
The number of patients with untreated CHC who have a quantitative and/or qualitative HCV RNA test recorded in the 6 months after the index date, as recorded in the MedicineInsight dataset
Timepoint [3] 368126 0
Six months after the date the practice receives the educational intervention (intervention arm)
Six months after the date of randomisation (control arm)
Secondary outcome [4] 368128 0
The number of untreated CHC who have an HCV genotype test recorded in the 6 months after the index date, as recorded in the MedicineInsight dataset
Timepoint [4] 368128 0
Six months after the date the practice receives the educational intervention (intervention arm)
Six months after the date of randomisation (control arm)
Secondary outcome [5] 368754 0
The proportion of patients with untreated CHC who have a quantitative or qualitative HCV RNA test recorded in the 6 months after the index date, as recorded in the MedicineInsight dataset
Timepoint [5] 368754 0
Six months after the date the practice receives the educational intervention (intervention arm)
Six months after the date of randomisation (control arm)
Secondary outcome [6] 368755 0
The proportion of untreated CHC who have an HCV genotype test recorded in the 6 months after the index date, as recorded in the MedicineInsight dataset
Timepoint [6] 368755 0
Six months after the date the practice receives the educational intervention (intervention arm)
Six months after the date of randomisation (control arm)

Eligibility
Key inclusion criteria
General Practice sites:
1. Participates in the MedicineInsight Program and meets MedicineInsight data quality requirements
2. Located in a geographical area serviced by one of the CSS field force delivering the intervention
3. Use of Medical Director or Best Practice for EHR management
4. Has 5 or more patients with possible or confirmed CHC* who visited the practice at least once in the 2 years prior to randomisation
*As part of a previous project related to hepatitis C, we have developed a set of search algorithms that scan the data in MedicineInsight for terms that indicate confirmed or possible CHC. These algorithms and terms are outlined in detail by Chidwick et al (2018) . The algorithms search for a patient’s most recent docle and pyefinch codes as well as free text expressions pertaining to hepatitis C in clinical system records that describe reason for encounter, reason for prescription, or diagnosis. Additional criteria are applied to confirm CHC in patients whose most recent status is indeterminate, including prescriptions, tests, and complications related to CHC.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Practices that participated in the 2017 NPS MedicineWise educational program on Hepatitis C will be excluded.

Practices that withdraw their consent to participate in this study, or in the MedicineInsight program, during the period of analysis will not be included in this study. Practice-level withdrawals are rare in MedicineInsight. Data for patients who opt-out from the program will be excluded from the study.

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)
The eligible practice sites will be identified by the data analyst on the research team using MedicineInsight data, before randomisation of the practice sites has occurred i.e. before allocation has occured.. Only after ALL the eligible sites have been identified,will they then be randomised by a statistican not involved in the study and allocated to control or intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
300 MedicineInsight practices (clusters) will be randomised in a 1:1 allocation to receive the NPS MedicineWise educational intervention. Clusters will be stratified according to high (>50) and medium/low (5-50) caseloads of patients with CHC. Block randomisation will be performed by a statistician not involved in the study. Outcome analyses will be conducted blinded to intervention allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Randomisation of 300 MedicineInsight practices (150 per arm) will provide 80% power at the 0.05 significance level to detect a 6% absolute higher proportion of patients with CHC prescribed a DAA among practices receiving the educational visit.
1. Cluster size of eligible population will range from 5 patients with possible or confirmed CHC in a low caseload practice through to 200 patients in a high caseload practice. A mean average cluster size of 20 (SD: 19) is assumed.* Methods to account for variable cluster size are recommended when cluster size variability is large, i.e. the coefficient of variation of cluster size, defined as the ratio of the standard deviation of cluster size Sn to mean cluster size n, is greater than 0.23 – here it is 0.952.
2. The mean (SD) and proportion of patients with confirmed CHC prescribed DAA therapy per control practices is 8% respectively.
3. The mean (SD) and proportion of patients prescribed DAA therapy in intervention practices is 14%, respectively.
4. An intra-class correlation coefficient of 0.05 for the primary outcome is estimated, with a resultant design effect of 2.45 to accommodate variation in prescribing rates across practices.
5. A conservative refusal rate of 33% (anecdotal reports from previous programs estimate that roughly 25% of MedicineInsight practices invited to participate in education programs might be expected to refuse)
Clusters will be stratified on caseload of patients with CHC– high, low. Data analysis will be performed on an intention-to-treat basis using standard techniques for cluster randomised designs such as mixed models and generalised estimating equations.
Data management and analyses will be conducted with SAS ® Enterprise Guide 7.1 (Cary, NC USA, 2017).

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)
ACT,NSW,NT,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 302227 0
Commercial sector/Industry
Name [1] 302227 0
Gilead Sciences Pty Ltd (via VentureWise)
Address [1] 302227 0
Level 6
417 St Kilda Road
Melbourne,
Victoria 3004
Country [1] 302227 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
NPS MedicineWise (Not-for-profit)
Address
Level 7,
418A Elizabeth St,
Surry Hills
NSW 2010
Country
Australia
Secondary sponsor category [1] 302087 0
None
Name [1] 302087 0
None
Address [1] 302087 0
Country [1] 302087 0
Other collaborator category [1] 280604 0
University
Name [1] 280604 0
The Kirby Institute (University of New South Wales)
Address [1] 280604 0
Level 6, Wallace Wurth Building
High Street, UNSW Australia
Kensington NSW 2052
Country [1] 280604 0
Australia
Other collaborator category [2] 280605 0
Charities/Societies/Foundations
Name [2] 280605 0
The George Institute for Global Health
Address [2] 280605 0
Level 5,
1 King Street,
Newtown, Sydney,
NSW 2042
Country [2] 280605 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302907 0
The Royal Australian College of General Practitioners NREEC
Ethics committee address [1] 302907 0
100 Wellington Parade
East Melbourne
Victoria 3002
Ethics committee country [1] 302907 0
Australia
Date submitted for ethics approval [1] 302907 0
12/11/2018
Approval date [1] 302907 0
Ethics approval number [1] 302907 0

Summary
Brief summary
Just over 180,000 people in Australia are living with chronic hepatitis C (CHC) and at risk of liver disease, liver cancer and death. Since 2016, medicines for CHC can be prescribed by GPs, which cure >95% of patients and prevent ongoing liver damage. So far 10% of GPs in Australia have prescribed CHC medicines, but to meet World Health Organisation targets for hepatitis C elimination all GPs will need to identify patients in their practice with the disease and recall them for treatment.
NPS MedicineWise has developed an educational intervention delivered by their field force of clinical service specialists (CSS) to general practice staff to support GPs in the diagnosis and management of CHC. The intervention includes a 1-hour educational small group meeting at the general practice, a personalised ‘audit and feedback’ report from the MedicineInsight program, that includes data specific to their practice, benchmarked against all practices, and an online audit tool. The intervention aims to raise awareness, provide education and increase confidence in management of CHC, as well as facilitating links between GPs and specialists who can provide approval for treatment and support GPs while they increase their experience in CHC management. During the 1-hour meeting, in addition to discussing the feedback reports, the education will include a case study, educational materials developed by ASHM, and an action sheet completed by the CSS during the visit. The intervention also includes encrypted patient lists from MedicineInsight identified as requiring follow-up at the practice.
This cluster randomised controlled trial will evaluate whether the NPS MedicineWise educational intervention, with data-based insights from MedicineInsight, is effective at improving case finding, assessment and treatment of patients with CHC. We will test the hypothesis that compared to control practices, those practices randomised to receive the NPS MedicineWise educational intervention will have a higher number and proportion of patients with CHC initiating direct acting antiviral (DAA) therapy and a higher number of patients being tested with an HCV (hepatitis C virus) RNA PCR test for diagnosis. Data will be evaluated using the general practice data program, MedicineInsight. MedicineInsight is a leading large-scale primary care data set of longitudinal de-identified electronic health records (EHR) used for quality improvement and research.
The results of this trial will help inform future initiatives in Australia as well as internationally to continue the treatment momentum to help eliminate CHC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91806 0
Mrs Kendal Chidwick (B.Pharm. MSc Epi)
Address 91806 0
NPS MedicineWise
Level 7 / 418a Elizabeth St
Surry Hills NSW 2010
Country 91806 0
Australia
Phone 91806 0
+61 2 8217 8620
Fax 91806 0
Email 91806 0
kchidwick@nps.org.au
Contact person for public queries
Name 91807 0
Mrs Kendal Chidwick (B.Pharm. MSc Epi)
Address 91807 0
NPS MedicineWise
Level 7 / 418a Elizabeth St
Surry Hills NSW 2010
Country 91807 0
Australia
Phone 91807 0
+61 2 8217 8620
Fax 91807 0
Email 91807 0
kchidwick@nps.org.au
Contact person for scientific queries
Name 91808 0
Mrs Kendal Chidwick (B.Pharm. MSc Epi)
Address 91808 0
NPS MedicineWise
Level 7 / 418a Elizabeth St
Surry Hills NSW 2010
Country 91808 0
Australia
Phone 91808 0
+61 2 8217 8620
Fax 91808 0
Email 91808 0
kchidwick@nps.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 2 years following main results publication
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access is subject to approvals by the Principal Investigator, the independent MedicineInsight Data Governance Committee, data fees from the data custodian, and requirement to sign data access agreement
What supporting documents are/will be available?
Study protocol
Summary results
No Results