improving community based diagnosis and treatment of ... · 2. inform government policy and...

‘B Positive’ Project Improving community based diagnosis and treatment of chronic Hepatitis BUSER GUIDE

SECTION 1_Using the GP Kit_V5.3_Folder

‘B Positive’ Project GP KIT CONTENTS

Part 1: Background and Rationale 2

Why B Positive 2

Project Aims 2 Project Management 3 Ethics 4 Expected Results 4 Evaluation 5

Part 2: B Positive – Your Role in Education and Recruitment

6 Educational Resources for Patients Educational Resources for General Practitioners

6 6

Recruitment Resources Patient Information Pack Patient Information and Consent Form Case Record Form - Enrollment Case Record Form - Follow-up Interpreter services Patient SPIN Number Record Table. B Positive Project Pathology Stickers Ordering More Resources

7 7 8 8 8 9 9

10 10

Part 3: B Positive Data Collection Phase 1: Initial Enrollment Phase 2: Confirmation of Enrollment and Follow-up Visits

11 11

12

Appendices: 1: Sample Case Record Form Follow-up Visit 2: Doctors’ Priority Line Registration Form

13 14 15


B POSITIVE PROJECT

The ‘B Positive’ Project: Improving diagnosis and treatment of chronic Hepatitis B in at-risk communities in NSW

A Cancer Council NSW Pilot Project

Part 1: Background and Rationale

Why B Positive?

Over the last 2 decades the liver cancer incidence in NSW has been increasing faster than

any other internal cancer. In NSW liver cancer exhibits a striking pattern of geographic

clustering, with the highest rates occurring in South Western Sydney. While liver cancer

ranks 15th in men and 20th in women overall in Australia, estimated age-adjusted incidence

rates are approximately 10 times higher in Eastern Asia, compared to those in Australia and

New Zealand, largely due to the high prevalence of chronic viral hepatitis, particularly

hepatitis B. The Cancer Incidence in New South Wales Migrants 1991-2001 report found that

people born in East and South East Asia (countries where hepatitis B infection is highly

prevalent) were 6-12 times more likely to develop primary liver cancer than Australian-born

individuals.

While universal Hepatitis B Virus (HBV) vaccination will bring about significant reductions in

the risk of developing liver cancer, its impact will not become apparent for several decades.

During this time the burden of liver cancer in Australia is likely to increase significantly, due

to the large population at risk and the slow progression from chronic hepatitis B infection to

the development of liver cancer.

The clustering of Hepatocellular Carcinoma (HCC) cases in NSW, along geographical and

ethnic lines provides opportunities for devising targeted public health interventions aimed at

achieving significant reductions in the liver cancer burden.

Project Aims

The ‘B Positive’ Project study aims to test the feasibility, acceptability, and cost-effectiveness

of a targeted Hepatitis B screening and surveillance program in individuals with chronic

hepatitis B infection, who are also at an increased risk of developing HCC. It also aims to

build up the evidence base for both State-Wide and National interventions using the B

Positive model of disease screening and targeted intervention.


This ‘B Positive’ Project aims are summarised below:

1. Determine if a primary-care based program of CHB screening and follow up

among at risk populations (identified based upon their country-of-birth) is:

(a) Acceptable to individuals in the study population,

(b) Acceptable to their treating GPs,

(c) Economically feasible and

(d) Clinically effective

2. Inform Government policy and clinical practice recommendations for the

treatment of CHB infection among Australian residents born in countries with

high endemicity of HBV infection.

This pilot study is aiming to optimize the screening, follow up and treatment pathways for

CHB infection and for screening for hepatocellular carcinoma in at-risk populations in defined

regions of Sydney. The study will enrol and follow up individuals with chronic hepatitis B

infection recruited through general practice and pathology records.

Project management

The project is supported by a Project Steering Committee, comprising technical and clinical

experts, with consultative advice provided by representatives from a range of stakeholder

organisations. The program was initially planned in collaboration with The Hepatitis

Foundation of New Zealand, which has been pioneering HBV screening and follow-up of at-

risk populations in New Zealand for the last 8 years.

Cancer Council NSW has responsibility for the overall governance of the project and has key

responsibilities for developing communication strategies with primary care practitioners and

at-risk communities. Project activities are being supported by culturally appropriate

community advertising, education and media liaison through Cancer Council NSW.

Cancer Council NSW is committed to it’s mission “to defeat cancer through engaging the

community” which is reflected in the ‘B Positive’ Project by engaging patients and local

general practitioners and community-based organisations serving the needs of specific

migrant groups in community education and overall awareness-raising. The collaboration of

high-profile professionals, clinicians and community organisational representatives with links

to the relevant target populations is paramount to development and implementation of the

project.


Ethics

Ethical approval for conduct of the ‘B Positive’ Project in accordance with the National Ethics

Application Form (NEAF) process was granted in May 2008 by the Ethics Review Committee

of Sydney South West Area Health Service through the Research Development Office at the

Royal Prince Alfred Hospital (RPAH ZONE) on behalf of NSW Health. This ethical approval

(HREC Ref. 08/RPAH/47) for the conduct of research is based on approval of specific project

documentation including the Clinical Protocol (reference number X08-0026) and the

supporting information contained in this GP KIT.

As the ‘B Positive’ Project will involve the participation of general practitioners in South

Western Sydney, ethics approval was also sought from The Royal Australian College of

General Practitioners via the National Research and Evaluation Ethics Committee (NREEC)

review process. Provisional ethics approval (of application NREEC 08/001) has been received

in August 2008, with amendments to the NEAF-approved documents agreed.

Expected Results

By focusing on the early detection and treatment of a chronic infection, CCNSW and partners

aim to prevent Hepatitis B associated hepatocellular cancer. B Positive will achieve this goal

by engaging key stakeholder groups including General Practice, non-government

organisations and their communities. This is an outcome that is consistent with our

organisational mission, values, objectives and strategic engagement priorities. Successful

piloting of the program should inform the development of State/Territory and National

chronic hepatitis B disease strategy, policy and practice.

The expected process and outcome deliverables from the pilot project include:

1. Development of a screening protocol and surveillance process

The clinical protocols developed as part of the project implementation are the result of a

collaboration involving GPs and hospital specialists and CCNSW staff and will provide the

most effective screening, treatment and clinical management of chronic hepatitis B infection.

2. Development of a Register of people with chronic HBV infection

The current management of chronic Hepatitis B is contingent upon opportunistic disease

diagnoses and referrals, as CHB is not funded as a ‘chronic disease’ under current initiatives

of the NSW State and Commonwealth Governments. The project provides a proof-of-concept

model for improving the integration of chronic hepatitis B prevention and management in

the Australian health care system as a targeted intervention in at-risk populations, which

incorporates the hepatitis B register and recall-reminder system.


3. The economic modelling sub-project will determine the cost-effectiveness of

alternative interventions aimed at reducing the impact of chronic HBV infection.

This sub-project brings together experts from the clinical domain, industry and academia to

identify what is the most effective and cost-effective strategy for screening, surveillance and

disease management. Results of this modelling have been publicly presented with

publication in an appropriate scholarly journal (details available on request).

4. Development of educational resources for primary care providers.

The Hepatitis B Monograph - All you wanted to know about Hepatitis B: A guide for primary

care providers has been developed as part of the project with funding from CCNSW and

technical support from the Australian Society for HIV Medicine Inc (ASHM). This monograph

has been distributed to all GPs in the Fairfield-Liverpool area of South Western Sydney in

collaboration with General Practice NSW (Including the Interim Services in Liverpool Fairfield

Region).

5. Developing effective communication strategies about hepatitis B infection and

liver cancer for at-risk populations.

Through the auspices and coordination of CCNSW in collaboration with the local Division of

General Practice, hospital specialists and community-based organisations, the Project will

reach ethnic groups at high risk of hepatitis B and HCC.

An outcome of this coordinated approach will be the building of community capacity. To

achieve this end, we are focusing our efforts on education and on building partnerships in

our target communities, via frequent and wide-reaching community presentations and public

speaking forums to key communities and their leaders in the Fairfield-Liverpool project area.

The B Positive pilot project includes a range of culturally appropriate information resources

about hepatitis B and liver cancer, translated into our main target audience languages,.

Evaluation The ‘B Positive’ Project evaluation process will occur in two stages;

Part 1 – Project Evaluation (concurrent with the project) and Part 2 – Project Components (5 expected results areas). The Project investigation team will provide opportunities for participating general

practitioners and clinical specialists to provide feedback and report on issues throughout the

course of the project, through the B Positive website. All development feedback and

implementation issues raised by participants and enrolling GPs will be recorded in an issues

log managed by the Project team, followed up promptly and reported to the Project Steering

Committee at its next available meeting as issues and actions taken.


Part 2: B Positive - Your role in Education and Recruitment Educational Resources for Patients Information pamphlets

Included in your GP pack are easy to read information pamphlets from Cancer Council NSW,

including a specific ‘Hepatitis B Fact Sheet’ in English, Chinese and Vietnamese languages for

your patients. Whilst these resources will be useful for patients enrolled in the B Positive

study, they can be used at your discretion to provide information to your patients and to the

local community. Section 3 of your GP KIT Folder contains order forms if you require

additional Cancer Council NSW information for your patients.

Cancer Council NSW ‘B Positive’ Project website

For patients who are willing and able to use the internet they can be directed to Cancer

Council NSW ‘B Positive’ Project webpage http://www.cancercouncil.com.au/bpositive/

The webpage will be continually improved with information in English, Vietnamese and

Chinese on the ‘B Positive’ Project, including a comprehensive collection of community

educational text, audio and visual information on hepatitis B and Liver Cancer.

For “Health Professionals” a publicly accessible sub-site will be maintained by Cancer Council

NSW separate from the consumer pages. This will have on-line resources for download,

including GP KIT contents, forms (clinical project documents plus administrative issues log,

feedback etc) and other educational resources for health professionals.

Educational Resources for General Practitioners

Section 4 of your ‘B Positive’ Project Folder contains the Clinical Protocol developed for the

project. The Clinical Protocol includes further information on the background and rationale of

the project, study design, target populations, methodology and other material providing a

comprehensive overview.

Your GP KIT also includes the recently developed Hepatitis B Monograph - All you

wanted to know about Hepatitis B: A guide for primary care providers, designed and

developed by expert clinicians in HBV management, in collaboration with the Australian

Society for HIV Medicine Inc (ASHM) and Cancer Council NSW. Please use this monograph


as an information source for explanations of any issues that may arise in your clinical

practice.

In addition, three educational seminars qualifying for RACGP Continuing Professional

Education points (Group 1, 2008-2010 Triennium) have been developed. Each seminar will

use reading materials from the Hepatitis B Monograph.

To qualify for RACGP points you are required to do the following:

Undertake a predisposing activity (pre-reading and test questions), structured learning

components and reinforcing activities (post-seminar questionnaire and other approved

activities).

Seminar dates:

Seminar 1: Epidemiology and Primary Prevention of Hepatitis B Infection – 24th June 2008.

Seminar 2: Hepatitis B testing, clinical assessment & treatment – 14th October 2008

Seminar 3: Hepatitis B patient care issues in liver disease, cancer and complex situations – 11th November 2008

For more information about the educational seminars or to find out more information please contact: Steve Tipper: Project Manager, Cancer Council NSW Ph: 02 9334 1910

Recruitment Resources Patient Information Pack Your GP KIT has 8 patient information packs, to be used for every one of your enrolled

patients. They provide every enrolled patient with information regarding resources the

purpose of the study, health issues associated with chronic hepatitis B and general

information about Cancer Council NSW. The patient information is available in the three at-

risk target community’s languages (English, Vietnamese and Chinese). The ratio of

languages will be based on the ethnic mix in the Fairfield-Liverpool area and contingent

upon individual GP requests for additional packs on reorder.

Patient Information Pack contents:

Patient Information and Consent Form Enrollment Case Record Form 10 Ways The NSW Cancer Council Can Help bookmark Alcohol and Cancer Fact sheets Cancer Council Helpline fridge magnet Understanding Liver cancer booklet Hepatitis B Fact Sheet

For information on how to order more Patient information packs please see Part 3: ‘Ordering More Resources’.


Patient Information and Consent Form The Patient Information and Consent Forms must be completed prior to each patient

being enrolled in the project and before patients begin to complete the patient section in

the Case Record Form - Enrollment (see below).

As the patient’s caring physician, please ensure that the patient is aware that the decision

to participate in the B Positive study is theirs to make and that they are aware that

all information they provide will remain confidential.

Depending on the health literacy level of your patient, they may require that the consent

form be discussed with you. You and your patient will have access to the B Positive

Vietnamese and Chinese Liaison Officers or Commonwealth Translation services for help

completing the form. (Please see the ‘Interpreter Services’ section below for further

information).

Case Record Form (CRF) - Enrollment

Each Patient Information pack contains an Enrollment Case Record Form (CRF) to be

completed after the patient has signed the Patient Information and Consent Form.

Each Enrollment CRF is separated into two parts:

Part 1: Patient Questionnaire

The patient questionnaire is divided into the following areas: Personal Health & Lifestyle and Risk Factor Assessment

Part 2: Doctor Questionnaire – Treatments and Tests Ordered

The doctor questionnaire requires basic height and weight details of the patient as well as

indications of the treatments, tests ordered and/or referral/s to clinical specialists.

Case Record Form (CRF) - Follow-up

Appendix 1 of this guide provides an example of the Case Record Form - Follow-up. The

form is similar to the doctor questionnaire in the enrollment CRF providing space for

updating the surveillance plan for your patient including new tests ordered and/or referrals

to clinical specialists. As required for the purposes of this study, the front section of the form

will be ‘auto completed’ with the test results of previous visits.


The CRF Follow-up ’s will be sent to participating general practitioners approximately five

months after the patients previous visit, along with a postage paid self-addressed envelop.

For an explanation of the process, please refer to Section 3: B Positive Data Collection

and your B Positive Data Collection Flow Chart.

Interpreter services

It may be necessary to use the service of interpreters when discussing details of the B

Positive Project with your non-English speaking patients.

You may be aware that the Department of Immigration and Citizenship provide a ‘Doctors

Priority Line’ 1300 131 450 which is a free telephone interpreting service available 24/7

for medical practitioners with non-English speaking patients. The appointment is claimable

under Medicare, is in a private practice? and is provided to non-English speakers who are

Australian citizens or permanent residents*.

If you are not registered for the Doctor's Priority Line, you will be required to complete the registration form (Appendix item 2).

*For more information about the ‘Doctors Priority Line and other interpreting services please visit:

http://www.immi.gov.au/living-in-australia/help-with-english/help_with_translating/free-services.htm

Additionally, Cancer Council NSW has recruited two part time community liaison officers

(Chinese and Vietnamese) for the duration of the project. They will be available for general

community awareness-raising on hepatitis B infection and liver cancer and also to help with

the initial enrollment of patients into the ‘B Positive’ Project, by providing translation support

for patients having difficulty in understanding the details in the Information and Consent

Form.

If you wish to organise the use of one of our translators for your patient please do so by

contacting one of our Community Liaison Officers from the contact information list on the

back of your GP KIT user guide.

Patient SPIN Number Record Table

Section 2 of your ‘B Positive’ Project Folder contains a table to record each patients name

against their ‘B Positive’ Project Study Patient Identification Number (SPIN). This number is

provided by the Registry upon confirmation of enrollment in the B Positive Project.

The will ensure that patients can be matched against their correct SPIN number on your

Patient Spin Number Record Form and also on the Follow-up Case Record Form.


B Positive Project Pathology Stickers

Each GP KIT contains a sheet of ‘B Positive’ project-specific stickers to be placed on your

pathology request sheet when ordering pathology results for patients enrolled in this study.

These stickers have been provided to ensure that patients enrolled in the study can be easily

identified and their test results extracted efficiently. All follow-up pathology requests for your

patients will require the use of stickers for the same purpose – These will be sent with

reminder letters and follow-up case record forms after your patient is enrolled in the study.

If you require any additional information on using the stickers please contact the ‘B Positive’

Project via email (mailto: [email protected] or phone 9334 1445).

Ordering More Resources

If you require more Project documents for your patients please refer to your Reorder Form

in Section 3 of your ‘B Positive’ Project Folder. Please use this to order or reorder any

resources required to continue enrolling patients in the ‘B Positive’ Project. Alternatively,

additional Cancer Council NSW resources can be ordered for distribution to your patients,

such as the Understanding Cancer series or pamphlets regarding lifestyle choices and the

risk of cancer or cancer recurrence.


Part 3: B Positive Data Collection This section is to be used along with your laminated A4 B Positive Flow Chart and Hepatitis B Screening and Surveillance Protocol in the front of the ‘B Positive’ Project Folder Data collection will occur in two distinct phases: 1. Initial enrollment 2. Confirmation of Enrollment and Follow-up Visits Phase 1: Initial enrollment

Step 1- Confirmation of Eligibility: o Patient is confirmed as chronically infected with hepatitis B

o Patient is aged >35 years

Step 2 – Recruitment: o Patient is provided with a Patient Information Pack

o Patient signs the Information & Consent Form and receives their signed copy.

Step 3 –Case Record Form – Enrollment: o Patient completes the Patient Questionnaire section of the Case Record Form.

o Doctor completes the Doctor Questionnaire section of the Case Record Form

Step 4 – Registration o The signed Yellow copy of the Patient Information & Consent Forms and the

Case Record Form - Enrollment are sent to the B Positive Project Registry in

the postage paid addressed envelop provided in your GP KIT.

Phase 2: Confirmation of Enrollment and Follow-up Visits Step 5 – Confirmation of Enrollment:

o Enrollment information is recorded

o Patient is allocated a Study Patient Identification Number (SPIN) which will be

automatically filled out on all successive Case Record Forms for this patient.

o General Practitioner is sent a confirmation letter informing them that their

patient is registered in the ‘B Positive’ Project. The letter will include a

reminder of the follow-up visit process as well as the patients’ identification

number to assign to your Patient SPIN Number Record Table

The Patient will also be sent a confirmation letter which will include their Study Participant Identification

Number.


Step 6 – Six Month Follow-up Reminders*:

o The enrolled patient is sent a reminder letter one month prior to their

scheduled bi-annual ‘check-up’ and reminded to bring this letter along for the

GPs visit

o General Practitioner is sent:

A letter confirming their patient will be making an appointment

The patient’s Case Record Form - Follow-up

‘B Positive’ Project Pathology Sticker

A postage paid self addressed envelope

Step 7 – GP Visit:

o Patient presents for their follow-up monitoring with letter.

o The completed Case Record Form – Follow-up is returned to the registry

in the envelope provided.

Step 8 – Registry Data Entry:

o Case Record Form data entered into the Registry

o Repeat step 6-8

* Each patient enrolled in the program will receive two reminder letters for their bi-annual check-up. The second reminder letter will be sent after three months if the patient is not identified by the B Positive database as having returned for their follow-up visit. If the patient has not been seen in a 12 month period they will be considered ‘Lost to System’ in this study.


Contact Information for GP User Kit Feedback

B Positive Project Community Liaison Officer (Vietnamese) Cancer Council NSW Ph: 02 9334 1413 Fax: 02 8302 3559 Email: [email protected]

Web: www.cancercouncil.com.au B Positive Project Community Liaison Officer (Chinese) Cancer Council NSW Ph: 02 9334 1987 Fax: 02 8302 3559 Email: [email protected] Web: www.cancercouncil.com.au B Positive Project Officer Cancer Council NSW Ph: 02 9334 1445 Fax: 02 8302 3559 Email: [email protected] Web: www.cancercouncil.com.au For further information on the Patient Information and Consent Form, Ethics Submissions, Case Record Forms and any other project information please contact Mr Steven Tipper, Manager of Scientific Development at Cancer Council NSW on 9334 1910. Other project contacts including the steering committee members can be found in your Clinical Protocol - Section 4 of your B Positive Project Folder.

Appendix 1

FINAL_Case Record Form_V9.8_20080926_FOLLOW UP_GP KIT

THE ‘B POSITIVE’ PROJECT

Improving Community-Based Diagnosis and Treatment Of Chronic Hepatitis B In At-Risk Communities In NSW.

A Cancer Council NSW Pilot Project

Case Record Form (CRF) – FOLLOW UP

Study Participant Number:

RESULTS OF TESTS ORDERED PREVIOUS VISIT

Hepatitis B serology: HBsAg [FIELD VALUE] HBeAg [FIELD VALUE]

anti-HBs [FIELD VALUE] anti-HBc [FIELD VALUE]

HBV DNA (qualitative PCR): HBV DNA titre (IU/ml) anti-HCV HCV RNA (PCR) anti-

HIV serology HBV DNA value (IU/ml)

Negative Positive Positive Quantity

EXPLANATORY NOTE FOR MEDICAL PRACTITIONERS: SEND COMPLETED FORM as per Flow Chart instructions This form is completed (after the baseline assessment) by you at follow-up visits of enrolled patients. The ‘B Positive’ Project Clinical Protocol (e.g., s5.2.3 Follow up testing variables to be recorded) MUST be referred to when considering tests to be ordered or referral of the patient.

PROJECT ENROLLMENT CONFIRMATION (Registry auto-completed fields)

Enrolling Doctor: GP Specialist Doctor address: «AddressBlock» Referring Dr. name: Date of last physical exam:

TREATMENT & TESTS (FOLLOW-UP VISITS) THIS PATIENT HAS BEEN RECEIVING CARE according to the following ‘B Positive’ Project Protocol (cross-mark ONE) Routine Hepatitis Care (Inactive CHB)

• GP-led 6-monthly recall & review • HBsAg (1 X per 12 month periods maximum) • ALT testing and assessment for any symptoms of liver damage , and • annual HBV DNA

Enhanced HCC Surveillance (Active CHB, Normal ALT) • GP-led oversight 6-monthly including same testing as above plus, • AFP test • Ultrasound (option of using HCC ultrasound ordered through specialists)

Specialist Referral Hepato-Cellular Cancer (HCC) Prevention: Routine Hepatitis Care + Enhanced HCC Surveillance + Specialist consideration of disease staging and treatment (Active CHB, High ALT or abnormal AFP &/or US)

• Ultrasound (option of using HCC ultrasound ordered through specialists) • Specialist oversight of any drug treatment (biopsy prior to treatment) • Specialist biopsy again in 5-10 years if considered appropriate • HCC treatment with liver resection or transplant or palliative care

TESTS ORDERED AT LAST VISIT: REGISTRY STAFF TO COMPLETE THIS RESULTS SECTION Date of last exam: PREVIOUS WEIGHT(KG):

Liver function tests: enzymes

Alanine aminotransferase (ALT) Alkaline phosphatase (ALP)

Aspartate aminotransferase (AST) Gamma glutamyl transferase (GGT)

Liver function tests: protein Albumin Total protein

total bilirubin AFP test (if previous ALT high)

Full blood count (incl Hb, clotting tests)

anti-HIV tests Test result:NAME1 Other tests results ordered at LAST visit: Test result:NAME2 Test result:NAME3 NEW TESTS ORDERED FOR ROUTINE HEPATITIS CARE & HCC SURVEILLANCE (Dr. TO CHECK ONLY THOSE ORDERED IN CURRENT VISIT): Date: HEIGHT(CM): WEIGHT(KG):

HBsAg (1 X 12 month period) HBV DNA (annual) anti-HCV HCV PCR

HCV genotype HCV titre AFP test imaging ordered (Lab. name:

Liver function tests ordered

AFP test (if previous ALT high)

FOLLOW UP ACTION (Dr. TO CHECK ONLY THOSE FOR FOLLOW-UP AFTER THIS VISIT): patient to go to Routine

Hepatitis Care patient to go to Enhanced

HCC Surveillance Specialist referral HCC Prevention

Dr. name: Registry to send patient

next (6 month) visit reminder letter

Registry to send GP next visit reminder

GP referral letter sent to Specialist (date:

FOLLOW UP TESTS by Specialist (if an existing liver clinic patient at baseline enrollment in the Project)

AFP test (if previous ALT high) imaging ordered (Lab. name:

Liver biopsy Additional Imaging: multiphasic CT or an MRI (Lab. name: Other tests ordered at this visit that are relevant to hepatitis B infection and liver disease management should be noted below: (e.g., glucose ,insulin, cholesterol, triglycerides, creatinine etc) Additional comments Registry use ONLY

Patient visit reminder sent (6 month letter) GP next visit reminder GP referral letter sent to Specialist (date:

Please mail this completed form to: The B Positive Project

PO Box 572 Kings Cross NSW 1340

Australia

FINAL_Case Record Form_V9.8_20080926_FOLLOW UP_GP KIT

CA

N45

7 10

/08

‘B Positive’ Project

www.cancercouncil.com.au/bpositive

improving community based diagnosis and treatment of ... · 2. inform government policy and...

Documents