UGEL 07: SAN BORJA

This form was used for doctors that underwent the training, and nurses received a similar consent form

PARTICIPANT INFORMATION LEAFLET AND CONSENT FORM

TITLE OF THE RESEARCH PROJECT: The development, implementation and evaluation of a training intervention for primary health care workers on brief behaviour change counselling and assessment of the primary health care workers competency in delivering this counselling intervention.

REFERENCE NUMBER: N11/11/321

PRINCIPAL INVESTIGATOR: Dr Zelra Malan

ADDRESS: Division of Family Medicine and Primary Care, University of Stellenbosch, Box 19063, Tygerberg, 7505.

CONTACT NUMBER 0823260041:

You are being invited to take part in a research project. Please take some time to read the

information presented here, which will explain the details of this project. Please ask the study staff or doctor any questions about any part of this project that you do not fully understand. It is very important that you are fully satisfied that you clearly understand what this research entails and how you could be involved. Also, your participation is entirely voluntary and you are free to decline to participate. If you say no, this will not affect you negatively in any way whatsoever. You are also free to withdraw from the study at any point, even if you do agree to take part.

This study has been approved by the Health Research Ethics Committees at Stellenbosch and Cape Town Universities and will be conducted according to the ethical guidelines and principles of the international Declaration of Helsinki, South African Guidelines for Good Clinical Practice and the Medical Research Council (MRC) Ethical Guidelines for Research.

What is this research study all about?

Primary care providers are in an excellent position to counsel patients on risky life style behaviours (smoking, drinking, unhealthy diet and lack of exercise). This study intends to introduce a new approach to brief behaviour change counselling in the training of primary care nurses and family physicians. This approach is based on the 5 A structure (Ask, Alert, Agree, Assist, and Arrange) and a guiding style of communication based on motivational interviewing. The study aims to

evaluate if primary care providers adopt the new approach through the training course and whether they implement it in their clinical practice.

Why have you been invited to participate?

You are a student, enrolled on the Masters of Medicine Degree in Family Medicine at Stellenbosch or Cape Town University and in your 2nd year of study. You will receive training in this brief

behaviour change counselling as part of the course. Evaluation will focus on your competency in the new approach after your training and whether you use the approach when you return to your clinical work.

Primary Health Care Doctors:

You are a doctor working in Primary Health Care. You will receive this training as part of a short course at Stellenbosch University. Evaluation will focus on your competency in HREC General ICF Version 2, July 2009

the new approach after your training, and whether you use the approach when you return to your clinical work.

What will your responsibilities be?

If you are one of the 20 doctors that have agreed to participate in the research project, you will be asked to counsel a standardised patient before and after training. The consultation will be

audiotaped. When you return to your clinical work you will also be expected to consult a

standardized patient, who will come to you as part of your usual clinical practice. You will consult as normal, and will not be made aware if the patient you consult is a regular or a standardized patient.

Will you benefit from taking part in this research?

You will benefit from this training, by obtaining the skills to deliver brief behaviour change counselling based on best evidence available, and your patients may benefit from this because evidence shows that brief behaviour change counselling from a primary health care provider lead to 5-15% of patients changing their behaviour.

Are there risks involved in your taking part in this research? There are no risks involved if you take part in this study

If you do not agree to take part, what alternatives do you have?

If you decide not to take part you will still receive the training as part of the course, but will not need to participate in any of the research related activities (i.e. assessment of consultations).The fees for these participants will be R1500.00

Who will have access to your study data?

The information obtained will be protected, and treated as confidential. The identity of all

participants will remain anonymous. The three researchers on this study, (Dr Z Malan researcher, Prof Bob Mash the supervisor of the study, and Dr Kathy Everett Murphy the co- supervisor) will be the only people who will have access to the information.

Will you be paid to take part in this study and are there any costs involved?

You will not be remunerated for participating in this study and will not incur any costs by participating in the study.

You can contact the researcher on 0823260041 if you have any other queries. You can contact the Health Research Ethics Committee at 021-938 9207/9677 if you have any concerns or complaints that have not been adequately addressed by your study doctor.

You will receive a copy of this information and consent form for your own records. Declaration by participant

By signing below, I ………..…………. agree to take part in a research study entitled.

The development, implementation and evaluation of a training intervention for primary health care workers on brief behaviour change counselling and HREC General ICF Version 2, July 2009 I declare that:

• I have read or had read to me this information and consent form and it is written in a language with which I am fluent and comfortable.

• I have had a chance to ask questions and all my questions have been adequately answered. • I understand that taking part in this study is voluntary and I have not been pressurised to take part.

• I may choose to leave the study at any time and will not be penalised or prejudiced in any way. • I may be asked to leave the study before it has finished, if the study doctor or researcher feels it is in my best interests, or if I do not follow the study plan, as agreed to.