Participant Information
Exploring Changing Patterns of Acute Respiratory Illness in Primary Care
Formal Study title: To explore the changing patterns of acute respiratory illness seen in Primary care post the arrival of COVID-19 and quantify associated health service utilisation at the general practice level
Lead Researchers: Professor Nikki Turner & Professor Tony Dowell
Ethics committee ref.: AH24249
Tēnā koe,
Your general practice is invited to take part in a study on evaluating the changing patterns of acute respiratory illnesses seen in Primary Care following the arrival of COVID-19 to inform policy about the management of future respiratory infections in primary care Whether or not your general practice takes part is your choice. If your general practice does not want to take part, you don’t have to give a reason. If your general practice would like to take part now, but change your mind later, your general practice can pull out of the study at any time.
This Participant Information Sheet will help you decide if you’d like to enroll your general practice into the study. It sets out why we are doing the study, what your participation would involve, what the benefits and risks to your general practice might be, and what would happen after the study ends. Your general practice does not have to decide today whether or not you will participate in this study. Before you decide you may want to talk about the study with other members of the practice team Feel free to do this.
If your general practice agrees to take part in this study, your general practice will be asked to sign the Consent Form on the last page of this document. Your general practice will be given a copy of both the Participant Information Sheet and the Consent Form to keep.
This document is 4 pages long, including the Consent Form. Please make sure you have read and understood all the pages.
VOLUNTARY PARTICIPATION AND WITHDRAWAL FROM THIS STUDY
Participation is voluntary. Your general practice is free to decline to participate or to withdraw from the research at any practicable time, without experiencing any disadvantage
If my practice decides to withdraw from the study prior to final outputs being produced my practice’s data won’t be included in any final output analysis. Unique identifiers will be assigned to allow the removal of your practice’s data.
WHAT IS THE PURPOSE OF THE STUDY?
The research will provide an accurate picture of the incidence of respiratory infection through general practice over the last ten years, and in particular, explore the impact of COVID-19 on the different presentations to General Practice.
HOW IS THE STUDY DESIGNED?
We are asking for your general practice to consent to provide de-identified patient data to the study, for potentially all your enrolled patients. Your general practice will not be required to undertake any work to participate. We will use advanced technology to apply natural language processing techniques and cross-match clinical classifications and prescribed medicines to identify people with a respiratory infection, without the need for you to code them
With your general practice’s consent, your PHO and DataCraft Analytics will collect data from your PMS, de-identify it, and make it available to the research team. The data we will collect is:
❖ Prescribed Medicines
❖ Clinical Codes (Classifications)
❖ Encounter data
❖ Appointment Book data
❖ Non-financial Invoice data
❖ Patient demographics
❖ Provider designations (GP / Nurse)
The purpose of using appointment book and non-financial invoice data is to help the research team identify genuine clinical contacts with patients by cross-matching it with encounter records.
Phase 1
For the first phase of this study, we will collect a limited number of de-identified clinical notes from your system (100-500) that will be used with other Phase 1 participants to train the text classifier algorithm to identify different respiratory illnesses. Two GP clinical experts will review the clinical notes along with a senior data scientist to assist in building a software algorithm that will be able to automatically classify notes Once the algorithm training is completed, these notes will be destroyed immediately and used for no other purpose.
Phase 2
Our software will scan your patient records and use them to classify each interaction to determine if it is for a relevant respiratory condition. Your clinical notes do not leave your practice, and all that is included in the research data set is a TRUE/FALSE flag indicating if the note matches the criteria for one of the respiratory groups being studied.
WHO CAN TAKE PART IN THE STUDY?
All consenting general practices in your PHO area can participate in the study.
WHAT WILL MY PARTICIPATION IN THE STUDY INVOLVE?
We are asking for your general practice to consent to provide de-identified patient data to the study. You will not be required to undertake any work to participate. To identify people with a respiratory infection, without the need for you to code them, advanced technology will apply natural language processing techniques and cross-match clinical classifications and prescribed medicines.
With your consent, DataCraft Analytics in conjunction with your PHO will extract data from your PMS, de-identify it, and make it available to the research team.
WHAT ARE THE POSSIBLE RISKS OF THIS STUDY?
We do not consider this study poses any ethical risks issues relating to confidentiality, privacy, or safety. The analysis will use data routinely collected on a monthly basis by the management services organisations and will be provided to the research team in deidentified form.
WHAT ARE THE POSSIBLE BENEFITS OF THIS STUDY?
The benefit of the research is that the research will provide an accurate picture of the incidence of respiratory infection through general practice over the last ten years, and in particular explore the impact of COVID-19 on the different presentations to General Practice.
WILL ANY COSTS BE REIMBURSED?
Participant will not incur any costs
W
HAT IF SOMETHING GOES WRONG?
We do not consider this study poses any ethical risks issues relating to confidentiality, privacy, or safety. The analysis will use data routinely collected on a monthly basis by the management services organisations and will be provided to the research team in deidentified form.
WHAT WILL HAPPEN TO MY INFORMATION?
It is important to note all data will be aggregated by DataCraft Analytics who will act as the stewards of the data and the data will be de-identified for both patients and providers. We will apply the same high standard of privacy safeguards and policies as we usually do with all data and its use. Upon conclusion of this study, a summary report will be available for your general practice’s interest.
CAN I FIND OUT THE RESULTS OF THE STUDY ?
Upon conclusion of this study, a summary report will be available for your interest from the project lead.
WHO HAS APPROVED THE STUDY ?
This study has been approved by the Auckland Health Research Ethics Committee on 26/7/2022 for three years. Reference number AH24249
WHO ARE DATACRAFT ANALYTICS?
DataCraft Analytics are a company who provide data related products and services to the health sector, including your PHO. They provide tools and services that enable your PHO to collect and report on population health metrics and they are a part of this research study. They are contracted with your PHO and that is why you are being contacted to participate in this study. They will be responsible for collecting, managing and ensuring data is deidentified, as well as participating in the study, study design, analysis, interpretation of results and assisting the research team with academic outputs where appropriate
WHO DO I CONTACT FOR MORE INFORMATION OR IF I HAVE CONCERNS?
If you have any questions, concerns or complaints about the study at any stage, you can contact:
Contact: Professor Nikki Turner
Email: n.turner@auckland.ac.nz
Mobile 021 790 693
AHREC Chair contact details: For concerns of an ethical nature, you can contact the Chair of the Auckland Health Research Ethics Committee at ahrec@auckland.ac.nz or at 373 7599 ext 83711, or at Auckland Health Research Ethics Committee, The University of Auckland, Private Bag 92019, Auckland 1142.
Approved by the Auckland Health Research Ethics Committee on 22/07/2022 for three years. Reference number AH24249
Consent Form
Exploring Changing Patterns of Acute Respiratory Illness in Primary Care
COMPLETE THE LINK ONLINE AT: www.datacraft.nz/short/practice OR
RETURN TO rachel@datacraft.nz
I have read, or have had read to me in my first language, and I understand the Participant Information Sheet. I have been given sufficient time to consider whether or not to participate in this study
I am satisfied with the answers I have been given regarding the study and I have a copy of this consent form and information sheet I understand that taking part in this study is voluntary (my choice) and that I may withdraw from the study at any time
If my practice decides to withdraw from the study prior to final outputs being produced my practice’s data won’t be included in any final output analysis, that my practice has provided
I understand that my participation in this study is confidential and that no material, which could identify our practice or our patients personally, will be used in any reports on this study. I know who to contact if I have any questions about the study in general.
I understand my responsibilities as a study participant. I wish to receive a summary of the results from the study.
Declaration by participant:
I hereby consent to take part in this study.
Participant’s name:
Designated and authorized on behalf of the General Practice
Signature: Date: