PARTICIPANT INFORMATION AND CONSENT Title: The nurse practitioners’ role in secondary prevention after heart attack Investigator: Patricia Harbman RN(EC), NP, (PhD Student)
Supervisor: Dr. Souraya Sidani (supervisor), University of Toronto, Faculty of Nursing I am inviting you to participate in a research study. In order to decide whether or not you want to be a part of this research study, you should understand what is involved and the potential risks and benefits. This form gives detailed information about the research study, which will be discussed with you. Once you understand the study, you will be asked to sign this form if you wish to participate. Please take your time to make your decision. Feel free to discuss it with your friends and family, or your family physician.
Background and Purpose
You are being invited to participate because you have had a recent heart attack. This study is about the recommendations and goals for care following heart attack. The purpose of this study is to examine how nurse practitioners and doctors provide care to patients after a heart attack. This study will also examine how well patients achieve goals for decreasing their risk of a heart attack in the future.
What will you be asked to do?
If you agree to participate in this study, the following things will happen:
1) If the doctor responsible for your care does not refer you to a nurse practitioner to deliver care while you are in hospital, you will be asked to continue under his/her care.
You will be asked questions about your health and health history at two points in time:
while in the hospital and three months later. While in the hospital and after obtaining permission, the researcher or her assistant will collect information about your health history from your medical chart. Three months later, you will also be asked to return for one clinic visit. During this visit, the researcher or her assistant will ask you questions about your health and health history. You will be weighed and your blood pressure taken.
You will be asked to have a blood test to measure your cholesterol levels and/or response to cholesterol medication, if this has not already been done by your doctor. The blood tests will require 1-2 small tubes of blood taken from your arm. You can decline these blood tests if you wish to do so, and this will not affect your care or participation in the study. If your blood has already been tested, the researcher or her assistant will telephone your doctor for those results. This visit will take less than 30 minutes.
2) If the doctor responsible for your care refers you to a nurse practitioner to deliver care while you are in the hospital, you will also be seen by the nurse practitioner delivering the study intervention (Patricia Harbman) at different points in time: before you are discharged from hospital, and two weeks, 6 weeks, and 3 months after discharge from
hospital. During the first visit in the hospital, the nurse practitioner conducting the study will collect information on your health history from your medical chart, and will spend approximately one hour with you discussing topics related to heart attack recovery and risk factors. The nurse practitioner will also telephone you one week after discharge from hospital to discuss how you are recovering. This telephone call will take up to 30
minutes.
3) If you are being cared for by a physician and nurse practitioner, you will be asked to return for clinic visits at the following times: 2 weeks, 6 weeks and 3 months after
discharge. At each of these visits the nurse practitioner will ask you questions about your health history and how you are feeling. You will have a physical examination (including blood pressure and weight) and you will have the opportunity to discuss topics related to your health and heart attack recovery. If you have not had blood tests to measure your cholesterol levels and/or your response to your medication, you will be asked to have these blood tests. The blood tests will require 1-2 small tubes of blood taken from your arm. You can decline these blood tests if you wish to do so, and this will not affect your care or participation in the study. If your blood has already been tested, the researcher or her assistant will telephone your doctor for those results. Any recommendations on changes to your medications (if applicable) will be made with your physician’s approval.
The researcher or her assistant will collect information about your health and health history from your medical chart for each clinic visit. The clinic visits with the nurse practitioner will be in addition to the care that your doctor provides.
How many people will be in this study?
About 66 persons who have had a heart attack will be asked to volunteer in this study.
Potential Benefits
You may not benefit directly from your participation in this study. However, the results of this study will provide us with information about the type of care that is provided to patients and that may contribute to decreasing the risk for future heart attacks.
Potential risks
The care provided by the nurse practitioner and doctors to patients taking part in this study follows standard recommendations and poses no known risks. You will have access to all usual cardiac, emergency, and medical care services as needed. The clinic visits for the study will be in addition to the care you are entitled to. All visits will be documented and information about your health will be given to your doctor if you request it. Any changes in your medications will be made in consultation with your doctor.
Cost
Your participation in this research project will not involve additional costs to you or your health care insurer.
Financial compensation
If you agree to take part, you will be reimbursed for your parking expenses for the clinic visits which are parts of this study.
Confidentiality
Information will not be shared with anyone except the researcher. To ensure privacy, all personal information such as your name, address, phone number, OHIP number, and family doctor’s name will be removed from your study records and will be replaced with a number. A list linking the number with your name will be kept in a secure place, separate from your file. All information about you will be securely stored in a locked office. All information obtained in this study will be used for research purposes only. If you wish, the researcher will send you a copy of the results of the study when completed.
If the results of the study are published, your name will not be used and no information about your identity will be released or published without your specific consent.
Contact
If you have any questions about the study, you can contact Patricia Harbman (Faculty of Nursing, room 308, 416-978-6969) or Dr. Souraya Sidani (416-978-2856). If you have any concerns about your treatment and rights as a research participant, you can call Nicole Pageau, Chair-Research Review Team Trillium Health Centre at telephone 905-848-7580 or by email: [email protected]; or Jill Parsons, Health Sciences Ethics
Review Officer, Ethics Review Office, University of Toronto, at telephone 416-946-5806 or by email: [email protected].
Right to Refuse or Withdraw
Your participation in this study is entirely voluntary and you are free to refuse to take part in the study or to withdraw at any time without affecting or jeopardizing your care.
Consent
Your signature on this form indicates that you understand the information regarding your participation in the research project and agree to participate. In no way does this waive your legal rights nor release the investigators, or involved institutions from their legal and professional responsibilities.
You, __________________________________, the undersigned, agree to participate in the research study described. Any questions have been answered and you understand what is involved in the study. You realize that participation is voluntary and that you will not benefit directly from your involvement. You acknowledge that a copy of this form has been offered to you.
Name of Participant
____________________________________
____________________________________ ________________
Signature of Participant Date
You would like to receive a copy of the study findings ______Yes _______ No
To be signed by the Investigator
To the best of my ability I have fully explained to the participant the nature of this research study. I have invited questions and provided answers. I believe that this individual fully understands the implications and voluntary nature of the study. I have been given a copy of this consent form.
_____________________________________ _______________
Signature of Investigator Date
Appendix H. Correlation Coefficients Representing Relationship Between Baseline and
Note. ANGIO = angiogram; PTCA = percutaneous transluminal coronary angioplasty; MI = myocardial infarction; TRIG ADM = triglyceride blood level during admission; BS ADM = blood glucose during admission; STATIN ADM = statin use on admission. * p < .05, ** p < .01
AGE GENDER MARTIAL
Note. Systolic blood pressure; DBP = diastolic blood pressure; LDL-C = low density lipoprotein cholesterol; HDL-C = high density lipoprotein cholesterol ; BMI
= body mass index ; CR = cardiac rehabilitation; HbA1C = glycosylated haemoglobin; ASA = aspirin; DC = discharge; F/U = follow-up; BB DC = beta blocker use at discharge; BB F/U = beta- blocker use at follow-up; ACE D/C = angiotensin- converting enzyme inhibitor use at discharge; ACE F/U= angiotensin- converting enzyme inhibitor use at follow-up; ANGIO = angiogram; PTCA = percutaneous transluminal coronary angioplasty;. MI = myocardial infarction; TRIG ADM = triglyceride blood level during admission; BS ADM = blood glucose during admission; STATIN ADM = statin use on admission. * p < .05, ** p < .01