CSI:OPIOIDS Clinical Context of Suicide Following Opioid Transitions UAB IRB Protocol #: IRB-300004342 VA IRBNet ID: 1681532 Principal Investigator Stefan G Kertesz, MD The purpose of this survey is to learn about people who have died by suicide after a change in prescribed pain medicines. We believe it is critically important to learn about these very difficult situations, so that they can be prevented in the future. For full study details, CSIOPIOIDS REDCap Survey Full Introduction.pdf
We are interested in finding people who are family members or partners of the person who died. This survey presents a series of basic questions. If you proceed with the survey, you are offering consent to be in the survey. This is a research study, approved by the Central Institutional Review Board of the Department of Veterans Affairs, Veterans Health Administration and by the Institutional Review Board at the University of Alabama at Birmingham. Further information about who is involved in this study can be found at this link. At the end of the survey, we will ask if you are willing to be contacted for a future study that would involve seeking an interview and medical records. Also, if do not complete the survey at one sitting, we will send a reminder with information on how to complete the survey at a later time. This reminder would be by email or telephone, based on the preference you indicate in the survey. Information obtained about you for this study will be kept confidential to the extent allowed by law. However, research information that identifies you may be shared with people or organizations for quality assurance or data analysis, or with those responsible for ensuring compliance with laws and regulations related to research. If you provide responses suggesting that you may be at significant risk of harm to yourself or others, we will report it to a third party in the interest of protecting the rights and welfare of you or the persons at potential risk. Participation in this survey is completely voluntary. There is no cost to participate in this survey. There is no compensation for participation in this survey. If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact: - VA Central IRB toll free at 1-877-254-3130 - UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday. If you have questions about this study, you can contact the following members of the research team. UAB Research and Recruitment Shared Facility: 1-866-283-7223, Option 1 or 205-975-7223. Principle Investigator Dr. Stefan Kertesz: skertesz@uabmc.edu or 205-996-2866 Co-Investigator Dr. Allyson Varley: avarley@uab.edu or 205-996-2866 Project Coordinator Ms. April Hoge: april.hoge@va.gov or 205-578-2749 CSI: OPIOIDS
Clinical contexts of Suicide following OPIOID transitionS
Study Description The purpose of this survey is to learn about people who have died by suicide after a change in prescribed pain medicines. We believe it is critically important to learn about these very difficult situations, so that they can be prevented in the future.
We are interested in finding people who are family members or partners of the person who died. This survey presents a series of basic questions. If you proceed with the survey, you are offering consent to be in the survey. This is a research study, approved by the Central Institutional Review Board of the Department of Veterans Affairs, Veterans Health Administration and by the Institutional Review Board of the University of Alabama at Birmingham. Further information about who is involved in this study can be found at this link .
We understand that this subject is a sensitive one. We know responding to a survey like this may be challenging. Thank you for your willingness to take a look at the survey. At the end of the survey, we will ask if you are willing to be contacted for a future study that would involve seeking an interview and medical records.
Also, if you do not complete the survey at one sitting, we will send a reminder with information on how to complete the survey at a later time. This reminder would be by email or telephone, based on the preference you indicated in the survey. What follows is standard information that we are required to provide to any person who wishes to be in an approved survey.
CSI:OPIOIDS
Clinical Context of Suicide Following Opioid Transitions
UAB IRB Protocol #: IRB-300004342
VA IRBNet ID: 1681532
Principal Investigator Stefan G Kertesz, MD, MSc
The purpose of this survey is to learn about people who have died by suicide after a change in prescribed pain medicines. We believe it is critically important to learn about these very difficult situations, so that they can be prevented in the future. For full study details, click here.
We are interested in finding people who are family members or partners of the person who died.
This survey presents a series of basic questions. If you proceed with the survey, you are offering consent to be in the survey. This is a research study, approved by the Central Institutional Review Board of the Department of Veterans Affairs, Veterans Health Administration and by the Institutional Review Board at the University of Alabama at Birmingham.
CSIOPIOIDS REDCap Survey Full Introduction.pdf
At the end of the survey, we will ask if you are willing to be contacted for a future study that would involve seeking an interview and medical records.
Also, if do not complete the survey at one sitting, we will send a reminder with information on how to complete the survey at a later time. This reminder would be by email or telephone, based on the preference you indicate in the survey.
Information obtained about you for this study will be kept confidential to the extent allowed by law. However, research information that identifies you may be shared with people or organizations for quality assurance or data analysis, or with those responsible for ensuring compliance with laws and regulations related to research.
If you provide responses suggesting that you may be at significant risk of harm to yourself or others, we will report it to a third party in the interest of protecting the rights and welfare of you or the persons at potential risk.
Participation in this survey is completely voluntary. There is no cost to participate in this survey. There is no compensation for participation in this survey.
If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact:
- VA Central IRB toll free at 1-877-254-3130
- UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
If you have questions about this study, you can contact the following members of the research team.
UAB Research and Recruitment Shared Facility: 1-866-283-7223, Option 1 or 205-975-7223.
Principle Investigator Dr. Stefan Kertesz: skertesz@uabmc.edu or 205-996-2866
Co-Investigator Dr. Allyson Varley: avarley@uab.edu or 205-996-2866
Project Coordinator Ms. April Hoge: april.hoge@va.gov or 205-578-2749
National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance.
CSI: OPIOIDS
Clinical contexts of Suicide following OPIOID transitionS
Study Description The purpose of this survey is to learn about people who have died by suicide after a change in prescribed pain medicines. We believe it is critically important to learn about these very difficult situations, so that they can be prevented in the future. We are interested in finding people who are family members or partners of the person who died. This survey presents a series of basic questions. If you proceed with the survey, you are offering consent to be in the survey. This is a research study, approved by the Institutional Review Board at the University of Alabama at Birmingham. Further information about who is conducting the study is at this link. We understand that this subject is a sensitive one. We know responding to a survey like this may be challenging. Thank you for your willingness to take a look at the survey. At the end of the survey, we will ask if you are willing to be contacted for a future study that would involve seeking an interview and medical records.
Also, if you do not complete the survey at one sitting, we will send a reminder with information on how to complete the survey at a later time. This reminder would be by email or telephone, based on the preference you indicated in the survey. What follows is standard information that we are required to provide to any person who wishes to be in an approved survey. Click 'Next Page' to proceed to read the study information.
INFORMATION SHEET TO BE PART OF A RESEARCH STUDY
Title of Research: Clinical context of Suicide following OPIOID transitionS (CSI: OPIOIDS)
UAB IRB Protocol #: IRB-300004342, VA IRB Net ID: 1681532
Principal Investigator Stefan G Kertesz, MD
Other Investigators : Allyson L. Varley, PhD, MPH; Kevin Riggs, MD, MPH; Megan McCullough, PhD; Adam Gordon, MD, MPH
Sponsor : Department of Veterans Affairs, Health Services Research & Development
General Information
You are being asked to take part in a research study. This research study is voluntary, meaning you do not have to take part in it. The procedures, risks, and benefits are fully described further in the information sheet.
Purpose
The purpose of the study is to build a registry of and survey persons who are interested in participating in research about suicides that have happened after a change in opioid pain medicine.
Duration & Visits
There will be a total of one visit to complete the survey. The survey will take about 25 minutes to complete
Overview of Procedures
You will be asked to complete a survey with questions about you and a family member/friend that has died by suicide following a change in their opioid medication. We will also collect contact information from you so that we can contact you again when funded for a larger study.
Risks
Potential loss of confidentiality is a risk. Questions on the survey about the death of a family member/friend may be emotional or uncomfortable.
Benefits
There are no direct benefits to you for participating in this study. The benefit to the researchers is to build a registry to demonstrate study feasibility and collect baseline information on these deaths.
Alternatives
The alternative is to not participate in this study.
This is an online survey. The purpose is to build a registry of persons who are interested in participating in research about suicides that have happened after a change in opioid pain medicine. We will enroll 200 people in the survey. We are recruiting family members, or close friends. Specifically, we are seeking people who could assist with getting data on the person who died, after we secure support for a future study. The information we collect in this survey will help shed light on how common this problem is, and help make the case that this kind of research should be done.
This survey asks questions about you, and about your relationship to the person who may have died by suicide. The questions include your name and how to reach you.
The questions also include information about who died, including their name and information about when they died, and where they were living. It asks questions about the death itself and about the life situation of the person who died.
There is a total of 46 questions. We expect that this survey will take about 30 minutes. Also, if you do not complete the survey at one sitting, we will send a reminder with information on how to complete the survey at a later time. This reminder would be by email or telephone, based on the preference you indicate in the survey.
Sometimes a question on a survey about a sensitive health topic can make a person feel upset or uncomfortable. If any of these survey questions upset you, you do not have to answer them. Another risk is the potential loss of confidentiality. We will make every effort to ensure your data is stored securely and confidentially.
Information obtained about you for this study will be kept confidential to the extent allowed by law. However, research information that identifies you may be shared with people or organizations for quality assurance or data analysis, or with those responsible for ensuring compliance with laws and regulations related to research. They include:
The VA Institutional Review Board (IRB). An IRB is a group that reviews the study to protect the rights and welfare of research participants. VA Privacy Officers and Information Security Officers The UAB IRB The Office for Human Research Protections (OHRP) UAB Division of Preventive Medicine The information from this research survey may be published for scientific purposes; however, your identity will not be shared. Similarly, we will not give out any identifiable information about the person who died.
Monitors, auditors, the Institutional Review Board for Human Use, and regulatory authorities will be granted direct access to our survey records for verification of survey data without violating confidentiality.
If you provide responses suggesting that you may be at significant risk of harm to yourself or others, we will report it to a third party in the interest of protecting the rights and welfare of you or the persons at potential risk.
Whether or not you take part in this study is your choice. There will be no penalty if you decide not to be in it. If you decide not to be in the study, you will not lose any benefits you are otherwise owed.
You are free to withdraw from this study at any time. Your choice to leave the study will not affect your relationship with this institution.
If you are a UAB student or employee, taking part in this research is not a part of your UAB class work or duties. You can refuse to enroll, or withdraw after enrolling at any time before the study is over, with no effect on your class standing, grades, or job at UAB. You will not be offered or receive any special consideration if you take part in this research.
There is no cost to participate in this survey.
There is no compensation for participation in this survey.
If you have any questions, concerns, or complaints about the research, please contact the Principal Investigator. You may contact Dr. Kertesz at 205-996-2866 or by emailing him at sktertesz@uabmc.edu
If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact:
- VA Central IRB toll free at 1-877-254-3130
- UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday."
If you have questions about this study, you can contact the following members of the research team
UAB Research and Recruitment Shared Facility: 1-866-283-7223, options 1 or
205-975-7223.
Principle Investigator Dr. Stefan Kertesz: skertesz@uabmc.edu or 205 996 2866
Co-Investigator Dr. Allyson Varley: avarley@uab.edu or 205 996 2866
Project Coordinator Ms. April Hoge: april.hoge@va.gov or 205 578 2749
Q1: Do you believe that someone close to you died by suicide after a change in pain medication?
Yes
No
Q2: Are you age 19 or older?
Yes
No
Q3: Do you reside in the United States of America?
Yes
No
Q4: Did the person who died reside in the United States of America?
Yes
No
Q5. Did this person ever serve in the US Armed Forces, including Army, Navy, Marines or Coast Guard?
Yes, they were a member at the time of their death
Yes, but they were no longer in the armed forces when they died
No
Don't know/Not sure
Q7: What is your E-mail address?
Q8: What is your preferred phone number?
Q9: Would you prefer to do this survey online or do you prefer to be directly called by a member of the UAB research team?
Online
I request a telephone call for the survey
*********** FOR DATA COORDINATOR ONLY *********** Do you want to start entering data?
Yes
No
Please click "Submit" and someone from our study team will be in contact with you shortly. Thank you! Please contact csiopioids@uabmc.edu with any questions.
Would you like to participate in the CSI Opioids Study? * must provide value
Yes, I agree to participate
No, I do not agree to participate
National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance.
You have not consented to move forward with this survey. If you wish to take part in this survey, click "Yes, I agree to participate" above, then click "Next Page" If you would like to complete survey at another time, please return to https://go.uab.edu/csiopioids at any point in the future. National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance
This is a study about people who have died by suicide after a change in prescribed pain medicines. The following survey includes questions about suicide, which can be distressing for some people. Please know that your involvement is completely voluntary - you are able to stop and exit this survey at any time. We are interested in finding people who are family members or partners of the person who died. We know that it can be hard to know for sure what happened. These questions can help us learn if our study team should contact you. Please note that we refer to "opioids" . Opioids are strong pain medicines that require a doctor's prescription. They can be sold under many names. Sometimes people call them "narcotics". We will ask about specific medicines further below.
National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance
We're sorry. At this time, it does not appear that you meet the qualifications to complete this survey. Thank you for your time and interest in this research study. Q10: What race best describes you?
White Black or African American American Indian or Alaska Native Asian or Pacific Islander Other, please specify Decline to Answer
Q11: Do you consider yourself to be Hispanic/Latino/Latinx?
Yes No Decline to Answer
Q12: What is your gender?
Male Female Other Decline to Answer
Q13: What state do you live in?
Q14: What city or town do you live in?
Q15: What is the best method to reach you?
Q16: Is there an alternate phone number you would like us to use?
Yes
No
Participant's alternate phone number
Q17: What is your preferred mailing address?
Q18: Please tell us if there is another way you prefer to be reached.
National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance
Thank You.
Now, these are questions about the person who died
Q19: Who is the person that died (please provide the name of that person)?
Q20: Roughly how old was the person who died, when they died
Q21: What was the gender of the person who died?
Female
Male
Other
Please provide additional information about the gender of the person who died, if you wish.
Q22: What was the race that best describes the person who died?
White
Black or African American
American Indian or Alaska Native
Asian or Pacific Islander
Other, please specify
Q23: Was the person who died Hispanic/Latino/Latinx?
Yes
No
Q24: What was the marital status of the person who died?
Single, never married
Married
Widowed
In a marriage-like relationship
Divorced
Separated
Don't know/Not sure
Other, please specify
Q25: Where did the person live at the time of death?
Don't know/Not sure
Q26: What is your relationship to the person who died?
Spouse, Mother, Father, Sister, Brother, Son, Daughter, Other Specify
Q27: Do you consider yourself to be in a family relationship with the person who died?
Yes
No
Q28: Did you live with the person who died at any time in the year before the death?
Yes
No
National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance
These are questions about the death itself.
Q29: Please describe how the person died, to the best of your knowledge.
Q30: To the best of your recollection, what was the date on which this person died?
Q31: How confident are you that this death was an intentional act of suicide?
* must provide value
Very Confident
Somewhat Confident
Neither Confident nor Unconfident
Somewhat Unconfident
Very Unconfident
Q32: To your knowledge did any of the following causes contribute to the death? (Check ALL that apply)
Q33: To your knowledge, was the death assessed to be a suicide by either a coroner, medical examiner or doctor?
Yes
No
Don't know/Not sure
Q34: To your knowledge, did the person ever previously attempt to die by suicide?
Yes
No
Don't know/Not sure
Q35: To your knowledge, in the last three years, did this person ever have an overdose where they needed to go to the emergency room or get medical care right away? Please respond "Yes" regardless of whether that event involved prescribed medicines or other substances.
Yes
No
Don't know/Not sure
Q36: To your knowledge, was this person EVER told by a doctor or other health professional that he or she had (Check ALL that apply)
Q37: Do you have a death certificate?
Yes
No
Q38: Was there an online obituary?
Yes
No
Don't know/Not sure
Q39: To your knowledge, how many times in the past, if any, did the person attempt to die by suicide?
# of suicide attempts
National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance.
These are questions about changes in pain medication. We understand you may feel uncertain regarding these questions. Please answer to the best of your ability. Opioids are strong pain medications like hydrocodone, oxycodone, morphine, fentanyl, and brand-named drugs, and they require prescription from a doctor.
Q40: To the best of your knowledge, did the person who died take these medicines for more than a year at any time in the 5 years before their death?
Yes
No
Don't know/Not sure
Q41: Is there any more detail you would like to offer on how long the person who died received these medicines?
Q42: To the best of your knowledge, did the person who died experience any of the following changes in any opioid pain medication? (Check All that apply)
* must provide value
Q43: To the best of your knowledge, did the person who died describe distress about a change in pain medication? This may include distress before a change is made, or after. The distress might include anxiety, frustration, depression, or being upset.
Yes
No
Don't know/Not sure
Q44: Do you have any other observations about what happened?
Yes
No
Q45: To your knowledge, do you have legal authority to request medical records regarding the person who died, such as would be the case for a named "Executor of Estate"?
Yes
No
Don't know/Not sure
National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance
We thank you for taking the time to complete this survey. Based on the information you have provided, we would like to contact you for a future study, when we obtain funding from an appropriate agency. Please provide any additional comments or questions in the text box below.
Q47: Are you willing to be contacted for a future study related to this death?
Yes
No
National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance
THANK-YOU SCRIPT FOR DISQUALIFIED PERSONS
Q48: We thank you for taking the time to complete this survey. Based on the information you have provided, you do not qualify for this study. May we contact you if there are future studies?
Yes
No
Don't know/Not sure
Q49: What is the best method to reach you?
E-mail
Telephone
Postal mail
Other, Specify
Q50: What is your E-mail address?
Q51: What is your preferred phone number?
Q52: Is there an alternate phone number you would like us to use?
Yes
No
Q53: What is your preferred mailing address?
Q54: Please tell us if there is another way you prefer to be reached.
Trialfacts
Health Survey, USA
Public Presentation by Staff or Investigators
Public Website
Social Media Advertisement
Other
Facebook
National Suicide Prevention Lifeline 24/7: Dial 988 Veterans Crisis Line 24/7: Dial 988 then Press 1
If your survey form skips questions, please notify the survey team at csiopioids@uabmc.edu and please begin the survey (if possible) on a different browser at https://go.uab.edu/csiopioids . Please call our team at 866-283-7223, Option 1, if you need further assistance
Submit
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