Enhancing Care in Addictions Treatment Programs
Charles Neighbors, Ph.D., MBA
Center on Addiction
633 3rd Avenue
New York, New York 10017
National Institute on Drug Abuse
You are being asked to join a research study. The purpose of a research study is to answer specific questions.
This consent form will explain:
It will also explain that you do not have to be in this study to receive treatment for addictions.
The study is testing whether putting new practices and procedures in place in outpatient treatment clinics improves clients’ health and well-being. You are being asked to participate because we want to know if people receiving treatment in a clinic making these improvements have better outcomes over time.
There will be a total of 40 people from your clinic. There will be 1,200 people in total for all the clinics participating in the study across NY State.
If you choose to take part in this study, you will be asked to answer three different surveys using a computer or your mobile phone browser during the next 6 months. You will not be asked to attend any in-person visits to answer these questions.
First, we need to get your formal consent to participate before we can move on. Once we have your consent to be in the study, we ask you to complete the first survey. The survey should take about 20 minutes.
The survey will ask questions about your drug use, any consequences you experience from drug use, your health, and how well you are doing in things like work, relationships with others, and living arrangements.
You will be asked to answer these questions at three different times. The first will be now, after you confirm that you consent to this study. The second time will be three months after today. The final time will be six months after today.
As part of this study, you are agreeing to send and receive text messages on your mobile phone. You will receive text messages asking you to link to the web site and answer the survey. If you do not answer the survey right away, you will be sent reminder text messages 3 and 7 days after the first reminder.
This information is being collected for research purposes only so that the researchers can learn whether the staff training is helping clients get better care. You can refuse to answer any questions that you do not feel comfortable answering, and you can refuse to complete the assessment by stopping at any time.
The questionnaire is designed so you can answer it using your mobile phone browser. If prefer, you can use your computer to answer the questions. Your mobile phone number will be used for this study. Reminder text messages will be sent to your phone. Depending on your phone plan, you may be charged for these messages. We will send you as few messages as necessary to remind you to answer the questions. At any point you can stop the messages by texting back STOP if the content in the text message is bothersome or if the timing of the message is inconvenient for you.
Collection of Sensitive Information:
Some of the questions you may answer on the surveys may seem very personal or embarrassing. They may upset you. You may skip any question that you do not want to answer. If the questions make you very upset, you may discuss them with your counselor or by contacting the Project Director at the phone number written below.
Data Use Overage:
If you do not have an unlimited text messaging plan you may be charged for the text messages you send and receive in this study. We will not compensate you for any charges you incur for text messages.
Text Message Security:
As with any mobile phone, there is a risk that messages that you send and receive can be read by unintended individuals. It is your responsibility to ensure your phone is appropriately secured and managed.
Technical Difficulties:
There may be days on which you receive no text messages, times when you might expect a text message and do not receive one, and days on which your text queries go unanswered due to failures in message transmission, message processing, network problems, or problems with your phone. These issues may also cause messages to be deleted from your phone company’s server. If this occurs, please contact us.
You may not receive any direct benefit from participating in this study. The information we learn from this study may help others who are clients in addiction treatment programs.
You do not have to participate in this study. Your participation will not affect your treatment. We will not communicate to your counselor or other staff at your clinic who is participating in this study and we will not share any information from the survey with the clinic or staff.
This research study is funded by The National Institute on Drug Abuse. You will not have any added costs for answering these survey questions. Neither you nor your insurance company will be billed for your participation in the surveys.
As part of the study, you will be paid $20 for each time you answer the surveys. There will be three surveys, one right now then one at 3 months, and another 6 months from now. You will receive payment even if you do not complete the whole questionnaire. After each time that you answer the survey, we will add $20 to the debit card you received.
Your participation in this project is voluntary. The quality of your treatment in the clinic you have recently enrolled at will be the same whether you join, refuse to join, or decide to leave the study.
If you do not join the study you will not be penalized or lose benefits to which you are entitled.
It is also possible that your participation in this study may end without your consent. This decision may be made by a researcher, study sponsor or the Institutional Review Board (IRB – the committee that oversees research at this institution).
Reasons for withdrawal may include:
If you withdraw from this study or if you are withdrawn from the study, any data already collected will continue to be used. However, no new data will be collected.
You will be told any new findings that may change your decision to continue to participate. Your consent to continue to take part in this study may be obtained again.
If you agree to be in this study, we will collect your phone number and a special identifier that is unique to you and lets us know the clinic where you are receiving treatment. We will also store your answers to the questions. We will only collect information that is needed for the research. If you sign this consent form, you are giving us permission to collect, use and share your health information. This permission is called authorization.
Study records that identify you will be kept private. You will not be identified in study records or publications disclosed outside the Center on Addiction except as detailed below.
Investigators will share information collected from this research study with:
The following reviewers may access your study and medical records to make sure that this study is being done properly:
We will do our best to protect the privacy of your records, but it is possible that once information is shared with people listed on this form, it will be released to others. However, these agencies are under strict guidelines to protect your information and only access the minimal information needed to conduct their duties.
In the future, we may publish results of this study in scientific journals and may present it at scientific meetings. If we do we will not identify you.
If the researchers learn about potential serious harm to you or someone else or other public health concerns, it will be shared with the appropriate authorities.
Your research records will not be used for decisions related to your care within the clinic. Only study staff will see your research records, they will not be shared with the clinic you are receiving treatment in or your treatment team.
There is no limit on the length of time we will keep your information for this research because it may be analyzed for many years. We will keep it as long as it is useful, unless you decide you no longer want to take part or we close the study. You are allowing access to this information indefinitely.
If you change your mind about being in the study, you may withdraw at any time. You may withdraw by contacting the principal investigator using the contact information provided below.
We may still use the information we have already collected. We need to know what happens to everyone who starts a research study, not just those people who stay in it.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this website at any time.
The investigators on this study will receive money that is directly related to your participation in this study. Funding for this research study is provided by National Institute on Drug Abuse, money they receive is to pay them back for the costs of conducting the research study. Part of the amount of money they receive is based upon the number of people enrolled in the study.
If you have any questions about the study, you may call Dr. Charles Neighbors at (212) 841-5267. If you have questions about problems by participating in the survey should call Dr. Charles Neighbors at (212) 841-5267. If you need emergency care, dial 911 or go to the nearest Emergency Room. If you have questions about your rights as a research participant, concerns about being in the study, or would like to offer input, you may contact the Solutions Institutional Review Board (the committee that oversees research at this institution) at (855) 226-4472 or by email at participants@solutionsirb.com.