UNIVERSITY HOSPITALS OF CLEVELAND
CONSENT FOR INVESTIGATIONAL STUDIES
(Patient Intervention Group) Project Title: Primary Practice Physician Program For Chronic Pain (4PCP Trial): A Controlled Study of an Experiential Learning and Clinical Support Intervention Applied in Primary Care Physician Practices Principal Investigator: Dr. Thomas Chelimsky
INTRODUCTION: You are being invited to participate in a study because you are suffering from chronic pain. The study is based at University Hospitals and is being conducted by Dr. Thomas Chelimsky, principal investigator. The study is called 4 PCP (Primary Practice Physician Program for Chronic Pain). This study is entirely non-invasive (questionnaires only) and will be trying to see whether pain care can be improved if your Doctor gets support from a specialized Pain Care Team as well as training from a group of physicians who are pain specialists (the Study Team). The Pain Care Team consists of an occupational therapist, a physical therapist, a psychologist, and a pharmacist. Your Physician, Dr.________________________________, is participating in this study. Taking part in this study is entirely voluntary. Before deciding whether to take part in the study, you need to understand why the study is being done and what it will involve. Please read these pages carefully and ask any questions that you have about what you read. Once you understand the information, and all of your questions have been answered to your satisfaction, you must sign this Consent Form before you can take part in the study. Nature and Purpose of this Study The purpose of this study is to find out if patients with chronic pain do better if their Primary Care Physician receives special consultation and training in Pain Care. Your Doctor has been assigned to the group that will receive this training and support NOW. If you decide to join this study, the Pain Care Team will (under the direction of your Primary Care Doctor) work with you to evaluate, treat and manage your chronic pain. The Pain Care Team treatment is considered standard in the treatment of chronic pain; it is not an experimental treatment.
WHAT IS INVOLVED IN THE STUDY? If you and your doctor agree that you are appropriate for this study, either your Physician’s office or you (depending on the office policy) will try to get approval from your insurance company for
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UNIVERSITY HOSPITALS OF CLEVELAND
CONSENT FOR INVESTIGATIONAL STUDIES
(Patient Intervention Group) Project Title: Primary Practice Physician Program For Chronic Pain (4PCP Trial): A Controlled Study of an Experiential Learning and Clinical Support Intervention Applied in Primary Care Physician Practices Principal Investigator: Dr. Thomas Chelimsky evaluations and treatment. Once approved, your pain care will be coordinated by the Pain Care Team under the supervision of your Physician. As part of the study, you will be asked to fill out questionnaire forms about your health and treatment for a period of 12 months. These forms are part of the research study only and will not be available to your physician or the Pain Care Team. Your doctor will manage your care in the standard manner for the type of pain problem you have. As part of routine care in this study, you may be scheduled for the following evaluations and treatment with people on the Pain Care Team: Baseline Physical exam and Medical History (doctor) Follow-up visits (doctor) Educational Group visits (doctor) Referrals to Anesthesia Pain Service for Consult (for possible injections or blocks) Evaluation and treatment by Occupational Therapy Evaluation and treatment by Physical Therapy Evaluation and treatment by Psychology Each caregiver providing you with direct care is responsible for this care, and for any adverse occurrences related to this care. Evaluations will result in specific treatment recommendations that may include a rehabilitation program consisting of 1) regular visits to your doctor; 2) occupational and physical therapy 2 hours total /3 days per week; 3) both individual and group psychology visits once a week; and 4) participation in a structured fitness program. The program may last anywhere between 3-5 weeks, depending on your clinical needs. Pain blocks or injections may also be recommended as appropriate. The rehabilitation program will be at a location in the general vicinity of your physician’s office. You will be responsible for transportation to any evaluations or treatment sessions that are part of the rehabilitation program. Your personalized care program will be organized by a member of the Study Team who will try to schedule your various treatments as close together as possible. However, there will be times when you will have to wait in between treatments. The planner will make all efforts to keep this wait time as short as possible. You will need to attend the rehabilitation program three times per week
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UNIVERSITY HOSPITALS OF CLEVELAND
CONSENT FOR INVESTIGATIONAL STUDIES
(Patient Intervention Group) Project Title: Primary Practice Physician Program For Chronic Pain (4PCP Trial): A Controlled Study of an Experiential Learning and Clinical Support Intervention Applied in Primary Care Physician Practices Principal Investigator: Dr. Thomas Chelimsky during the 3-5 week period. Different treatment options will be available and offered to you if you do not require the treatment options listed above. As part of the study you will be strongly encouraged to enroll in a structured Fitness Program at a fitness center of your choice. The research staff for this study will work with you to help you identify and enroll in a reasonably priced program. The exercise program should be progressive and include cardiovascular and strength-training components. If you decide to participate in the intensive rehabilitation treatment following your doctor’s recommendation, you will be required to participate in an exercise program 3 times a week during the intensive treatment which will last from 3-5 weeks. If you do not feel that you can commit to such an exercise program, you may be eligible for components of the rehabilitation treatment rather than the complete program. In order to get maximum benefit from your treatment, it is highly recommended that you continue this exercise program following the completion of that treatment.
Follow-up visits You will have follow-up visits with your Doctor and members of the Pain Care Team as appropriate. The Study will gather information about your response to treatment upon entering the study, and every three months thereafter for a total of 12 months. During each of these visits you will be asked to fill out questionnaire forms about your health and treatment since your previous visit. Again, these forms are part of the research study only and will not be available to your physician or the Pain Care Team.
Risks The risks of the study are the same as they would be if you participated in the standard clinical care offered through a Pain Program. Exercise, if excessive, could result in bodily injuries, or chest pain due to decreased blood flow to your heart if you have a pre-existing heart condition. Both of these risks will be minimized. Your physical therapist will carefully supervise your exercise routine while in the intensive program, and you will receive specific instructions for your exercise in the fitness center. Your doctor will screen you for any cardiac risk, before recommending participation in the study.
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UNIVERSITY HOSPITALS OF CLEVELAND
CONSENT FOR INVESTIGATIONAL STUDIES
(Patient Intervention Group) Project Title: Primary Practice Physician Program For Chronic Pain (4PCP Trial): A Controlled Study of an Experiential Learning and Clinical Support Intervention Applied in Primary Care Physician Practices Principal Investigator: Dr. Thomas Chelimsky
If your doctor drops out of the study, we will continue to have you fill out the questionnaire forms. You will continue to receive care from your doctor and he or she will be responsible for your treatment. As such, you and your doctor will together decide whether or not you will continue with the program If you discontinue the program, there is a risk that you may be disappointed if you placed a lot of hope in this treatment. Benefits You may or may not receive any personal benefit from participating in this study. However, your participation in this study may help with the overall care of chronic pain patients. It may also help Primary Care Doctors gain knowledge through working with a specialty clinical care team and educational program in pain management. Alternatives(s) To Participation If you choose not to participate in the 4PCP program, you will receive standard care prescribed by your Primary Care Doctor. Such care may include referrals to other professionals such as physical therapy or anesthesiology for evaluation, therapy, or medical interventions. Confidentiality All information obtained from this study that can be identified with you will remain confidential. In any written reports or publications, you will not be identified or identifiable, and only combined data will be presented. By signing this consent you are allowing members of the Pain Care and Data Management Teams, who are acting under confidentiality guidelines, to view your medical records. Cost To Patients There is no charge for any of the research aspects of this study. Thus, if you are scheduled for a meeting with the research coordinator or a member of her staff for the purpose of filling out research forms, there will be no charge to you. It is important to realize that the pain care team is providing care that is standard and not experimental. Therefore, , you or your medical insurance will be responsible for paying for all clinical tests, procedures and treatment. Since the benefit of intensive treatment results from more frequent visits to your doctor, psychologist, physical and occupational therapists, your short-term costs are likely to be higher due to more frequent copays.
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UNIVERSITY HOSPITALS OF CLEVELAND
CONSENT FOR INVESTIGATIONAL STUDIES
(Patient Intervention Group) Project Title: Primary Practice Physician Program For Chronic Pain (4PCP Trial): A Controlled Study of an Experiential Learning and Clinical Support Intervention Applied in Primary Care Physician Practices Principal Investigator: Dr. Thomas Chelimsky
Summary of your rights as a participant in a research study
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. If you decide to drop out of the study at any time, you may do so by telling either your doctor or the research coordinator ((216) 844-4PCP(4727)). If information generated from this study is published or presented, your identity will not be revealed. In the event that new information becomes available that may affect the risks or benefits associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating. If you experience physical injury or illness as a result of participating in this research study, medical care is available at University Hospitals of Cleveland (UHC) or elsewhere; however, UHC will not provide either free care or compensation for lost wages.
Disclosure of your study records
Efforts will be made to keep the personal information in your research record private and confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals of Cleveland Institutional Review Board may review your study records.
Contact information
________________________________________ has described to you what is going to be done, the risks, hazards, and benefits involved, and can be contacted at (216) 844-4PCP(4727). Further information with respect to illness or injury resulting from a research procedure as well as a research subjects' rights is available from the Office of the Chief Medical Officer at (216) 844-3695.
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UNIVERSITY HOSPITALS OF CLEVELAND
CONSENT FOR INVESTIGATIONAL STUDIES
(Patient Intervention Group) Project Title: Primary Practice Physician Program For Chronic Pain (4PCP Trial): A Controlled Study of an Experiential Learning and Clinical Support Intervention Applied in Primary Care Physician Practices Principal Investigator: Dr. Thomas Chelimsky
Signature
Signing below indicates that you have been informed about the research study in which you voluntarily agree to participate; that you have asked any questions about the study that you may have; and that the information given to you has permitted you to make a fully informed and free decision about your participation in the study. By signing this consent form, you do not waive any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may have. A copy of this consent form will be provided to you. Date____________ __________________________ Signature of Participant ___________________________ Printed Name of Participant
Date____________ _______________________________ Signature of Person Obtaining Consent ___________________________ Printed Name of Person Obtaining
Date ___________ ___________________________________ Signature of Primary Care Physician Physician _________________________ Printed Name of Primary Care
___________________________________________ Date_____________ Signature of Principal Investigator (Affirming subject eligibility for the Study and that informed consent has been obtained.)
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