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Sample System Description An inbound Patient Diary Interactive Voice Response System for use of 300 - 900 patients involved in a study. Patients are assigned a PIN (Personal Identification Number), and use it to identify themselves to the system. Patients dial in on a weekly basis into an 800 number so that patients can dial in toll-free from around the world. The system will be available on a 24/7 basis. A minimum of six incoming lines is dedicated to this project, so that the chance of a busy signal is very remote. Six months for patient enrollment and monitoring is allowed for. The script consists of QOL, Treatment compliance, work missed, and ER / re-hospitalization questions, and be available in English, French, and Spanish. JestaRx will have the script translated into these languages, as well as provide a certificate of back translation. It is anticipated that each call will take approximately two to four minutes. Reporting Monthly, all data captured will be reported to the Sponsor. In addition, we will also provide summary call data on a monthly basis, as well as a weekly 'Alert' report of all patients who have not called in for more than two weeks. This will allow the Sponsor to monitor the status of these patients. At the end of the study, statistical analysis was performed on the data. Data All data will be treated in a confidential manner and shall be considered the property of the Sponsor. PIN: 99999 Instructions: When you call the toll-free number, you will be asked to enter your personal identification number (PIN). Your PIN may be found at the top of this Information Guide. This system uses telephone-based Interactive Voice Response (IVR) technology to monitor your overall satisfaction with your treatment and quality of life. This process allows data to be automatically recorded and stored in a database for analysis. Through an automated system, you will be asked a series of questions. You can respond to each question by pressing the appropriate keys on your telephone. The entire process takes only about 5 - 10 minutes and will be repeated each month while you are receiving services from us. Listen carefully to the options before making your selection. If you did not hear a question, don't hang up! Each question will be repeated after 3 seconds, or you may press the star key to repeat a question. If you give a response that the automated system does not understand, the question will be repeated automatically. It is important that you answer every question in the survey as best you can. And remember, this is not a test and there are no wrong answers. We are simply looking to gain an understanding of what impact your illness is having on you and your life. Confidentiality: Your responses are confidential and will be shared only with your healthcare provider (and only if your answers indicate that your quality of life could be improved with some medical advice). Why we want this information: This survey system has been designed to collect information about your health-care experience. This project involves a survey to evaluate the beneficial effects of the services and medication you are receiving to improve your health. The data you provide will also be used to help researchers improve the quality of life for other patients like you. Sample Script Has your disease affected your ability to: Go to work on a regular basis (Press 1 for No, 2 for rarely, 3 for occasionally, 4 for often, 5 for all the time) Engage in social activities (like going out to dinner) (Press 1 for No, 2 for rarely, 3 for occasionally, 4 for often, 5 for all the time) Engage is leisure activities (like reading a book or watching a movie) (Press 1 for No, 2 for rarely, 3 for occasionally, 4 for often, 5 for all the time) Find or maintain housing (keep the place of residence you had prior to becoming sick) (Press 1 for No, 2 for Yes) Other questions related to QOL / Work. Have you taken all the medications prescribed by your doctors? (Press 1 for No, 2 for Some of the time, 3 for Most of the time, or 4 for All of the time) If Not all the time, Why Not? Press 1 if you forgot to take the medication, Press 2 if the medication had unpleasant side effects, Press 3 if you could not afford the medication, or Press 4 if you did not take you medication for some other reason. Have you gone to the Emergency Room in the last month (Press 1 for No, 2 for Yes) Have you been hospitalized during the last month (Press 1 for No, 2 for Yes) Etc... |
