Consent Cover Letter
SHEPheRD: Improving Outpatient Use Through Implementation and Evaluation of Core Elements of Outpatient Antibiotic Stewardship:
Acceptability Survey of ARI campaign for University of Utah Affiliated Pediatric Clinics
DESCRIPTION OF RESEARCH BY INVESTIGATOR
The purpose of this research study is to reduce unnecessary antibiotic use in diverse types of primary, urgent/episodic, and emergency care settings, and implement change in our culture of overprescribing in the outpatient setting within the University of Utah-affiliated Pediatrics and Dental facilities. Endpoints that will be measured in this study include rates of antibiotic use per 1000 population, divided by diagnosis category and drug class. Clinical outcomes that will be tracked include return visits, hospitalization, recovery of antibiotic resistant organisms, and adverse drug events.
Procedures
You will be asked to complete an online survey by clicking on the supplied link via e-mail and answering questions aimed to gauge your opinions on the ARI Campaign elements and suggestions for improvement. Questions will assess your perspectives concerning ARI Campaign components you may have experienced including: audit-feedback reports, academic detailing and other antibiotic stewardship related enablers. The survey will include questions in the form of multiple choice, Likert score, or short free-form text . Your participation in this study will have no direct or indirect risk to your employment. All information gathered will be kept strictly confidential, and no corrective or disciplinary action will result from the information collected from your answers to our questions. Aggregate data will only be reported in research-related publications and reports.
CONFIDENTIALITY
Our authorized research team will have access to your survey data. The survey will be administered through the University of Utah’s RedCap Survey Tool and downloaded onto a secure University of Utah server. Electronic data containing information that could identify you will be stored on a secure server behind the University of Utah firewall with restricted access. Any paper documents will be stored in locked file cabinets behind locked doors. Any information that could identify you will be deleted or replaced with a code prior to the study data being e-mailed or otherwise disclosed. If the identifiers are replaced with a code, the documentation of the procedure by which the code is used will remain with the University of Utah at all times.
PERSON TO CONTACT
If you have any questions complaints or if you feel you have been harmed by this research, please contact the Principal Investigator Matthew Samore, MD at (801) 582-1565, ext. 2423 or the Program Manager Catherine Loc-Carrillo, PhD. at (801) 582-1565, ext. 3492 during the hours of 9am - 5pm Monday through Friday.
Contact the Institutional Review Board (IRB) if you have questions regarding your rights as a research participant. Also, contact the IRB if you have questions, complaints or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at [email protected].
It should take approximately 30 minutes to complete the survey. Participation in this study is voluntary. You can choose not to take part. You can choose not to finish the survey without penalty or loss of benefits.
By participating in the survey, you are giving your consent.
Your participation in this study is greatly appreciated. The information gathered will be used to help implement outpatient antibiotic stewardship in diverse types of primary, urgent/episodic, and emergency care settings.
Footer for IRB Use Only Version: 112011 |
|
«Image:Stamp» |
«Institution» «IRB» «Approved» «ApprovedDate» «Expiration» «ExpirationDate» «Number» |
| File Type | application/msword |
| File Modified | 0000-00-00 |
| File Created | 0000-00-00 |