Letter of Information for Participation in the
Post-Operative Pain Management Quality Improvement Project
The following information is being supplied to you to address any questions you may have regarding participation in the Post-Operative Pain (POP) Management Quality Improvement Project.
1) The purpose of this project is to encourage hospitals to implement quality improvement activities to improve the management of post-operative pain. Hospitals joining the project receive POP materials and resources that can help them to establish quality improvement efforts. The subjects in this study are hospitals. Participation in the POP Project is voluntary. The duration of participation in the project is approximately 18 months.
2) There could be a risk of loss of reputation if the POP team revealed hospital-specific information about quality assurance activities, but no such hospital-specific information will be reported.
3) Actual and potential benefits of participation in the POP Project are: receipt of all project materials including training tools and materials and data abstraction instruments; support from project team staff at University of Wisconsin-Madison Medical School; a model for pain quality improvement that can be exported to affiliated home care, long term care, behavioral health and ambulatory care settings; assistance in the development of acute pain management performance measures which meet JCAHO standards; improved acute post-operative pain management; participation in a collaborative multi-state project with the University of Wisconsin-Madison Medical School; acknowledgement as a participating institution.
4) Participants will be provided with information about other resources pertaining to pain management quality improvement.
5) Approval by your institution’s Institutional Review Board (if applicable) is recommended. Submission of requested data to the POP Project Team is voluntary. All patient data shared with the POP Project Team at University of Wisconsin-Madison are confidential and unidentifiable. Data from participating organizations will be aggregated, analyzed, and published following the conclusion of the project.
6) There is minimal risk associated with this project. Interventions are QI-based.
7) If you have any questions or concerns, please contact Marty Skemp, POP Project Coordinator, University of Wisconsin-Madison Medical School, 1300 University Avenue, Rm 4720, Madison, WI 53706; (608) 265-9173 / (608) 265-4014 (fax) / mmskemp@facstaff.wisc.edu.
8) All participants will receive the same materials and resources provided by the POP Project Team.
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If you do not plan to collect data you probably do not need IRB approval.
If you plan to collect data in order to assess the impact of your pain management improvement process (and we strongly encourage you to do so!) you may need IRB approval. You must decide whether you plan to collect data from medical record audits, patient surveys or both. When you speak to your IRB representative, be clear about what kinds of data you wish to collect, and with whom you will share the data.
Finally, we very much hope that you will collect data and, that you will share the data with the project team at the University of Wisconsin. We want to use data from participating hospitals to evaluate the impact of the POP project. If you plan to share your data with us, you most likely need IRB approval. If you share data with us, we ask that you collect data using the accompanying Microsoft Access® database. Please DO NOT share any data that could identify individual patients. For example, we do not want their names, medical record numbers, or any other information that could identify them.
Obtaining IRB approval:
1. Identify a resource person with knowledge about how to obtain IRB approval.
2. Decide which patient population (adults and/or children, surgical procedures) will be included.
3. Decide whether you will use medical record audits, patient surveys, or both.
4. Decide if you will be sharing your data with us.
5. Informally discuss the POP project and data you plan to collect with the resource person or IRB chairperson.
6. Obtain, complete and submit the necessary IRB application forms.
7. Consider obtaining letters of support for the project from key administrators such as the Director of Quality Improvement, Director of Nursing, and Director or Chairperson of Surgical Services.
8. The IRB may return your application with questions. Do not be alarmed for this is not uncommon. Consult with the IRB representative and answer the questions.
9. If you have difficulties, call Marty Skemp, Project Coordinator at 608-265-9173 or email: mmskemp@facstaff.wisc.edu
Download a pdf version of these strategies
Q What is the purpose of the data collection?
A: o assess the quality of post-operative pain management. Data generated from this study will be used to enhance existing pain management efforts and used for longitudinal outcome monitoring. Data will be shared with the POP project team for aggregate project data analysis.
Q: If there are no identifiers for the Hospital or the patient, why do we need IRB approval? We have been involved in many UHC projects with chart audits and haven't required IRB approval.
A: You need to check with your own IRB to see if their approval is required for any aspects of your data collection. The IRB at the University of Wisconsin (that approved the POP project) recommended that each participating hospital obtain its own IRB approval as well. Our IRB guidelines require protocol approval whenever data are to be shared, presented, or published outside of the institution, even if it is quality assurance data. Although you may only do chart audits for POP, we encourage everyone to set up a longitudinal plan for monitoring which would include patient surveys.
Q: In an effort not to reinvent the wheel, do you have a patient informed consent form you could share with me? Could you also include a history of the form (i.e., was it reviewed by an attorney, etc.)? If not, I will need to develop one to satisfy my IRB requirements.
A: Because each IRB has its own specific protocol requirements and preferences we specifically chose not to include a template for a consent form. In fact, we have never been required to use a consent form to survey patients about their pain experiences and instead use a letter of information which requires no signature. The letter briefly describes the length and purpose of the survey and provides some assurances about confidentiality and anonymity. We recommend you get advice from your own IRB about the need for review by an attorney.