Appendix D - Informed Consent 6-04-09

Appendix D

Reducing ED Crowding and Improving Patient Flow

Qualitative Interview Informed Consent

Background and Purpose:

You are being asked to participate in a research study about the implementation and impact of strategies designed to improve patient flow and reduce emergency department (ED) crowding. The insights and lessons learned from this study will provide important guidance to other hospitals that may consider the adoption of similar strategies in the future. This study will take place from May 2009 until March 2010.

Participation:

A master key-informant interview protocol will be used to inform interviews of 9-16 individuals from each of the six hospitals participating in the Urgent Matters Learning Collaborative. Interviewees will include nurse/physician leaders, other ED staff, senior hospital leadership, and staff from ancillary services, information systems, and finance. The aim of this qualitative analysis is to provide insights into how, how well, and how easily different types of EDs incorporated various interventions and changed their patient flow. This analysis will then inform case studies that will focus on the efforts of each of the participating hospitals. Each key-informant interview should last approximately 45-60 minutes. The HRET Evaluator in charge of each hospital will be in charge of recruiting individuals for key-informant interviews. With your permission, this interview will be audio recorded for quality purposes. You may choose for the recorder to be turned off at any point in the conversation. After the interview, the recording will be transcribed for data analysis.

Your individual participation in the assessment process is voluntary and informed consent will be sought from all participants. You have the option to not participate. During the time of the training and assessment processes, you may stop your participation without any penalty or loss of benefits.

Confidentiality:

Information gathered in the interviews will be confidential and will not be attributed to any individual participant. All results will be stored in a secure file and will be erased upon completion of the project. Only research staff associated with the project will have access to the results and all project staff members are required to maintain the confidentiality of all information gathered through the assessment process.

Results of this study may be used for qualitative improvement measures, research, publications, or presentations at scientific meetings. If your individual comments are discussed, your identity will be protected by using a study code number rather than your name or other identifying information.

At the end of this consent form, you will be given the option of allowing us to make an audio recording of the interview, which will be used to ensure the accurate transcription and analysis of your responses.

Risks and Benefits:

There are no known risks associated with participation in the study. Although there are no individual benefits to participants, your participation will potentially benefit your hospital and other hospitals seeking to reduce E.D. crowding and increase patient flow.

Alternatives:

You may choose to not participate in this research study.

Financial Information:

Your participation in this study will involve no cost to you. You will not be personally paid for your participation in this study, however your hospital has been provided $10,000 for compensation of staff time spent on all elements of this project (data collection, staff time, qualitative interview time, etc.)

Subject’s Rights:

Your participation in this study is voluntary and you are free to withdraw at any time. Choosing not to participate or withdrawing from this study will not affect your employment in any way. You are free to choose not to answer particular questions if you do not want to. You may ask that the tape recorder be turned off at any point during the interview if there is something that you do not want to have recorded. You also have the right to request that your audio-recorded interview be deleted in its entirety and removed from the study. You must request access and/or deletion of your audio-recorded interview before the end of the first business day following your interview.

Contacts:

You may obtain further information about your rights as a research subject by contacting Jeanette Lyons, Grants Manager, Health Research & Educational Trust, at 312-422-2631 or at jlyons@aha.org. For more information about the project or if you have questions about the research, contact Megan McHugh, Research Director, Health Research & Educational Trust, at 312-422-2634 or at mmchugh@aha.org.

Optional Study Elements:

Please initial one of the following to indicate your choice:

_____ (initial) I agree to participate in the audio-taping of my interview.

_____ (initial) I do not agree to participate in the audio-taping of my interview.

Consent:

“I have read this form and the research study has been explained to me. I have been given the opportunity to ask questions and my questions have been answered.

You will be given a copy of this document for your records and future reference.

______________________________________ [Participant Name – Please Print]

______________________________________ [Participant Signature ___/___/___ (date)]

______________________________________ [Interviewer Name – Please Print]

______________________________________ [Interviewer Signature ___/___/___ (date)]

______________________________________ [Investigator Name – Please Print]

______________________________________ [Investigator Signature ___/___/___ (date)]