Blackburn, Justin
Balio, Casey P.
Carnahan, Jennifer L.
Fowler, Nicole R.
Hickman, Susan E.
Sachs, Greg A.
Tu, Wanzhu
Unroe, Kathleen T.
Article History
Received: 26 January 2021
Accepted: 19 April 2021
First Online: 24 May 2021
Declarations
:
: OPTIMISTIC was conducted as a demonstration project under contract to the Centers for Medicare and Medicaid Services (CMS) in the United States utilizing a suite of interventions, staff education, and quality improvement strategies already proven effective. It was explicitly deemed by CMS to not be a research study and did not require individual informed consent of participants. Per CMS regulations and guidance, residents of nursing facilities, or their legally authorized representatives (proxies) were informed of the project by nursing facility leaders via letter and were provided an opportunity to opt-out of the demonstration project. The OPTIMISTIC demonstration project also underwent an independent review and was approved by the Indiana University Institutional Review Board (IRB). The IRB similarly determined that as an evaluation of a program for federal Medicare beneficiaries, informed consent was not required from individual participants and granted a waiver of informed consent. All project methods were carried out in accordance with relevant guidelines and regulations.
: N/A.
: Kathleen Unroe is CEO and Founder of Probari, Inc., a program to train nurses to reduce nursing home hospital transfers. All other authors have no conflicts of interest to disclose.