Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Optimizing Surgical Outcomes at UPMC
Abstract
The purpose of this project is to determine the effect of various interventions to improve patient outcome as defined by hospital free days at day 90 for adult patients undergoing elective surgery. Within this project, multiple studies may be conducted.
The structure of this project permits:
* the testing of multiple treatments at the same time within the same patient
* the use of early study results to provide better treatment options to future patients
* the removal of treatments which are shown to be less effective than the other treatments
* the addition of new treatments
The first study to be conducted under this project (IRB STUDY19090186) is the Strategies to Promote ResiliencY (SPRY) clinical trial (IRB PRO18060038).
The SPRY clinical trial will determine the effectiveness of Metformin on improving surgical outcomes among nondiabetic older adults who are scheduled for elective surgery.
Conditions: Aging.
Primary outcome: Hospital Free Days (HFD).
Enrollment: 302 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 302 participants or records.
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