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Protocol for Project Recovery: Cardiac Surgery - Leveraging Digital Platform for Efficient Collection of Longitudinal Patient-Reported Outcome Data Towards Improving Postoperative Recovery

By Makoto Mori, Cornell Brooks, Erica Spatz, Bobak J Mortazavi, Sanket S. Dhruva, George C. Linderman, Lawrence A. Grab, Yawei Zhang, Arnar Geirsson, Sarwat I. Chaudhry, Harlan Krumholz

Posted 16 Jan 2020
medRxiv DOI: 10.1101/2020.01.12.20017269

IntroductionImproving postoperative patient recovery after cardiac surgery is a priority, but our current understanding of individual variations in recovery and factors associated with poor recovery is limited. We are using a health-information exchange platform to collect patient-reported outcome measures (PROMs) and wearable device data to phenotype recovery patterns in the 30-day period after cardiac surgery hospital discharge, to identify factors associated with these phenotypes and to investigate phenotype associations with clinical outcomes. Methods and analysisWe designed a prospective cohort study to enroll 200 patients undergoing valve, coronary artery bypass graft, or aortic surgery at a tertiary center in the U.S. We are enrolling patients postoperatively after the intensive care unit (ICU) discharge, and delivering electronic surveys directly to patients every 3 days for 30 days after hospital discharge. We will conduct medical record reviews to collect patient demographics, comorbidity, operative details and hospital course using the Society of Thoracic Surgeons (STS) data definitions. We will use phone interview and medical record review data for adjudication of survival, readmission, and complications. We will apply group-based trajectory modeling to the time-series PROM and device data to classify patients into distinct categories of recovery trajectories. We will evaluate whether certain recovery pattern predicts death or hospital readmissions, as well as whether clinical factors predict a patient having poor recovery trajectories. We will evaluate whether early recovery patterns predict the overall trajectory at the patient-level. Ethics and disseminationThe Yale Institutional Review Board approved this study. Following the description of the study procedure, we obtain written informed consent from all study participants. The consent form states that all personal information, survey response, and any medical records are confidential, will not be shared, and are stored in an encrypted database. Strengths and limitations of this studyO_LIThis study will assess the patient perspective on recovery after cardiac surgery at a high frequency within the 30-day postoperative period with surveys and activity monitoring via a health information platform and wearable devices. C_LIO_LIUsing longitudinal patient-reported outcomes measure (PROM) data, this study will define recovery patterns and factors associated with different recovery trajectories and guide the development interventions to improve recovery and support expansion of the study to additional sites. C_LIO_LIThe study is single center and the sample size is limited. C_LI

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