Post-Surgery Wound Healing Tracking With MyHealthPal App

Imageability is defined as the percentage of wound incision photos that received an surgical site infection (SSI) risk prediction (high enough quality photos) by the MyHealthPal (MHP) app artificial intelligence algorithm among all photos uploaded by patients. High imageability is a critical step in MHP's predictive effectiveness. MHP Patient app guides patients on how to take surgical incision photos that are high enough quality for analysis. Target imageability percentage is greater than or equal to 95%.

Positive/negative percent agreement will be sought for each MyHealthPal (MHP) prediction by receiving feedback from one of the study investigators. The investigator will be prompted to agree or disagree with each MHP prediction (elevated or standard risk for a surgical site infection, or SSI). Final positive/negative agreement percentage will be calculated after the last subject completes the 16-week study period. The objective threshold for agreement percentage is >90%.

MyHealthPal (MHP) effectiveness is directly dependent on patient use and data entry. This study aims to demonstrate >70% patient compliance with the monitoring plan data entry requirements. Patient compliance with data entry will be calculated by input category, wound photo, wound inputs, vital signs, medication adherence, and well-being, as well as overall patient compliance with all data entry requirements that are defined in the patient monitoring plan.

When clinicians agree or disagree with the MyHealthPal (MHP) app's prediction, they are encouraged to submit their feedback on incision characteristics that they observe in the photos. This feedback is particularly helpful in identifying early/leading indicators of surgical site infections (SSIs). In this study, an objective is for clinicians to submit their comments greater than or equal to 95% of the time they have agreed or disagreed with a prediction.

MyHealthPal (MHP) is a digital platform that complements current patient care and does not impact the standard of care. Nevertheless, one of the study's objectives is to confirm that MHP use does not pose any patient safety risks. Risk factors for affected wound healing will be recorded for both the control and MyHealthPal app group as well as surgical site infection rates in both groups. Data from patients with similar risk factors across both groups will be compared to ensure that there is not a significant difference in infection incidence when MHP usage is a factor in post-operative wound monitoring.

The final primary objective is to measure patient satisfaction at the 6-week post-operation visit, which is typically the final follow-up visit for operation recovery per the Pain Management Clinic's standard of care. By having controls and app users complete this survey at the 6-Week mark, the level of satisfaction with their care can be compared; this study aims to demonstrate that the added tracking via MyHealthPal will increase patient comfortability and satisfaction with post-operative care.

Specificity measurement refers to the comparison of the MyHealthPal (MHP) application predictions against a reference standard. In this study, the reference standard will be an infection diagnosis by a study investigator (classified as definite or probable). Specificity refers to how often the test is negative when the condition of interest is absent. For this study, a negative new test is a standard risk prediction, while positive new test is an elevated risk prediction. True positive or true negative events (infection or no infection) will be determined by an investigator through standard clinical diagnostic tests. A secondary objective is calculated specificity to be equal to or greater than 85%.

Sensitivity refers to how often the test is positive when the condition of interest is present. In this study, the reference standard will be an infection diagnosis by a study investigator (classified as definite or probable). For this study, a negative new test is a standard risk prediction, while positive new test is an elevated risk prediction. True positive or true negative events (infection or no infection) will be determined by an investigator through standard clinical diagnostic tests. A secondary objective is calculated sensitivity to be equal to or greater than 85%.

Another secondary objective is to measure the rate of surgical site infections (SSIs) in participants using the MyHealthPal (MHP) app in comparison to non-app participants. There should be no change in number of SSIs between groups as MHP is not an SSI prevention tool.

Another secondary objective is to measure number of surgical site infection (SSI) related complications when using the MyHealthPal (MHP) app in comparison to non-app participants. There should be a reduction in the number of SSI-related complications in the MHP group.

Another secondary objective is to measure the SSI mortality rate in participants using the MyHealthPal (MHP) app and non-app participants. There should be a reduction in the SSI mortality rate in the MHP group.

Another study measure is the amount of infection-related visits to the Emergency Department (ED) and hours spent there. There should be a reduction in ED visits and time spent at the ED in the MyHealthPal (MHP) group.

Another study measure is the number of infection-related readmissions to the hospital and days spent admitted. There should be a reduction innumber of readmissions and days spent admitted in the MyHealthPal (MHP) group.

A secondary objective will be measuring patient satisfaction in post-operative care at the 16-Week post-operation study endpoint. As this is ten weeks past the standard of care final visit, this survey will be optional for control subjects.