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临床试验/NCT06395636
NCT06395636招募中不适用

Using the Fitbit for Early Detection of Infection and Reduction of Healthcare Utilization After Discharge in Pediatric Surgical Patients

Ann & Robert H Lurie Children's Hospital of Chicago4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
4
主要终点
Trends in Participant Fitbit Data (Physical Activity, Heart Rate, Sleep) during the Recovery Period post Complicated Appendectomy

研究概览

简要总结

The purpose of this study is to analyze Fitbit data to predict infection after surgery for complicated appendicitis and the effect this prediction has on clinician decision making.

详细描述

We propose to investigate the use of objective near-real time data from the Fitbit consumer wearable device (CWD) for early detection of postoperative infection in children after appendectomy for complicated appendicitis, and its influence on clinician decision-making, time to first contact with the healthcare system, and postoperative healthcare use. SSI is usually associated with increased heart rate (HR) and reduced physical activity (PA), and sleep disturbances due to discomfort, pain, and fever.13-15 To help monitor patients post-discharge, CDWs can be used to detect physiologic changes, prompting early management.16,17 CWDs generate continuous, valid HR data comparable to clinical-grade HR monitor data for children, as well as objective PA and sleep data, which are good indicators of recovery.18-21 CWDs, then transmit these data in near-real time to a cloud-based system potentially accessible to a clinician. Although health systems have incorporated CWD data into electronic health records,16,17 use in post-discharge monitoring of pediatric surgery patients has been limited18 since it is difficult to monitor and interpret the large volumes of data generated by CWD in clinically meaningful ways.18 Machine learning (ML) methods, which reduce CWD data into clinically meaningful signals are needed.22 Since these algorithms are based on data from multiple CWD sensors, they are more accurate than threshold-based alerts.

We collected Fitbit data on 160 pediatric appendectomy patients21,23,24 and showed slower normative recovery PA trajectories in children with complicated versus simple appendicitis, and deviations from normative PA trajectory (decreased PA) before parents sought healthcare for complications.20 We then applied ML methods to Fitbit data of 80 post appendectomy patients with complicated appendicitis to predict infection. The preliminary algorithm predicted 90% of infections, 2 days before parental report. In parallel, we developed a proof-of-concept dashboard that delivers Fitbit data daily and on-demand in near real-time to clinicians. Using the dashboard, clinicians evaluated hypothetical post-discharge pediatric appendectomy scenarios with and without Fitbit dashboard data. Availability of Fitbit data (even without ML) substantially changed clinicians' likelihood of recommending ED care. While our early results are promising, a larger study is needed to definitively elucidate the association of changes in Fitbit data with postoperative infection and to assess the effect of Fitbit data on clinician decision-making and healthcare use. We propose to develop a ML algorithm for postoperative infection using Fitbit data of children 3-18 years old undergoing a appendectomy for complicated appendicitis at the Ann and Robert H. Lurie Children's Hospital of Chicago (LCH), a tertiary care children's hospital and two affiliated hospitals Loyola University Medical Center, a university hospital), and Central DuPage Hospital (CDH), a community hospital. Our two aims are:

Aim 1: Develop and externally validate an ML algorithm for postoperative infection. In addition to the 80 patients already recruited in our preliminary study, we will prospectively recruit 170 patients for a total of 250 from LCH for development and internal validation. We will then externally validate our infection ML algorithm using data on 122 appendectomy patients from LCH and its two affiliates.

Aim 2: Conduct a pre-post study to determine the effect of near real-time availability of the infection alert from Fitbit on clinical decision-making, time to first contact with the healthcare system, and healthcare utilization. We will place a Fitbit on 94 children after appendectomy recruited from LCH and its two affiliates, and send their surgeons daily reports of their recovery progress and near real-time, ML-based, clinical alerts of infection. In Aim 2a, we will use critical incident technique to qualitatively assess surgeons' decision-making after receiving Fitbit alerts and daily reports. In Aim 2b, we will compare median time to first contact with the healthcare system, healthcare use patterns (e.g., ED visits) and costs pre and post receiving alerts and daily reports.

Impact: This study is well aligned with NINR's priority to advance symptoms science. Developing CWD alerts to detect infection and evaluating their effect on clinical care have the potential to transform pediatric surgical care and pave the way for wide uptake of CWD. By proactively reaching to patients, this technology also has the potential to reduce existing disparities in seeking care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •children aged 3-18 years
  • •must be post-surgical laparoscopic appendectomy for complicated appendicitis (Appendicitis is categorized as complicated if perforation, phlegmon, or abscess was present at surgery.)

排除标准

  • •children who are non-ambulatory or have any pre-existing mobility limitations
  • •children who have a doctor-ordered physical activity limit >48 hours post-surgery
  • •children who have a comorbidity which will impact a patient's recovery
  • •children and/or parents who do not speak English or Spanish (Translation services beyond Spanish will not be available at this time)

研究组 & 干预措施

Aim 1 - Validation

No Intervention

1a. Development and Internal validation

  • analyze Fitbit data (PA, HR, sleep) by applying ML methods to create an infection algorithm indicating onset of infection.

1b. External Validation

  • Once the ML classifier has been internally validated (using Lurie Children's data only) for its ability to detect the presence or absence of postoperative infection using LOSO cross-validation, where each subject is iteratively held out from the training data and used as a test set. External validation will involve applying this classifier to a newer cohort at LCH and cohorts at Loyola University Hospital and CDH and evaluating its performance.

Aim 2 - Implementation of Algorithm

Experimental

2a. Exploratory & Inductive analysis

  • one transcript will be coded to generate initial themes, using qualitative analytic software 2b. Time to first contact with the healthcare system & Healthcare use
  • Cox regression model will be used to model the time to first contact, adjusted for covariates
  • All comparisons between the two groups will be tested using a chi-square test. Cost will be modeled as a continuous variable and is expected to be skewed, as is typical of cost data. We will use a general linear model (GLM) to model cost outcomes.

干预措施: Infection-Prediction Algorithm (Device)

结局指标

主要结局

Trends in Participant Fitbit Data (Physical Activity, Heart Rate, Sleep) during the Recovery Period post Complicated Appendectomy

时间窗: Fitbit data metrics will be collected for 30 days starting at date of enrollment.

Participant Fitbit data metrics (particularly PA, HR, Sleep) will be extracted from the app and analyzed using Machine Learning methods to eventually develop an algorithm to predict infection during the postoperative recovery period.

次要结局

  • Number of Reported Symptoms and Complications during Recovery(Daily Diary/Survey Submissions will be asked to be completed daily for 30 days starting day of enrollment.)
  • Healthcare Utilizations during Recovery Period(The diary / survey will require a submission every day for 30 days starting at day of enrollment.)
  • Change in Clinician Decision Making from Algorithm Results(For 30 days starting at day of participant enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fizan Abdullah, MD, PhD

Fizan Abdullah M.D., Ph.D

Ann & Robert H Lurie Children's Hospital of Chicago

研究点 (4)

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