Postoperative Pain Procedure Patient Remote Monitoring With MyHealthPal Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Patient Satisfaction (6-Week Point)
研究概览
简要总结
The investigators want to explore the use of a smartphone app that allows patients to take photos of their wounds in early stages of healing, so that clinicians can monitor wound-healing remotely with the assistance of an AI program.
Participants will choose whether they want to be in the control group or the app group. Participants in the app group will be asked to download an app on their personal smartphone before their surgery. After the procedure, participants will upload a photo of their surgery site as well as answer some questions about its characteristics either on a daily or weekly basis. A healthcare provider and the app's AI algorithm will observe this information to determine the risk of infection. Participants in the control group will not be asked to use the app. Their medical record will be monitored by study staff intermittently to see if they develop infection. This study will take approximately 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years old and older).
- •Ability to understand consent process and questionnaires. Patients with ready access to a smartphone, compatible smart device (operating system 5.0 version, also known as Lollipop, for Android and 13 or later version for iOS), smartphone aptitude, smartphone with sufficient memory space for the relevant app, and willingness to participate in the study as assessed by a questionnaire.
- •Patients undergoing one of the following surgeries within the Brigham and Women's Pain Management Practice:
- •Spinal cord stimulator implantation
- •Spinal cord stimulator explant
- •Spinal cord stimulator revision
- •Intrathecal pump implantation
- •Intrathecal pump explant
- •Intrathecal pump revision
- •Ability to attend all standard surgery follow-up appointments at Brigham and Women's Hospital.
- •Ability to understand and sign written informed consent documents.
排除标准
- •Cognitive or physical impairment that would prevent patient from entering data in MHP.
- •Any acute or chronic condition that would limit the ability of the patient to participate in the study.
- •Any patient who is experiencing an ongoing infection prior to undergoing a surgical revision/explant
研究组 & 干预措施
MyHealthPal App Users
If a participant chooses to be in the app study group, they will be provided with training materials on the MyHealthPal app. After set-up is complete, they will be asked to complete a quick survey on how the set-up went. After wound dressings are removed at the post-op visit, the participant will begin using the MyHealthPal app on their smartphone. For about 14 days, they will upload a photo of their surgical wound each day and answer a few questions about their wound and how they are feeling. After Day 21 (21 days after the surgery), they will upload a photo of their surgical wound and answer the same questions once every week for 4 months. The app will use the photos and answers to track wound healing and assess risk of infection. It will use AI to assess risk, and that assessment will be sent to the provider to confirm its accuracy. The participant will be asked to complete four more surveys regarding their opinion of the app and their post-op care.
干预措施: MyHealthPal App (Device)
Controls
Control participants will be required to complete one patient satisfaction survey six weeks post-operation, and will be given the choice to complete a second satisfaction survey sixteen weeks post-operation.
结局指标
主要结局
Patient Satisfaction (6-Week Point)
时间窗: From enrollment of first subject to 6 weeks post-operation of last subject
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.
Imageability
时间窗: From enrollment to end of app usage at 16 weeks post-surgery
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
时间窗: From enrollment to end of app usage at 16 weeks post-surgery
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%.
Patient Usage/Data Entry
时间窗: From enrollment to end of app usage at 16 weeks post-surgery
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.
Clinician Feedback
时间窗: From first enrollment to final subject's end of app usage at 16 weeks
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.
Safety Risk
时间窗: From first enrollment to final subject's end of app usage at 16 weeks
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.
次要结局
- Patient Satisfaction (16-Week Point)(From first enrollment to final subject's end of app usage at 16 weeks)
- Surgical Site Infection (SSI) Mortality Rate(From first enrollment to final subject's end of app usage at 16 weeks)
- Infection-Related Emergency Department Visits(From first enrollment to final subject's end of app usage at 16 weeks)
- Specificity(From first enrollment to final subject's end of app usage at 16 weeks)
- Sensitivity(From first enrollment to final subject's end of app usage at 16 weeks)
- Surgical Site Infection (SSI) Rate(From first enrollment to final subject's end of app usage at 16 weeks)
- Surgical Site Infection (SSI) Related Complications(From first enrollment to final subject's end of app usage at 16 weeks)
- Infection-Related Hospital Readmissions(From first enrollment to final subject's end of app usage at 16 weeks)
研究者
Olivia Sutton
Principal Investigator
Brigham and Women's Hospital