1300 Participants Needed

Pip Care Platform for Abdominal Surgery

Recruiting at 5 trial locations
CR
AM
Overseen ByAmy Monroe, MPH, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Pip Care Digital Health Platform treatment for abdominal surgery?

Research shows that using a mobile app for collecting patient-reported outcomes in surgery can improve patient care by providing real-time feedback and preventing unnecessary hospital visits. This suggests that digital health platforms like Pip Care could enhance recovery and resource use in abdominal surgery.12345

How is the Pip Care Digital Health Platform treatment different from other treatments for abdominal surgery?

The Pip Care Digital Health Platform is unique because it uses a digital approach to monitor and support patients after abdominal surgery, providing real-time feedback and personalized care through a mobile application. This contrasts with traditional treatments that may not offer continuous, personalized monitoring and feedback outside of the hospital setting.16789

What is the purpose of this trial?

Pip Care is developing a personalized, interactive surgical journey platform with a live health coach that works directly with health systems to optimize the perioperative care process. Our Health Insurance Portability and Accountability Act (HIPAA)-compliant platform, Pip, can be integrated into any electronic medical record (EMR), thus alleviating the administrative burden by making operational workflows more efficient. The PIP empowers patients and their families to be more involved in their care by breaking down a patient's healthcare plan into definable, easy-to-understand, and easy-to-complete tasks. Additionally, a health coach completes a health intake to create a personalized perioperative care plan, meets regularly with the patient to encourage goal accomplishment, and facilitates care coordination. This project has 2 phases; Phase I is to assess usability of the Pip Care platform in surgical patients, Phase II is a RCT (Randomized Controlled Trial) to assess surgical clinical outcomes while using Pip compared to standard of care.

Research Team

JH

Jennifer Holder-Murray, MD

Principal Investigator

University of Pittsburgh, UPMC

Eligibility Criteria

This trial is for patients undergoing abdominal surgery. Participants must be willing to use the Pip Care digital health platform alongside standard care protocols. Specific eligibility criteria are not detailed, but typically include factors like age, health status, and type of surgery.

Inclusion Criteria

Daily access to a smartphone or tablet.
I am scheduled for a major surgery in one of the specified areas within 2 to 8 weeks after joining.

Exclusion Criteria

Unable to use a smartphone or tablet independently or with daily assistance
Currently pregnant (assessed via standard-of-care pre-operative workup)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Participants receive personalized care plans and tasks by their Health Coach, including weekly video or voice calls and access to educational content.

1 week
Weekly video or voice calls

Surgery and Immediate Postoperative Care

Participants undergo their scheduled elective, inpatient surgery and receive immediate postoperative care.

Up to 7 days

Postoperative Follow-up

Participants retain access to the digital health platform for 30 days following surgery, with continued engagement and monitoring for safety and effectiveness.

30 days

Treatment Details

Interventions

  • Pip Care Digital Health Platform
Trial Overview The study is testing if using the Pip Care digital platform with a live health coach improves surgical outcomes compared to just following standard care protocols. Phase II of this study randomly assigns patients to either receive Pip Care or stick with usual procedures.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Pip Care Intervention GroupExperimental Treatment1 Intervention
Subjects randomized to the Pip Care Intervention group will receive access to the Pip Care digital health platform 1-week prior to their scheduled elective, inpatient surgery and retain access to the digital health platform for 30-days following surgery.
Group II: Standard of Care GroupActive Control1 Intervention
Subjects randomized to the standard of care group will receive routine standard of care for their planned elective, inpatient surgery.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Findings from Research

A digital monitoring application was developed through collaborative design with patients and health professionals to support colorectal cancer patients during the first 30 days post-surgery, aiming to improve patient care and outcomes.
The app allows patients to report concerns to healthcare providers, which can help in early identification of issues, reduce readmission rates, and enhance recovery experiences by providing timely support and relevant information.
Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery.Miller, M., Roxburgh, CS., McCann, L., et al.[2023]

References

Using a Mobile Application for Real-Time Collection of Patient-Reported Outcomes in Hepatopancreatobiliary Surgery within an ERAS® Pathway. [2020]
Utilising Electronic PROMs to Measure a Change in Health Following Elective Laparoscopic Cholecystectomy: A Feasibility Study. [2023]
An acute knee injury: tracking a two-year recovery online. [2019]
Impact of Digital Health upon the Surgical Patient Experience: The Patient as Consumer. [2023]
The next step in surgical quality improvement: outcome situational awareness [2021]
Patient experiences of an electronic PRO tailored feedback system for symptom management following upper gastrointestinal cancer surgery. [2022]
Assessing patient-reported outcomes of cholecystectomy in short-stay surgery. [2021]
Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery. [2023]
Development and Feasibility of an Interactive Smartphone App for Early Assessment and Management of Symptoms Following Pancreaticoduodenectomy. [2020]
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