Pip Care to Improve Surgical Patient Outcomes
Utilization of Digital Health Platform Plus Live Coaching Improves Surgical Patients Outcomes - Phase II
2 other identifiers
interventional
1,300
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedStudy Start
First participant enrolled
October 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
October 28, 2025
October 1, 2025
2.9 years
October 24, 2024
October 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Length of Hospital Stay
The total length of hospital stay (# of days) compared between study groups. Outcome will be reported as mean(SD).
Up to 7 days following surgery
Hospital Readmission
This outcome will be measured by the count of participants who experience hospital readmission following surgery in each study group.
Up to 30 days following surgery
Secondary Outcomes (3)
Emergency Room Visits Post-Operatively
Up to 30 days following surgery
Discharge to Long-term Care Facility
Up to 30 days following surgery
Complication Rates
Up to 30 days following surgery
Study Arms (2)
Pip Care Intervention Group
EXPERIMENTALSubjects 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.
Standard of Care Group
ACTIVE COMPARATORSubjects randomized to the standard of care group will receive routine standard of care for their planned elective, inpatient surgery.
Interventions
Pip Care Digital Health Platform is a smartphone application granting access to a health coach who will assist the patient in completing a health intake, creating personalized perioperative care plans, and meets regularly with the patient to encourage goal accomplishments and supports healthy surgical recovery.
Subjects in this intervention group will receive routine, standard of care throughout their surgery and hospital stay as determined by their acting clinical care team.
Eligibility Criteria
You may qualify if:
- Adult patient ≥18 years old
- Planned elective, inpatient surgery between 2 to 8 weeks following enrollment in Pip within the following surgical specialties: complex abdominal surgery (general surgery, colorectal surgery, surgical oncology), gynecologic oncology, thoracic surgery, spine surgery, and orthopedic joint surgery
- Daily access to a smartphone or tablet.
You may not qualify if:
- Unable to speak English
- Unable to use a smartphone or tablet independently or with daily assistance.
- Currently pregnant (assessed via standard-of-care pre-operative workup)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
UPMC Jameson Hospital
New Castle, Pennsylvania, 16105, United States
UPMC East Hospital
Pittsburgh, Pennsylvania, 15146, United States
UPMC Horizon
Pittsburgh, Pennsylvania, 15213, United States
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15213, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Holder-Murray, MD
University of Pittsburgh, UPMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 24, 2024
First Posted
October 28, 2024
Study Start
October 13, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
October 28, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will become available as soon as it is retrieved per subject and will be available for 3.5 years (duration of the study enrollment and one year after for data analysis purposes)
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
De-identified data may be shared with others inside and outside of the University who are conducting similar research. Though, at this time, there is no plan to share data with outside universities. De-identified data will be shared with PIP CARE INC.