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Pip Care to Improve Surgical Patient Outcomes

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
Enrollment reduced 31% 1300 → 900 participants
See other at-risk trials from University of Pittsburgh

Record History

  1. Primary endpoint(s) modified Enrollment reduced: 1300 → 900 participants · Eligibility criteria revised · Secondary endpoints: 3 to 4 · 1 morev7 Show 4 more changesShow less
    • Enrollment reduced: 1300 → 900 participants
    • Eligibility criteria revised
    • Secondary endpoints: 3 to 4
    • Site contacts updated at 8 of 8 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 7 to 8v6
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 6 to 7 · Start date changed from estimate of Aug 30, 2025 to Oct 13, 2025v5 Show 2 more changesShow less
    • Study sites: 6 to 7
    • Start date changed from estimate of Aug 30, 2025 to Oct 13, 2025
  4. Start date: Jun 30, 2025 to Aug 30, 2025v4
  5. Start date: Apr 1, 2025 to Jun 30, 2025 Site contacts updated at 1 of 6 sitesv3 Show 1 more changeShow less
    • Site contacts updated at 1 of 6 sites
  6. Start date: Feb 1, 2025 to Apr 1, 2025 Study sites: 5 to 6 · Interventions: Pip Care Digital Health Platform (Device), Standard of Care Protocol (Other) to Pip Care Digital Health Platform (Other), Standard of Care Protocol (Other) · Study description revised · 1 morev2 Show 4 more changesShow less
    • Study sites: 5 to 6
    • Interventions: Pip Care Digital Health Platform (Device), Standard of Care Protocol (Other) to Pip Care Digital Health Platform (Other), Standard of Care Protocol (Other)
    • Study description revised
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06661291
Lead Sponsor University of Pittsburgh
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Abdominal Surgery
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov