Clinical trial NCT06661291: Pip Care to Improve Surgical Patient Outcomes
Official title: Utilization of Digital Health Platform Plus Live Coaching Improves Surgical Patients Outcomes - Phase II
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Surgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-10-28
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Clinical Trial to determine the effectiveness of Pip Care in improving clinical and patient reported outcomes when compared to standard perioperative care in 1300 subjects.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: In the United States (US), 48 million surgeries are performed annually, and despite medical and surgical advancements, postoperative complications are the third leading cause of death. Perioperative risk varies between patients based on their health and surgical procedure. Patients with intermediate or high perioperative risk experience extended hospital stays, higher readmission rates, and frequent adverse events, including death. The national burden for such cases costs $31.35 billion annually. As a result, the healthcare industry is prioritizing the advancement of perioperative care to reduce postoperative complications and improve patient outcomes. While clinical care teams provide clinical pathways for patients, patients find the perioperative journey complex and impersonal. Patients often don't have access to a tailored preparation plan and personal guidance, emotional support, and motivation despite the high level of perioperative care detail and the vulnerable status of patients. Therefore, there is an unmet need to provide patients with comprehensive perioperative care guidance and support with the enhanced human touch to reduce postoperative complications. Integrating clinical pathways prepared by interdisciplinary care teams and digital health platform offers opportunities to improve patient outcomes through improved prehabilitation and postoperative engagement.

PRELIMINARY DATA:

The first version of Pip included three pathways (nutrition, fitness, and smoking cessation). In a pilot study with the Center for Perioperative Center (CPC) at the University of Pittsburgh Medical Center (UPMC), implementation of Pip resulted in the reduction of the median length of stay (LOS) by one day. The same-day surgery cancellations were avoided 99.5 % of the time. Pip also received an aggregate patient satisfaction score of 4.8 out of 5 (vs. industry benchmarks of 3.8-4.3).

Pip Care partnered with the UPMC CPC to digitize and implement clinical pathways, created by perioperative experts at UPMC, into modular digital care contents. Pip Care, CPC, and surgical offices developed a workflow that was both operationally and clinically seamless. The Pip DHP was designed to replace the time-consuming clinic follow-ups and care coordination through the different phases of the perioperative process. In addition to Health Coach follow-up, patients were invited to not only receive notifications and report outcomes, but to explore a library of educational multimedia resources on disease processes and why optimization of said diseases is important prior to surgery. Pip also identified patients who were not engaging with the clinical team and offered further remediation to help prevent poor outcomes.

Pip Digital Platform Development. The Pip technology platform is powered by two connected components: (1) Back-end platform utilized by health coaches and (2) Front-end native digital mobile application utilized by patients. The front-end digital mobile application contains four key features, which are represented by separate pages within the digital application: (1) Pip My Plan, which displays when patients are assigned personalized care plans and tasks by their Health Coach, (2) Pip Appointments, which patients schedule and join weekly video or voice calls with the Health Coach, (3) Pip Messages patients have access to unlimited engagement with their Health Coach, and (4) a library of health system-approved education content, including articles and videos, to assist with their surgery preparation and recovery. Figure 4 summarizes the initial Pip care plans: 8 total care plans including 3 clinical pathways (smoking cessation, weight management, and nutrition). To make the application patient-centered and accessible to all with mobile technology while improving communication, language for the application (e.g., questions, answers, instructions), and other content within the application are presented at a maximum reading level of the eighth grade. Pip is designed to function on both iOS (Apple Inc, Cupertino, CA) and Android (Google Inc, Mountain View, CA) operating systems.

Case Matched Pilot Clinical Study. A pilot clinical study at UPMC recently demonstrated feasibility and improved outcomes in case matched patients. The investigators have developed and validated the feasibility of the Pip Care digital platform with Health Coach and digital protocols. This was a Quality Improvement approved descriptive, prospective feasibility study of patients scheduled for elective surgery, invited to enroll in Pip from 2.5-4 weeks preoperatively through 4 weeks postoperatively at UPMC between 11/2/2022 - 3/27/2023. Descriptive primary endpoints included patient satisfaction, patient engagement, Pip Health Coach evaluations, and other PROs. Secondary endpoints included length of stay (LOS), readmission rates, and emergency department utilization rates within 30 days. Mean age was 64 years.

High Engagement and Satisfaction Scores. Our primary outcomes focused on feasibility of deployment of the combined platform and the patient assessment of the experience. Out of 283 patients invited to Pip, 172 patients (61%) were enrolled compared to industry benchmarks between (5% and 30%). Of those enrolled, 143 (83%) had one or more Health Coach sessions. During the study, of the patients who had one or more Health Coach sessions, 138 (97%) proceeded to surgery, a 4-8% improvement compared to industry benchmarks (90-93%). After surgery, 97 (70%) patients engaged with Pip postoperatively, a 35-126% improvement compared to industry benchmarks (31-52%). Pip received a total of 95 patient satisfaction survey submissions. Patients reported an overall high satisfaction based on the satisfaction survey (average score 4.8 out of 5, n=95). Patients strongly agree that Health Coach helped them throughout the perioperative process based on Pip Health Coach evaluation (average score 4.97 out of 5, n=33). The average Net Promotor Score, a customer experience metric, was 9.7 out of 10.

LOS and Readmission. Stabilized inverse probability of treatment weighting (SIPTW) was created to reduce selection bias and balance the patient characteristics (i.e., age, procedures, and perioperative risk score) in Pip and non-Pip cohorts. A total of 128 patients in the Pip cohort were compared to 268 patients in the non-Pip cohort. Pip was significantly associated with a 24% reduction in postoperative LOS (mean 2.4 vs. 3.1 days; median 1.9 vs. 3.0 days; mean ratio: 0.76; 95%CI: 0.62-0.93). Pip was associated with a 49% lower risk in 7-day readmission (relative risk: 0.51; 95%CI: 0.11-2.31) and 17% lower risk in 30-day readmission (relative risk: 0.83; 95%CI: 0.30-2.31), though not statistically significant. Pip and non-Pip groups had similar risk in 30-day ED returns (relative risk: 1.06; 95%CI: 0.56-2.01).

Patient Feedback to the Health Coach. An overwhelmingly positive aspect was the patient feedback and response to the Health Coach. The following comments support current evidence that high level engagement is very important to patients and their outcomes

"This has been a medical experience I will not forget. \[The Health Coach\] was patient and kind and encouraging. His support was vital to my experience." - Patient

"Talking to \[the Health Coach\] has helped me to feel a bit better and know that I am doing all that is in control to get ready for surgery." - Patient

Eligibility criteria: Inclusion Criteria:

1. Adult patient ≥18 years old
2. 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
3. Daily access to a smartphone or tablet.

Exclusion Criteria:

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

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: Up to 7 days following surgery
measure: Hospital Readmission
timeFrame: Up to 30 days following surgery
Secondary outcomes:
measure: Emergency Room Visits Post-Operatively
timeFrame: Up to 30 days following surgery
measure: Discharge to Long-term Care Facility
timeFrame: Up to 30 days following surgery
measure: Complication Rates
timeFrame: Up to 30 days following surgery
Other outcomes:
Locations:
city: New Castle
country: United States
facility: UPMC Jameson Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Horizon
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Magee Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Passavant Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, UPMC
name: Jennifer Holder-Murray, MD
role: PRINCIPAL_INVESTIGATOR
References: