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Clinical Trials/NCT06668870
NCT06668870
Not yet recruiting
Not Applicable

Electronic Health Record-Integrated Patient-Generated Data to Support Clinical Care and Research

Wake Forest University Health Sciences0 sites200 target enrollmentApril 1, 2026

Overview

Phase
Not Applicable
Intervention
Supplemental Text Messaging
Conditions
Sepsis
Sponsor
Wake Forest University Health Sciences
Enrollment
200
Primary Endpoint
Proportion of Completed Versus Requested Patient-Generated Data
Status
Not yet recruiting
Last Updated
last month

Overview

Brief Summary

The purpose of this study is to find out if patients that receive supportive messaging with response adaptation are more likely to adhere to patient-generated data collection and electronic health record integration, compared to patients that do not receive supportive messaging.

Detailed Description

This project will directly inform re-usable strategies to support the integration of important patient-generated data (PGD) into the electronic health record to improve clinical care and research. For this application, investigators propose to develop and test the PGD translational science innovation in patients recovering from sepsis. This diverse patient population frequently suffers from long-term complications that are ideally suited for development and demonstration of strategies to collect, integrate, and examine PGD and builds directly on the study team's robust research portfolio on improving sepsis recovery.

Registry
clinicaltrials.gov
Start Date
April 1, 2026
End Date
October 1, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Discharged alive from the hospital without hospice care who meet clinical criteria for infection and organ dysfunction consistent with sepsis
  • Enrolled into the Sepsis Transition and Recovery program
  • Enrolled or willing to enroll as an Epic MyChart user

Exclusion Criteria

  • Discharged from the hospital with hospice care

Arms & Interventions

Supportive Messaging

Supportive messaging is a behavioral intervention delivered to motivate patients to engage with targeted patient-generated data collection tools. Participants will be asked to complete patient-generated data. At baseline, all patients will receive education about the collection of patient-generated data, training in using the data collection tools, and guidance on the standard frequency for collection and sharing of information. At baseline and regular intervals throughout follow up, the supportive messaging arm will receive added text messaging to engage patients and deliver personalized reminders to complete monitoring tasks.

Intervention: Supplemental Text Messaging

No Supportive Messaging

Participants will be asked to complete patient-generated data. At baseline, participants will receive education about the collection of patient-generated data, training in using the data collection tools, and guidance on the standard frequency for collection and sharing of information. Participants will not receive added text messaging to engage patients and deliver personalized reminders to complete monitoring tasks.

Intervention: Education and Training for Patient-Generated Data

Outcomes

Primary Outcomes

Proportion of Completed Versus Requested Patient-Generated Data

Time Frame: 90 days post hospital discharge

Patient generated data completion defined as the proportion of completed vs requested patient generated data elements.

Secondary Outcomes

  • Number of Readmissions(90 days post hospital discharge)
  • Number of Deaths(90 days post hospital discharge)
  • Number of Emergency Department Visits(90 days post hospital discharge)
  • Number of Outpatient Clinic Visits(90 days post hospital discharge)
  • Number of Hospital-Free Days(90 days post hospital discharge)

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