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Electronic Health Record-Integrated Patient-Generated Data

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06668870
Enrollment
0
Registered
2024-11-01
Start date
2026-04-01
Completion date
2026-10-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

patient-generated data collection, electronic health record monitoring, transitional care

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.

Interventions

BEHAVIORALSupplemental Text Messaging

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. Supplemental text messages will be sent to engage patients and deliver personalized reminders to complete monitoring tasks.

BEHAVIORALEducation and Training for Patient-Generated Data

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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Completed Versus Requested Patient-Generated Data90 days post hospital dischargePatient generated data completion defined as the proportion of completed vs requested patient generated data elements.

Secondary

MeasureTime frameDescription
Number of Readmissions90 days post hospital dischargeNumber of readmissions to inpatient or observation status due to any cause assessed via electronic health record.
Number of Deaths90 days post hospital dischargeNumber of participant deaths due to any cause, assessed via electronic health record and national data sources integrated in the enterprise data warehouse.
Number of Emergency Department Visits90 days post hospital dischargeNumber of Emergency Department visits assessed via electronic health record.
Number of Outpatient Clinic Visits90 days post hospital dischargeNumber of outpatient clinic visits assessed via electronic health record
Number of Hospital-Free Days90 days post hospital dischargeNumber of hospital-free days calculated by total of days alive minus days hospitalized, measured from electronic health record data.

Contacts

PRINCIPAL_INVESTIGATORMarc Kowalkowski, PhD

Atrium Health Wake Forest Baptist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026