Electronic Health Record-Integrated Patient-Generated Data

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Sepsis
• Intervention / Treatment: Behavioral: Supplemental Text Messaging; Behavioral: Education and Training for Patient-Generated Data

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Supplemental 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.
Active Comparator: 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.	Behavioral: Education 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Completed Versus Requested Patient-Generated Data	Patient generated data completion defined as the proportion of completed vs requested patient generated data elements.	90 days post hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Readmissions	Number of readmissions to inpatient or observation status due to any cause assessed via electronic health record.	90 days post hospital discharge
Number of Deaths	Number of participant deaths due to any cause, assessed via electronic health record and national data sources integrated in the enterprise data warehouse.	90 days post hospital discharge
Number of Emergency Department Visits	Number of Emergency Department visits assessed via electronic health record.	90 days post hospital discharge
Number of Outpatient Clinic Visits	Number of outpatient clinic visits assessed via electronic health record	90 days post hospital discharge
Number of Hospital-Free Days	Number of hospital-free days calculated by total of days alive minus days hospitalized, measured from electronic health record data.	90 days post hospital discharge

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Marc Kowalkowski, PhD, Atrium Health Wake Forest Baptist

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: transitional care; patient-generated data collection; electronic health record monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Investigative Techniques; Epidemiologic Methods; Data Collection; Socioeconomic Factors; Population Characteristics; Records; Medical Records; Health Records, Personal; Educational Status; Patient Generated Health Data
• Other Study ID Numbers: IRB00113850; 1UM1TR004929-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification will be shared (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Will share with researchers who provide a methodologically sound proposal to assist in achieving aims in the approved proposal. Proposals should be directed to ehale@wakehealth.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No