Electronic Health Record-Integrated Patient-Generated Data

NCT06668870 | Withdrawn

• 2 other identifiers: IRB001138501UM1TR004929-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Supportive Messaging

EXPERIMENTAL

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

No Supportive Messaging

ACTIVE COMPARATOR

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

Interventions

Supplemental Text Messaging BEHAVIORAL

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.

Supportive Messaging

Education and Training for Patient-Generated Data BEHAVIORAL

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.

No Supportive Messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Discharged from the hospital with hospice care

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Sepsis

Interventions

Educational Status; Patient Generated Health Data

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Health Records, Personal; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• Marc Kowalkowski, PhD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.