Electronic Health Record-Integrated Patient-Generated Data

Wake Forest University (WFU)

Status: Not yet enrolling

Conditions: Sepsis

Treatments: Behavioral: Supplemental Text Messaging; Behavioral: Education and Training for Patient-Generated Data

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06668870

1UM1TR004929-01 (U.S. NIH Grant/Contract)

IRB00113850

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Supportive Messaging

Experimental group

Description:

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.

Treatment:

Behavioral: Supplemental Text Messaging

No Supportive Messaging

Active Comparator group

Description:

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.

Treatment:

Behavioral: Education and Training for Patient-Generated Data