SepsisNCT06668870
Electronic Health Record-Integrated Patient-Generated Data
A study testing Supplemental Text Messaging and Education and Training for Patient-Generated Data in people with Sepsis, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Supplemental Text Messaging and Education and Training for Patient-Generated Data
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Discharged from the hospital with hospice care
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Supplemental Text Messaging, Education and Training for Patient-Generated Data
- Keywords
- patient-generated data collection, electronic health record monitoring, transitional care
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental Text MessagingBehavioural
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.
Education and Training for Patient-Generated DataBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education and Training for Patient-Generated Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Completed Versus Requested Patient-Generated Data
Patient generated data completion defined as the proportion of completed vs requested patient generated data elements.
Measured: 90 days post hospital discharge
Secondary outcomes (5)
Number of Readmissions
Number of readmissions to inpatient or observation status due to any cause assessed via electronic health record.
Measured: 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.
Measured: 90 days post hospital discharge
Number of Emergency Department Visits
Number of Emergency Department visits assessed via electronic health record.
Measured: 90 days post hospital discharge
Number of Outpatient Clinic Visits
Number of outpatient clinic visits assessed via electronic health record
Measured: 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.
Measured: 90 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: protocol changes were made and study no longer a clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Marc Kowalkowski, PhD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668870
- Sponsor's protocol ID
- IRB00113850
- Other IDs
- 1UM1TR004929-01
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification will be shared (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Health Record-Integrated Patient-Generated Data to Support Clinical Care and Research
- ClinicalTrials.gov ID
- NCT06668870
- Acronym / sponsor ID
- IRB00113850
- Conditions
- Sepsis
- Keywords
- patient-generated data collection, electronic health record monitoring, transitional care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: protocol changes were made and study no longer a clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Messaging | Experimental | Behavioral: Supplemental Text MessagingSupportive 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. |
| No Supportive Messaging | Active comparator | Behavioral: Education and Training for Patient-Generated DataParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Discharged from the hospital with hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental Text MessagingWill 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. | Behavioural | Supportive Messaging |
| Education and Training for Patient-Generated DataWill 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. | Behavioural | No Supportive Messaging |
Primary outcome
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.
5 secondary outcomes
Number of Readmissions
Time frame: 90 days post hospital discharge
Number of Deaths
Time frame: 90 days post hospital discharge
Number of Emergency Department Visits
Time frame: 90 days post hospital discharge
Number of Outpatient Clinic Visits
Time frame: 90 days post hospital discharge
Number of Hospital-Free Days
Time frame: 90 days post hospital discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification will be shared (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Kowalkowski, PhD principal investigator
Atrium Health Wake Forest Baptist
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental Text Messaging and Education and Training for Patient-Generated Data in people with Sepsis, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Completed Versus Requested Patient-Generated Data (time frame: 90 days post hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.