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| ID | Type | Description | Link |
|---|---|---|---|
| 1UM1TR004929-01 | U.S. NIH Grant/Contract | View source |
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protocol changes were made and study no longer a clinical trial
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Kowalkowski, PhD | Atrium Health Wake Forest Baptist | Principal Investigator |
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Individual participant data that underlie the results reported in this article, after deidentification will be shared (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
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.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D000076206 | Patient Generated Health Data |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D055991 | Health Records, Personal |
| D008499 | Medical Records |
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| 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. |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |