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| Name | Class |
|---|---|
| Leaf Healthcare, Inc. | INDUSTRY |
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The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.
This single site, open label, two arm randomized control trial aims to evaluate whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Optimal turning procedures will be obtained with the use of a patient monitoring system (Leaf Healthcare, Inc.) and compared to standard preventative care practices.
Sensors were placed on all participants as they were admitted to ICU. A nurse's user dashboard was turned on for participants in the Optimal Turning Group, but was not turned on for participants in the Standard Care group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment - Optimal Turning | Experimental | All patients will have a sensor applied. Patients within this arm will receive care from nurses who have access to a User Dashboard that provides visual advisories for patient turning, based on data obtained from a wearable patient sensor (Leaf Healthcare, Inc.). |
|
| Control - Standard Care | Active Comparator | All patients will have a sensor applied. Patients within this arm will receive care from nurses who DO NOT have access to a User Dashboard that provides visual advisories for patient turning. Instead, these patients will receive standard care practices, patient turning initiated by nurses as necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimal Turning | Other | Patients within this arm will receive optimal turning practices. Nurses caring for these patients will receive real-time quantitative measures of patient turning procedures from the User Dashboard and provide a visual advisory to the nurse for the time to next turn. |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers | NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported.
| Duration of ICU admission (average 1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Patient Turning Procedures | Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours. | Duration of ICU admission (average 1 week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Pickham, PhD | Stanford Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27053145 | Derived | Pickham D, Ballew B, Ebong K, Shinn J, Lough ME, Mayer B. Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial. Trials. 2016 Apr 6;17:190. doi: 10.1186/s13063-016-1313-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment - Optimal Turning | All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor. |
| FG001 | Control - Standard Care | All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Allocation |
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| Treatment |
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Per protocol population according to treatment received (met minimum monitoring period (>2h) and did not receive both interventions)
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment - Optimal Turning | All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor. |
| BG001 | Control - Standard Care |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers | NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported.
| Per protocol population according to treatment received (met minimum monitoring period (>2h) and did not receive both interventions) | Posted | Count of Participants | Participants | Duration of ICU admission (average 1 week) |
|
Duration of ICU admission (average 1 week)
Adverse events are reported according to treatment received
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment - Optimal Turning | All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David Pickham | Stanford University School of Medicine | 650 701 6830 | dpickham@stanford.edu |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
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| Standard Care Practices | Other | Patients within this arm will receive standard preventative care practices - that is, nurses will provide standard care as necessary, without the aid of visual advisories from a patient sensor. |
|
| Patient Sensor | Other | A small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside. |
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| COMPLETED |
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| NOT COMPLETED |
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All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.
| OG001 | Control - Standard Care | All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary. |
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| Secondary | Compliance With Patient Turning Procedures | Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours. | Per protocol population according to treatment received (met minimum monitoring period (>2h) and did not receive both interventions) | Posted | Mean | Standard Deviation | percentage of time | Duration of ICU admission (average 1 week) |
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| 0 |
| 709 |
| 0 |
| 709 |
| EG001 | Control - Standard Care | All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary. | 0 | 603 | 0 | 603 |
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