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| ID | Type | Description | Link |
|---|---|---|---|
| 2023 Dixon Translational Grant | Other Grant/Funding Number | Northwestern University Clinical and Translational Sciences Institute |
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| Sibel Health Inc. | INDUSTRY |
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Randomized controlled trial of a time motion study of time spent obtaining and charting vital signs for inpatients, comparing use of a wireless Bluetooth vital sign array as intervention versus routine vital sign obtainment activity on a general medical floor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention--Device Array Use | Experimental | Inpatients will wear the ANNE One device array for obtainment of vital sign assessments. |
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| Control--Routine Vital Sign Obtainment | Active Comparator | Inpatients will have vital signs determined by routine practice, using any other standard of care-accepted method or device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device Array Use | Device | Study participants assigned to the intervention study arm will wear a wireless Bluetooth capable vital sign detection array, with one device externally worn on each of their chest, one finger, and one arm, with healthcare providers using an additional oral temperature probe. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Motion Assessment of Time Spent Obtaining and Recording Vital Signs | The number of seconds spent by a healthcare provider obtaining and charting vital signs will be witnessed and recorded by a research staff member. | Number of seconds spent obtaining and charting vital signs is obtained at 8a daily, for maximum of three days for each study participant, and are added together to equal the total time spent on vital sign assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality of Inpatient Study Participants | Sleep quality will be determined by use of the Potential Hospital Sleep Disruptions and Noises Questionnaire survey, administered to study participants after a night of study enrolment. The survey scores sleep quality from 1 to 5 with 1 signifying no disruption and 5 signifying extreme disruption. | Survey conducted 24-72 hours after enrolment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory (Randy) R Smith Jr, MD MS | Contact | 312-926-5893 | g.smith@nm.org | |
| Jane S Kim, MS MEd | Contact | 312-926-7272 | jane.kim@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gregory (Randy) R Smith Jr, MD MS | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinberg 16 West, Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
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Randomized Controlled Trial
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| Routine Vital Sign Measurement | Device | Study participants randomized to the control arm will have their vital signs obtained by routine means, without use of the wireless vital sign device array. |
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| Patient Satisfaction with Inpatient Sleep Quality | Question 8, "During this hospital stay, how often were you able to get the rest you needed?" of the Hospital Consumer Assessment of Healthcare Providers and Systems post-discharge questionnaire will be collected for study participants. Survey responses include: never, sometimes, usually, always. | Survey sent within a week of hospital discharge and collected within the subsequent thirty days. |
| Healthcare Provider Experience with the Vital Sign Device Array | Healthcare providers who use the device array will be surveyed with a Technology Acceptance Method survey to assess usability of the device array. | The electronic survey will be administered twice during the study. Each survey will take approximately ten minutes to complete. |
| Northwestern Memorial Hospital | Not yet recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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