Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity

Keywords

• time motion study
• vital signs
• sleep quality
• inpatient sleep
• wireless device
• patient satisfaction

Lead sponsor

Northwestern University is the lead sponsor of 1,398 studies on the registry; 201 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Study arms

• Experimental
  Intervention--Device Array Use

  Inpatients will wear the ANNE One device array for obtainment of vital sign assessments.

  Device: Device Array Use

• Active comparator
  Control--Routine Vital Sign Obtainment

  Inpatients will have vital signs determined by routine practice, using any other standard of care-accepted method or device.

  Device: Routine Vital Sign Measurement

Interventions

• DeviceDevice Array Use

  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.

• DeviceRoutine Vital Sign Measurement

  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.

Primary outcomes

1. 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.

   Time frame: 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.

Secondary outcomes

1. 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.

   Time frame: Survey conducted 24-72 hours after enrolment.

2. 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.

   Time frame: Survey sent within a week of hospital discharge and collected within the subsequent thirty days.

3. 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.

   Time frame: The electronic survey will be administered twice during the study. Each survey will take approximately ten minutes to complete.

Individual participant data

Plan to share: No