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

Not Applicable

Recruiting

• Conditions: Vital Sign Evaluation; Vital Sign Monitoring; Sleep Quality; Provider Behavior; Patient Satisfaction

• Registration Number: NCT06995742
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-05-21
• Study First Posted: 2025-05-29
• Status Verified: 2025-06
• Study Start: 2025-06-02
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Inpatients admitted to Northwestern Memorial Hospital, Feinberg Unit 16 West.

Exclusion Criteria

• Primary language other than English, under isolation status, pregnant patients, prisoners, employees or students of the hospital or Northwestern University.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time Motion Assessment of Time Spent Obtaining and Recording Vital Signs	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.	The number of seconds spent by a healthcare provider obtaining and charting vital signs will be witnessed and recorded by a research staff member.

Secondary Outcome Measures

Name	Time	Method
Sleep Quality of Inpatient Study Participants	Survey conducted 24-72 hours after enrolment.	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.
Patient Satisfaction with Inpatient Sleep Quality	Survey sent within a week of hospital discharge and collected within the subsequent thirty days.	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.
Healthcare Provider Experience with the Vital Sign Device Array	The electronic survey will be administered twice during the study. Each survey will take approximately ten minutes to complete.	Healthcare providers who use the device array will be surveyed with a Technology Acceptance Method survey to assess usability of the device array.

Trial Locations

Locations (2)

Feinberg 16 West, Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States