Health TrialsbyHealthPanel

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

ConditionsVital Sign EvaluationVital Sign MonitoringSleep QualityProvider BehaviorPatient Satisfaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Intervention--Device Array UseExperimental treatment 1 intervention
Group B: Control--Routine Vital Sign ObtainmentActive comparator 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

University of Minnesota Medical School/University of Minnesota Foundation

Collaborator

Sibel Health Inc.

Collaborator

Source ClinicalTrials.gov
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