Providing Access to an Alternative Nurse Call

Voxello - V-1, Alternative Nurse Call

To address the needs of the many patients who cannot access the standard nurse call systems Iowa Adaptive Technologies has developed the Noddle, a smart switch that can take the smallest intentional gesture a patient can make (e.g. tongue click, wink) and allow the patient to access the nurse call system and control a speech-generating device. This study will assess how patients and their nurses as well as family members perceive the impact of having a device that would allow them to summon the nurse and to be able to effectively communicate. Patients will be provided a Noddle and will be free to use it as much or a little as they like during their hospitalization. Patients will either use the Noddle just to access the nurse call system or they will use it to access the nurse call system and a speech-generating device. Patients, nurses and family members will be asked to complete an exit questionnaire prior to discharge from the hospital.

Study Overview

• Status: Completed
• Conditions: Problems With Access to Health Care
• Intervention / Treatment: Other: Provide alternative nurse call and communication device

Detailed Description

The study will evaluate the responses of patients, nurses and family members to the use of the Noddle switch to enable the patients to access the nurse call system and a speech generating device. Patients who cannot access the standard nurse call and who may not be able to speak due to mechanical ventilation will be recruited to the study and provided the opportunity to use the Noddle switch as long as they want while they are hospitalized at UIHC. Prior to their discharge or when they no longer need or want to use the Noddle switch, they along with their nurses and family members (if present) will be asked to complete a survey to assess their ability to effectively communicate. The data from the study participants will be compared to data from two groups of patients from a previous study who were either able to or unable to access the nurse call system and communicate with caregivers.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must be conscious, able to produce an intentional gesture and appropriately respond to yes/no questions.
2. Patients must be severely limited in their mobility and unable to access the nurse call system and/or must be unable to use normal modes of oral and written modes of communication.

Exclusion Criteria:

1. Patients who are sedated or unconscious (patients who are sedated for limited time may be considered).
2. Can access the nurse call and speak without other assistance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noddle Group; Patients who received noddle to allow access to the nurse call system.	Other: Provide alternative nurse call and communication device; Evaluate impact of providing access to the nurse call system and a speech generating device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exit Survey Responses	Patient and Nurse Exit Surveys	Completed on the 1 day the patient finished use of the device(s).

Collaborators and Investigators

• Sponsor: Iowa Adaptive Technologies, Inc.
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Richard R Hurtig, Ph.D., Iowa Adaptive Technologies Inc. (dba Voxello)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: patient-provider communication; alternative access
• Other Study ID Numbers: Voxello V1; R44NR016406 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified survey results are stored and could be shared as Excel files

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No