A Remote Evaluation of NAVIFY Oncology Hub Using Clinical Simulation

NCT05478135 | Completed Results

• 1 other identifier: HLR-NOH-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This work seeks to understand current clinical workflow practice and validate use cases for NAVIFY Oncology Hub. The main purpose of NAVIFY Oncology Hub is to enhance clinical and operational effectiveness, from diagnostic workup to treatment planning and management. This might free up providers' time and capacity to provide better and more personalized care to patients. This research protocol builds on previous work that validated clinical simulation methods as a means for clinicians to generate useful insights during the testing and development of digital health tools (Gardner et al. 2020). Accordingly, this study aims to test the ability of NAVIFY Oncology Hub to increase the work efficiency of oncologists and reduce the cognitive burden/mental fatigue associated with patient care and decision-making. The insights generated will be used to guide the development of NAVIFY Oncology Hub and optimise user experience, as well as provide a better understanding of the opportunities for it to have maximal impact in the decision-making process.

Conditions

Oncology

Keywords

Digital Health; Health tech; Clinical simulation; Healthcare technology

Outcome Measures

Primary Outcomes (5)

• System Usability Scale (SUS)

  The System Usability Scale (SUS) a reliable tool for measuring the usability. It consists of a 10-item questionnaire with five response options for respondents; from Strongly disagree to Strongly agree. The participant's scores for each question added together and multiplied by 2.5 to convert the original scores of 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average.

  90 mins

• Participant-reported Efficiency When Preparing for Patient Consultations, Likert Scale

  Count of participants self-reporting that they were "a lot more efficient" or "somewhat more efficient" when using navify Oncology Hub to review patient information.

  90 mins

• NASA Task Load Index (NASA-TLX)

  Number of participants who required "low" or "very low" levels of mental demand, temporal demand, and effort to successfully complete tasks using NAVIFY Oncology Hub.

  90 mins

• Participant-reported Efficacy of Using Navify Oncology Hub to Facilitate Patient Discussions and Collaborate Care

  Number of participants self-reporting who felt nOH would be "significantly better" or "somewhat better" than their existing solution at facilitating patient discussion and coordinating care.

  90 mins

• Participant-reported Fidelity of Synthetic Patient Cases

  Number of participants self-reporting that the synthetic patient cases were either 'very similar' or 'somewhat similar' to cases seen in routine clinical practice

  90 mins

Study Arms (1)

NAVIFY Oncology Hub

EXPERIMENTAL

We will first conduct a small number of simulation sessions (3-5) to validate study methods and data collection procedures. Study methods may then be refined before conducting simulation sessions with a larger number of participants (approx. 25). In this phase, each participant will participate in a 90-minute simulation session in which they will use NAVIFY Oncology Hub to review synthetic patient cases. Participants will be tasked with reviewing the cases as if they were preparing to see a patient in a real clinical setting.

Device: NAVIFY Oncology Hub

Interventions

NAVIFY Oncology Hub DEVICE

NAVIFY Oncology Hub is a platform that aggregates and organizes disparate data into an intuitive, longitudinal view of the patient's cancer care journey. The platform is designed to optimize and support oncology workflows and decision-making by providing quick access to the most relevant data in one place, so that providers can make decisions more efficiently and collaborate more seamlessly.

NAVIFY Oncology Hub

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Board-certified, US-based oncologist
• Minimum 50% spent in clinical practice
• Active member of a tumor board

You may not qualify if:

• Experience using NAVIFY Oncology Hub
• Inability to speak English

Sponsors & Collaborators

• Prova Health Limited: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Prova Health Limited

London, SE13XF, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr Jack Halligan
• Organization: Prova Health

jack.halligan@provahealth.com

07742161980

Study Officials

• Saira J Ghafur, MD

  Prova Health Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 28, 2022
• Study Start: May 15, 2022
• Primary Completion: October 22, 2022
• Study Completion: November 3, 2022
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)