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OncologyNCT05478135

A Remote Evaluation of NAVIFY Oncology Hub Using Clinical Simulation

A study testing NAVIFY Oncology Hub in people with Oncology, run by Prova Health Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Oncology
What is being tested?
NAVIFY Oncology Hub
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited Kingdom
Study dates
15 May 2022to 3 Nov 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Experience using NAVIFY Oncology Hub
  • Inability to speak English

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Prova Health Limited

    London, SE13XF

Other trials in United Kingdom

About this study

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.

Read more

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.

Read the detailed description

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.

Clinical workflow is critical for the efficient and safe delivery of patient care. In most healthcare settings, clinical workflow is highly complex, and reflects the multidisciplinary collaboration and communication required of most clinical tasks. Studies have demonstrated a positive association between leveraging health information technology workflow tools for care coordination and patient engagement, and improved process quality metrics in preventive screening, diabetes control, as well as maternal and child health (Kruse \& Bean 2018; Kranz et al. 2018). Embedded decision support tools have also been proven to improve the performance of risk assessments conducted by providers, as well as enhance patient safety and decrease mortality (Chaudhry et al. 2006; Wells et al. 2008; Jones et al. 2014; Campanella et al. 2015).

A set of 10 synthetic breast cancer patient cases will be developed by Prova Health. Cases will include history and examination findings, pathology reports, radiology reports and images (USS, mammogram, CT as applicable) and reports on tumor characteristics. The case details will be representative of a long term patient journey, inclusive of treatment lines such as adjuvant and neoadjuvant therapies. Cases will be selected to span the range of potential case scenarios seen in typical practice. Specifically, cases will be selected to include common invasive breast cancers (eg. IDC, ILC), as well as less common invasive breast cancers (eg. inflammatory). Cases will also represent a range of cancers with different molecular subtypes, such as whether the patient is HER2 positive or negative, hormone receptor (HR) positive or negative or triple negative. Finally, cases will also reflect the presentation of patients at various stages (eg. primary diagnosis, locally and regional advanced breast cancer, recurrent breast cancer, or metastatic advanced breast cancer).

Each participant will participate in a 90-minute remote (e.g., online) simulation session. During scheduling, participants will be given a link to use to join the session. This link will take them to a video conference call hosted through Google Meet. At the session, the moderator will facilitate the session and take notes.

Participants 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. This task will involve searching for, identifying, reviewing and synthesizing relevant clinical information (demographic information, pathology reports, clinical course, etc.) that supports decision-making. As such, this task is meant to simulate the same activities they would perform in their typical practice before inviting a patient into the clinic room for a consultation, and will permit this study to examine the usage of NAVIFY Oncology Hub on those activities.

Ultimately, the aim of the study is to investigate how NAVIFY Oncology Hub improves efficiency and reduces cognitive burden associated with reviewing and synthesizing patient information, and having participants engage with the platform requires them to go through those tasks.

Conditions
Oncology
Being tested
NAVIFY Oncology Hub
Keywords
Digital Health, Health tech, Clinical simulation, Healthcare technology
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NAVIFY Oncology HubDevice

    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.

Study groups in NCT05478135
Study groupRoleWhat they receive
NAVIFY Oncology HubExperimentalWe 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.
Receives: Device: NAVIFY Oncology Hub

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 90 mins

  2. 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.

    Measured: 90 mins

  3. 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.

    Measured: 90 mins

  4. 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.

    Measured: 90 mins

  5. 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

    Measured: 90 mins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start15 May 2022
  3. Primary completion22 Oct 2022
  4. Study completion3 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478135
Sponsor's protocol ID
HLR-NOH-001
Status last verified
Nov 2024
First submitted
22 Jul 2022
Last updated
8 Nov 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study will not share IPD

Questions about this trial

What is this clinical trial studying?

A study testing NAVIFY Oncology Hub in people with Oncology, run by Prova Health Limited at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (SUS) (time frame: 90 mins). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

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