A Remote Evaluation of NAVIFY Oncology Hub Using Clinical Simulation
Phase: NA
Conditions: Oncology
Sponsor: Prova Health Limited

A remote evaluation of NAVIFY Oncology
Hub using clinical simulation
Study Management Group
●
Dr Saira Ghafur, Chief Medical Oﬃcer, Prova Health (Principal Investigator)
●
Gianluca Fontana, Chief Executive Oﬃcer, Prova Health
●
Dr Jack Halligan, Chief Operating Oﬃcer, Prova Health
●
Dr Ethan Goh, Digital Health Consultant
Funder
 
F. Hoﬀman-La Roche Ltd
 
This protocol describes the A remote evaluation of NAVIFY Oncology Hub using
clinical simulation and provides information about procedures for entering
participants. Every care was taken in its drafting, but corrections or amendments
may be necessary. These will be circulated to investigators in the study.
Problems relating to this study should be referred, in the ﬁrst instance, to the
Study Management Group.
 
This study will adhere to the principles outlined in the UK Policy Framework for
Health and Social Care Research. It will be conducted in compliance with the
protocol, Data Protection Act 2018 and General Data Protection Regulations
(Europe) and other regulatory requirements as appropriate.
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Table of Contents
1.   INTRODUCTION
3
1.1 Background
3
1.2 Study Rationale
3
2. STUDY OBJECTIVES
3
2.1 Study objectives
4
3. STUDY DESIGN
4
4. STUDY POPULATION
5
5. STUDY PROCEDURES
5
5.1 Recruitment
5
5.2 Conduct of semi-structured interviews
5
5.3 Conduct of simulation sessions
5
5.3 Ensuring ﬁdelity during remote participation
6
5.4 Case Construction
7
6. STUDY VARIABLES AND MEASURES
7
6.1 To assess the usability of NAVIFY Oncology Hub
7
6.2 To assess the eﬃciency of using NAVIFY Oncology Hub
7
6.3 To assess the mental eﬀort required with using NAVIFY Oncology Hub
8
6.4 To gather feedback on the study methods
8
7. ANALYSIS
8
8. REGULATORY ISSUES
9
8.1 Ethics approval
9
8.2 Consent
9
8.3 Conﬁdentiality
9
8.4 Indemnity
9
8.5 Sponsor
9
8.6 Funding
9
9. STUDY MANAGEMENT
9
10. PUBLICATION POLICY
10
11. APPENDICES
10
Appendix A: Post-Simulation Survey (attached separately)
10
Appendix B: Interview guide
10
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1.   INTRODUCTION
1.1
Background
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).
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).
1.2
Study Rationale
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.
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.
2.
STUDY OBJECTIVES
This work seeks to generate evidence and insights that will inform product development
and support go-to-market activities for NAVIFY Oncology Hub.
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2.1 Study objectives
This work is designed as a 2-phase study.
Phase 1 objectives (semi-structured interviews):
1.
Understand current clinical practice
2.
Validate use cases of NAVIFY Oncology Hub
Phase 2 objectives (simulation study):
1.
To assess the usability of NAVIFY Oncology Hub
2.
To assess the eﬃciency of using NAVIFY Oncology Hub
3.
To assess the mental eﬀort required with using NAVIFY Oncology Hub
4.
To gather feedback on the study methods
3.
STUDY DESIGN
This study will run over 2 phases.
Phase 1 (semi-structured interviews) – We will conduct a total of 12 semi-structured
interviews with 12 US oncologists. These interviews will seek to:
(i) Understand incumbent clinical practice for activities that NAVIFY Oncology Hub is
seeking to improve, for example, accessing cancer patient data, and care coordination.
(ii) Validate use cases of NAVIFY Oncology Hub and its perceived beneﬁts, for example,
reducing cognitive burden, increasing shared decision-making, etc.
There are 5 proposed use cases for NAVIFY Oncology Hub:
1) New patient consultation
2) Returning patient, follow-up visit
3) Cross team care coordination
4) Facilitating patient discussions and education
5) Enrichment of the patient record
The results from Phase 1 will inform potential adjustments to simulation study
procedures for Phase 2, such as the duration of the simulation sessions.
An interview guide has been provided in Appendix B.
Phase 2 (simulation study) – This phase of the study will have approximately 30 US
oncologists. 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. This task will involve searching for, identifying, reviewing and
synthesizing relevant clinical information (demographic information, pathology reports,
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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.
4.
STUDY POPULATION
US adults, age 18 and older, ﬂuent in written and spoken English who are
board-certiﬁed oncologists with an MD/DO degree from an accredited institution.
Participants will be aﬃliated with a healthcare institution where they are an active
member of a tumor board and spend at least 50% of their time in clinical practice. We
will recruit a mix (as equal as possible) of oncologists based in a community setting
and those based in larger academic centers. Because prior work demonstrates an
inﬂuence of oncologist experience on treatment outcomes (Go et al. 2015; Huntington
et al. 2018; Shanafelt et al. 2012), we will include a mix of participants in terms of
experience and type of practice institution. All participants will perform at least ﬁve
clinical sessions per week.
5.
STUDY PROCEDURES
5.1 Recruitment
We will recruit potential participants working in the United States for a remote study.
Potential participants will be identiﬁed and recruited by the Prova Health team
through email and phone. For those who meet criteria and agree to participate, a
digital or written informed consent will be obtained. They will then be scheduled for
the remote simulation session.
5.2 Conduct of semi-structured interviews
Semi-structured interviews: Participants will participate in a 60-minute remote (e.g.,
online) interview. A topic guide for the interview can be viewed at Appendix B. 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. The interviewer will use
Google Meet to record the participant’s audio. At the conclusion of the session,
participants will be compensated.
5.3 Conduct of simulation sessions
Simulation sessions: Participants 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. The
moderator will be a member of the Prova Health team with clinical practice
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experience. At the beginning of the session, participants will be instructed to share
their screen with the moderator so that participants’ use of NAVIFY Oncology Hub can
be recorded. The moderator will then use Google Meet to record the participant’s
screen. Participants will be instructed to turn oﬀtheir camera to preserve anonymity
while ensuring data retention. At the conclusion of the session, participants will be
compensated.
A timeline of the simulation sessions is provided below.
Activity
Duration
(mins)
Introductions and consent
5
Review of simulation session guide
5
Training on NAVIFY Oncology Hub
20
Prepare 10 cases using NAVIFY Oncology Hub
50
Post-Simulation Survey
10
Total
90
5.3 Ensuring ﬁdelity during remote participation
Participants will participate in the simulation sessions remotely (e.g., using an online
video conference call). To ensure data visual ﬁdelity, we will request that participants
close any other programs that involve heavy internet usage (e.g., internet browser other
than the one used for participation, video conferencing software) and mute their cell
phone to minimize the risk of interruption of the study. They will also be requested to
use headphones for the duration of the study, to ensure all instructions are heard
clearly.
The only requirements for remote participation will be a web browser and an internet
connection. Participation will occur through Google Meet video conferencing software.
This platform does not require that participants download anything; participants can
join from a standard internet browser. During scheduling for both the training and
simulation sessions, participants will be given a link to Google Meet for the session.
Prova Health will provide support to ensure internet connections and access. If the
participant is removed from the video conference call, Prova Health’s personnel will
attempt to re-contact. If the participant’s computer is no longer functional or if the
participant’s computer no longer has internet access, an attempt will be made by Prova
Health personnel and the participant to correct the issue. If this is not successful in a
reasonable
amount
of time (accounting for the participant’s schedule and any
subsequent testing sessions), the session will be terminated. If the session is terminated
before the participant has begun preparing cases, the participant will be rescheduled
for a new session (if they are interested in continuing to participate). This session will be
treated as an entirely new session (e.g., the participant will complete all measures).
However, if the participant had already begun preparing patient cases, the participant
will not be rescheduled.
5.4 Case Construction
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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).
6.
STUDY VARIABLES AND MEASURES
6.1 To assess the usability of NAVIFY Oncology Hub
At the end of the simulation session, some of the study’s outcome measures will be
collected via a Post-Simulation Survey (see Appendix A). The usability of NAVIFY
Oncology Hub will be assessed using the System Usability Scale (SUS), a 10-item
validated questionnaire for assessing the usability of websites and software
applications.
In addition, useful information from a product development perspective will be
collected on the Post-Simulation Survey, for example:
●
Which aspects of NAVIFY Oncology Hub did you ﬁnd most useful?
●
Are there any changes you would make to NAVIFY Oncology Hub if you
could?
●
What aspects of NAVIFY Oncology Hub were most challenging?
●
How likely would you be to use NAVIFY Oncology Hub in your typical practice?
●
How likely would you be to recommend NAVIFY Oncology Hub to your
colleagues?
The participant’s screen will also be recorded using Google Meet. This will be used to
corroborate moderator recordings. These recordings will also be available to the
funder to provide user insights to support product development.
6.2 To assess the eﬃciency of using NAVIFY Oncology
Hub
The Post-Simulation Survey will be used to measure the perceived eﬃciency of using
NAVIFY Oncology Hub when compared to standard practice.
The moderator will also note the start and ﬁnish time for each case, which will permit
measurement of 1) Time spent on each case, and 2) Overall session time.
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6.3 To assess the mental eﬀort required with using
NAVIFY Oncology Hub
The mental eﬀort required to prepare each individual case will be measured
subjectively in the Post-Simulation survey using the NASA Task Load Index (NASA
TLX). This 6-item multi-dimensional scale assesses mental demand, temporal demand,
performance, eﬀort and frustration. We recommend the use of this measure because
it has been well-validated (Hart, 2006) and used widely across a number of domains,
including research on those in the medical community (Hoonakker et al. 2011; Mazur
et al. 2012; Ruiz-Rabelo et al. 2015; Sartang et al. 2017; Young et al. 2008). It has been
speciﬁcally designed to assess the workload associated with a given task, one of the
key objectives of this study.
6.4 To gather feedback on the study methods
As clinical simulation is a relatively novel methodology to assess digital health
technologies, additional questions on the use of clinical simulation will be put to
participants on the Post-Simulation Survey. Example questions/topics include:
●
How similar the cases were to the cases the participant typically prepares
in their day-to-day practice in terms of complexity, demographics, information
available, prognosis, etc.?
●
How similar was this task to tasks you complete during a typical week?
●
How diﬃcult did this task seem to you? What made it more or less diﬃcult?
On the Post-Simulation Survey, additional questions will be asked to provide useful
information about each oncologist’s clinical experience and familiarity with digital
solutions. For example, how many patients the participant typically sees each week,
how many many years the participant has spent as part of a tumor board in their
career, what information they typically review before seeing a patient, what
solutions/technologies the participant might use to prepare for consultations and
collaborate with colleagues. See the full Post-Simulation Survey at Appendix A.
7.
ANALYSIS
Thematic analysis of interview outputs will be performed by reviewing recordings from
study participants in Phase 1. This analysis seeks to validate potential beneﬁts and use
cases for NAVIFY Oncology Hub, especially in areas such as accessing cancer patient
data, care coordination, cognitive burden and shared decision-making.
Data from the simulation sessions will involve calculating summary descriptives (e.g.,
means and percentages) on case-speciﬁc endpoint measures. Counts or percentages
may also be calculated on tabulated responses to survey questions to determine
whether certain themes regarding the study participants’ participation experience prove
common across the participants and, therefore, warrant attention.
8.
REGULATORY ISSUES
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8.1
Ethics approval
Prova Health will obtain approval from a provider of Institutional Review Board (IRB)
services based in the US. The study will be conducted in accordance with the
recommendations for physicians involved in research on human subjects adopted by
the 18th World Medical Assembly, Helsinki 1964 and later revisions.
8.2
Consent
Consent to enter the study must be sought from each participant only after a full
explanation has been given, with an information leaﬂet oﬀered and time allowed for
consideration. Signed participant consent should be obtained. The right of the
participant to refuse to participate without giving reasons must be respected. All
participants are free to withdraw at any time.
8.3
Conﬁdentiality
The Study Management Team will preserve the conﬁdentiality of participants taking part
in the study and fulﬁl transparency requirements under the General Data Protection
Regulation for health and care research. Data and all appropriate documentation will be
stored for a minimum of 10 years after the completion of the study.
8.4
Indemnity
Prova Health and its subcontractors hold negligent harm insurance policies which apply
to this study.
8.5
Sponsor
Prova Health will act as the main Sponsor for this study.
8.6
Funding
Hoﬀman-La Roche Ltd. are funding this study under the terms of the Research
Agreement for an Investigator Initiated Study entered into between Prova Health and F.
Hoﬀmann-La Roche Ltd.
Participants will be compensated for their time, with the amount varying by level of
experience, as speciﬁed by Roche HCP Services Fair Market Value Guidelines. For
those deemed Local Thought Leaders, compensation will be no more than $400 per
hour; those deemed Region Thought Leaders will be compensated at a rate of no
more than $520 per hour; those deemed National Thought Leaders will be
compensated no more than $660 per hour.
9.
STUDY MANAGEMENT
The management of the study will be coordinated by the study team at Prova Health
and Roche/Genentech.
Principal Investigator, providing oversight and accountability:
●
Dr Saira Ghafur, Chief Medical Oﬃcer, Prova Health
Day-to-day management of the study:
●
Dr Jack Halligan, Chief Operating Oﬃcer, Prova Health
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●
Dr Ethan Goh, Digital Health Consultant, Prova Health
Signiﬁcant involvement of senior staﬀproviding advice and guidance:
●
Gianluca Fontana, Chief Executive Oﬃcer, Prova Health
Additional guidance provided by Roche/Genentech:
●
Clinical subject matter expertise (e.g., review of cases) provided Dr Ernie Lo,
Senior Director Medical Aﬀairs, Roche Information Solutions
●
Study management (e.g., feedback on study design, coordinating access to
NAVIFY
Oncology Hub) provided by Delphine Chabut, Healthcare Insights
Evidence Lead, Roche Information Solutions
10. PUBLICATION POLICY
The results of the study will be written up in a report for Roche Information Solutions.
Pseudonymised quotes from participants may be published along-side their job role.
Participants will not be named in any reports/publications.
11.
APPENDICES
Appendix A: Post-Simulation Survey (attached
separately)
Appendix B: Interview guide
_____________________________________________________________________________________
Intro
What are semi-structured interviews?
Semistructured in-depth interviews are commonly used in qualitative research
and are the most frequent qualitative data source in health services research.
This method typically consists of a dialogue between researcher and participant,
guided by a ﬂexible interview protocol and supplemented by follow-up
questions, probes and comments. The method allows the researcher to collect
open-ended data, to explore participant thoughts, feelings and beliefs about a
particular topic and to delve deeply into personal and sometimes sensitive
issues.
Source: Semi-structured interviewing in primary care research: a balance of relationship and rigour
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Objectives of semi-structured interviews:
●
Understand current practice for oncology workﬂows in a patient’s cancer
care journey by:
○
Identifying and deﬁning common denominators in the oncology
workﬂow (characterize from each interviewee’s experience: 1. actors
involved, 2. workﬂows and interactions)
○
Understanding what kind of data matters, depending on the current
phase of a patient’s oncology care journey - across diagnostic
workup, treatment planning and treatment management (which
milestones matter? Diagnostic information, treatment response, relapses,
treatment-related issues, etc.)
○
Understanding how healthcare IT systems are used in the oncology
workﬂow to access data and coordinate care (cost and resource
eﬀectiveness, cognitive burden, user satisfaction, level of doctor-patient
engagement, etc.)
●
Inform the design of a study protocol and validate use cases for NAVIFY®
Oncology Hub using clinical simulation.
○
Collect information on actual and/or potential use of NAVIFY®
Oncology Hub in the interviewee's practice with the objective to build
the case for integrating NAVIFY® Oncology Hub into the workﬂow.
○
Identify the most appropriate outcome measures for the utility of
NAVIFY® Oncology Hub in clinical practice.
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NAVIFY Oncology Hub - Interview script
Introduction
Thank you for participating in this interview. We are seeking to understand how
oncologists access cancer patient data and coordinate care in clinical practice. This
project is funded by Roche/Genentech and the insights will be used to inform the design
of a research study to evaluate a clinical workﬂow and decision support solution.
The interview will be recorded and will be used by Prova Health for note-taking only - it
will not be shared with Roche/Genentech or with anybody else outside of the Prova
Health team.
Do you have any questions before we start? Answer any questions.
Before we begin, are you happy for me to start the recording? Start the recording.
Interview Section
Questions
(i) Demographics
What is your role at the cancer center?
Probes:
●
How long have you worked here?
●
What is the practice size and type? (eg. oﬃce based,
clinical in-patient unit, academic center etc.)
●
How many cancer patients per week would you typically
see?
●
Can you describe your clinical experience in oncology?
●
How many years have you been working in this ﬁeld?
●
Do you work primarily for the cancer center or do you
practice at multiple organizations?
(ii) Current clinical
practice
We will ask you a number of questions on how you currently
manage cancer patients in your practice. It will be important for
us to understand as much as possible about how you conduct
your consultations with cancer patients.
What information/data do you look at prior to consulting with
a cancer patient?
Probe:
●
Why is this data important?
●
How long does it take you to gather this data?
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Can you talk us through, step-by-step, how you would come up
with a management plan for a cancer patient during a
consultation?
Probe:
●
What factors make the consultation productive or
challenging?
(iii) Usage of
healthcare IT
systems
We will ask you a number of questions on how you use
healthcare IT systems to access patient data and coordinate
care.
Can you describe how healthcare IT systems support your
current workﬂow?
Probe:
●
What healthcare IT system(s) do you use?
●
How easy is this system to use?
●
How productive are you able to be with this system?
●
Can you walk us through how your healthcare IT systems
facilitate complex treatment decisions?
(iii) Barriers with
current
healthcare IT
systems
What factors make the consultation challenging with the current
healthcare IT systems?
Probe:
●
Thinking about the entire visit continuum, from pre-visit
prep to the consultation, what kind of barriers to care
exist with current healthcare IT systems? (e.g.
eﬀectiveness, cost, cognitive burden, patient
engagement, provider satisfaction)
●
How do you assess whether a healthcare IT system in
your workﬂow was a worthwhile investment of your time
and resources?
(iv) Use cases for
NAVIFY® Oncology
Hub
Thank you. We will now ask some questions about potential use
cases for NAVIFY® Oncology Hub.
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New patient
consultation
Can you talk us through, step-by-step, how you use healthcare
IT systems when assessing a new cancer patient?
Probe:
●
What parts of the consultation do they help with?
●
Can you access all data from one system, or do you have
to deal with multiple systems?
Returning patient,
follow-up visit
Can you talk us through, step-by-step, how you use healthcare
IT systems when assessing returning cancer patients?
Probe:
●
What parts of the consultation do they help with?
●
Can you access the most relevant data for follow-up
patients quickly?
●
What additional information would have been helpful for
you to have had on your returning patients?
Cross team care
coordination
Can you describe how healthcare IT systems support your
workﬂow in conveying information and coordinating care with
other providers in the care team?
Probe:
●
Can you talk us through, step-by-step, how you would
coordinate care with other providers?
●
Are you able to quickly and concisely convey information
and coordinate care between providers?
●
Overall, do you think healthcare IT systems improve
cross team care coordination? If yes, how do they help?
Do you believe they have any impact on outcomes?
●
What metrics would you use to help assess a good
‘outcome’ for cross team care coordination?
Facilitating patient
discussions and
education
How do you use healthcare IT systems to facilitate discussion
or to educate your patients (if at all)?
Probe:
●
Have healthcare IT systems improved your patient
interactions?
●
Has it hurt your interactions with patients in any way?
●
How much time do you spend communicating with
patients?
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Enrichment of
patient record
How do you access and synthesize unstructured data on patient
records? For example, a PDF report of a patient’s biopsy results.
Conclusion
This brings us to the end of our interview. Thank you very much again for taking the
time out to speak with us. As a next step, we will share a payment form for you to
complete so that we can process payment for this interview. Before we ﬁnish, do you
have any further questions?
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