1. uSing rolE-substitutioN In care-homes to improve
oRal health (SENIOR)
Training slides for Care-Home Managers and/or
allocated staff

2. Detail of what we plan to cover
1. Learning objectives and outcomes
2. SENIOR trial: overview of the study
3. Good Clinical Practice and GDPR
4. Accounting for !COVID!

3. Learning objectives and outcomes
• We will:
– Provide an overview of the
study
– Provide an overview of Good
Clinical Practice (GCP)
• We will be able to:
– Understand the nature of the
study
– Understand the importance
of GCP and how it relates to
your role in the study

4. SENIOR: why are we doing the study?
• Tooth decay and gum disease are
very common problems for older
adults residing in care-homes
• Oral health is also strongly
connected to general health in
this age group
• Oral health has a major impact on
how residents eat, speak and
smile, their quality of life and
their dignity
• This issue is increasingly
becoming recognised as a
significant UK-wide problem

5. SENIOR: what are we proposing to do?
• Instead of using dentists to
provide dental care, other
members of the dental team
could offer an alternative to
improve the provision of care and
access to services
• Dental Therapists and Dental
Nurses have been used in a
number of research studies that
have shown their potential in
these settings
• 'Skill-mix' has been used for some
time in dentistry, but limited
research has been undertaken in
care-homes

6. SENIOR: what are we proposing to do?
• We plan to run a randomised
controlled trial over a twelve
month period comparing usual
care with a model based on 'skill-
mix'
• One group of care-homes will
receive dental care from DTs and
DNs ('skill-mix') for six-months,
whilst the other group of care-
homes will receive their usual
care

7. SENIOR: what are we proposing to do?
• The eligibility criteria for care-
homes (what they have to fulfill
to take part in the study) will be
that they should have at least ten
residents 65 years and over
• Care-homes won't be able to take
part if they:
1. Are currently participating
in an oral health
programme or a research
study for older people in
care homes
2. Specialise in end-of-life or
palliative care
• Residents in each care-home will
be chosen according to the
following:
1. 65 years and over
2. Have at least six natural
teeth
3. Full-time resident in care
facility
• Of the residents that fit these
criteria, a maximum of fifteen
residents will be chosen per care-
home (minimum of five) by the
study team

8. SENIOR: what are we proposing to do?
• The key thing we will measure
will be dental plaque
• This is a white layer on the teeth
that is formed of bacteria and
sugar
• It is important because it is the
cause of decay and gum disease
• We will measure this when the
study starts, at six-months and
then again at twelve-months
• This will be measured by dentists
from the Community Dental
Services

9. SENIOR: what are we proposing to do?
• We will also be recording the
following clinical measures:
– Bleeding when the gums are probed1
– Pain1
– New tooth decay1
– Quality of life1
– Episodes of unscheduled care2
1-Measured by dentists in your Community Dental Service on six index teeth per resident
2-Measured by the care-homes

10. SENIOR: what will DTs and DNs do?
• Care-homes that receives dental
care from DTs and DNs will have:
– Appropriate dental care1
– Prescription of high-fluoride
toothpaste1
– Application of high-fluoride varnish
every three-months2
– Oral hygiene advice2
– Information about healthy eating2
– Advice and guidance for care-home
staff2
• The other group of care-homes
will receive their usual dental
care
1 Provided by DTs
2 Provided by DNs
Dentists undertaking the baseline examination will provide the prescription for the fluoride

11. SENIOR: timeframe of the intervention
• Resident provides consent
(undertaken by study team
and care-home manager)
• Dental examination by the
CDS epidemiologist
• Month 1: DT visit
• Month 1: DN visit
• Month 2: DN visit
• Month 3: DN visit
• Month 6: DN visit
• Month 6: DT visit
• Month 6: Dental
examination by the CDS
epidemiologist
• Month 12: Dental
examination by the CDS
epidemiologist

12. SENIOR: timeframe of the intervention
• DTs will visit their care-
homes twice (M1 and M6
before the six-month
measurement):
– Appropriate dental care
– Oversee high-fluoride
toothpaste use
– Oral hygiene advice
– Information about healthy
eating
– Advice and guidance for care-
home staff
• DNs will visit their care-
homes after baseline:
– Advice and guidance for care-
home staff (after baseline)
• DNs will again visit in M1,
M2, M3 and M6:
– Application of high-fluoride
varnish every three-months
– Reinforce oral hygiene advice
– Reinforce information about
healthy eating

13. Documents that the DNs will be using
• DNs will work with the care-home staff to improve the oral
health of your residents
• This will involve appointing a local champion (member of the
care-home staff) who will work with the DN
• The local champion will be responsible for coordinating the
delivery of good oral healthcare to individual residents:
– Establish oral health care plans for each resident, which should be
displayed in their rooms
– Ensure a daily oral care monitoring form is displayed and completed
on a daily basis
– Be aware of common oral health complaints and when to seek advice

14. We will provide these documents

15. We will provide these documents

16. We will provide these documents

17. Summary of your involvement
1. Consent on behalf of the care-home to
taking part in SENIOR
2. Work with the local study team to select
residents to be randomised
3. Work with the local study team to
consent the residents and collect 6-CIT
4. Enter the unique ID on the consent form
(this enables you to link their ID with the
residents name) and onto the proformas
for the study (called Case Report Forms)
5. Store the consent forms in a locked
cabinet/drawer
6. Provide the epidemiologist with the CRF
for baseline assessment
7. Complete a AE/SAE form if required
during the intervention period and notify
the local study team
7. Provide the CRF for the M1 DT visit and
file in the ATF when complete
8. Repeat for the M1 DN visit
9. Repeat for the M2 DN visit
10. Repeat for the M3 DN visit
11. Repeat for the M6 DN visit
12. Repeat for the M6 DT visit
13. Repeat for the M6 epidemiologist visit
14. Repeat for the M12 epidemiologist visit
15. Maintain the ATF during the study and
send on necessary CRFs for SENIOR
ID numbers need to be entered onto the CRF to
ensure research records relate to the same resident
and that we comply with GCP and GDPR (see later)

18. Good Clinical Practice and GDPR

19. Good Clinical Practice
• Good Clinical Practice (GCP) is a term that describes how
research studies should be conducted
• It is similar in principle to the guidance that covers how you
provide clinical care
• It is important that you are aware of GCP, but most of what
follows has already been undertaken or is overseen by the
research team
• GCP is a set of internationally agreed ethical and scientific
quality standards that ensures the rights, safety, dignity and
well-being of study participants are protected
• GCP covers trial design, conduct, recording and reporting
(ensuring and protecting the credibility of the study)

20. Good Clinical Practice
• Your Local Study Team will be ensuring that GCP is maintained
• There are thirteen basic areas of GCP
1. Ethical conduct: trials should be conducted according to the ethical
principles originating from the Declaration of Helsinki
2. Risks & benefits: trials should only be conducted if the anticipated
benefits justify the risk
3. Participants (residents) safety: trials should ensure that participants
rights and safety prevail
4. Adequate background information: trials should only be conducted
when there is adequate justification
5. Protocol: all trials should have a clear and detailed protocol,
describing the rationale and process of the study (peer reviewed)

21. Good Clinical Practice
• Continued…:
6. Follow the protocol: those involved in trial delivery should ensure
they follow the protocol and a system to review the process and
monitor non-compliance needs to be in place
7. Responsibility for medical care: those responsible for medical care of
participants must be appropriately qualified and this should be
overseen by the Principal Investigator at each site
8. Training, education, experience: Everyone involved in a trial must be
suitably educated, trained and experienced to perform their
delegated task(s)
9. Informed consent: all participants must provide informed consent

22. Good Clinical Practice
• Continued…:
10. Trial documentation: all study records (called Case Report Forms)
need to be handled and stored in a manner that ensures accurate
reporting, interpretation and verification
11. Data protection/security: Personal Identifiable Data must be
collected, stored and handled in accordance with the 2018 Data
Protection Act (including GDPR)
12. Investigative Medicinal Products: not applicable to SENIOR
13. Quality Assurance: systems and procedures must be in place to
ensure the quality of trial conduct and delivery

23. Good Clinical Practice (trial records)
• You will need to keep a number
of documents in a folder called
the Abridged Trial File (ATF)
• The ATF should be stored in a
locked cabinet/drawer
• This should be separate from the
consent forms from each resident
(again in a cabinet/drawer)
• The consent forms are classed as
Personal Identifiable Data so both
GCP and GDPR applies
• Your local study team can help
provide advice and keep you on
the right track
• Your ATF will contain the
following information to ensure
compliance with GCP and GDPR
• Details are provided later
• The SENIOR trial is moderate risk
and to align with GCP we may
have to undertake a monitoring
visit during the duration of the
study and the ATF is key to this
process
• Monitoring ensures the rights
and well-being of your residents
are protected and the reported
trial data is accurate, complete
and verifiable

24. Good Clinical Practice (AEs/SAEs)
• In keeping with GCP, we have to
record anything untoward that
could have been caused by the
trial
• These are known as Adverse
Events (AEs) and Serious Adverse
Events (SAEs)
• AEs are any adverse occurrences
that happen to the resident as
part of the study (even if it
appears unrelated e.g. a fall)
• We collect data on AEs and SAEs
from when the resident starts the
study to one month after the final
visit
• SAEs are occurrences that cause
the death of the resident, are life
threatening, lead to significant
disability or incapacity or where
the resident requires
hospitalisation
• Your role here is not to
distinguish between these, only
to report anything untoward to
the care-home manager

25. Good Clinical Practice (AEs/SAEs)
• The care-home manager will be
required to keep a record of all
AEs and SAEs during the trial
• So, if you see anything untoward
(in terms of the resident's health)
this may require the care-home
manager to complete the
necessary Case Report Form
• The local study team will liaise
with you about when the care-
home manager should send the
relevant Case Report Form to the
local study team
• On behalf of the research team
the Principal Investigator will
review these forms on a regular
basis and determine whether the
AEs/SAEs have been caused by
the trial (see 'key roles and
responsibilities' slide)
• These forms are also reported to
two independent panels which
provide over-sight on the trial
• Pre-existing conditions do not
qualify as AEs unless they worsen
• This is detailed later in these
training slides

26. Allergies to Duraphat
• Adverse reactions to Duraphat
are rare but include mucositis
and/or an allergic response
• Should this occur the DTs and
DNs will enter this into their
clinical notes and will notify the
care-home manager
• The care-home manager will
need to complete the AE/SAE
form
Duraphat is contraindicated in patients
with ulcerative gingivitis and stomatitis
There is a very small risk of allergy to
colophony in Duraphat: application
should be avoided
where there is a history of
allergic episodes requiring hospital
admission, including asthma

27. Good Clinical Practice (summary)
GCP principle How this applies to your role
1-Ethical conduct: trials conducted according to the Declaration of Helsinki Ensure you follow this training
2-Risks & benefits: benefits outweigh the risk Not directly applicable to you
3-Participants' safety: participants rights and safety prevail Ensure residents' rights and safety
4-Adequate background information: trials should have adequate justification Not directly applicable to you
5-Protocol: all trials require a detailed protocol Not directly applicable to you
6-Follow the protocol: all involved should follow the protocol Ensure you follow this training
7-Responsibility for medical care: interventions should be undertaken by appropriately people Ensure you follow this training
8-Training, education, experience: everyone involved in a trial must be trained Ensure you follow this training
9-Informed consent: all participants must provide informed consent This is undertaken by the Local Study Team
10-Trial documentation: all study records need to be handled and stored appropriately Care-home manager will oversee the ATF
11-Data protection/security: Personal Identifiable Data must be managed appropriately No Personal Identifiable Data should be sent on
12-Investigative Medicinal Products: not applicable to SENIOR Not applicable
13-Quality Assurance: systems/procedures needed to promote robust trial conduct and delivery Not directly applicable to you

28. Key roles and responsibilities
Sponsor
Bangor University
Chief Investigator (CI)
Paul Brocklehurst
Principal Investigator (PI)
London
George Tsakos
Local study team
Care homes
Local study team Local study team
Care homes Care homes
Principal Investigator (PI)
Wales
Paul Brocklehurst
Principal Investigator (PI)
Northern Ireland
Gerry McKenna
• All responsibilities and tasks are documented in a delegation log in the ATF
• There will be a specific delegation log for your care home in your ATF

29. Abridged Trial File
• Your local study team will provide you with the Abridged Trial File
• This contains all the important study documents (see next slide)
• As mentioned earlier, it is important that you keep this and all the study
documents in a safe and secure but easily accessible place
• Consent forms must be kept in a separate locked cabinet/drawer
• The local study team will help you to keep everything up-to date by
sending you any updated documents
• We do monitor the documentation, so it is important that you ensure all
study data and documents are available for this purpose
• All the detail of the study can be found in the study protocol (in the
Abridged Trial File)
• A copy of the ethical and other approvals are also found in the file

30. Abridged Trial File for SENIOR
Sections How this applies to your role
1-Current protocol The local study team will keep this updated
2-Ethical and governance approval The local study team will keep this updated
3-Confirmation of capacity and capability The local study team will keep this updated
4-Case Report Forms (CRFs) These are the most important documents for you. You will need to enter the resident's ID on each blank
CRF and once completed file in the ATF until the local study team picks them up (as appropriate)
5-Participant Information Sheet This is for information
6-Consent Form You need to file the completed consent forms in a separate locked cabinet/drawer
7-Finance, contracts and insurance This is a copy of the agreement for SENIOR
8-Reporting procedure for AEs and SAEs This is a copy of the process for managing AEs and SAEs
9-Trial Specific Procedures This is for information
10-Site Closure Details This is for information
11-Delegation Log This describes who does what in the trial
12-Publications This is for information
13-Contact Lists This is for information
14-Other This is for information

31. Case Report Forms
Document title Welsh version How this applies to your role
SENIOR_CRF_6CIT v1 dated 24/07/2020 SENIOR_CRF_6CIT_V1CY Your local study team will help you complete this to assess the extent of any
cognitive decline in your residents after they consent. Once complete this should
be handed to the local study team
SENIOR_CRF_CE v1 dated 08/07/2020 This is the CRF to be handed to the epidemiologist at the beginning of the study,
at M6 and M12. The ID for the relevant resident must be added to the form and
this should be handed to the local study team after the examination
SENIOR_CRF_CHQ v1 dated 28/10/2020 61901-SENIOR_CRF_CHQ_V1-CY This CRF needs to be completed by the care-home and handed to the local study
team
SENIOR_CRF_DEM v1 dated 16/07/2020 61901-SENIOR_CRF_DEM_V1-CY This CRF needs to be completed for the resident (overseen by the care-home and
local study team). The ID for the relevant resident must be added to the form
and this should be handed to the local study team after completion at the
beginning of the study
SENIOR_CRF_EQ-5D-5L v1 dated 08/07/2020 This CRF is a questionnaire that measures quality of life. The ID for the relevant
resident must be added to the form and this should be handed to the local study
team after completion at the beginning of the study, at M6 and M12
SENIOR_CRF_Intervention v1 dated 08/07/2020 This CRF records what the DT and DN do. The ID for the relevant resident must
be added to the form and this should be handed to the local study team
SENIOR_CRF_OIDP v 1 dated 08/07/2020 61901-SENIOR_CRF_OIDP_V1-CY This CRF is a questionnaire that measures oral health related quality of life. The
ID for the relevant resident must be added to the form and this should be
handed to the local study team after completion at the beginning of the study, at
M6 and M12
SENIOR_CRF_SAE v1 dated 16/07/2020 61901-SENIOR_CRF_SAE_V1-CY This CRF records any serious adverse events
SENIOR_CRF_SCL v1 dated 08/07/2020 61901-SENIOR_CRF_SCL_V1-CY This is the CRF to be completed on a weekly basis by the care-home manager.
The ID for the relevant resident must be added to the form and this should be
handed to the local study team
SENIOR_CRF_WDL v1 dated 16/07/202 61901-SENIOR_CRF_WDL_V1-CY This form needs to be completed by the care-home manager and local study
team for any resident that withdraws from the study

32. Delegation log
• All members of staff involved in the study will need to sign the delegation log
• If new members of staff become involved in the study, the list should be updated
• Your local study team will provide you with some help initially to explain the process

33. Mistakes and deviations
• Mistakes and deviations can sometimes happen in a study, but every effort
should be made to ensure they are minimal
• A deviation is a change or departure from the study protocol
• It is important that any deviations to the protocol are promptly reported
to the local study team
• Examples of deviations include:
– Unreported serious adverse events
– Incorrect or missing Case Report Forms
• On the next two slides we will detail the Consent Form and Case Report
Forms for the study

34. Care-home questionnaire
• This CRF needs to be completed
by the care-home and handed to
the local study team
• This will be undertaken at the
start of the study
• This is also available in Welsh

35. Resident's consent form
• Enter the unique ID on the
consent form (this enables you to
link their ID with the residents
name) and onto the CRFs for the
study
• Store the consent forms in a
locked cabinet/drawer
• This should be separate from the
ATF (again in a cabinet/drawer)
• There is also a consent form for
the health economic evaluation
• The consent forms are classed as
Personal Identifiable Data so both
GCP and GDPR applies
Need to initialed
not ticked

36. 6-CIT
• Your local study team will help
you complete this to assess the
extent of any cognitive decline in
your residents after they consent
• This will be undertaken at the
same visit as the consenting of
the residents
• Once complete this should be
handed to the local study team

37. Resident demographics
• This CRF needs to be completed
for the resident (overseen by the
care-home and local study team)
• The ID for the relevant resident
must be added to the form and
this should be handed to the local
study team after completion at
the beginning of the study
• This will be undertaken at the
same visit as the consenting of
the residents
• This is also available in Welsh

38. Clinical examination
• This is the CRF to be handed to
the epidemiologist at the
beginning of the study, at M6 and
M12
• The ID for the relevant resident
must be added to the form
• This should be returned to you
after the resident's examination
• If the local study team is not at
the care-home, please store
securely and the local study team
will collect this from the care-
home (every two months)

39. EQ-5D-5L questionnaire
• This CRF is a questionnaire that
measures quality of life
• The ID for the relevant resident
must be added to the form
• This should be undertaken at the
beginning of the study, at M6 and
M12
• If the local study team is not at
the care-home, please store
securely and the local study team
will collect this from the care-
home (every two months)

40. OIDP questionnaire
• This CRF is a questionnaire that
measures oral health related
quality of life
• The ID for the relevant resident
must be added to the form
• This should be undertaken at the
beginning of the study, at M6 and
M12
• If the local study team is not at
the care-home, please store
securely and the local study team
will collect this from the care-
home (every two months)
• This is also available in Welsh

41. Weekly symptom checklist
• This is the CRF to be completed
on a weekly basis by the care-
home manager
• The ID for the relevant resident
must be added to the form and
this should be handed to the local
study team when completed
• If the local study team is not at
the care-home, please store
securely and the local study team
will collect this from the care-
home (every two months)
• This is also available in Welsh

42. Intervention
• This CRF records what the DT and
DN do
• The ID for the relevant resident
must be added to the form and
this should be handed to the local
study team on completion
• If the local study team is not at
the care-home, please store
securely and the local study team
will collect this from the care-
home (every two months)

43. Adverse and Serious Adverse Events
Any forms should be passed onto the local study team on a weekly basis
This will then be reviewed by Principal Investigator (see 'key roles and responsibilities slides')

44. Withdrawal of the resident
• This form needs to be completed
by the care-home manager and
local study team for any resident
that withdraws from the study
• The ID for the relevant resident
must be added to the form and
this should be handed to the local
study team when completed
• If the local study team is not at
the care-home, please store
securely and the local study team
will collect this from the care-
home (every two months)
• This is also available in Welsh

45. Summary

46. What is GDPR?
• The General Data Protection
Regulation (GDPR) is a European
law that came into effect in May
2018
• Along with the Data Protection
Act (2018), it seeks to strengthen
personal data protection
• The Information Commissioner’s
Office (ICO) leads on GDPR in the
UK and penalises breaches
• New principles have been
introduced:
– New rights (e.g. ‘right to be
forgotten’)
– Emphasis on transparency and
record-keeping
– Mandated data breach reporting
– Larger fines

47. What is GDPR?
• We need to be open and explicit
about how Personal Identifiable
Data (PID) is used
• We shouldn't keep data longer
than necessary
• We need to ensure it is accurate
• We need to ensure it is safe
• We need to recognise and know
what to do in a breach
• The good news is that these
principles are also enshrined in
GCP and align to the processes in
this training
• What is personal data?
– Any information that can be used
to identify a living person
(directly and indirectly) e.g.
resident's name
– It could also include other
information that leads to an
individual being identified (which
could be: physical, genetic or
cultural)
– Care needs to be taken with
sensitive personal data e.g.
health data

48. What is GDPR?
• Under GDPR consent needs to
have the following elements:
– Must be informed
– Must be freely given
– Requires positive action i.e. opt-
in (failure to opt-out is not
consent)
– It must be granular: separate
consent should be given for
distinct activities
• The good news is that these align
to the processes in this training
• What happens if there is a
complaint to the ICO?
• ICO take a risk based approach to
enforcement
• Minor complaints can trigger ICO
investigation into policies and
procedures
• Evidence will be sought that
everyone understands the rules
and how to achieve compliance

49. Accounting for !COVID!

50. Accounting for !COVID!
• Everyone entering the care-home
environment needs to be mindful
of the impact that the COVID
pandemic has had on care-homes
• Given this, all members of the
study team and those delivering
the epidemiological element and
the intervention should actively
seek to reduce the burden that
care-homes have already
experienced
• The COVID risk assessment tool
should be completed prior to any
face-to-face contact with
residents

51. Where to find materials?
https://awfdcp.ac.uk/

52. Diolch yn fawr iawn
i chi am wrando
p.brocklehurst@bangor.ac.uk