SIST EN 17398:2020

SLOVENSKI STANDARD
oSIST prEN 17398:2019
01-julij-2019
Vključevanje bolnikov v zdravstveno varstvo - Minimalne zahteve za oskrbo,
osredotočeno na posameznika
Patient involvement in health care - Minimum requirements for person-centred care
Patientenbeteiligung bei der Gesundheitsversorgung - Mindestanforderungen an die
personenzentrierte Versorgung
Ta slovenski standard je istoveten z: prEN 17398
ICS:
11.020.10 Zdravstvene storitve na Health care services in
splošno general
oSIST prEN 17398:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 17398:2019


DRAFT
EUROPEAN STANDARD
prEN 17398
NORME EUROPÉENNE

EUROPÄISCHE NORM

May 2019
ICS 11.020.10
English Version

Patient involvement in health care - Minimum
requirements for person-centred care
 Patientenbeteiligung bei der Gesundheitsversorgung -
Mindestanforderungen an die personenzentrierte
Versorgung
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 450.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17398:2019 E
worldwide for CEN national Members.

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Contents Page
European foreword . 3
Introduction . 4
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 The patient´s narrative and experience of illness . 9
4.1 General . 9
4.2 Requirements . 10
4.2.1 Organisational level . 10
4.2.2 Point-of-care level . 10
5 Partnership . 11
5.1 General . 11
5.2 Requirements . 11
5.2.1 Organisational level . 11
5.2.2 5Point-of-care level . 11
6 6. Documentation, care plan and information sharing . 12
6.1 General . 12
6.2 Requirements . 13
6.2.1 Organisational level . 13
6.2.2 Point-of-care level . 13
7 Patient and Public Involvement in Management, Organisation and Policy . 13
7.1 General . 13
7.2 Requirements . 14
Annex A (informative) Cases . 15
A.1 General . 15
A.2 Follow-up in primary care . 15
A.3 Dentistry . 16
A.4 Breastfeeding . 17
A.5 Patient and public involvement . 18
A.6 Patient with psychosis . 19
A.7 Long-term care . 20
A.8 Woman with aphasia after stroke . 21
A.9 Paediatrics . 22
Annex B (informative) Patient involvement in different levels and phases of health care . 24
B.1 General . 24
B.2 Patient involvement and person-centred care . 24
B.3 Partnership in person-centred care and responsibilities . 24
B.4 Resources and tools . 26
Bibliography . 28

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European foreword
This document (prEN 17398:2019) has been prepared by the Technical Committee CEN/TC 450 “Patient
involvement in person-centred care”, the secretariat of which is held by SIS.
This document is currently submitted to the CEN Enquiry.
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Introduction
This document aims to facilitate patient involvement and the development of a partnership between the
patient and the care personnel. Patient involvement and partnership originates from the patient’s
resources, capacities, wishes and needs, primarily focusing on the patient ́s narrative/story, shared
decision-making, information sharing as well as documentation on the individual, operational and
strategic level (see annex B.1).
Guiding principle
This document provides minimum requirements for patient involvement in health care. It aims to
facilitate the partnership between patients and care personnel in the design, implementation and
evaluation of services. The document can be used to help in the planning, management, implementation
and systematic evaluation of daily activities, enabling the patient to manage his/her daily life and be
empowered in his/her own care process. In addition, it can be used to support patient involvement on a
systemic level; ensuring that the patients' perspective is included in the development, implementation
and evaluation of health care services, research and policy.
This document is focused on patient involvement in health care. However, in many situations social care
is closely related to, or occurs alongside, health care services. Thus, this document could be used as a
guide for social care alongside health care services.
This document applies to all health care services, e.g. general practice, primary care centres, dental
practices, home care, rehabilitation, preventive and long-term care. Further, when the needs of the
patients are being considered, these also should include the family and support networks around the
patient e.g. patient proxy and representatives where appropriate (see Annex B).
This document can be used before, during and after a procurement process. It provides all parties with a
common understanding of the minimum level of patient involvement and enables related processes and
structures to be put in place for all aspects of the contact between the patient, care personnel and health
care service providers. This also includes transitions between different levels of care.
The document can be used for education, training and continuous professional development of health
care providers (see Annex B). The document can support quality aspects related to patient involvement,
e.g. in EN 15224.
Patient involvement
Effective inter-professional communication, that involves the patient in sharing knowledge and creates a
common understanding of goals and self-care strategies, is a key aspect of optimising care. The health
care provider should create favourable conditions for establishing a partnership with the patient.
A partnership involving patients respects confidentiality, privacy and necessary consents when
applicable, and builds on the notion of:
— at least two parties, including the patient;
— the sharing of information and knowledge and taking into account the patient´s perspective;
— striving together towards a consensus about the goalsetting and outcomes;
— a context in which there is access to documentation and possibility for the patient to provide input
regarding the plan of care and any follow-up.
Person-centred care
Person-centred care (PCC) is a model with a more structured approach in which the patient takes part in
his or her care, decision-making process and self-care. A person has capacities, feelings, wishes and needs
– and should therefore be a partner (in some cases may also involving relatives) in his/her care and
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treatment. This reflects an understanding that patients are experts on their own condition by virtue of
their health knowledge and lived experience. Patients are persons and should not be reduced to their
health status alone, but rather be integrated within a given environment, with their rights and future
plans recognised. Hence, during most of time, the patient is in a context that is not health care. Therefore,
there is a strong reason to acknowledge and endorse every patient´s resources, interests, needs and
responsibilities in situations which concern him or her. Particularly in a lifelong disease state, a person
manages his/her life for the vast majority of time without his/her care provider, putting importance on
the person’s resources for self-care capacities. PCC is facilitated when care personnel work together with
people who use health care services, tailoring them to the resources and needs of the individual towards
what matters to them.
PCC is a shared understanding and agreement about:
1. what really matters to the patient in order to set care goals that incorporate what health and quality
of life means for the individual person,
2. the professional judgment and guideline driven care that incorporates evidence-based care and
national/local routines (see Annex A for examples).
Patients and care personnel identify and discuss problems and strategies related to the patient’s
condition(s), giving due consideration to the patient's experiences and preferences, clinical analyses,
tests and treatments and the practical, social, and emotional effects of their condition(s) and care on their
daily lives.
In a Cochrane review of central components of PCC (n=19.000 patients), significant improvements were
observed in medical outcomes, increased self-efficacy and self-care and management when PCC was
applied. Controlled clinical trials have shown positive outcomes regarding shorter length of hospital stay,
cost reduction, improved activity of daily living and discharge process, increased self-efficacy, disease
knowledge, improved health status and improved quality of life in end of life care.
While the above mentioned approaches are often seen as a basis for modern health care, it has been
described that there is a lack of structure, knowledge and policies to operationalise patient involvement,
something that should be seen as the basic level of providing high quality health care.
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1 Scope
This document specifies the minimum requirements enabling patient involvement in health care services
with the aim to create favourable structural conditions for person-centred care.
It is intended to be used before, during and after the actual care provided by care personnel and to be
available for use by the patient who is the recipient of the care.
This document is also intended to be used on a strategic level for quality assurance and improvement,
during procurement, education and supervision as well as to be used as a guiding document for research
and development projects within intervention and implementation of person-centred care.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
care
health care services, social care services or an integration of both, including informal carers
Note 1 to entry: An informal carer includes any person such as a family member, friend or a neighbour, who is giving
regular ongoing assistance to another person without payment for care given.
3.2
care period
time lapse during which a person receives care, starting at the first request or contact between care
seeker and care provider until that episode of care is ended
3.3
care personnel
individuals working in the provision of health or social care services, whether as individual practitioners
or employees of health institutions and programs
3.4
care plan
plan with regards to needs, expectations, goals and resources, developed by the provider in partnership
with the patient
Note 1 to entry: In some European countries, an individual care plan is provided by national legislation to patients
with long term health needs.
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3.5
contact
any interaction or communication between patient and care personnel
Note 1 to entry: any interaction includes physical and non-physical communication as facilitated by assistive
technology.
3.6
continuum of care
provision and consistency of care over a period of time spanning all levels and intensity of care
3.7
documentation
data repository regarding the health and health care of a patient, based on the patient's narrative
3.8
health care
activities undertaken by care personnel that are intended to maintain and improve health, prevent harm
and illness, slow down deterioration of health and palliate pain and suffering
3.9
health care service
service that considers the whole spectrum of care from promotion and prevention to diagnostic,
rehabilitation and palliative care, as well all levels of care including self-care, home care, community care,
primary care, long-term care and hospital care in order to provide integrated health services throughout
life
3.10
health state
physical and mental functions, body structure, personal factors, activity, participation and environmental
aspects as the composite health of a subject of care
3.11
inter-professional team
team composed of members from the same or different professions and occupations with varied and
specialised knowledge, skills, and methods, who are committed to a common purpose, performance goals
and approach for which they are held mutually accountable
Note 1 to entry: Terms such as interdisciplinary, inter-professional, multi-professional, and multidisciplinary are
often used interchangeably.
3.12
narrative
patient's own account about what matters to them in relation to the current situation, past experience
and future expectations
3.13
partnership
collaboration and mutual respect between patient and care personnel
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3.14
patient
person seeking or needing care or being provided health or social care services
Note 1 to entry: In situations where patients for any reason are incapable of defending their interest, a patient proxy
should assist or stand in for the patients.
Note 2 to entry: in some care facilities patients are not labelled as “patients” but rather as residents, clients, etc.
Note 3 to entry: a person can be with or without a diagnosis.
3.15
patient involvement
patient’s participation in their care on organisational or individual level
3.16
patient proxy
representative who acts with or on behalf of the patient in the narrative, decision-making and patient
care
Note 1 to entry: A patient proxy can be a legal guardian who acts with or on behalf of a person in need of care if
persons are incapable of making decisions. A legal guardian can be appointed to act on behalf of the person
Note 2 to entry: A patient proxy and representative includes legal guardian, legal representative, relative, patient
representative, patient advocate, legal interest and coordinator
Note 3 to entry: The term patient proxy can have different meaning and legal context depending on national
legislation
3.17
process
set of interrelated or interacting activities that use inputs to deliver an intended result
[SOURCE: ISO 9000:2015, 3.4.1]
3.18
public involvement
participation, or attempt thereto, of public or lay people and/or organisations in decision- and policy
making
3.19
quality in health care
degree to which health care fulfils requirements related to defined quality aspects
[SOURCE: EN 15224:2016, 3.11]
3.20
quality of life
patient’s perception of their life regarding physical health, psychological state, personal beliefs, social
relationships and their relationship to their environment
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3.21
self-care and management
person’s behaviour and actions regarding their own health and care, and ability to engage in health
promoting activities, and if needed facilitated by collaborative partnership between the patient and care
personnel or other parties
3.22
service
output of an organisation with at least one activity necessarily performed between the organisation and
the customer
Note 1 to entry: In health care and social care, the service can be provided by an individual.
[SOURCE: ISO 9000:2015, 3.7.7, modified - Note 1 to entry has been added]
3.23
shared decision-making
decision-making in partnership between patient (3.14) and care personnel
3.24
social care
care provided that focuses on help and support in coping with activities of everyday life
Note 1 to entry: The content of social care varies between the European countries and can be regulated in national
legislation.
4 The patient´s narrative and experience of illness
4.1 General
The patient’s narrative is essential to identify the person’s own views of their goals, needs, preferences,
values and resources, as well as their perception of their own role in their care. The narrative includes
information regarding everyday life, their condition, symptoms, disease knowledge and perception, and
motivations/goals. The question "what matters to you" can be a starting point for the patient to present
her/himself as a person in the form of a narrative. (see annex A.1) The narrative should then build on a
collaborative, equalitarian partnership between care personnel and patient that encourages and
empowers patients to take part in the provision of care.
Through narratives care personnel listen and try to understand the request (for health services) for each
specific individual. This can be a request for preventive care or the patient’s experience of an illness.
Diseases and conditions can be described according to different criteria, but to understand what illness
means in daily life, care personnel should listen carefully to each patient´s narrative. The care personnel´s
responsibility is to understand the patient’s goals and extent of the patient’s knowledge, skills and
confidence to self-manage his or her health, to strengthen this where necessary and to ensure that
relevant interventions and support services are available (see annex A.3). The essence is to understand
what an illness means in daily life for the person. This needs to be the point of departure for all
subsequent interventions in the care of that patient. This can be very well captured through a narrative,
but also through other means of communication that are needed when the patient is not able to provide
a useful narrative. Through a process of interpretation, from words or observations, the care personnel
gather the needed insights (see annex A.7 for an example).
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In order to facilitate patient involvement in health care services, the following focus areas regarding
narrative and experience of illness need to be considered to guide the process:
— inter-professional person-centred approach,
— respect for values, preferences, and expressed needs,
— physical comfort,
— emotional support.
Functional communication between care personnel and patients is a prerequisite for patient
involvement. It needs to be recognised that e.g. sensory or cognitive impairments, educational
differences, differences in language, or culture can hamper communication between patient and care
personnel (see annex A.7).
In paediatric settings, the patient may be represented by their parent or legal guardian who can help form
their narrative and experience of illness. However, it is also essential to involve children and young
people as much as possible in an appropriate way, in discussions about their care, even if they are not
able to make decisions on their own. A young patient’s ability to communicate and contribute to their
narrative, and make decisions depends more on their ability to understand and consider options, than on
their age. It is important that assessment of maturity and understanding is made on an individual basis.
Even a very young child will be able to contribute to some degree (see annex A.8 for an example).
4.2 Requirements
4.2.1 Organisational level
The organisation shall ensure that:
a) patient’s narrative can be shared within legal context of patient confidentiality among related parties
in the inter-professional team as soon as possible, and if needed also share all subsequent revision(s)
of the narrative which are required throughout the care period.
b) the environment facilitates the possibility for the patient to be prepared prior to the contact, if the
situation is deemed possible (see annex B.3 for tools and resources).
c) allocated care personnel time allows discussion and exploration of the patient's narrative.
d) care personnel are sufficiently trained to obtain the narrative.
4.2.2 Point-of-care level
The care personnel shall ensure that:
a) the environment facilitates capturing and sharing of the patient's narrative, while recognising the
need for privacy (see annex B.3 for tools and resources).
b) patients have the opportunity at each contact and on a timely basis thereafter to provide their
narrative.
c) the patient's narrative can include the following:
— Why the patient seeks help or advice and how their everyday life is impacted;
— The patient's feeling of wellbeing;
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— The patient's goals, motivations and values regarding the process and outcome of care.
d) when a narrative is not possible to obtain, an alternative approach is used to capture the information
needed (see Annex A.7 and A.8).
5 Partnership
5.1 General
Applying an inter-professional person-centred approach throughout the continuum of care, including
transitions between levels of care, where the patient is a partner of the team is a key aspect in care. All
involved experts including the patient should be taking part in the decisions concerning the care. In order
to facilitate patient involvement in health care services, the following focus areas need to be considered
to guide the partnership process:
— inter-professional person-centred approach
— coordination and integration of care
— information
— communication
— continuous education.
5.2 Requirements
5.2.1 Organisational level
The organisation shall ensure that:
a) there are routines and systematic access enabling the patient to be continuously involved in the
decision process, follow up and revision (if necessary) of the care process during the care period.
b) through a systemic structure, dedicated care personnel time is set aside to enable patient-care
personnel in establishing partnership.
c) in situations where a partnership is not possible due to cognitive/physical status, language barriers
or other aspects of communication, the decision of the care personnel shall be explicitly documented
and re-evaluated as soon as possible with the patient.
5.2.2 5Point-of-care level
The care personnel shall ensure that:
a) the patient´s understanding and preferences regarding how shared decision-making is undertaken
is established.
b) the patient´s motivations, values, and goals are explicitly discussed and strategies for supporting the
patient’s resources, goals, wishes and needs are incorporated into the care plan (see annex A.2 and
A.3).
c) the patient and the health care professional have a common and mutual understanding regarding
care, impact on symptoms and possible side effects including the foreseeable consequences of lack
of care (see annex A.1).
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d) the patient´s concerns and fears are explicitly discussed and strategies for reducing the patient
concerns and fears are incorporated into the care plan (see annex A.6).
e) shared decision-making processes are continued throughout the care period, and if required also
throughout the transition of care/continuum of care including self-care and self-care management.
f) a common agreement is set regarding the responsib
...