Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04085796 |
| Other study ID # |
22232 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2019 |
| Est. completion date |
July 9, 2021 |
Study information
| Verified date |
July 2023 |
| Source |
Bournemouth University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Study Objectives
1. To gather rich, evocative accounts of older patients aged 65 years and over -who may
have felt disorientated in the Accident and Emergency department (A&E) of a district
hospital and who received an Intentional Compassionate Communication Intervention
(ICCI)- about their personal experience of the A&E
2. To gather rich and evocative accounts of a member of staff who delivers an Intentional
Compassionate Communication Intervention (ICCI) to older people in the A&E of a district
hospital about their personal experience of doing so.
Description:
1.1 Background The number of hospital emergency admissions has dramatically increased in
England, by 42%, over the last 12 years (The Health Foundation 2018). Qualitative research
published between 1990 and 2006 on the patient experience within the emergency department
showed that most patients arrived at the A&E with the perception that their injury or
condition was serious or life threatening (Baraff et al. 1992; Olsson and Hansagi 2001;
Nystrom et al. 2003) and this perception was often accompanied by physical pain (Britten and
Shaw 1994). The situation is one in which patients feel vulnerable, anxious, stressed and
fearful (Olsson and Hansagi 2001; Kihlgren et al. 2004).
In the UK, nearly a quarter of the people arriving at A&E are over 65 years (Geddes 2013),
older patients represent a demographic group whose emergency admissions have seen a
particularly sharp rise over the last 12 years, especially patients aged 85 years or older
(The Health Foundation 2018). This entails hospital staff having to deal in the emergency
situation with patients presenting with much more complex needs associated with
co-morbidities and often with less external support than younger people (Sorrel 2010).
Older patients are more prone to feel disorientated in A&E. This can be due to a high
percentage of them presenting with dementia, delirium, delirium superimposed on dementia or
other CSD (Cognitive Spectrum Disorders), and they are also at higher risk of developing
delirium while in the emergency department (Reynish et al. 2017). Delirium is a common
medical problem that is characterised by changes in cognitive function. When delirium occurs,
people are confused. Its onset is quite sudden, but it usually lasts only for a few days (NHS
2018). However, if not addressed delirium can become a serious complication which can lead to
longer length of stay in hospital and higher mortality (Witlox et al. 2010). Stress is one of
the common triggers for delirium and there is also some evidence that longer and particularly
stressful A&E experiences are associated with the risk of older patients developing delirium
over the following hours (Bo et al. 2016).
There have been a few published studies exploring the experiences of A&E from the specific
point of view of older patients which report that most of them believe that their symptoms
pose a serious threat to their life or to the control they exert over their lives (Olsson and
Hansagi 2001; Kihlgrenet al. 2004) and that the attitudes of nurses in A&E are often
perceived as indifferent and inattentive, thus causing a feeling of exclusion and
disappointment (Olofson et al. 2012). Empathy and compassion are perceived by patients to be
the most significant elements of good care in A&E (Kihlgren et al. 2005).
Compassionate Care is not a new concern for the NHS but following high profile failings
(Francis 2013) government policies such as the Compassionate Care in the NHS (Department of
Health 2015) have been introduced, further emphasising the importance of humanised care
(Todres et al. 2009). Recent literature has explored different perspectives, from the poor
experiences of care by older people living with frailty which, has been uncovered by the
Francis Report (Singh et al. 2013), to the challenges experienced by nurses expected to
deliver compassionate care, who often struggle to align the reality of practice to their
ideals (Curtis et al. 2012).
Cornwell and Goodrich (2009 p.15), in a study exploring patients' experiences state: "the
presence or absence of compassion often marks the lasting and vivid memories patients and
family members retain about the overall experience of care in hospital". This is valid also
for patients who are temporarily confused and/or live with dementia. Projects like the
"Dementia diaries" project, show that people can not only be aware of how they are treated
and how they feel even in the middle of an extremely confused state, but they can also be
able to recall this (Agnes' story 2018). Patient satisfaction should be considered a goal in
itself; however, the literature also suggests that patients receiving clear and compassionate
communication are more likely to disclose their symptoms enabling greater understanding of
their situation and more accurate diagnoses (Epstein et al. 2005 and Cornwell and Goodrich
2009).
The evidence from the paragraphs above indicates that an investment in targeted compassionate
communication for older people in A&E could make their care more effective, with the
potential to reduce complications and make healthcare delivery more economically sustainable
for the NHS alongside giving patients and their families a better experience.
The awareness of the high incidence of stress in A&E, and of the importance of compassionate
care for older people has driven the development of a specific Intentional Compassionate
Communication Intervention (ICCI) within the A&E of a district hospital. The ICCI comprises
proactive communication-focused support to older people. It involves a member of staff taking
responsibility for the ICCI to meet older patients' psychological needs and relieve their
anxieties through talking to them, sharing information with them and reassuring them when in
A&E.
The delivery of the intervention gives priority to support older people who are in A&E alone
and to those of them who appear to be cognitively impaired. The aim is to provide patients
who may feel disorientated additional support in order to reduce the anxiety associated with
being in A&E. Using effective communication skills the member of staff demonstrates
compassion and empathy to the older patients whilst they are in a busy A&E department.
Activities may include talking to them, gently re-orientating them if confused, by asking
simple questions while using a friendly and reassuring tone of voice, offering a glass of
water or a cup of tea, maybe a blanket. The member of staff can also try to reassure patients
by enquiring with other staff about the outcome of an examination or about the next step into
the patient's hospital stay when it happens to be too busy or staff is under too much
pressure to be able to communicate with patients promptly and efficiently.
She also holds many hands, because of pain or because of fear. She purposefully uses a sense
of humor to prompt a smile or a quick laugh. If words are not helpful (because the cognitive
impairment is too severe, for example) she might play some music using an I-pad or bringing
some soft toys for patients to cuddle. What lays at the basis of this intervention is the
meeting between two human beings whereas one of them is in pain (psychological and often also
physical) and the other one somehow "feels" that pain and has a genuine wish to relieve it.
The ICCI is totally person-centered and does not rely on any particular technique, rather it
is exclusively based on a shared, deeply human drive.
A systematic review of literature Sonis et al. 2017) highlighted that most recent studies of
patient experiences at A&E are quantitative and use methods such as surveys or interviews,
concentrating on judgments of patients after their A&E visit. A few qualitative studies have
been carried out. Baraff et al. (1992) showed that patients are very concerned about losing
autonomy and independence, and Olthuis et al. (2014) showed that during the A&E stay patients
not only have to deal with their disorder, its consequences, and the situation they are in,
but they are also continuously troubled by all kinds of matters. They found that it is a
struggle for them to admit that something is wrong with them, to trust the health care
professionals, to endure waiting periods, to have a blood sample taken, to undress, to deal
with their relatives and reassure them, and even to get something to drink or eat.
Despite this, we still do not know very much about disorientated patients experiences in A&E.
Considering the above, and that there are few studies focusing on the lived experience of
older patients in A&E but currently no published studies that focus on the experience of
Intentional Compassionate Care Interventions (ICCI) within A&E, improved understanding of the
lived experience of patients with regards to the provision of ICCI within A&E would be of
great value in nursing; particularly considering that the experience of older people in A&E
is often characterized by discomfort, fear, and pain, and can trigger disorientation and
confusion. Moreover, people with Dementia or other cognitive impairments have a unique
contribution to make in research. Hearing their voices can help people see the A&E experience
from their point of view, contributing to fight the assumptions and the stigma often
associated with such a diagnosis (Alzheimer's Society 2018).
1.2 Clinical Data In the UK, nearly a quarter of the people arriving at A&E are over 65 years
(Geddes 2013) and older patients represent a demographic group whose emergency admissions
have seen a particularly sharp rise over the last 12 years (The Health Foundation 2018). The
experience of older people in the A&E is often characterised by discomfort and anxiety
(Baraff et al. 1992; Olsson and Hansagi 2001; Kihlgrenet al. 2004; Olofson et al. 2012).
Stressful experiences may represent a possible trigger for delirium, a common and significant
complication between older hospital patients which can affect the following course of
recovery and the overall hospital length of stay (Cunningham and MacLullich 2013). There is
some evidence that longer and particularly stressful A&E experiences are associated with the
risk of older patients developing delirium over the following hours (Bo et al. 2016).
Compassionate care seems to reduce patient anxiety (Gilbert and Procter 2006 and studies
conducted in A&E show that empathy and compassion are the most significant elements of good
care for older patients in A&E (Kihlgren et al. 2005).
1.3 Rationale
The results of the research will contribute to a deeper understanding of older potentially
disoriented patients' lived experiences of being in A&E and receiving an A&E based ICCI. This
study could impact upon NHS consideration of possible new roles in A&E that are responsible
for ICCI and how to make older patients' care more effective and sustainable, and give this
patient group a better experience and outcome. Including people living with dementia or
experiencing other cognitive disorders in the study is not only a way to improve their care,
but also a way of valuing their contribution to society.
1.4 Risks/Benefits During the study patient participants will have the opportunity to reflect
on their experience of being in A&E, on their emotional needs and if and how these were met
during their period in A&E. Reflecting and acknowledging our need for human connection and
meaningful interactions raises our awareness and this can translate into a benefit for these
participants.
The recruitment of patient participants for interview may include those living with dementia
or other cognitive impairments and it is recognised that they represent a vulnerable
population. However, only those who have been identified as being able to give informed
consent by a registered health care professional member of the Dementia Care Team, will be
invited to participate to the study.
The researcher will remain sensitive to any sign of distress during the interview and suspend
or stop their participation if indicated. Taking extra-care when interacting with vulnerable
people is essential, however, excluding patients living with dementia from participation in
research interviews could represent a form of discrimination, as their voice would seldom be
heard in research and by the services they use. Lack of capacity can make people with
dementia particularly vulnerable to discrimination (Alzheimer's Society 2018) and this is
also valid for their participation to research. Under the Mental Capacity Act a person is
presumed to be able to make their own decisions "unless all practical steps to help them to
make a decision have been taken without success" (Mental Capacity Act 2005).
When interacting with another person like during an interview, there is always a degree of
risk of exposure to the Covid19 virus or other viruses for both the participant and the
researcher. However, to minimise the risk for both parts, the researcher will only approach
participants who have already been tested negative for Covid19 at their admission to the
ward, and will do so in a Covid-Cold ward (where only patients tested negative to Covid19 are
admitted, and where patients are regularly tested for Covid19.). She will approach them only
after having carefully washed her hands and while wearing the appropriate PPE in place at the
hospital. She will also maintain the appropriate safety distance suggested by the latest UK
Government guidelines, and will not have any physical contact with the participant. The
interview will last a maximum of 40 minutes to minimise the risk.
The researcher will not travel to the hospital if she develops symptoms of Covid19.
Also, the professional delivering the ICCI will be asked to participate in a series of online
interviews about their experience (it is expected to run around 3 to 5 interviews which are
expected to take place weekly) using a secure online platform, assessed and chosen following
GDPR principles, and the same criteria of informed consent and freedom to withdrawn will
apply too. The questions might touch on sensitive issues for the professional, and the
researcher will remain sensitive to any sign of distress during the interview and suspend or
stop their participation if indicated, also offering them emotional support. If further
support is needed, she will signpost them to appropriate psychological support services.
The researcher will use good practices to ensure maximal security: the researcher will make
sure to connect via a BU laptop which has all the required firewalls in place and that their
internet connection is protected and will ask the professional to ensure her connection is
similarly protected. the researcher will make sure that the online platform used for the
online meeting is secure enough following GDPR principles and she will personally password
protect and lock each meeting as soon as it starts. She will make sure that nobody else is in
the room with her and will ask the ICCI professional to do the same to protect
confidentiality. In addition, the researcher will make use of headphones so that there is no
chance of participant being overheard, and will advise the participant to do the same.
2. Study Objectives and Design 2.1 Study Objectives
1. To gather rich, evocative accounts of older patients aged 65 years and over -who may
have felt disorientated in the Accident and Emergency department (A&E) of a district
hospital and who received an Intentional Compassionate Communication Intervention
(ICCI)- about their personal experience of the A&E;
2. To gather rich and evocative accounts of a member of staff who delivers an Intentional
Compassionate Communication Intervention (ICCI) to older people in the A&E of a district
hospital about their personal experience of doing so.
2.2 Study Endpoint The end point will be the completion of the qualitative analysis of
transcripts from patients' interviews and the ICCI professional's interviews, when enough
rich data to answer the research questions have been collected.
2.3 Study Design This is a qualitative study whose aim is to explore the lived experience of
a sample of older patients (65 years and over) who may have felt disoriented in the A&E of a
district hospital and who received an ICCI.
Using Interpretative Phenomenological Analysis (IPA), in-depth interviews will be carried out
with up to 15 patients and the professional delivering the ICCI at the site, and the data
created from the transcripts will be analysed thematically.
2.4 Recruitment and consent: The researcher has spent more than one year collaborating with
the Dementia Care Team both providing emotional support to patients at bedside and supporting
staff and volunteers in relating to older patients in hospital. She also ran informal
observations of the ICCI delivered in A&E to orientate herself to the setting. As a result of
this she developed a network of gatekeepers and has access to the wards and to different
professionals, particularly in the context of the Dementia Care Team.
The Dementia Care Team will identify possible participants for the study across different
wards in the hospital. An appropriately qualified professional member of the Dementia Care
Team will assess participant's mental capacity specifically around the decision to consent to
participate to the research at all three key points in the study: a) at introduction b)
immediately before Informed Consent is given and c) immediately before the interview.
At introduction, after patients' permission for the researcher to visit them has been gained
by a member of the care team, the researcher will approach them to give oral and written
information (Participant Information Sheet V.6) and to ask for consent. This will happen in a
so called Cold-Covid ward (where only patients tested negative for Covid19 are admitted) only
when the care team has considered them physically and mentally fit for this and they have
been tested negative for Covid19. In accordance with the Mental Capacity Act, the
professional will verify if the patient is able to understand, retain, use and weight the
information provided and to communicate his decision (Mental Capacity Act 2005).
Patients will be given as much time as they need to make their decision on whether to
participate.
The professional delivering the ICCI will be initially approached by email -to their secure
NHS trust email address- by the researcher's clinical supervisor to ask if they want to
consider participate. If they agree, they will be given the researcher's contact details.
When the professional will have contacted the researcher, they will be given all information
needed about the study and their participation. If they still want to go ahead, they will
receive a copy of a specific PIS (Participant Information Sheet for ICCI Professional V.1)
and they will be allowed to ask any question via telephone or email and as much time as they
need to make their decision. If they decide to participate, hey will then receive a copy of a
specific ICF (ICF for ICCI professional V.1) and only after they will have signed it -in
accordance with HRA and MHRA joint statement on seeking consent by electronic methods 2018 a
typed electronic signature is sufficient for this study- and send it back to the researcher,
an appointment for the first interview will be booked.
It is recognized that there is the potential for feelings of coercion in the workplace when
asking a member of staff to take part to a study like this. With this in mind, it will be
made very clear -both verbally and in the PIS- to the person involved, that there is no
obligation for them to participate, and that if they refuses, that will not have any impact
on them, on their job, or on their relationships with their manager and colleagues.
