Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04866693 |
| Other study ID # |
279409 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2021 |
| Est. completion date |
February 28, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
King's College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
Patient safety incidents are a leading cause of death and disability worldwide. So far,
existing safety improvement work has largely focused on physical healthcare. Only a small
body of research has studied safety as it applies to mental healthcare, with these studies
concentrating primarily on psychiatric inpatient units. However, mental healthcare is
increasingly delivered in community settings, through primary care and secondary care mental
health provision, rather than in hospitals. Less is known about the safety problems service
users experience in community-based mental healthcare. It is important that safety problems
in community-based mental health services are better understood, so that care can be
improved.
Objective:
This research will aim to understand the nature of the safety problems experienced by adult
users of community-based mental healthcare, from the perspective of service users, carers,
and healthcare providers. The study will also aim to identify priority areas and effective
practices to improve safety in these settings.
Method:
Individual in-depth interviews or focus groups will be held with service users, carers, and
frontline healthcare providers employed within appropriate community-based mental healthcare
settings. Interviews or focus groups will last for approximately one hour and will be carried
out face-to-face or via secure videoconferencing technology (e.g. Microsoft Teams or Zoom),
depending on up-to-date guidance relating to the Covid-19 pandemic. With participant consent,
interviews and focus groups will be audio-recorded and transcribed. Transcripts will be
analysed using thematic analysis, with themes developed, defined, and revised throughout the
analysis process.
Discussion:
Study findings will help to fill key evidence gaps concerning safety in community-based
mental healthcare. More broadly, the results may lead to the development of evidence-informed
interventions to address the safety issues which are raised in participant discussions.
Description:
Background:
Patient safety problems are widespread. Research suggests that around 10% of inpatients
experience an adverse event during their hospital admission, with almost half of these
incidents judged to be preventable. There have been considerable advancements in initiatives
to improve patient safety in medical settings in the past 20 years. However, safety in mental
healthcare remains an under-researched and poorly understood issue, with only a limited
amount of research having explored safety as it uniquely applies to this population.
Self-harm, suicide, and coercive interventions (such as physical restraint) are some of the
specific risks which may affect mental health service users.
The small body of research focusing on safety in mental healthcare has primarily concentrated
on hospital-based inpatient care. This is problematic for improving mental healthcare safety
and quality, as only a minority of mental healthcare episodes take place within psychiatric
inpatient services. As such, research into the types of safety problem experienced by users
of community-based mental healthcare is of great importance to improving care and reducing
harm.
Despite a willingness to share their perspectives, mental health service users and carers
have reported barriers to raising their safety concerns with professionals. These include
feeling as if their concerns were not listened to, as well as challenges associated with the
process of raising a complaint whilst unwell. Likewise, frontline care providers and service
managers within mental health services can also provide different yet complementary
professional insights into safety.
Community-based mental healthcare provision is diverse, often involving complex relationships
between and joint responsibly of multiple agencies. Because of this, the safety problems
associated with different care pathways are likely to be varied in nature. In order to fully
understand safety and broader quality of care problems, it is important to draw upon the
perspectives of mental health service users, carers, and healthcare providers from a range of
community settings. Using qualitative research methods, this research will begin to address
this evidence gap, focusing on services for working-aged adults.
Aims:
The primary aim of this study is to gain a deeper understanding of the safety problems which
occur in the context of community-based mental healthcare. Specifically, drawing upon the
perspectives of multiple stakeholder groups, including service users, carers and frontline
care providers, the objectives are to investigate the following:
1. To explore perspectives on the meaning of 'safety' in mental healthcare;
2. To understand the nature of the safety problems faced by people accessing
community-based mental health services;
3. To learn about experiences of good practice in the delivery of safe mental healthcare;
4. To identify priority areas and strategies for intervention to improve care safety.
Study design:
The study design will comprise in-depth qualitative interviews or focus groups, with three
participant groups: (a) working-age adult service users, (b) carers, (c) staff within
community-based mental health services (frontline providers and service managers). The
research team consulted with service users and carers about the study design, and received
positive feedback about the proposal to conduct either individual qualitative interviews or
focus groups.
Data analysis:
Interviews and focus groups will be audio-recorded and transcribed verbatim by a professional
transcription company from King's College London's list of approved suppliers. Prior to
analysis, any interview or focus groups excerpts containing information which could
potentially identify the participant, will be redacted. Interview and focus group data will
be managed in NVivo and analysed using a reflexive approach to thematic analysis, according
to the methodologies outlined by Braun and Clarke (2006). Themes will be developed and
revised through an iterative process.
Paper consent forms will be stored in a locked filing cabinet within the university premises,
to which only the research team will have access. Digital files, such as interview
transcripts and electronically completed consent forms, will be stored on the researcher's
secure university account server, which is password protected. Audio recordings will also be
stored here up until the point of transcription, after which they will be securely deleted.
Data will be stored anonymously and archived in line with King's College London's policy on
data storage.
Study setting:
This study will focus on service users, carers, and staff members employed within general
adult community-based mental health services. Community-based mental health services herein
refers to non-institutional mental health services which deliver multidisciplinary care
accessed by service users living independently, or in supported accommodation (excluding
settings with 24-hour on-site care from qualified nurses, which resemble institutional care
models). As such, participants associated with a range of settings may be recruited,
including community mental health services within secondary care (e.g. Assertive Outreach
Services) and mental health support available through primary care (e.g. from a general
practitioner).
Sampling:
In order to capture a range of perspectives, participants will be purposively sampled
according to several key characteristics. The recruitment strategy will aim to recruit
service users, carers, and healthcare professionals who have experience of different types of
community-based mental health services. To reflect the range of care contexts and
professional roles, the investigators will seek to sample healthcare professionals from
different disciplinary backgrounds. This will likely include clinical service managers,
psychiatrists, occupational therapists, nurses, social workers, and psychologists. Efforts
will be made to recruit people within each group who represent a range of sociodemographic
characteristics, including participants of different sexes and from different ethnic groups.
Potential participants will be recruited via community-based mental health services and via
an open recruitment call (e.g. via online advertisements, or existing service user and carer
network newsletter mailings). Snowball sampling techniques may also be used to supplement the
sample. As such, recruited participants may be asked to invite other people they know to
contact the research team directly, if they are interested in taking part and meet the study
eligibility criteria. These sampling approaches have been selected due to their
appropriateness for qualitative research which seeks to capture the range and diversity of
participant perspectives, rather than aiming to achieve a representative study sample.
Procedure:
Those who express interest in taking part will receive a participant information sheet at
least 24 hours before taking part in a scheduled interview or focus group. Potential
participants will have the opportunity to ask questions and receive further information about
the study before deciding whether to take part and providing their informed consent.
Interviews or focus groups will last for approximately one hour and be conducted in a private
space. Interviews and focus groups will be primarily conducted remotely (due to COVID-19
safety considerations) via secure digital communications software (e.g. Microsoft Teams or
Zoom). Where face-to-face interviews are held, these will be conducted in accordance with
up-to-date safety guidance.
