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Mental IllnessNCT04866693

Improving Safety and Quality in Mental Healthcare

An observational study of Mental Illness, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mental Illness
What is being tested?
None - this is an exploratory qualitative study to understand patient safety problems in community-based mental healthcare.
How many people
43 participants
Where
1 siteUnited Kingdom
Study dates
10 May 2021to 28 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: People with experience of community-based mental health services, in either a service user, carer, or healthcare professional capacity.

Who may be able to join

  • Over 18 years old.
  • Able to speak sufficient English to provide informed consent to take part in an interview or focus group.
  • Current or prior experience of using general adult community-based mental health services (within the past 12 months).
  • Over 18 years old.
  • Able to speak sufficient English to provide informed consent to take part in an interview or focus group.
  • Current or prior experience of caring for an individual accessing general adult community-based mental health services (within the past 12 months).
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  • Over 18 years old.
  • Able to speak sufficient English to provide informed consent to take part in an interview or focus group.
  • Currently employed within a community-based service which provides general adult mental healthcare.

Who cannot join

  • Unable to speak sufficient English to take part in an interview or focus group.
  • Unable to give informed consent to take part in an interview or focus group.
  • Currently receiving inpatient mental healthcare at a psychiatric hospital, or care from a service for older adults.
  • Deemed by the researcher to be distressed or too unwell to take part in an interview or focus group.
  • Their experience of services primarily falls outside of the remit of general adult mental health services, e.g. they have a primary diagnosis of Substance Use Disorder, or their care is provided by specialist tertiary care providers such as forensic mental health services.
  • Carers.
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  • Unable to speak sufficient English to take part in an interview or focus group.
  • Unable to give informed consent to take part in an interview or focus group.
  • Carers who have a caring responsibility for:
  • A child (0-17 years),
  • An individual using older adult mental health services,
  • An adult using services which fall outside of the remit of general adult mental health services,
  • Someone without a mental health problem.
  • Healthcare professionals.
  • Unable to speak sufficient English to take part in an interview or focus group.
  • Unable to give informed consent to take part in an interview or focus group.
  • Healthcare professionals who are currently working in a mental health service which:
  • Is not based in a community setting (e.g. inpatient care),
  • Falls outside of the remit of general adult mental health services,
  • Provides services to children (0-17 years) or older adults.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Institute of Psychiatry, Psychology and Neuroscience, King's College London

    London, Greater London, SE5 8AF

Other trials in United Kingdom

About this study

Official title: Understanding the Nature of the Safety and Quality of Care Problems Experienced by Service Users Accessing Community-based Mental Health Services: a Qualitative Study

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.

Read more

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.

Read the detailed 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.

Conditions
Mental Illness
Being tested
None - this is an exploratory qualitative study to understand patient safety problems in community-based mental healthcare.
Keywords
Patient safety, Community mental health services
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None - this is an exploratory qualitative study to understand patient safety problems in community-based mental healthcare.Other

    Qualitative study

Study groups in NCT04866693
Study groupRoleWhat they receive
Service usersUp to 20 people with current or recent experience of using community-based mental health services will be recruited to the study. Participants will take part in one in-depth interview or focus group discussion.
Receives: Other: None - this is an exploratory qualitative study to understand patient safety problems in community-based mental healthcare.
CarersUp to 20 family members/ carers with experience of supporting another adult who is accessing community-based mental health services, will be recruited to the study. Participants will take part in one in-depth interview or focus group discussion.
Receives: Other: None - this is an exploratory qualitative study to understand patient safety problems in community-based mental healthcare.
Healthcare professionalsUp to 20 healthcare professionals from different disciplinary backgrounds and community-based mental health services will be recruited to the study. Participants will take part in one in-depth interview or focus group discussion.
Receives: Other: None - this is an exploratory qualitative study to understand patient safety problems in community-based mental healthcare.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety problems in community-based mental health services

    In-depth qualitative interviews or focus group discussions will be conducted to identify patient safety problems within community-based mental health services, from the perspective of each participant group (service users, carers, healthcare professionals).

    Measured: The outcome will be assessed on day 1 of participation, during a one-off interview/focus group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start10 May 2021
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04866693
Sponsor's protocol ID
279409
Status last verified
Feb 2022
First submitted
22 Apr 2021
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Illness, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety problems in community-based mental health services (time frame: The outcome will be assessed on day 1 of participation, during a one-off interview/focus group). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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