NCT04866693

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

April 22, 2021

Last Update Submit

February 28, 2022

Conditions

Keywords

Patient safetyCommunity mental health services

Outcome Measures

Primary Outcomes (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).

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

Study Arms (3)

Service users

Up 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.

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

Carers

Up 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.

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

Healthcare professionals

Up 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.

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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • 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).
  • 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,
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry, Psychology and Neuroscience, King's College London

London, Greater London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Claire Henderson, FRCPsych

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 30, 2021

Study Start

May 10, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations