NCT07284368

Brief Summary

Advance Choice Documents (ACDs) are statements of preferences for mental health care and treatment made when service users have capacity to do so. This is done with their care team and others as desired, e.g. carers/supporters or advocates. In addition to improving therapeutic relationships, ACDs have been shown to reduce compulsory psychiatric admissions by 25%. South London and Maudsley is currently implementing ACDs into routine practice across its services and the Advance Choice Document Implementation (ACDI) project, run by researchers at King's College London, is supporting the development of related resources and the evaluation of the effectiveness of the implementation. Advisory groups will also guide the study approach throughout. The project comprises four work packages. Work Package 1 involves focus groups with stakeholders (service users, carers, staff) to inform implementation for Older Adults and CAMHS services. This is to understand the barriers and facilitators for ACD implementation in these services; and learn what adaptations are needed to the ACD resources and procedures for use in these services Work Package 2 is a prospective study of ACD completion and use throughout all directorates. This will comprise interviews with service users after ACD creation and after an event where the ACD is expected to have been used; interviews with their care-team during expected use events; and interviews/focus groups with staff facilitating the creation of ACDs to understand the integration of their role in SLaM. Work Package 3 is a retrospective study examining the impact of ACD creation on health service use and routinely collected outcomes. Work Package 4 is a prospective study of ACD use and its relationship to ACD content. Work Packages 3 and 4 will use de-identified data collected via South London an Maudsley's Clinical Records Interactive search System (CRIS). For more information on ACDI, the people involved, and related publications, please visit: https://www.kcl.ac.uk/research/acdi

Trial Health

75
On Track

Trial Health Score

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

Enrollment
374

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress41%
Sep 2025Mar 2027

Study Start

First participant enrolled

September 29, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

December 16, 2025

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

November 13, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Advance StatementsAdvance Choice DocumentsPsychiatric Advance DirectivesMental Health ActInvoluntary hospitalisationCoercionDetention rates

Outcome Measures

Primary Outcomes (1)

  • Number of admissions under the Mental Health Act sections 2, 3, 135 and and associated bed days

    Mental Health Act sections Section 2, 3, 135 and 136 are a means to detain someone in a psychiatric facility, in England and Wales. Evaluation will be done over different follow-up periods and include participants admitted under all Sections of the Mental Health Act and associated bed-days, compared to number of participants admitted voluntarily (non-Mental Health Act) and associated bed-days.

    18 months

Secondary Outcomes (10)

  • Number of Home Treatment Team events

    18 months

  • Number of events of acute mental health and emergency service use

    18

  • Rates of restraint

    18

  • Number of days spent in seclusion

    18 months

  • Number of events of involuntary medication

    18 months

  • +5 more secondary outcomes

Study Arms (1)

ACD holders

service users with a history of detention under the Mental Health Act that create Advance Choice Documents

Other: Advance Choice Document Implementation

Interventions

Creation and application of Advance Choice Documents

ACD holders

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with severe mental Illnesses

You may qualify if:

  • WP1: Focus Groups Service users-Young people Aged ≥ 16 Experienced detention under the MHA while in the care of CAMHS Currently under the care of community mental health services (CAMHS / EI / CMHT)
  • Older adults
  • Experienced detention under the MHA while under services for Older Adults
  • Currently under the care of older adult community mental health services
  • Carers / Informal supporters Aged ≥ 16 years A relative or friend of a service user who is eligible for the study
  • Professionals Professional potentially involved in supporting the completion of ACDs (i.e., community mental health team (CMHT) staff, advocates, peer workers) SLaM professionals potentially involved in referring to ACDs (i.e., inpatient and emergency department liaison mental health staff, home treatment, place of safety and street triage staff) Approved mental health professionals (AMHPs) and Section 12 (MHA) approved doctors involved in detention.
  • Ambulance, prison mental health and Emergency Department staff General Practitioners, including mental health leads, or other primary care professionals who care for people with SMI discharged from secondary services
  • WP 2: Prospective study of ACD completion and use Service users All service users: accepted referral to an ACD facilitator for ACD creation Young people
  • Aged ≥ 16
  • Experienced detention under the MHA while in the care of CAMHS
  • Currently under the care of community mental health services (CAMHS / EI / CMHT/)
  • Accepted referral to an ACD facilitator for ACD creation; including participants who decline to complete and ACD after referral to an ACD facilitator.
  • Older adults
  • Experienced detention under the MHA while under services for Older Adults
  • Currently under the care of older adult community mental health services
  • +12 more criteria

You may not qualify if:

  • Service users Aged under 16 years Lacking capacity to provide consent and/or is unwilling to do so Currently detained under the MHA in psychiatric hospital Currently under the care of eating disorder services
  • Carers/informal supporters Aged under 16 years Is not a relative or friend of a service user who is eligible for the study
  • Professionals Is not a mental health professional or Section 12 (MHA) approved doctor Is not a professional involved in supporting the completion of ACDs Is not a General Practitioner or mental health lead caring for people with SMI discharged from secondary services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South London and Maudsley/Institute of Psychiatry, Psychology, and Neuroscience-King's College London

London, SE5 8AZ, United Kingdom

Location

Related Links

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

December 16, 2025

Study Start

September 29, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

December 16, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Individual Participant Data will not be publicly available due to risk of reidentification.

Locations